chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He got a bad reaction to it. He was sicker from the injection than he was with COVID; This is a spontaneous report from a contactable consumer (patient), based on information received by Pfizer (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-053531). This case was split from master case # 2021681255 to capture a 83-year-old male patient received COVID-19 Vaccine and experienced Sickness.  A 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date May2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 from Jan2021 to an unknown date, atrial fibrillation from 20Apr2021 to an unknown date, drug allergy statins, pneumonia, fall, CVA, cardiovascular disease, unspecified. Concomitant medications included apixaban (ELIQUIS) taken for cerebrovascular accident prophylaxis from 20Apr2021 to 01Jun2021, evolocumab (REPATHA), amlodipine, omeprazole, clopidogrel, tamsulosin. The patient previously took steroids. On an unspecified date the patient reported he got a bad reaction to it. he was sicker from the injection than he was with covid. His HCP told him to stretch the second injection out a little longer to five or six weeks. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was administered in the right arm. All the symptoms and adverse side effects happened in the left arm, opposite of the one the vaccine was administered in. Lost sensation in the arm, felt excruciating pain, lost sensation in the arm and felt complete numbness. Have seen a golf ball sized bulge in the upper arm and it was visibly traveling up and down the arm. Veins popped out. Was prescribed muscle relaxers and pain killers but did not have any effects. Have been getting acupuncture treatments.
Patient developed dizziness and headache with subsequent fall the day of vaccination.  Next day awoke with left sided weakness and paresthesia.  Presented to the ER on 7/22 and found to have an occluded right M2 artery with infarction affecting the right temporal-parietal and occipital lobes.
Moderate pain at site injection. Flu like symptoms: chills, body aches, joint pain, dizziness, tired,    Also got a few itchy small red bumps above the knee on upper legs and a couple on the right breast. The symtoms built up over 3 days and are beginning to subside on 4th day but I am still not normal. I am basically a very healthy person who walks 2-3 miles a day, works on our farm, and rides my horse. I am considering NOT taking the second shot.
Pt had emesis x1 with a syncopal episode. Pt returned on 8/7/2013 with persistant nausea, vomiting and headaches.
I had a Sinus infection with a running nose, sinus pressure. I also had a knot on my right arm. Also the day after the injection I was really fatigued for a couple hours. I seen a provider on 01/22/2022.
Observed patient vomiting with copious amts of saliva, crying, skin red all over at our "check out" window. Pt brought immediately, back to exam room and MD notified. RR 36 P 80. patient observed in office x 50 mins. PO Benadryl. Hsp given & oral meds  15mg 15ml, 1 tsp given. Both administered by mom .
Information has been received from a physician's assistant concerning a female patient who in approximately February 2011 ("around two months ago"), was vaccinated with a first 0.5 ml dose of GARDASIL. Subsequently the patient said her arm where the injection was given, it swelled up and she had a lot of pain about 5 days around the injection site. The swelling continued for days as well. She had limited use in her arm because of the swelling. It was reported after 5 days the adverse events improved. The patient did not want to continue the second and third dose. At the time of reporting, the patient was fine. The patient did not seek medical attention. The "arm where the injection was given, swelled up" was considered to be disabling ("She had limited use in her arm because of the swelling"). No further information is available.
Bleeding nose; Eye discomfort; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (Bleeding nose) and OCULAR DISCOMFORT (Eye discomfort) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced EPISTAXIS (Bleeding nose) and OCULAR DISCOMFORT (Eye discomfort). On 13-Mar-2021, EPISTAXIS (Bleeding nose) and OCULAR DISCOMFORT (Eye discomfort) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to -MODERNATX, INC.-MOD-2021-069928 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-069928:Case for second dose
Red itch spot at injection site several days after vaccination.  According to ?doctor ? Covid arm.
Edema & erythema along entire right thigh. This is the side where varicella & IPV were given.
Sore arm shortly after, painful to lift (this is typical for me after flu shot each year). Woke up the next day with severe back and hip pain on both sides, a deep ache. Painful to move around and walk normally. Legs felt weak and heavy to lift, difficult to control and coordinate such as flexing toes.  Very fatigued.  Two days after vaccine still experiencing some back and leg pain, feet very cold. Wore thick socks and winter boots indoors all day. Headache throughout day. Today is day three after vaccine and my legs and back still don?t feel entirely normal but much improved from the previous two days and feel more within my control again, ability to curl/flex toes easily and fully has returned . These are not symptoms I experience from any other known conditions and seemed to come on immediately after the vaccination on Wednesday afternoon. I get the flu shot every year and other than arm soreness at injection site have never had an issue until now.
Information has been received from a nurse concerning a 65 year old female with no pertinent medical history or drug reactions/allergies, who on 09-OCT-2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659199/1541U) IM into her left arm.  There was no concomitant medication.  The nurse reported that the patient experienced a fever 102F, nausea and vomiting after administration of PNEUMOVAX 23 on 09-OCT-2008.  The patient developed erythema of left arm with central induration at the injection site.  The skin was warm to touch.  She was unable to raise her left arm.  The events were considered disabling, as the patient was not able to "perform household duties".  At time of reporting, the patient had not recovered.  There were no lab diagnostic studies performed.  The patient sought medical attention with an office visit.  This is the first of three patients for reporter.  The nurse requested a lot check.  This is one of three reports from the same source.  Additional information has been requested.
This spontaneous report was received from a office manager refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 20-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K012921 (expiry date: 29-NOV-2015 (dosage not reported). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
On Wednesday the 21st he came home and was tired. It got gradually worse on the 22nd. Was also feeling rib pain on the right side. Was a little bit short of breath. Went to the ER on 4/23 and they gave him IV fluids and pain medications. Put him on Tylenol, Naproxen, and Eliquis. States today 4/26 he is feeling a little bit better.
Pt became dizzy after shot. Mother came back to clinic and reported above. Briefly lost consciousness. Awake, alert. No pain when leaving 10 min later.
Information has been received from a physician concerning an approximately 8 year old male who on 07/28/1997 was vaccinated with the first dose of varicella virus vaccine . On 02/28/2005 the pt developed a mild case of breakthrough chicken pox. Unspecified medical atttention was sought. At the time of this report the pt was recovering. No further information was  given. No product quality complaint was involved. Additional information has been requested.
Patient was given J&J vaccination, proceeded to sit down in observation area , few minutes later fell face forward, got back up immediately, ambulance came, he is feeling ok now. He was clammy, sweaty
13 YO MALE PATIENT GOT THE  VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 13 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced 13 yo male subject got the vaccine. On 22-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 13 yo male patient got the vaccine and off label use was not reported. This report was non-serious.
Swollen arm, itchy, very hot to the touch w/rash that spread. very bad headache. fever, chills and sweating. Lethargic and very tired. Missed work. Felt very bad for 4 days and then felt worn out for another 1 1/2 weeks.
This spontaneous report as received from a certified medical assistant refers to an 11 year old female patient. No information regarding the patient's medical history and concurrent conditions was reported. On 19-APR-2016 at 12:39, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL 9 injection, lot # L044475, expiration date: 12-MAY-2017, intramuscularly in the right arm (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine was purchased with public funds. The certified medical assistant also reported that the vaccine underwent a temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. No previous temperature excursion was reported. The call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same reporter. Additional information is not expected as all required correspondence has been received.
Tinnitus followed by acute hearing loss left side approximately 4 weeks after second COVID 19 dose. Currently treated with Prednisone with little improvement. Scheduled for MRI 3/25
no adverse event; The medical assistant gave expired vaccine to 2 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The medical assistant gave expired vaccine to 2 patients) and NO ADVERSE EVENT (no adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The medical assistant gave expired vaccine to 2 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The medical assistant gave expired vaccine to 2 patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The medical assistant gave expired vaccine to 2 patients).    No concomitant product reported by reporter.  Vaccine was initially stored in the refrigerator on 19-Oct-2021 and was administer on 29-Oct-2021. Vial did not undergone any temperature excursions.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live follow-up received. Reporter information added. Patient age group added. Event onset date added. Narrative updated.
felt lethargic; felt bloated; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated). At the time of the report, LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-355582 (Patient Link).
Received PREVNAR 13 on Wednesday, April 29, 2015. She said arm was sore that night and a little red the next day at injection site. She said by Sunday or Monday (May 3d or 4th) she had a rash at injection site about size of thumb print and it was warm when touching rash. She came to our pharmacy on 5/7/2015 at 9:55 and the rash is significantly larger (about 4 inches round), red and feels warm. She is going to dr today to see what to do. I tried calling at 6:00p, on 5/7/2015 and left message for her to call back.
pt recv vax 5NOV98 & devel an inj site rxn measuring 2cm & crying for over an hour;
Syncopal episode  5 minutes after vaccine administration. Patient was monitored and fully recovered within 10 minutes.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Her response was not to the vaccine. As soon as the nurse administered the shot, she said she passes out cold after ANY vaccination
pt exp fever, sz jerk movements-unresponsive; to er via ambulance; pt was sleepy; t104; dx febrile seizure; recvd no more dpt vax;
Cluster headache; Bronchitis; UTI infection; sinus infection; Tremors in my hand, It's gotten worse; Lost over 15 pounds in three and a half weeks; This is a spontaneous report received from a contactable consumer. A 55-year-old female consumer (patient) reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in left arm on 28Jul2021 at 15:02 (at the age of 55-year-old) for COVID-19 immunisation. Relevant medical history included fibromyalgia, bipolar disorder and bronchitis. Concomitant medications included alprazolam (XANAX) for anxiety 1mg tablets 4 times a day then 3 times a day, gabapentin for a condition that she had in her legs (a fissure type, fissure balls), oxcarbazepine 300mg 1 and a half in the morning, first and a half in the evening and then first at the bedtime for bipolar disorder, salbutamol (ALBUTEROL) as rescue inhaler and hydrocodone bitartrate/paracetamol (HYDROCODONE/ACETAMINOPHEN) for 15 years 4 times a day then 3 times a day as needed. The patient was also taking five different medications for fibromyalgia and 'Flexural' (to be clarified) tablet at 10 milligrams tab, 3 times a day for severe muscular pain. The patient had a cluster headache that has not get rid of for three and half week. She also had  UTI infection, a sinus infection and bronchitis (new occurrence, not an aggravation of the medical history). The patient had a nebulized machine. She lost over 15 pounds in three and a half weeks and started having tremors in her hand. The patient was doing breathing treatment at home, she was on Azithromycin 250 milligrams tablet, take one by mouth daily for 10 days and Prednisone20 milligrams tablet, take one by mouth daily for 10 days. The cluster headache started within 24 hours the UTI was with started within 42 hours with the sinus infection on top. Headache was serious as causing hospitalization. Because of bronchitis the patient was on Flovent, helping her lungs to open (2 puffs usually once in the morning and then 12 hours later) and Flonase to try and keep her nose from the infection when she cannot breath. The patient did blood work earlier to check cholesterol, she also had CAT scan, MRI and ultrasound (no results provided). COVID test on 23Aug2021 was negative. Tremor was not resolved, outcome for the other events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Dizziness/vertigo starting ~ 8 am, 1 1/2 days after the vaccination, lasting for most of the day.h
Patient experienced bouts of confusion and blurry vision, headache described as starting over L eye and a "weird feeling" spreads accross the forehead.
lack of energy; trouble walking up a single flight upstairs; reduced appetite; She overall feels exhausted as of now; About 6 days later, she started with muscle pain; About 6 days later, she started with joint pain; His wife had lethargy and headache for 24 hours after receiving 2nd dose; His wife had lethargy and headache for 24 hours after receiving 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose), ASTHENIA (lack of energy) and MYALGIA (About 6 days later, she started with muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided.  Concomitant products included LISINOPRIL, ROSUVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose) and HEADACHE (His wife had lethargy and headache for 24 hours after receiving 2nd dose). On 23-Feb-2021, the patient experienced MYALGIA (About 6 days later, she started with muscle pain). 23-Feb-2021, the patient experienced ARTHRALGIA (About 6 days later, she started with joint pain). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), ASTHENIA (lack of energy) and FATIGUE (She overall feels exhausted as of now). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose), ASTHENIA (lack of energy), MYALGIA (About 6 days later, she started with muscle pain), ARTHRALGIA (About 6 days later, she started with joint pain) and HEADACHE (His wife had lethargy and headache for 24 hours after receiving 2nd dose) outcome was unknown and FATIGUE (She overall feels exhausted as of now) had not resolved.
Inject site red, swollen, warm to touch. Tx: cold compress, Rx for Keflex given.
Pt state right "achy" arm down to elbow sight of FLUZONE high dose.
On Wednesday May 13th I visited my primary care physician for a routine physical examination.  He recommended that I receive both Tetanus and Pneumococcal vacciations.  The pneumococcal vaccine was recommended due to an underlying chronic condition-Crohn's disease.  He did not administer either vaccine himself which was performed by a female nurse in the injection clinic.  I do not know her name.  She did clean each injection site with alcohol swabs prior to administering the vaccines.  The evening of May 13th, I experienced a moderate amount of injection site pain in my left shoulder (site of the Tetnus injection).  I also experienced moderate to severe injection site pain in my right shoulder (site of the pneumococcal vaccine) which radiated down my arm ending before the joint of my elbow.  That evening I experienced severe pain whenever I attempted to lift my right arm.  I actually could not move my arm from my right side without experiencing severe pain.  Later that evening I took 600 mg Motrin for the pain.  The following morning the pain in both arms was tolerable.  By the middle of the day (Thursday) my right arm (bicep and tricep) was swollen, red, painful-hot and hard to the touch.  The injection site was moderately painful.  Later that evening I took another 600 mg Motrin.  The following morning (May 8th) the right arm pain (bicep/tricep) and swelling worsened.  I visited my PCP mid Friday morning at 9:45AM.  He diagnosed my symptoms as being a "moderate allergic reaction- to the pneumococcal vaccine".  He prescribed Atarax for itching (although I had not experienced itching at this point) and cold compresses.  He also recommended that if my symptoms did not improve or worsened overnight to visit the emergency room.  I did not begin the prescribed treatment until later that evening after work taking Atarax and applied cold compresses.  Over the next two days the pain improved but the swelling, hardness and redness did not.  On Sunday, May 10, my arm (bicep/tricep) started itching and red raised bumps appeared.  I continued the prescribed treatment and as of today Tuesday May 12, all symptoms have resolved.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ML, 10 unit dose tube, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.