chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after the vaccine shot, complained of itching to arms and neck. Arms were red, but no hives visible. 10 minutes later, she was still itchy.  Given Benadryl. Relieved 20 minutes later. Wanted to go home with husband.
pt recv vax 30DEC96 & on 31DEC96 pt exp fever, cough & malaise;the reporting physician was not the physician who administered the vaccine;
My baby started to get fever on Monday night 11/16/2009 around 7pm, and the fever went up to 105 degree (rectal taken at the hospital by Tuesday night 9pm).  She continued to have fever for the next 4 days from 102-103 (armpit temp).  She developed red raised rashes on Tuesday morning, but just a few spots on her face and a few on the side of her abdominal, but the rashes were all over her body by Wednesday, covering her from head to toes.  She couldn't swallow and refused to eat or drink because of the rashes/swollen throat. We took her to the hospital the second time on Thursday, concern of her dehydration.  The hospital did blood work and the result was negative for virus or any other illnesses.  The pediatrician at the hospital said my daughter had a adverse reaction to the MMR shot.  She gave her IV, Tylenol and Magic Mouth Wash to help reduce her uncomfort in mouth.  The fever was finally gone by Friday night 11/20/2009 and the rash started to fade little bit on the face, then her upper body by Saturday afternoon 11/21/20009.
her foot got stuck so she fell and broke three ribs; last night and started feeling tight and tight; she couldn't walk; has arthritis and it has gotten worse; her foot got stuck so she fell and broke three ribs; Yesterday it was strong- pain in the caller's arm, legs, and hands; caller got worse but the doctor said she would get better; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 26Nov2021 (Lot number: EL9266) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart surgery" (unspecified if ongoing), notes: Verbatim: heart surgery she had three bypasses; "Arthritis" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Blood cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; METFORMIN taken for diabetes mellitus; ATORVASTATIN taken for blood cholesterol; GLIPIZIDE XL taken for diabetes mellitus; GABAPENTIN taken for arthritis. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, lot EL9266), administration date: 23Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "headache", "pain in her arm"; Bnt162b2 (DOSE 2,SINGLE, lot EN6207, Second dose: its like a rash where the balls are like 25 cent or 10 cent currency and its like a rash and it is inside her skin.), administration date: 16Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "its like a rash", "Shingles", "feel more pressure and is starting to get scared". The following information was reported: RIB FRACTURE (medically significant), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "her foot got stuck so she fell and broke three ribs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "last night and started feeling tight and tight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "she couldn't walk"; ARTHRITIS (non-serious), outcome "unknown", described as "has arthritis and it has gotten worse"; PAIN (non-serious), outcome "unknown", described as "Yesterday it was strong- pain in the caller's arm, legs, and hands"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "caller got worse but the doctor said she would get better". Clinical details: Patient sat down last night and started feeling tight and tight and she couldn't walk. The caller has arthritis and it has gotten worse. The caller called because her foot got stuck so she fell and broke three ribs. Yesterday it was strong- pain in the caller's arm, legs, and hands. The patient saw her new doctor but she didn't pay too much attention.
Chills and body aches began at 4:30pm (6 hours after vaccine), rested Fever and headache began around 6pm and lasted until morning. Took 500mg Tylenol around 6 and around midnight, neither helped with headache  Headache is ongoing.
Patient stated that the next day after getting the second vaccine she had  a fever and chills. She was extremely weak and tired. She experienced a high level of fatigue.
This spontaneous report was received from a pharmacist and refers to an elderly male patient. It was reported that the patient had no drug reactions or allergies. Concomitant therapies included furosemide (manufacturer unknown), pravastatin and isosorbide mononitrate (manufacturer unknown). On 03-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported) to prevent shingles. On unknown dates, the patient developed 3 cases of shingles after being vaccinated with ZOSTAVAX. In approximately 2015, the patient experienced pain. It was reported that the patient sought medical attention, he contacted the pharmacist. In August 2015, the patient was prescribed hydrocodone and tramadol for pain, but the reporter could not confirm if the patient was taking these medications for shingles related pain. No PQC (product quality complaint) was involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
dry mouth/fatigue Narrative:  Approx. 2 hrs after second dose, complains of not feeling well with fatigue and dry mouth.
2 months post vaccine, I developed a severe chest cold. I had a productive cough I would get lightheaded from the cough with a slight fever, I couldn't taste or smell my ears were really sore I was out of work and normal activities for 5 days or so. I tested negative for Covid and strep throat and both strains of influenza the doctor ruled it out as viral and stated it would run its course. I had 2 separate office visits. The first was with   at  and followed up with my PCP at .
Patient feels injection given too high on the arm and arm/shoulder all stiff and sore.  Reports decreased ROM 1 wk after shot given.  Patient returned to clinic 11/8/08 with continued stiffness in shoulder and decreased ROM.
some of the vaccine to drip out on my arm; my arm was painful and kind of sore where the injection site was; some of the vaccine to drip out on my arm; A spontaneous report  was received from a consumer, who is 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate dose of vaccine administered and some drops went out, pain and soreness at injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 27 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient received the vaccine resulting in the event of inappropriate dose of vaccine administered and some of liquid went down from shoulder to her wrist. The patient experienced pain and soreness at injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, inappropriate dose of vaccine administered, was considered as resolved on 27-Janp-2021 and the event, pain and soreness at injection site, was not reported.; Reporter's Comments: This case concerns a 62 old female patient who received  her first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection and resulting in the event of inappropriate dose of vaccine administered and some drops went out, and non-serious listed event of pain and soreness at injection site. Based on the current available information, the event of pain and soreness at the injection site is an expected event.
Right after administration, felt a little tingling on my left arm, went away after a few minutes. 25 mins after, I started feeling Nausea throughout the day. Nausea continued till the next day followed by sever chills and body aches (no fever) and redness, tender and hot around the area of injection. Managed with 600mg of Ibuprofen. Felt the same the next morning of 2/7/21, managed with 600 mg of Ibuprofen.  Nausea, severe body aches, sever chills, Left arm tingling and soreness. red/hot reaction around the area (half size of a baseball).
low frequency hearing loss; Right Ear Fullness and Ringing/Tinnitus; Right Ear Fullness and Ringing/Tinnitus; This is a spontaneous report from a contactable consumer (patient).   A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 40-year-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 15:00 (Lot Number: ER8737) as 1st dose, single for covid-19 immunisation.  Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medications were not reported.  The patient experienced right ear fullness and ringing/tinnitus. No symptoms before and it had been constant since. Followed up with Hearing test showing low frequency hearing loss on 02Apr2021.  Previous (unrelated) hearing test 3 months earlier shows no hearing loss (normal) in 2021. The events were serious disability. The events start date was on 02Apr2021.  The event resulted in Doctor or other healthcare professional office/clinic visit.  Therapeutic measures were taken including prednisone. The events outcome was not recovered.
This spontaneous report was received from a male physician (reporting on himself) of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose, and route not reported). Other suspect therapies included PNEUMOVAX23 (Lot #, dose and route not reported); given on the same day as ZOSTAVAX. Concomitant therapy was not reported. On an unknown date the patient developed a rash around injection site after receiving ZOSTAVAX. The outcome of rash around injection site after receiving ZOSTAVAX was reported as recovered on an unknown date. Additional information has been requested.
Pt developed redness, swelling and hives on back and on both thighs. He was treated with Benadryl; given 1 tsp po per the doctor. No SOB. Site was warm to touch.
Narrative: 76 yo female of unknown past medical history received Moderna, second dose at the clinic on 3/25/2022. On 3/28/2022, she called the clinic to inform staff that she had in the ED on 3/26/2022 for shortness of breath, joint pain, fever, chills and weakness. No ED record has been sent from the local hospital. According to the patient, she was given fluids and will follow up with her PCP in the community. She felt better and was discharged on 3/26/2022 from the ED. Of note, patient had no reaction with the first dose received at the clinic on 2/18/2022 (Moderna was administered at that time).
Extremely severe headache that lasted 48 hours.  Low grade fever and general flu like symptoms.  I was tested for Covid and flu.  Both tests were negative.  The symptoms resolved.
Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Within 8 hours of administration, entire leg became red and swollen.  Temperature 99F axillary.  Very fussy.  Seen in office the next day-redness gone but large firm tender swelling at injection site.
Patient complains of headache, shakiness, sweating profusely, and nausea.
Patient reports developing severe headache the evening after vaccination. Patient reports nausea/vomiting. Patient reports pain in unilateral under arm area (side of vaccination). Symptoms improved with time and have now (48 hours post vaccination) resolved. Patient has small red/inflamed patch on inner portion of the injection site arm. This redness appears to be localized around anatomic sites of lymph nodes.
patient states that she had a "throat congestion" feeling following her first dose in January 2021. Patient at that time received Benadryl IM at vaccine clinic and was transported down to the ER. She stats that she was released after monitoring and to pre-medicate with Benadryl prior to her 2nd dose. She states with her second dose, she did not have any "throat congestion" after pre-medicating. Today she presented for her Pfizer booster. She pre-medicated with Benadryl 25 mg PO at 1208. Patient received her 3rd dose at 1245. at 1300 she reported feeling the same way after her 1st dose with "throat congestion". She was then given 25mg IM in her right arm. VS at 1307 were BP 124/90, 99% on RA and HR 85. EMT hospital team called at 1315. at 1318 she stated that she felt she was clearing her throat more and felt worse. vitals at 1320 were 99% on RA and HR 77. EMT arrived at 1321 and transported patient to ER.
Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        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 relevant concomitant medications were reported.   This case was linked to MOD-2021-020650 (Patient Link).
a little bruise; a little sore; Ball shaped rash on left arm just below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a little bruise), PAIN (a little sore) and VACCINATION SITE RASH (Ball shaped rash on left arm just below the injection site) in a 65-year-old female patient 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 CONTUSION (a little bruise), PAIN (a little sore) and VACCINATION SITE RASH (Ball shaped rash on left arm just below the injection site). At the time of the report, CONTUSION (a little bruise) and PAIN (a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: significant live follow up
head colds; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the second of 2 reports.  A male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced head colds (non-serious) in 2021 with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216429 same reporter/drug/AE, different patient
This spontaneous report as received from a health professional and administering HCP refers to a 17 years old female patient with no preexisting allergies, birth defects or medical conditions. On 04-JAN-2012 at 15:14, the patient was vaccinated with lot # (670048/0963AA) dose 1 GARDASIL in her right deltoid, FLUMIST and HAVRIX. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report as received from a mother refers to her 18 years old daughter. The patient was vaccinated with the first dose of GARDASIL (lot# unknown) intramuscular on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-AUG-2012 the patient experienced pain at the injection site and broke out with hives. It was unknown that if the patient had sought medical attention. The outcome was unknown. Additional information is not expected.
Patient received Moderna vaccine IM to left deltoid. 10:20 AM Patient reported dizziness and nausea. Patient denies any chest pain, SOB, severe headache. BP 107/89 P 80 o2 sat 97% on room air. Patient transported via wheel chair to Walkin Clinic for further evaluation. Patient transported via wheel chair to Walkin Clinic for further evaluation and treatment.
PATIENT WAS HERE FOR THE MMR AND RECEIVED THE PROQUAD INSTEAD. PATIENT DOES NOT HAVE ANY ADVERSE EVENTS.
Nausea, vomiting, fever, swollen and redness on injection site redness spread from deltoid to below elbow.vigorous reaction to TD she got on 7/23 localized. She has had all of shots. It got red, swollen, hard and painful. No fever now had one for 48 hrs now worried as the redness is slowly moving distal no more swelling and overall much improved. OBJECTIVE: L deltoid area with <dime sized tender palp bump deep at injection site. Mild erythema without heat or pain extending to 3 cm from the elbow no adenopathy no fever.  A/P: 1. swelling of limb due to Td local reaction --now > 1 week out and much better listed as an allergy even though it is not anaphylactic  reviewed the data on Meningococcal vaccine and advised she wait a week and then get it so that she has protection at school  discussed how it works  advised it is risk reduction  etc  future ordered     Soreness in armpit
THE ABOVE PATIENT C/O FEELING DIZZY S/P #2 COVID VACCINE. 15 MINUTES LATER C/O FEELING DIZZY BP 144/98, P/23. P.O 99%, HYDRATION WAS OFFERED WITH REST THE PATIENT IMPROVED CONTINUED ON BACK  3/30/21 1PM Continued from front: Hx HYPERTESION      OPEN HEART/LUNG/VALVE SURGERY      HIGH CHOLESTEROL.  NO ALLERGIES    MEDICATIONS          COUMADIN          ASA          GABAPENTIN          AMIORDONE          ATROVASTIN THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH PCP - FOR ABNORMAL RAPID HEART BEAT
Fainted 10 minutes after receiving shot. Next day, (starting 12 hours after vaccine) severe muscle aches, nausea, fatigue, slight fever, all for approximately 12 hours. Felt slightly fatigued the next day but back to normal after that.
Deviation from recommended age group; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group) outcome was unknown.        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.   This case was linked to MOD21-069812, MOD21-069804, MOD21-069810, MOD21-069811, MOD21-069813, MOD21-069814, MOD21-070440 (E2B Linked Report).; Sender's Comments:  MOD21-069812: MOD21-069804: MOD21-069810: MOD21-069811: MOD21-069813: MOD21-069814: MOD21-070440:
1/6/22 47 yr/o male who presents with 2-day history of sore throat, fever, chills, headache, body aches, cough and congestion, loss of taste and smell, vomiting and diarrhea.  His girlfriend with whom he lives has COVID-19.  Also reports multiple recent sick exposures with young children who have upper respiratory symptoms.  States he has chronic pancreatitis secondary to hypertriglyceridemia with chronic epigastric abdominal pain.  States since last night the pain has been more severe, sharp and intermittent, associated with "aggressive "vomiting which has been brown in color. Constitutional:  Well developed, Well nourished, No acute distress, Non-toxic appearance. Eyes:  PERRL, EOMI, Conjunctiva normal, No discharge.  Chest:  Normal breath sounds, No respiratory distress, No wheezing,  Cardiovascular:  Normal heart rate, Normal rhythm, No murmurs, No rubs, No gallops.  GI:  Bowel sounds normal, Soft, epigastric tenderness, No masses, no rebound or guarding.  Back: Normal inspection.  Nontender Musculoskeletal: No edema, No tenderness, No cyanosis. Normal ROM Integument:  Warm, Dry, No erythema, No rash.  Neurologic:  Alert, No focal deficits noted.  Psychiatric:  Affect normal, Insight and Judgment normal   DIsharge note: Patient is a 47-year-old male with past medical history of traumatic brain injury, diabetes mellitus type 2, hypertension, asthma, hyperlipidemia, anemia, reports chronic pancreatitis secondary to hypertriglyceridemia, DVT on Eliquis and bipolar disorder who presented to ED with complaints of shortness of breath, cough and abdominal pain.  Describes abdominal pain and severe and sharp. Reports associated fever, chills, sore throat, body aches, headache, loss of taste and smell, brownish  emesis and diarrhea.  His girlfriend whom he lives with has COVID-19. Denies CP, denies edema, denies hematemesis or urinary s/s.