chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excessive sweating; weakness; Neck ache; severe headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (excessive sweating), ASTHENIA (weakness), NECK PAIN (Neck ache), HEADACHE (severe headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HYPERHIDROSIS (excessive sweating), ASTHENIA (weakness), NECK PAIN (Neck ache), HEADACHE (severe headache) and FATIGUE (fatigue). At the time of the report, HYPERHIDROSIS (excessive sweating), ASTHENIA (weakness), NECK PAIN (Neck ache), HEADACHE (severe headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience slight headache and some fatigue. Within an hour, extreme shaking, fatigue and worse headache ever experienced in my life. Went to bed, covered up and tried to rest, but headache was too severe. About 6:00pm, took ibuprofen and headache began to subside, but too weak to walk without holding onto support items. Nausea left me unable to eat and drinking water was unpleasant. Fell asleep about 10pm and woke at midnight with cold shakes and did not get back to sleep. Went to work next morning and just felt somewhat fatigue and had no appetite.
broke out in Shingles; ill all day; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2022, the patient received Shingrix. On 15th April 2022, 1 days after receiving Shingrix, the patient experienced unwell. On 18th April 2022, the patient experienced shingles. On an unknown date, the outcome of the shingles and unwell were unknown.   It was unknown if the reporter considered the shingles and unwell to be related to Shingrix.  Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received Shingrix on a Thursday night. The patient was ill all day Friday and then broke out in Shingles Monday. The patient had never had Shingles before.  The patient's doctor said that, she had never had this happen.  The reporter wanted to know that how rare was this. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Initial and follow up information has been received from a registered nurse concerning a 41 year old female who on 09/28/2004 was vaccinated intramuscularly in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  On 09/28/2004, the patient was also vaccinated intramuscularly in the left deltoid with a dose of concomitant therapy influenza virus split virion 3v vaccine inactivated (Fluzone).  Other concomitant therapy included Necon, MSD, Biaxin, and Avelox.  Subsequently, 09/28/2004, she experienced tender redness and warmth from her shoulder down to her elbow with pain.  Unspecified medical attention was sought and it was reported that the adverse experience improved on therapy.  In follow up, the nurse reported that on the morning of 09/29/2004, the patient developed a large area of redness, warmth and tenderness at the site of vaccine given in the right arm/deltoid area.  The patient was seen in the physician's office.  On 10/18/2004, the patient recovered.  There was no product quality complaint involved.  No additional information is expected.
The morning after, I woke up with major body aches and pains. I had a fever that never went above 100. I had extreme fatigue and chills. I had been given a refill on the steroids. I took it the night after the injection. This kept the duration to about a week the 2nd time opposed to the length of the first.
Pt reported that 1 wk after vaccine she developed rash with itching on her left arm that was golf ball size.  Pt reports she applied benadryl ointment.
FORGOT TO TAKE THIRD AND FOURTH DOSE OF VIVOTIF ON TIME; A spontaneous case report was received from a pharmacist on 17-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000389 (PVX2019-1238; wife) and PVX201905-000390 (PVX2019-1239, husband) were created and cross-linked in the database.  This case describes a male consumer who "forgot to take third and fourth dose of Vivotif on time". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif on 10-May-2019 and 12-May-2019, respectively. Then, he forgot to take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000389:
Muffled hearing in my right ear started a couple days after the vaccine, it got worse over the next 3-5 days. Then it?s just stayed at that hearing loss/muffled hearing state ever since.
Fever, chills, nausea, myalgia, headache, swelling and pain of the injected arm, redness at the injection site, extremely swollen and extremely tender supraclavicular and axillary lymph nodes.
Soreness and stiffness of left arm. Unable to hold up arm, unable to lift items over 2-3 pounds with left hand/arm, shooting pain when attempting to to lift arm over head, shooting pain when attempting to move arm behind back. Soreness in shoulder/arm socket. Radiating pain down left arm from shoulder to hand. Discomfort when sleeping on left side.
Pt received a Td vaccination left deltoid, IM on 7/29/03. She complained of pain and weakness to upper left arm since 8/4/03 and states that the pain "seems to be getting worse." MD appt 8/8/03. 8/25/03 Pt reports left arm pain and weakness seems to be resolving.
01/18/2022 on the day of my vaccination I began to get arm swelling and was not feeling well at all. I began to get fevers and bad chills. My arm swelled up and was red and bruised. Over some time I started coughing very bad, and it continued to get worse and worse including the fevers. I noticed that I was then getting yellow and green mucous out of my coughs. I then received a covid test that was negative and came back with pneumonia as the diagnosis. The fever has now gone away including chills. My arm is now back to normal size and I just have a residual cough left after the pneumonia. Prescriptions given for pneumonia were Benzonatate helped with coughing and breathing and Doxycycline, and also Prednisone helped with opening airways and breathing as well.
1 week post vaccine started getting red, hot painful, increasing in size each day. Today (2/13/2021) it is the size of a softball, with streaking coming from site, red, hot to touch, so painful I cannot lift arm, and pain runs from elbow to shoulder. Went to urgent care where I was diagnosed with cellulitis.
No additional AE's; PNEUMOVAX 23 that underwent a temperature excursion was administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 31-MAR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S034299 and expiration date 01-JUL-2021; strength, dose and route were unknown) for prophylaxis. The vaccine was exposed to temperature excursions between 36 to 46 degrees Fahrenheit (47.5 degrees Fahrenheit) for 20 minutes and another 20 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
6:45 pm Received two injections today.  Within 1 minute, complained of feeling dizzy.  Had not eaten since morning.  Color slightly pale, slightly diaphoretic. Reclined in reclining chair, given a sucker and juice to sip. VS checked at 6:50 and 6:55 pm (BP 108/76 p.92,BP 106/76 p.88).  At 6:55 pm color was pink, skin warm and dry, "felt better".  Assisted to sitting position. Tolerated well.  7 pm Ambulated to lobby with assistance, tol. well.  Discharged with Mom.
same day of vax pt exp light headedness, chest pain, weakness. treated w/fluids
Extreme headache, neckache, and vertigo onset 6 hours after administration of vaccine. Vertigo lasted about one week.
HPV #3 GIVEN 4-14-09 AND PATIENT REPORTS ONSET OF SEVERE HEADACHE ON 4-15-09.
after the 2nd injection severe pain at the injection site/right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (after the 2nd injection severe pain at the injection site/right arm) 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 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (after the 2nd injection severe pain at the injection site/right arm). At the time of the report, VACCINATION SITE PAIN (after the 2nd injection severe pain at the injection site/right arm) outcome was unknown.            No concomitant medications reported.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-260047 (Patient Link).
10May2021 to get a second dose, already late/ could not administer the dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The  reporter stated that, till the time of reporting, patient did not received 2nd dose of Engerix B, which led to incomplete course of vaccination. The reporter mentioned that, patient came back on 10th May2021 to get a second dose, but was already late, and also no adequate dose for a 19 year old patient was on stock and could not administer the dose and told patient to come back at a latter date when stock was replenished. The reporter consent to follow up. This case has been linked with case US2021103281, reported by the same reporter.
Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. 3 to 4 percent of the patients who received the Shingrix at reporter's facility, experienced flu-like symptoms, that lasted for 1 day after receiving the 2nd dose of the series. No further details were provided during the call. The reporter consented to follow up. This case had been linked to the case US2019185181, reported by the same reporter.
extreme fatigue 6pm - 9pm, around 9pm fever started (didn't measure), slight runny nose and sneezing, slept for 13 hours and body is still fatigued and wants to sleep, while sleeping, very very cold but also hot at the same time probably due to fever, 2:30 pm on the 26th, fever 100F, extreme fatigue, runny nose, sneezing
SORE THROAT; DRY NON PRODUCTIVE COUGH; FEELING FEVERISH; LACK OF ENERGY; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26. cov2. S (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 01 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, 01 total administered on 16-JUN-2022 to left arm for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported.  On 24-JUN-2022, the patient experienced sore throat, dry non productive cough, feeling feverish (Laboratory data included: Body temperature 97.9 F) and lack of energy (all events in dose number series 2). On 27-JUN-2022, Laboratory data included: Rapid antigen covid-19 home test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, feeling feverish, dry non productive cough, and lack of energy. This report was non-serious.
patient was one sick cookie; at the same time also got pneumonia; 2 weeks ago got Influenza A; Initial information received on 28-Dec-2022 regarding an unsolicited valid serious social media case received from a consumer/non-hcp.   This case involves a patient of an unknown age and gender who was one sick cookie, at the same time also got pneumonia and 2 weeks ago got influenza A after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect of INFLUENZA VACCINE produced by unknown manufacturer (lot number, dose, expiry date, formulation, strength: not reported) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a serious event and was one sick cookie (illness), at the same time also got pneumonia (pneumonia), 2 weeks ago got influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event patient was one sick cookie, same time also got pneumonia and was Not Recovered / Not Resolved for the event 2 weeks ago got influenza a.  Seriousness Criteria: hospitalized for these events (illness), (pneumonia), (influenza) and medically significant for event (pneumonia).; Sender's Comments: Sanofi company comment dated 02-Jan-2023: This case involves a patient of an unknown age and gender who was one sick cookie, at the same time also got pneumonia and 2 weeks ago got influenza A after receiving vaccine INFLUENZA VACCINE. The causal role of drug cannot be excluded for the event. However,  lack of information regarding event details, vaccination history, lab data, concomitant and past medications, risk factors and medical history precludes the comprehensive assessment of the case.
3 day headache/migraine that just won't fully go away even with medication; tremors; insomnia; headaches/3 day headache/migraine that just won't fully go away even with medication; muscle aches; severe arm pain of injected arm; chills; fatigue/ extreme fatigue; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 17:30 (Lot number: FF2588) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic migraine" (unspecified if ongoing); "chronic sinus infections" (unspecified if ongoing); "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes" (unspecified if ongoing). Concomitant medication(s) included: SUMATRIPTAN; AMPHETAMINE; ESTRADIOL; HYDROXYZINE. The following information was reported: MIGRAINE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "3 day headache/migraine that just won't fully go away even with medication"; TREMOR (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "tremors"; INSOMNIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "insomnia"; HEADACHE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "headaches/3 day headache/migraine that just won't fully go away even with medication"; MYALGIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "muscle aches"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "severe arm pain of injected arm"; CHILLS (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "fatigue/ extreme fatigue"; PYREXIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of migraine, headache. Therapeutic measures were not taken as a result of tremor, insomnia, myalgia, pain in extremity, chills, fatigue, pyrexia.  Additional information: Since the vaccination, has the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
sleeping difficulties; redness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleeping difficulties), ERYTHEMA (redness) and VACCINATION SITE PAIN (injection site pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21H and 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (injection site pain). On an unknown date, the patient experienced INSOMNIA (sleeping difficulties) and ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (sleeping difficulties), ERYTHEMA (redness) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Allergy; Initial information received on 27-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 70 years old female patient who experienced allergy after receiving vaccine Tetanus Toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Tetanus Toxoid produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious allergy (hypersensitivity) (unknown latency) following the administration of Tetanus Toxoid.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event Allergy.  At time of reporting, the outcome was Unknown for the event allergy.
Waken up by excruciating stomach pain, and possibly constipation. I don't have a thermometer to check my temperature.
itchy rash, little red bumps (blister like), on face, neck, trunk of body, arms & on head; sore joints, (hips, shoulder, knees); had no energy & generally did not feel good;
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported , lot # K026529, expiration date 02-JUN-2017). There was no adverse event reported. Additional ifnromation has been requested.
Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history nor allergies who on 06-AUG-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# not reported).  On an unspecified date in November 2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 09-MAR-2010 the patient was diagnosed with a right ovarian cyst.  It was reported that the patient presented with abdominal pain and an ultrasound revealed a 2.5 cm right ovarian cyst.  Unspecified medical attention was sought.  The patient was referred to an unspecified gynecologist.  At the time of this report, the patient's ovarian cyst persisted.  Follow up information has been received from the physician who reported that he didn't think there was a vaccine adverse experience report that he had to do relating to the GARDASIL vaccine given.  What happened was, in the course of time on one of the patient's visit, she had to be work-up for a right lower abdominal pain.  Abdominal-pelvic ultrasound had to be done which revealed an ovarian cyst on the right side.  The physician stated that he didn't think it had anything to do with the patient receiving the GARDASIL vaccine and having an adverse event to report.  Additional information is not expected.