chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and EAR INFECTION (ear infection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EAR INFECTION (ear infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and EAR INFECTION (ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
reports feeling faint ? HR has been up and she feels tingly all over ? did not eat breakfast.  BP is high as well (154/100) pulse 113 ? per ED physician ? suspect vagal reaction ? EKG k, labs OK, fluids given ? recommend patient should eat. She did receive diphenhydramine 25 mg Iv x 1, famotidine 20 mg IV x 1, methylprednisolone 125 mg IV x 1,  h/o reaction to amoxicillin & Cipro - hives
FATIGUE; This spontaneous report received from a consumer 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, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432555.
Patient took pneumonia shot and it was supposed to last for 10 yrs but only lasted for 5.
I have severe dizziness when I am laying down/sleeping.  Each time I wake up 1-2 times per night) my head is spinning.  When I am awake and standing I don't have the spinning, but I do have a faint headache/fog and with that, nausea.
flushing, lip numbness/tingling, lightheaded, HA. Evaluated by EMS-Cleared
Information has been received from a registered nurse concerning a 61 year old female who on 24-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included Metformin, glipizide (GLUCOTROL XL), hydrochlorothiazide, diltiazem HCL, propranolol Hcl, aspirin, lorazepam (ATIVAN), omega-3 marine triglycerides, vitamins (unspecified), albuterol, acetaminophen/hydrocodone bitartrate (LORTAB), hyoscyamineSO4, lovastatin, lisinopril, rabeprazole sodium (ACTPHEX), nitrofurantoin, fluconazole (DIPLUCAN), fluoxitene, naproxen (NAPROSYN) and nystatin (MYCOSTATIN). On 22-FEB-2008 the patient developed herpes zoster. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown.
After receiving the vaccination I experienced swollen lymph glands bilateral armpits and clavicle.
High heart rate. Couldn't breathe. Wake up drenched in sweat. Exhausted. No energy
Administered Hib vaccine and developed Pneumococcal meningitis approximately 20 hours later. Admitted to ER, transferred to ICU. Currently still being treated. Also diagnosed with OM, URI, and a seizure. 60 day follow up states the patient is believed to be deaf and has limited eyesight. The patient is also having motor skill complications and still suffers from seizures. An annual follow up report received 10/20/2003 adds: Pt has since died. Information and records to follow.
Fever of 101 degrees 24 hrs after mumps + Tdap vaccines then soreness in neck 48 hrs after.  Fever lasted 24 hrs.  Soreness is present currently.
Patient reports after administration of first vaccine dose, got rash in a period time of 7 hours and itchiness in cheeks area. Third day bleeding in stool for 3 days.
Extreme nausea, vomiting, retching. Fever, chills, and headache. Chest and stomach pain.
Localized reaction; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs).   A 65-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced localized reaction. The pharmacist was informed that there may be corn in the product and she stated maybe that was why the patient had a reaction so she wanted to know if there was any corn derived products in the vaccine.  Information on the batch number has been requested.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 01-AUG-2018 the patient inadvertently vaccinated with an expired dose of VAQTA (lot # L017757, expiry date: 08-APR-2018) (dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Patient received Vaccine March 10 at 8am, Couple hours (10am) headache, muscle aches, Low Grade fever 38.4  chills. Lasting for the remainder of the day and symptoms dissipated next morning
No additional adverse event; the patient was inadvertently administered a dose of PROQUAD, that was expired; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 20-FEB-2020, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection for prophylaxis (lot # R013575 and expiration date: 10-NOV-2019; strength and route was not reported) (expired product administered). No additional adverse event was reported. The outcome of expired product administered was unknown.
Body aches; 99-101 degree fever; Chills; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 03Apr2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), fexofenadine hydrochloride (ALLEGRA), calcium glycerophosphate (PRELIEF), and fluticasone propionate (FLUTICASONE PROPIONATE GLUCOCORTICOID) all from an unknown date for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 14Mar2021 at 11:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 00:30 the patient experienced fever 99-101 degree (UNITS UNSPECIFIED), headache, chills, general body pain. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of events fever, chills, headache, general body pain was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). The patients received improperly stored doses of ROTATEQ (dose, frequency and route were unknown, lot # M039061, expiration date: 28-APR-2018, lot # M042821, expiration date: 14-JUN-2018, lot # M005732, expiration date: 19-OCT-2017) for prophylaxis on multiple unknown dates between 01-JAN-2017 to 01-AUG-2017. The temperature excursion was at 32 Fahrenheit Degree to 35 Fahrenheit Degree for 24 hours and 47 Fahrenheit Degree to 77 Fahrenheit Degree for 32 hours. The previous temperature excursion was reported as yes. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008435: US-009507513-1708USA013804: US-009507513-1709USA008434.
When I received my first shot, I was on my menstrual and I noticed that the bleeding had lingered a few days longer than usual. Two weeks after, I started bleeding again. This has never happened to me before. I called my GYN Dr. and she had me take a pregnancy test (it was negative) to see if that was it or she thought maybe I could be going through early menopause. I bled for a few days and it stopped. I just received my second shot on Saturday and Sunday I started bleeding again. Here it is Thursday and I am still bleeding  about a week and a half after it finally stopped the second time after getting the first shot. I do believe the shot have me bleeding like this. Has anyone else had this problem before?  I have an appointment with the GYN on May 26th
Urticaria throughout scalp, ears, neck; diffuse macular rash to upper and lower extremities Most severe for 48 hours, now over 2 weeks of continued intermittent symptoms
pt recv vax 2MAR98 & 4MAR98 pt devel a rash;
Arm Soreness started 12/28/20 @9:00 PM. Arm is still sore but getting better. Fever started 12/29 around 11:00PM.  I am still getting fevers intermittently. The highest recorded was 101.0. My current temperature is 100.2.
Started to feel an irritation behand my right ear, then along my jaw line.  Thought it was irritation from mask wearing. Then I had a burning sensation in my hair.  Similar to a sunburn then getting chills.  Wednesday night I noticed three pimple like bumps in my hair--right posteriorly.  A bit itchy at times.  Thursday right under my jaw line seems to have swelling. This morning it feels the same.  Burning like irritation in my hair.
Shortly after giving the patient the H1N1 vaccine, she began c/o rapid HR, dizziness, and flushing. She did not have any SOB, hives, or swelling. I let her sit for 15 min and her HR decreased from 100 to the 80s. She still felt dizzy and palpitations after sitting for 45 min. Because she wasn't feeling better, I called EMS and she was taken to the ER for further evaluation.
Received shingles vaccine 24 hours ago.  From about 1 hour to 6 hours afterward, had allergic reaction.  Hives and itching.  Size about a dime to sligtly larger, behind knees, in armpits, around waist.  This eventually went away with no treatment.  From about 12 hours afterwards until now, have redness and itching at vaccination site.  About size of your hand.  Have not treated.  Checked with nurse and she said I could take Benadryl but have not done so yet.
In the arm that she got the vaccine it was real sore and then got fine.  The problem is in the right shoulder, which she did not have a vaccine in.  It was Friday morning at 8:00 AM.  Previously had rotator cuff surgery 16 years ago in that arm, something has happened to the right shoulder.  Not able to raise the arm at all.  Cannot raise it up towards her face.  Left arm is crippled due to a fall 5 years ago and broke it in 3 places, but not able to move that.  Not having any  other problems, not sure if this was associated with the vaccine or not since it was the opposite arm.
Day 1, Fri: ~6hrs post injection: tired Day 2,  Sat:  strong pain at injection site and whole arm soreness; tired; headache; chest pain/shortness of breath Day 3, Sun: tired; headache; shortness of breathe.  Day 4-7: tired and headache
Pain in all finger joints. Continuous hand pain since 2nd shot. I have now have all the workup done to rule-out any form of arthritis.
Information has been received from an unspecified source concerning a patient who was vaccinated with a dose GARDASIL. Subsequently, the patient indicated that "the shot really does hurt! It hurts a lot going in, and then it fades quickly." No details on date of administration. No further information is available.
Couldn't sleep; in a lot of pain; whole body feels like pain from a serious back injury; Feels like hit on head with a baseball bat; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), HEADACHE (Feels like hit on head with a baseball bat), PAIN (in a lot of pain) and PAIN (whole body feels like pain from a serious back injury) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), HEADACHE (Feels like hit on head with a baseball bat), PAIN (in a lot of pain) and PAIN (whole body feels like pain from a serious back injury). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache and Pain, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), HEADACHE (Feels like hit on head with a baseball bat), PAIN (in a lot of pain) and PAIN (whole body feels like pain from a serious back injury) outcome was unknown.            No concomitant medications details were not reported.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. West Point; manufactureraddress: 770 Sumneytown Pike; manufacturercity: West Point; manufacturerstate: PA; manufacturercountry: UNITED STATES; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 11-year-old male patient who received BEXSERO (batch number 148901B, expiry date 30th September 2016). On 26th February 2016, the patient received 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased. The patient was treated with ibuprofen and no-drug therapy (Cold Compresses). On and unknown date, the outcome of the injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased were recovered/resolved. It was unknown if reporter considered injection site lump, injection site warmth, injection site swelling, injection site tenderness, injection site rash, injection site discomfort and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine in the left arm. On 2nd March 2016, the patient was seen in office due to local reactions consisting of pain, lump, swelling, rash and difficulty with range of motion and no fluctuance was observed. The physician assessment about the events were local vaccine response. The event were managed with Ibuprofen initially 300 gm weaning back as arm pain settled. Gentle massages and ranging were given to the patient as tolerated. He was also treated with topical cool compresses frequently. The physician had asked the patient to call if the events were not improving and no contraindication were suggested for future vaccines. After patient's reaction to 2nd dose of BEXSERO (see case US2016123683) it was brought to reporter's attention that he had a reaction to the 1st dose as well.
CoughWheeze & NauseaVomiting Narrative: Employee reports called in sick to work 8/2, 8/3, 8/4 for increase in asthma symptoms, uri sx of congestion, runny nose after recieving covid vaccine with her pcp. Recovered at home, now returned to work. Advised to follow up with PCP for asthma flare and advisement prior to completing #2 dose of covid vaccine, sees pulmonologist. Treated with monthly mepolizumab injections for moderate-severe asthma.
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) 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 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 NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.
Information has been received from a physician concerning 200 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates between 2014 and 2015, improperly stored doses of PROQUAD (dose, route, lot# and expiration date were unknown) were administered to the patients for prophylaxis. The doses of PROQUAD were exposed to a temperature excursion of -14 to -10 Celsius degree (time frame unknown), which was detected by data logger. There was multiple temperature excursions (unspecified details). No adverse events were reported. This is one of two reports from the same reporter. As on 08-AUG-2017, all telephone attempts to obtain follow up information had been unsuccessful.; Sender's Comments: US-009507513-1706USA007775:
Patient experienced nausea and dizziness upon taking 1, 2, 3 capsules.
About nine days after the vaccination, I began to have episodes where I felt as though I was about to faint. These episodes sometimes occur along with heart palpitations and headaches. I have these episodes two to three times a day, and they last between ten minutes to an hour. They occur at various times of the day, but commonly between 9 am and 7 pm. I have not lost consciousness at any point, but I sometimes feel unsteady and have to sit down as soon as I possibly can. During the first five days of the symptoms, I also felt some body aches and may have had a fever (which I was unable to verify). After the first five days, I have had the original faintness consistently, almost every day, for the last five weeks. I have not felt safe enough to drive during this time. The episodes do not show any signs of going away; I am having one now as I write this.    On the first day I experienced the symptoms, I visited an urgent clinic, where the facility tested my blood pressure and blood sugar, ran other blood tests, and administered an EKG. None of these tests brought back significant results, so I went home to rest and hoped that the episode would not occur again. A couple of days later, I felt the symptoms more severely, and went to an emergency room. The hospital admitted me and administered an MRI, an echocardiogram, a CT scan, and more bloodwork. However, the hospital physician did not see any clinically significant results. As I had no medical history whatsoever that would give me these symptoms, he asked about my COVID-19 vaccination status. So far, this has been the only explanation that the hospital physician, my primary care physician, and the cardiologist to whom I was referred have been able to advance. The symptoms have been frequent and consistent for the last five weeks. I currently have a heart monitor prescribed by a cardiologist to explore whether I am experiencing arrhythmia when these episodes occur. Whenever my blood pressure is measured, it is on the lower end of the normal scale (ex. 98/60), but has not dipped below the threshold of a low blood pressure event.
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 26-MAR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
p/vax pt vomited & became pale. gradually became shakier & chilled. treated w/epi & benadryl
A report has been received from a Health Professional concerning a 62 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUARDIVALENT started on 10-Oct-2013. A nurse reported that on 10-Oct-2013, they inadvertently gave FLUMIST to a 62 year old. The patient had not reported any symptoms at the time of reporting. The outcome of the event of INADVERTENTLY GAVE FLUMIST TO A 62 YEAR OLD is unknown. The report was considered to be non-serious.