chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER, Lot number: EL1284, expiry date not reported), via an unspecified route of administration on 04Jan2021 09:00 at a single dose on Left arm for COVID-19 immunisation. Medical history included Migraine, asthma, seasonal allergies, RLS (Restless legs syndrome). Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), sumatriptan succinate (IMITREX), fluticasone propionate (FLONASE ALLERGY RELIEF). The patient previously took Amoxicillin, codeine and experienced allergies. The patient experienced ocular migraine, onset at 14:00, took 1 dose of Imitrex (25 mg) at 14:15. Vision began to improve at 14:40. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 01-March-2022 the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Severe Vertigo accompanied with nausea beginning approximately 4:30 a.m. and primarily subsiding by 12 p.m. Did epley maneuver around 10:30 a.m. Took 25mg Meclizine at approximately that time. Visited clinic at 2:00 p.m. Took another Meclizine approximately 9:00 p.m. No further symptoms until approximately 7:45 a.m. on 3/13/21 when dizziness returned upon waking and moving head suddenly. No severe nausea this time. Shortly after that, did the epley maneuver twice (once on each side). Took a 25 mg Meclizine at 9:45 a.m. Dizziness gradually subsided until primarily gone by 10:00 a.m.
Few blister, redness the next day. Looks like the bruising (all located below deltoid). Pt put ice on area day of injection and played tennis next day.
A report has been received from a Health Professional concerning a 57 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The registered nurse reported that a 57 year old received FLUMIST on 26-Nov-2013. Patient had not reported any adverse effects. The outcome of the event 57 year old received FLUMIST is unknown. The report was considered to be non-serious.
At injection site: raised swelling, pain, hot to the touch. Margins about 2.5 inches in diameter. Tiredness. Even with premedication with diphenhydramine.
This spontaneous report as received from a physician refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMVOAX 23, lot #, dose, frequency and route unspecified. Concomitant therapies included PREVNAR, lot #, dose, frequency and route unspecified. On an unknown date the physician vaccinated an unspecified amount of patients with PNEUMOVAX 23, and then used a "booster dose of PREVNAR on the "appropriate patients. No adverse effect reported. Additional information is not expected.
Unusual events: uncontrollable shaking, incontinence, loss of consciousness. Other typical side effect. No treatment. Felt bad for about a week. Then called docs to tell them.
21NOV96 pt recv vax & on 22NOV96 pt reported 4x4cm area of tender, erythema w/induration @ site of vax;tx cool compress & advil;
Developed swelling of left upper arm and right foot with 24 hrs of immunization. Seen in ER. No fever or respiratory symptoms. Treated with diphenhydramine. Resolved within 24-48 hours.
CLIENT CALLED ON 6/24/15 AT 4:17PM AND INFORMED RABIES CLINIC NURSE THAT SHE HAD BEEN A LITTLE DIZZY SINCE AND HOUR AFTER RECEIVING RABIES POST EXPOSURE PROPHYLAXIS. THE CLIENT STATES IT IS NOT INTERFERING WITH HER DAILY ACTIVITIES AND SHE HAS TRIED TO KEEP BUSY BY DOING LAUNDRY, CLEANING, GOING TO WORK. INFORMED CLIENT THAT DIZZINESS IS A SIDE EFFECT OF THE RABIES VACCINE AND SHE SHOULD RELAX AT HOME AND NOT TRY TO PERFORM A LOT OF ACTIVITIES.
I had two symptoms that are normal, they were on the list of side effects, I had soreness on my left arm, I couldn't sleep on my left arm due to this soreness. This started the day the soreness started. The following day and up till now I felt very tired and like I needed to take a nap. Due to work I have not been able to nap. On Sunday I noticed I had a fever blister on the right side of face, under my lip by my chin. It looked like a herpes blister. I rarely get them unless there is a serious stressor to my body or if my body is emotionally stressed. Valacyclozir I took 4 of those in the morning and 4 tablets in the evening after noticing them. I put a cream on the blister. On Tuesday or Wednesday 3 or 4 days after the vaccine I felt a pain in my gum by back two teeth, the gums were very painful when I brushed my teeth or put my tongue on it.  I went to the dentist Friday the 22nd, however the dentist said it was intraoral herpes that he believes it is looked to the vaccine. Dr. believes the COVID vaccine activated the dormant herpes in my system . He said says it is located over the Greater Palatine Foramen.  The herpes on my chin went away. I still feel light sensitivity and fatigued. Dr recommended to see my dermatologist. Either the 22nd or 23rd I had a virutal appointment with my dermatologist. She recommended I take 4 Valacyclozir in the AM and PM. And then 1 day for 10 days. Both doctors recommended not getting the 2nd dose until the herpes vaccine goes away. Once it goes away they suggested taking the Valacyclozir before taking the 2nd dose. I am still not feeling normal. My dentist said he was going to consult a group of dentists to see if any other dentists have seen the correlation between the COVID vaccine and activating the herpes virus.  I plan to consult my PCP about if I should delay the 2nd dose.
Low-grade fever (around 99° F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever (around 99° F)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Low-grade fever (around 99° F)). On 03-Apr-2021, PYREXIA (Low-grade fever (around 99° F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 99 (Low) low-grade fever (around 99° F).         No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-390249 (Patient Link).
Clinical Summary Patient is a 88 y.o. female with a history of HTN and COPD who presented to Observation 12/16/2022 with 10 days of fatigue, cough, malaise and home positive COVID-19 test 12/12/22. She required O2 on admit. Course prolonged by placement.    1. COVID-19 Pneumonia: Positive home test on 12/12/22 and PCP started Paxlovid 12/14/22. Positive COVID-19 on 12/16/22 at the HCF. Required O2 on admit. Decadron x 10 days, completed on 12/26/22. 2. Acute COPD Exacerbation: with concomitant smoking. Increased mucous production and hypoxia and underlying COVID. S/p course of zithromax and omnicef. Steroids continued as above. Inhalers continued. 3. Acute Hypoxic Respiratory Failure: Not on home O2. Due to COVID. Requiring 2L O2; CT PE 12/24/22: no PE, showed R lower lobe pneumonia. Monitor at SNF, RA at discharge. 4. Community acquired pneumonia: seen on CT PE 12/24/22: posterior consolidative mass L lower lobe. Ceftriaxone / azithromycin continued. Radiology recommended follow-up imaging 4-6 weeks post treatment is recommended to assess for malignancy, if in line with goals of care. 5. Elevated Troponins: suspect demand ischemia. Troponin 45 to 41. EKG nonacute. TTE 12/19/22 showed stable EF 51%, no wall motion abnormalities 6. Abnormal CT scan: CT PE 12/24/22: gastric wall thickening, could be gastritis or infiltrative process. Pt declined GI consult for upper endoscopy  7. Hydronephrosis: bilateral hydronephrosis, with severely distended left extrarenal pelvis or large parapelvic cyst on CT chest 12/24/22, radiology suggested correlation with CT urogram, pt declined on multiple occasions. Deferred urology consult as creatinine normal, recommend outpatient urology referral.
My arm swelled up like there was an egg under my skin, it itches really bad, the area was very red and warm.
This spontaneous report was received from the mother of a female patient (age unknown).  Medical history and concomitant medications were not provided.  The patient received two doses of GARDASIL in approximately 2011 (reported as about six years ago) by an anonymous physician for "cancers caused by human papillomavirus" (route and lot number not provided).  On an unspecified date, the pateint began to experience unspecified "health issues".  The outcome of the even was unknown. Additional information is not expected as the reporter did not provide contact information.
12 hours later I began to suffer from shaking, fever, chills, nausea. This continued off and on for about 14 hours. I used Advil around 10am and it broke my fever.
Diverticulitis and it started with stabbing muscle pains that were so severe I couldn't work or drive, doctor at clinic on Saturday said to go to the emergency room. I was given antibiotics. It happened the following Saturday a week after my 3 dose shot. The three odd things that happened was the shot throwing my thyroid out of control, the phantom smelling of orders for hours that no one else could smell and the diverticulitis.
Individual reports about 14 hours after receiving vaccine at 2 a.m. she started to get a severe zinging followed by a pop in her head. She also reports hallucinations at this time of a cat running around her legs with a dogs head. She reports these things lasted for a couple of days. Denies any dizziness or being light headed. She reports she was so frightened she did not want to leave her home to seek medical attention. She reports after a couple of days the symptoms went away. Her friend recently told her she should have reported the symptoms so she made a call into us today.
Covid-19 after Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 after Moderna shot) in a male patient of an unknown age 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 COVID-19 (Covid-19 after Moderna shot). At the time of the report, COVID-19 (Covid-19 after Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.  This case concerns a male patient of an unknown age with no medical history, who experienced the AESI COVID-19. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273. The rechallenge was is not applicable since no vaccination dates or dosage was given. No clinical or treatment details were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history, who experienced the AESI COVID-19. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273. The rechallenge was is not applicable since no vaccination dates or dosage was given. No clinical or treatment details were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Increased back pain; sore arm; Muscle aches; This is a spontaneous report from a non-contactable other healthcare professional. A 51-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 on 10Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain from nursing injury. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications included rivaroxaban (XARELTO); taken for an unknown indication on an unknown date and unknown if ongoing. 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, day after second dose, the patient had sore arm, muscle aches and increased back pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of sore arm, muscle aches and increased back pain and included treatment with acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, muscle aches and increased back pain were recovered an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the injection site has started to become red; injection site has started to become irritated,; injection site has started to become red, irritated, itchy/minor itching; injection site was swollen; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose on 11Apr2021 for covid 19 immunization. The patient medical history and concomitant medications were not reported. On 20Apr2021, 9 days after first dose, the injection site has started to become red, irritated, itchy, and swollen. She noted that 2 days after the vaccine was given, the injection site was swollen but not red and there was some minor itching, but the caller was concerned that the symptoms mainly started 9 days after the dose of the vaccine. The patient enquired whether this is normal or has this been reported before. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe Headache - 3 to 4 days, High Fever 2 days,  Severe muscle and Joint pain - 4 to 5 days.  Heart Palpations -3 to 4 days. Fatigue, Sleepiness, Loss of appetite, chills, confusion, strange dreams, loopy thinking, 2 to 3 days.
Vomiting, Diarrhea, fever 101F, muscle aches, migraines with photosensitivity,  fatigue.  Duration of symptoms: 4 days.
The patient developed SIRVA after the vaccination. I do not personally know the time course, as the patient has not returned my calls. She did see her PCP as a result of the adverse reaction.
Shortly after vaccination, the patient "lost color" and "felt faint" as reported by her mother. She was not diaphoretic. BP= 130/90, P= 80. She leaned over and vomited a small amount, color returned and she felt better after approx 15 minutes.
Pfizer 10/11/21 and 11/1/2021. Positive on 1/17/22
Pt developed cellulitis with edema and erythema nontender10cm x 12cm on right arm. Pt was put on Keflex 25mg/5ml 3/4 tsp prn x 10 days. Recheck scheduled.
Had COVID after Ist dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had COVID after Ist dose of the Moderna COVID 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had COVID after Ist dose of the Moderna COVID 19 vaccine). At the time of the report, COVID-19 (Had COVID after Ist dose of the Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Seen by primary care physician on 11/28/01. Diagnoses with atypical varicella. Trunk with erythemotous popular lesions with some scabs, few vesicles.
Information has been received from a consumer concerning a friend's 19 month old daughter "who went to the emergency room with a 105 degree fever 2 months ago (approximately January 2009) after receiving a dose of MMR II vaccine. Lot number is not available. It is not known if she was admitted to the hospital." The patient was recovered on an unspecified date. This is one of several reports from the same source. No further information was available.
flu like symptoms for a day or two; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose was received on unknown date refer case - US2023AMR074879) and Pfizer Covid-19 Vaccine with an associated reaction of malaise (also had experienced unwell).  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms for a day or two). Rechallenge with Shingrix was positive. The outcome of the influenza-like symptoms was resolved.  It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.  Linked case(s) involving the same patient: US2023AMR074879  Additional Information: GSK receipt date: 24-MAY-2023 The patient usually had some type of side effects with vaccines like Shingrix, 2 doses, both times he/she had flu like symptoms for a day or two, Covid the same thing that, he/she felt kind of tired and yucky and stuff like that.  The physician was recommended that get, but reported that had issues with other vaccinations in the past including Shingrix and the Pfizer Covid-19 Vaccine. The reporter reported that he/she had malaise and does not felt good for a day or so after receiving the Pfizer Covid-19 Vaccine. The reporter was a nurse anesthetist in hospital so was on the first round of getting Covid shots; every time, he/she have had malaise and did not feel good for a day or so, that was how react to most vaccines. Upon further discussion, the reporter called and stated that the physician had recommended Prevnar 20 since he/she just turned years old. There was plan to get it today(on the day of reporting), expecting same side effects as he/she have had with other vaccinations so ok to take Motrin. The reporter have always heard the debate whether or not he/she should take Motrin or to just allow the immune response to occur to have vaccine more effective. After response, stated that, the anesthetist nurse was an agreed to be transferred, but disconnected before successful transfer. Upon further clarification of which Covid vaccination, stated that, it was Pfizer's Covid 19 vaccine. No additional information and response discussed per Product Information (PI) noting no specific information about impact of Motrin on efficacy of vaccination (reviewed section 7.2 Immunosuppressive Therapies). Shared most commonly reported adverse reactions and referred to healthcare for further discussion on management recommendations as Pfizer was unable to make recommendations as may vary by individual patient. The reporter had denied consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR074879:Same patient 1st dose
Patient developed a rash, pain and sweling at the site. She recieved Cephalexin and Prednisone for treatment.
Shingles-like rash (tingling, unpleasant feeling under skin, bright red and raised patches) to right forehead started on 8/15/21,  Spread to left forehead on 8/16/21.  Patches turning to pencil-tip sized bumps later on 8/16/21.  Seen urgently by Dr.  On 8/17/21 swelling and under skin discomfort to inner canthus, bilaterally.  Seen urgently by opthalmologist.  Some mucus membrane swelling noted at eye clinic, but no eye involvement.   Fever of 100 - 101, fatigue, and muscle aches from 8/12/21 - 8/15/21.   Bumps did not form vesicles as they appeared they might.  Redness to forehead and swelling near eyes much improved as of today.   Patient received both doses of Pfizer Covid19 vaccine in March 2021.
SHORT TERM MEMORY LOSS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced short term memory loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of short term memory loss was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. No medical history provided. On 17-OCT-2013 (also reported as 18-OCT-2013) the patient was vaccinated with expired ZOSTAVAX (vial, lot # 0467AE; expiration date 04-APR-2013) for vaccination. No adverse event was reported. No outcome was reported. Additional information in not expected.
pt recv vax 1045AM & 1050AM c/o tiredness & sleepiness;immed started to slide in chair & began a grand mal sz as directly observed by MD;pt was incontinent of urine & flutter was heard;tx w/02;