chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 17 year old female patient who on 28-FEB-2009 was vaccinated with the first dose of GARDASIL (lot number and route not reported) in her arm. After receiving the vaccination, the patient felt dizzy and had ringing in her ears. So the office had the patient lay down for 10 minutes with an ice pack on her head and then she was "ok" to leave the office. The nurse stated that on 5-MAR-2009 the patient called the office and stated that she woke up with a red bump on her arm near the injection site. The patient was told to put ice on the bump and if the bump would not go away or get worse by the weekend then she should call the office back. The red bump on her arm persisted at the time of this report. Additional information has been requested.
slight headache and body ache after the first 2 doses; slight headache and body ache after the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache and body ache after the first 2 doses) and MYALGIA (slight headache and body ache after the first 2 doses) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL) and GABAPENTIN for an unknown indication.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache and body ache after the first 2 doses) and MYALGIA (slight headache and body ache after the first 2 doses). At the time of the report, HEADACHE (slight headache and body ache after the first 2 doses) and MYALGIA (slight headache and body ache after the first 2 doses) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-522878, MOD-2022-522960 (Patient Link).
PT HAD REDNESS SWELLING AND ITCHING NEXT MORNING AT INJECTION SITE VISITED DR ON MONDAY 9/17 HE STARTED PT ON LEVAQUIN 500MG DAILY FOR 5 DAYS RECCOMMENDED 2ND SHOT BE GIVEN IN LEFT ARM.
This spontaneous report was received from a physician via a company representative, referring to a 24 year old female patient. The patient had no medical history, concurrent condition, drug and allergy history to be reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, lot #, expiration date were not reported) for prophylaxis. On 15-MAR-2017, the patient was vaccinated with GARDASIL 9, intramuscular into her shoulder joint, (dose, lot #, expiration date were not provided) for prophylaxis.  The patient's concomitant medications were not reported. The reporter stated that after the patient received the vaccine into her shoulder joint, she felt pain immediately, and the pain continued approximately until 22-MAR-2017 (reported as for a week). It was also reported that the patient developed bursitis on an unknown date in 2017, and had to received physical therapy for an unspecified duration. None laboratories were performed. The outcome of pain and bursitis was reported as recovered.  At the time of this report, the causality between GARDASIL 9, GARDASIL and the aforementioned events was unknown. Additional information has been requested.
Recv'd Td & Hep B injections on 10/26/99.Pt dvlped redness, & tenderness @ injection site for approx 3 days.10/30/99:Noted increased redness,swelling,& warmth b/w inject site & elbow. Also complained of low grade fever.
over several hrs following vax pt noted progressive malaise, weakness, stiffness of neck, somnolence & eventually paresis; rxn lasted 2-3 days;
Information has been received from a medical assistant (MA) concerning a male patient with asthma who on 07-MAY-2008 was vaccinated IM into the right deltoid with a dose of PNEUMOVAX 23 (lot #657143/0380U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), TENORMIN, ezetimibe (MSD), unspecified therapy ("CELZONE"), NEXIUM, ADVAIR, VENTOLIN, DIAZEPAN, prednisone and unspecified therapy ("HYOSEYMINE"). The MA reported that the patient contacted the office on 09-MAY-2008 and reported that he was experiencing anxiety. On 10-MAY-2008 he visited the emergency room and he was admitted to the hospital. He was discharged on 11-MAY-2008. He had developed cellulitis at the site of the deltoid-bicep area and the "underneath area" of the right arm. He was given an unspecified antibiotic. On 14-MAY-2008, he was seen by his physician in the office. The patient complained of swelling. There was no redness or signs of cellulitis. No further information was available. The patient was recovering. Additional information has been requested.
severe h/a, muscle pain, lower back pain, photosensitivity.  Dx as having aseptic meingitis, coma ?polyradiculoneuropathy
Two days after injection my left arm started to hurt and my arm down to my fingers on the left arm tingle constantly, like it fell asleep.  It is April 13 and still have the issue. See a little more tired and irritable too.
Fever of 103.2. Was not able to hold food or water for more than 10 minutes. Lethargic. Severely dehydrated.
Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA189745 (same reporter). This case involves a one-month old male patient who was vaccinated with a 0.5 mL Booster dose of QUADRACEL (lot C532BA, expiry date: 14-Nov-2019) intramuscularly in left arm on 02-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that this was patients fourth polio and fourth DTAP dose. No other vaccines were given at the same time. The doctor was aware of this. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Presents for sx consistent with COVID x8 days, tested positive 2 days PTA & received monoclonal antibody infusion day before arrival. Admitted for COVID-19 pneumonia with acute hypoxic respiratory failure. recommended supportive treatment and she was not a candidate for remdesivir. Tx: O2, vitamin C, zinc, decadron, tocilizumab. DC home w/O2.
Rash on left arm. Not painful, but somewhat swollen and warm to touch. About 2.5x3inches
woke up approximatey 1:00am April 11, 2021, felt "flu-like" and cold, when waking up again at approximately 4:00am I had a fever, slight headache, body aches, chills and fatigued/weak and could do nothing but lay in bed and sleep.  My arm hurt that same day and my husband pointed out my arm which had a huge bump (size of an egg) and red.  I remained feeling this way until fever  broke April 12th in the afternoon however still fatigued and week and remained in bed most of the day.  April 13, 2021 I am feeling a little better however still very fatigued and not able to do much.  Also note I showed the pharmacist a photo of my left arm from the 1st does of Moderna Vaccine which  2 weeks after being vaccinated still had a red rash and bump.
Passed Out; Felt really bad and weak; Achy in his shoulders and neck; Chills; Temperature started at 99.6 then 100-101F; Burn really bad when he urinated; Traces of blood in urine; Threw up really bad; Fatigue; Joint Pain; Nausea; A spontaneous report received from a Consumer concerning, 82-year-old male patient who received first dose of the Moderna COVID-19 vaccine and experienced a lot of incidences. /MedDRA PT: [Incidences]   The patient's medical history included Type 2 Diabetic. Patient's concomitant included Metformin 500mg daily.   On 13FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient friend stated he got the Moderna vaccine on 13FEB2021 at 2:30pm in the right arm. He urinated fine at church the next day on 14FEB2021. At 2:30pm, Patient friend stated he started feeling bad and weak and could barely unlace his shoes. Patient friend stated that he had achy in his shoulders and neck, and chills. Patient friend stated he is a type 2 diabetic and he thought his blood sugar was very high and took a 500mg metformin (usually takes it once a day). Patient checked blood sugar which was 99 (low for him). Patient friend stated that she gave him apple juice to bring it back to normal. Patient friend stated his temperature started at 99.6F and an hour later it was 100-101F. Patient was told by HCP to take Tylenol. Patient friend stated that he had burning and traces of blood in his urine. Patient friend stated that the second time he urinated; it was less burning. Patient friend stated that he had severe vomiting and passed out. Patient went to bed at 7PM and then at 8:45PM, without the Tylenol, temperature went back to 99.6F. Patient friend stated that he feels completely fine now. Patient friend stated that she only gave him only two 500mg Tylenols for the whole 24 hours of the reactions. Patient friend stated that he had other symptoms including fatigue, muscle pain, joint pain, chills, nausea, vomiting, and fever but no headache. Patient friend would like to know if the Moderna COVID-19 do something to his kidney or bladder? Patient friend would like to know if he should get the second Moderna COVID-19 vaccine. However, the patient still would like to get the second vaccine to be protected from COVID-19.  Patient was treated with 1 500mg Metformin and 2 500mg Tylenols.    Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns an 82-year-old male who experienced a serious unexpected event of Loss of consciousness along with NS unexpected feeling abnormal, dysuria, blood in urine, and NS expected fever, chills, myalgia, arthralgia, nausea, vomiting, fatigue.  Event onset 1 day after the first dose of mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chest/Heart pain, Underarm pain and Left side Neck pain.  Referred to HCF for eval.
In January 2023 I started having a persistent cough that not only lingered it would not abate. It was causing my chest and back to hurt I was coughing so much. With having COPD, I have been advised by my health care team to go into the emergency room if they are not available to get evaluated. Upon arriving at the emergency room, they did a chest x-ray and CAT scan that came back positive for inflammation. I stayed overnight for a stress test that came back fine.
Small raised red rash at site of injection - intensely itchy - suggested hydrocortisone of BENADRYL to applied
Dizzy, groggy, left side of face and left arm numbness; left eye draining for several hours.  Numbness subsided; left eye draining persists after 3 days.
Colon cancer; A spontaneous report was received from a consumer concerning a 75-year old female patient who found to have colon cancer (colon cancer).  The patient's medical history was not reported. Concomitant product use was not reported.  On 18 Feb 2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 19 Feb 2021, next day of receiving vaccine, the patient found out she had colon cancer and needed surgery.   Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, colon cancer (colon cancer). was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Colon cancer could have been an existing medical condition  prior to vaccination. Further information has been requested.
my fever spikes up to like 102; Diarrhea; Headache; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 03Aug2021 (lot number: EW0171), at an unknown route, dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced my fever spikes up to like 102, diarrhea and headache. The patient laboratory investigation included fever was 102 on Aug2021 date. The patient started spiking a fever like four days after took the shot. Took the COVID-19 shot on Tuesday and had headache since then and then started spiking the fever yesterday which is four days after taking the shot and some like passing diarrhea but fever spikes up to like 102. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
This felt like "swimmers ear"; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection), EAR DISCOMFORT (pressuring and constant), HYPOACUSIS (it difficult for the patient to hear), EAR PAIN (This is also painful) and OTITIS EXTERNA (This felt like "swimmers ear") in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02BL20A and 026L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), CARVEDILOL (COREG) and EZETIMIBE (ZETIA) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 EAR INFECTION (ear infection), EAR DISCOMFORT (pressuring and constant), HYPOACUSIS (it difficult for the patient to hear), EAR PAIN (This is also painful) and OTITIS EXTERNA (This felt like "swimmers ear"). At the time of the report, EAR INFECTION (ear infection), EAR DISCOMFORT (pressuring and constant), HYPOACUSIS (it difficult for the patient to hear), EAR PAIN (This is also painful) and OTITIS EXTERNA (This felt like "swimmers ear") outcome was unknown. Not Provided          Treatment medication include antihistamine.  Action taken in response to mRNA-1273 was considered to be not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Left facial numbness, worsening by the next morning at 6:30, when tinnitus and pinching sensation in left eye became additional symptoms. Then seen at ER and treated with prednisone and valacyclovir. Symptoms resolved within 24 hours of medications.
Round rash 2" in diameter on and around the area where I was vaccinated. Extremely itchy. I applied a Benadryl Extra Strength Itch Stopping Cream which helped. After 3-4 days the itching stopped and the rash area reduced in size.  A week and 2 days after the vaccine (4/3/21), I went hiking and the rash appeared again that night--  the same size, red, swollen and itchy. I've been applying the Benadryl Extra Strength again which seems to at least diminish the rash.
(L) leg red, swollen, warm to touch. Advised to monitor, call if worse.
Patient had Dizziness that started approximately 3 weeks after the first shot. Then, one and one-half days after the second shot that was given on 7/11/22 the patient developed Shakiness, episodes of passing out for 10-12 seconds and small seizures, patient had pains in his legs and numbness in his hands. Patient has headaches and diarrhea. Also, the  patient developed tightness of his chest.
Patient experienced weakness on lower legs post 3 hours of receiving COVID-19 first dose that lasted for a few minutes.  The weakness subsided after 15 minutes of resting and only complaint of mild headache.  Patient has a medical history of HTN and type II diabetes.  The facility called 911 and the paramedics crew took patient with them to monitor the vital signs.
Lower back pain for 2 days after first shot, very painful in hips and radiating lower muscles
We received from a physician the following information on 19 NOV 2008: A 12-year-old boy, born on 11 AUG 1996, received FLUVIRIN, batch-no. 89976, on 13 NOV 2008. "Over the weekend the patient developed influenza-like symptoms (weakness, aches, sore throat)". It is reported that on 18 NOV 2008 he had a tonic-clonic seizure lasting for 5 minutes. The seizure did not require a treatment. At the time of report the patient has malaise and is still ill. An EEG is planned.
This is a spontaneous report from a contactable consumer who reported for himself. A 78-year-old male patient received PREVNAR 13 (expiry date 01Feb2017, NDC # 0005-1971-01) intramuscular, in right arm, on 11Sep2015, at 0.5 ml single. Medical history included memory impairment and low density lipoprotein (LDL). Concomitant medications included ongoing omeprazole tablets started years before, 20 mg, 1x/day, for heartburn, ongoing vitamin E started years before, ongoing vitamin D started years before (no use in winter when very little sun), ongoing multivitamins, ongoing glucosamine, started years before, ongoing calcium, started years before, ongoing magnesium, started years before, ongoing zinc, started years before, ongoing vitamin C 1000 mg, started years before, ongoing ginkgo biloba to remember stuff, started years before, ongoing niacin to help with LDL, started 5 years before and ongoing krill oil, started years before. Two weeks after the vaccination, the patient experienced rash with outcome of not recovered, hives with outcome of not recovered, blisters with outcome of not recovered, really tired-weak with outcome of not recovered, redness with outcome of unknown, all on an unspecified date in 2015. The rash became red, turned scaly and blisters appeared. Some have gone away but he has 50-100 of them and they keep coming. He had talked to his doctor to ask what he could do and the HCP did not have a solution. He also had gone to a dermatologist for another reason and had shown the symptoms but did not get a solution either. Events 'rash' and 'really tired-weak' required hospitalization and did not require a treatment. Hives, blisters did not require hospitalization. Follow up (07Apr2016): New information from the same contactable consumer includes: vaccine expiry date and NDC number, route of vaccination, updated vaccination date, concomitant drug details, event 'rash' and 'really tired-weak' updated to serious, events clinical course details. Follow-up attempts completed. No further information expected.
Patient admitted with myopericarditis, no traditional risk factors for cardiac disease or concern FH. Left sided chest pain, worse in supine position and noted to have acute myocardial injury pattern on labs. No signs of infections.
04/10/03: Developed dull ache in left chest- lasted all day.  No increased pulse rate, no sweating, no fever. 4/15/03: EKG WNL-no further pain.
Migraine headache; unable to raise my arm and dress myself; unable to raise my arm and dress myself; low blood pressure; low body temperature; nausea; dose 1 administered on 03Aug2021 and dose 2 administered on 30Sep2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 48-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration in arm left on 30Sep2021 at 08:00 AM (at the age of 48-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergies: Sulfa, NutraSweet. Past drug event included doxycycline, experienced known allergies: doxycycline and Keflex, experienced known allergies: Keflex. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration in arm left on 03Aug2021 at 08:00 AM (at the age of 48-years-old) as a dose 1, single for COVID-19 immunization and experienced blood pressure dropped to 78/52, body temp 92, debilitating headache. It was reported that, 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 01Oct2021 at 05:00 AM, the patient experienced migraine headache, the worst headache she ever had in her life, even worse than the first house which she did not think was possible, unable to raise her arm and dress herself, nausea, low blood pressure, low body temperature. On 30Sep2021, the patient had dose 1 administered on 03Aug2021 and dose 2 administered on 30Sep2021. The adverse events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature. On 01Oct2021, the patient underwent lab tests and procedures which included low body temperature (body temperature), resulted as decreased. The device date was on 01Oct2021. The outcome of the events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature was not recovered, while for the other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
100.5, fever, cough, sneezing, headache, sore throat. Starting 9/29/21.
Raised itchy rash on scalp, face, abdomen, & back of 3 days duration; sleep disturbance; MD reported to mom that "rt ear pink", but child crying during exam treated w/Septra & Benadryl.
This spontaneous report was received from a pharmacist and a pharmacy technician and refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On 21-NOV-2016, the patients were vaccinated with doses of improperly stored ZOSTAVAX lot # M034765, expiration date 26-NOV-2017 (dose, route and site of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered doses of ZOSTAVAX vaccines were exposed to temperature excursion of 43.3 degrees Fahrenheit for an unknown time frame. At the time of the report the temperatures were not back within the recommended range. Data logger was involved. There were no previous excursions reported. Additional information is not expected because there was no consent to contact the reporting pharmacist.