chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in the arm; Typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 15 patients. This is 10th of 15 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced soreness in the arm, had the typical arm swelling, headache and tiredness, all on unspecified dates in Jan2021. The outcome of the events were unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026413 same reporter/product/events, different patient
Narrative:  Patient received Janssen Vaccine on 03/29/2021 and reported onset of headache two days later. Patient reports taking Excedrin (aspirin and caffeine) tablets. Denies fever, vomiting, and other symptoms. On 07/22/2021 patient was seen in ED for headache, and left without being seen or treated per ED DC note.  Also noted in chart; chronic sinusitis, chronic neck/shoulder pain, is being followed up by PCP.
Three hours after I received the vaccine, I began to feel extremely tired and had a headache. Five hours after, the injection site had a pinkish color and felt sore. Then it was difficult to move my arm due to the soreness that traveled from my right upper arm to my right shoulder. I went to bed after taking Tylenol due to the headache and body aches. I woke up on 01/08/2021 with a severe migraine and general body aches. I took Tylenol in the morning and spent the day sleeping due to the migraines, malaise, and body ache. Throughout the day, I also experienced hot flashes and minimal nausea.
may have gotten a double dose/ gave him shots in both arms/ thought they inadvertently gave him two doses of it/ unsure if he received two doses or if he only got one; both arms were sore; This is a spontaneous report from a contactable consumer (reported for himself). A male patient of an unspecified age (Age: 73; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: en6200), via an unspecified route of administration on 17Feb2021 at single dose in arm for COVID-19 immunization. Medical history included Heart stents. The patient's concomitant medications were not reported. The patient previously took flu shot for immunization and experienced arms were sore. The patient reported that he may have gotten a double dose today (17Feb2021). They gave him shots in both arms, but said the first shot did not have any thing in it so they gave him another shot. He asked if a double dose was bad they said don't worry about it. Both arms were sore but not any worse than the flu shot. The consumer further reported that he got his first shot today and he thought they inadvertently gave him two doses of it. He got two shots, one in each arm and he was wondering if that's a bad thing. Caller stated they stuck him in one arm and she said "oh there was nothing in it, I'm going to give you another shot in another arm." Caller stated that he was unsure if he received two doses or if he only got one. Caller stated that the vaccination card he was provided only had one lot number and expiration date. Caller stated he was pretty sure he felt stuff go in each arm and both arms were sore, but its no more soreness than the flu shot. Caller asked if he was in danger and if he should watch out for side effects. No Covid prior vaccination. No Covid tested post vaccination. The event was non-serious per the reporter. The outcome of the events was unknown.
I am the patient and do not have all of the information requested.  I was contacted after responding to the routine text health checks and was sent this e-mail link to complete the reaction information. This information was taken from the vaccination card. My second dose was 3/2/21 at the same location.  I have had frequent headaches and muscle aches since the vaccinations. Also pain in joints.
Following morning woke with a temperature of 101.2 F. Accompanying chills with fever. Treated with ADVIL with reduction in fever and no reoccurrence.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. Patient did not receive the other vaccine in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid-began on day 3 after symptom start date. No other underlying conditions and takes no meds.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective, COVID 19  and the suspect drug BNT162B2 cannot be excluded.
This spontaneous report as received from a licensed practice nurse refers to two patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L029306, expiration date 26-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50 degrees Fahrenheit for 6 minutes, 59.8 degrees Fahrenheit for 29 minutes, 59.9 degrees Fahrenheit for 49 minutes, 48.2 degrees Fahrenheit for 5 minutes, 48.6 degrees Fahrenheit for 4 minutes, 48.1 degrees Fahrenheit for 4 minutes, 56.2 degrees Fahrenheit for 18 minutes, 49.4 degrees Fahrenheit for 5 minutes, 47.7 degrees Fahrenheit for 3 minutes, 54.4 degrees Fahrenheit for 9 minutes, 60.5 degrees Fahrenheit for 28 minutes, 49 degrees Fahrenheit for 2 minutes, 49.6 degrees Fahrenheit for 5 minutes and 48.5 degrees Fahrenheit for 7 minutes. Data logger was not involved. There were no previous excursions reported. Additional information is not expected.
Patient was seen in our office on 5/18/2010.  Patient has scattered, raised scabbed areas on body - <20.
Patient was given KINRIX and PENTACEL at the same date and time instead of Hib vaccine only. Patient also received MMR, Hep A and MMR in the same day.
spleen taken out; She just got Prevnar 20 and the doctor told her she needs a second dose in two months; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Agency.  A 65-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPLEEN DISORDER (medically significant), outcome "unknown" described as "spleen taken out"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown" described as "She just got Prevnar 20 and the doctor told her she needs a second dose in two months." Therapeutic measures were taken as a result of spleen disorder.  Additional information: The reporter called about Prevnar 20. She has a patient who got her spleen taken out. She just got Prevnar 20 and the doctor told her she needs a second dose in two months. He also told her she is supposed to get another pneumonia vaccine every two years. She wanted to know what the recommendations are for this population. Spoke from the ACIP recommendations under Summary, which included patients with certain underlying conditions. Also spoke from 'Pneumococcal Vaccine Recommendations' Table 1 where it discusses certain underlying conditions, including asplenia. Offered all of these recommendations in writing for their evaluation. Referred to the CDC for further discussion as these are their recommendations that Pfizer is independent of. Explained that this would be looked further and if there is any additional information regarding this will be included in writing in the fulfillment.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The spleen disorder requiring surgical intervention with splenectomy represents the patient's underlying medical condition unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
LEFT LEG DEEP VENOUS THROMBOSIS NOV 2021 TREATED WITH ELIQUIS DEEP VENOUS THROMBOSIS SITE UNKNOWN APRIL 2021 PER PATIENT REPORT
Brain fog; have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101482276 (pfizer).  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 17:40 (Lot number: FF8841) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 20Oct2021, outcome "not recovered", described as "have the ringing in my ears and I never had this before so, I am wondering if, it''s from the vaccine/ They are a little worse maybe."; FEELING ABNORMAL (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Brain fog". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Is report related to a study or programme- No. Consumer had a side effect after the first dose of the vaccine and scheduled for second dose in November at 4:00 and asking that Should consumer get the second dose or not. And stated that consumer was not received any vaccines. No follow-up attempts are possible. No further information is expected.
PATIENT REPORTED TO PHARMACY ON 5/16/17 AT 10:00 AM THAT ON SATURDAY 5/13/2017, HE BEGAN TO EXPERIENCE REDNESS, SWELLIN, AND PAIN. HE VISITED HIS PCP ON 5/16/2017, AND TOLD HIM THERE WAS NO SIGN OF INFECTION TO TREAT WITH ICE AND BENADRYL.
I was at a nonprofit meeting in the evening and I felt a cramp in my left leg. And I walked off the cramp but upon sitting down again I felt another cramp and the next thing I knew I was on the floor. And my next memory was an EMT at the meeting was asking questions i.e.; what year it was, who was the President was. The EMT took my vitals and everything was fine. I was told and at the point I called my husband no emergency help was called. I had mowed the yard that day and my doctor and I felt it was dehydration but I have been referred to a Cardiologist and that appointment is 01JUN2023.
Fever to 101 degrees F, myalgias, chills, headache, and arthralgias
Redness near where vaccine was given, tenderness around area; By afternoon, the redness began turning puffy and aches began in upper arm where vaccine was given. That evening I became dizzy in shower. Had to sit down. Upon leaving shower, I had to lie down on bed and wait ten minutes in order to dry off. That night, I could not sleep on right arm for more than a few minutes as pain was severe. By 10/6/2016, welt-like puffiness, redness, heat covered much of upper right arm. By that night at shower, I noticed this red puffiness had gone to elbow of right arm, with a large swollen area right on inside elbow joint. No itching but terribly sore. By bedtime, I was able to sleep a bit more on that arm but not well.
Eustacian tube dysfunction ,  dizziness, pain/tightness around the head and neck, tinnitus
Headache; Muscle aches; Fever; Vomiting; Diarrhea; Swollen fingers; swollen hands/feet; Heavy chest; High blood sugars; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, celiac disease, sarcoidosis, migraine, sulfonamide allergy and spice allergy (dill). Concomitant medications included insulin glargine (TOUJEO), lisinopril (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), ondansetron (ZOFRAN) and insulin aspart (NOVALOG); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 19Mar2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patient previously took morphine (MANUFACTURER UNKNOWN), prochlorperazine edisylate (COMPAZINE), metoclopramide (REGLAN) and tizanidine (MANUFACTURER UNKNOWN); all on unknown dates for unspecified indications and experienced allergy.  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 09Apr2021 at 16:30, the patient experienced headache, muscle aches, fever, vomiting, diarrhea, swollen fingers/hands/feet, heavy chest and high blood sugars. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events headache, muscle aches, fever, vomiting, diarrhea, swollen fingers/hands/feet, heavy chest and high blood sugars were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
One day post vax, the pt began to have episodes of jerking then of jerking and staring. These were brief occurring 2-3 times a day. Over the next several weeks, the episodes became more frequent. He required hospitalization for seizure control and was diagnosed with infantile massive spasms. He has since become severely developmentally delayed and microcephalic. He is on medication but his seizures are not controlled.
I HAVE BEEN SICK SINCE THE DAY AFTER MY SECOND VACCINE THAT I RECEIVED ON THE 9TH OF MAY. MY GLANDS HAVE BEEN SWOLLEN, COUGHING, MY JOINT ACHE, MY MUSCLES ACHE, MY MOUTH  IS DRY, NIGHT SWEATS, FATIGUE, AND MY THYROID HURTS TO THE TOUCH. I JUST WENT TO A SPECIALIST WHO DIAGNOSED ME WITH THYROIDITIS DUE TO THE VACCINE. IT HAS BEEN A MONTH TODAY.
Pain started 1 hour after receiving injection. Pain radiated from L shoulder to hand and fingers. Also reports L arm weakness, numbness, pain, like frozen shoulder now 2 weeks after injection. Initially treated with prednisone, acetaminophen and ice 10/29/18. Then prescribed tramadol and referred to orthopedist 11/9/18.
Seemed to have sz; No jerking just tilted head back & then became drowsy; Post-ictial state; No fever; Upon exam appeared normal
SMALL RAISED RED BUMPS APPEARED AT ALL VACCINATION SITES. RASH ON BILATERAL ARMS RESOLVED AFTER 5 DAYS. RASH REMAINS ON BILATERAL THIGHS. AREA OF RASH APPROX 1 WEEK LATER WAS 2 INCH DIAMETER. DENIES FEVER, DENIES ITCHINESS. SIMILAR REACTION AT EACH OF PREVIOUS REACTIONS. MOTHER OF CLIENT STATES COOL BATH HELPS FOLLOWING REACTION. AT MOST PREVIOUS VACCINE ADMINISTRATIONS, BANDAIDS WERE NOT USED ON CLIENT ARMS OR LEGS.
FLUVAX given 2pm 10/15/09; at 3pm on 10/16/09 - severe pain of entire arm left side where injection given pain and stiffness to L shoulder making movement difficult - no strength in arm. Upper arm swollen no redness. Also had burning sensation. 10/17/09 - swelling reduced, less pain 10/18/09 - resolved.
p/vax pt exp yellow/green vomiting w/every breast feeding; 10% dehydration treated w/IVF x2day; intussusception  dx'd w/ barium enema & reduced in radiology;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date during 2016, the patient was treated at a hospital by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt presents left arm with generalized redness at the site of the injection and is warm to the touch.
Patient was given a dose of expired vaccine (Dtap-IPV-Hib, Pentacel). Called manufacturer and they said the vaccine is rendered ineffective when it is past the expiration date. Manufacturer stated that vaccine should be administered to patient again to complete dose requirements.  Manufacturer stated that there should be no issues with giving another dose  to the patient.
Left arm swelling and redness. No fever. Recommended ice, motrin and benadryl. Three patients seen within one week with reaction to varivax
Pain/swelling in armpit  and  pain  in medial arm almost to elbow.  (Lymphnodes)
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    51 doses was received to several patient from Lot AS7140C. Concomitant medications were not reported.  No treatment information was provided
arm soreness; couldn't sleep at night; firey red and hot; arm swelled up about the size of a baseball; hard knot; painful shoulder; nausea; firey red and hot; very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball) and LYMPHADENOPATHY (hard knot) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Anxiety and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone level NOS abnormal, LOSARTAN and AMLODIPINE for Hypertension, DONEPEZIL HYDROCHLORIDE (ARICEPT) for Memory disturbance (excl dementia), GABAPENTIN, BUPROPION and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 12-Mar-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) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball), LYMPHADENOPATHY (hard knot), ARTHRALGIA (painful shoulder), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (firey red and hot) and VACCINATION SITE PAIN (very painful). At the time of the report, PAIN IN EXTREMITY (arm soreness), INSOMNIA (couldn't sleep at night), VACCINATION SITE WARMTH (firey red and hot), PERIPHERAL SWELLING (arm swelled up about the size of a baseball), LYMPHADENOPATHY (hard knot), ARTHRALGIA (painful shoulder), NAUSEA (nausea), VACCINATION SITE ERYTHEMA (firey red and hot) and VACCINATION SITE PAIN (very painful) outcome was unknown.            No treatment was taken. The reaction had recovered but at it still hurts sometimes. After the 2nd shot, her arm swelled up about the size of a baseball and it went down to her elbow. It got firey red and hot. It was very painful. She could not sleep at night.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional Events Insomnia, Vaccination site warmth, Peripheral Swelling, Vaccination site erythema, Vaccination site pain are updated.
Approximately 3 hours after injection upper forearm became hard, swollen, sore & deep red. This area was about the size of a playing card. This persisted about 2 weeks and 4 days. Took Tylenol & applied cold compress. Hardness & swelling went away first. The pain subsided next and the redness ended lastly.
Rash developed on back of hands and forearms approximately 4 hours after injection. Rash was red, with raised bumps, and itchy. Treated with 25mg IV Benadryl.
joint pain  in the shoulders, arms, elbows, wrists, hands, and knees.  burning/stinging/numbing pain in arms , elbows, wrists, hands and knees.  weakness of the arms, wrists, and elbows. I  have difficulty opening cans or even carrying my hand bag due to pain that renders my arms, wrists and hands weak. I've never had these symptoms in my life until I  was given Tdap on 10/16/2019.  I  have read up on some of the rare side-effects such as brachial neuritis and i'm very concern that I may be experiencing this.