chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Person vaccinated on 4/9/21, called the Public Health Covid hotline, and left a message that he had received his 2nd Moderna vaccine today at a public health clinic, and after a few hours, he became itchy, and developed a rash.  He was called back from the Hotline staff and he stated how he had hives, an itchy rash with papules, was taking Benadryl which was helping, but refused to leave work to go to the doctor for his reaction.
developed a red, slightly swollen, slightly warm, slightly tender 5 cm in diameter area on left arm noted the morning after the injection
No adverse reaction was reported by patient.  Patient received Moderna vaccine two-dose series even though they were only 16 years of age at the time of vaccination, rather than the recommended 18 years of age. Pharmacy was notified by another pharmacy when patient presented to receive booster shot.  We are reporting this as a vaccination error due to the patient's age.  It was recommended to patient to receive the Pfizer vaccine as a booster dose.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040321A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information included shower and eating.   This case was linked to MOD-2021-127502 (Patient Link).
I have coughing and choking spells. I went to the premed allergists. They ran test on me to see what I was allergic to but they didn't give me any results yet.
Severe pain in upper back and upper left arm. Ibuprofen and naproxen sodium had no effect. Cyclobenzaprine and Lortab controlled pain used for one week until pain was reduced to moderate pain.
Pt presented to the Hospital with S/P Fall. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 18Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2023) Positive, notes: First symptoms began Wednesday 08Feb and tested positive the next morning; (12Feb2023) Negative, notes: I tested negative starting Sunday, 12Feb; (17Feb2023) Positive, notes: 16Feb and I tested positive the next day. Therapeutic measures were taken as a result of drug ineffective, covid-19 which is Paxlovid from 09Feb2023 to 12Feb2023.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
headache; warm sensation through neck and shoulder; body ache; fever 101.6; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever 101.6), HEADACHE (headache), CHILLS (chills), FEELING HOT (warm sensation through neck and shoulder) and MYALGIA (body ache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills). On 02-Feb-2021, the patient experienced PYREXIA (fever 101.6). On an unknown date, the patient experienced HEADACHE (headache), FEELING HOT (warm sensation through neck and shoulder) and MYALGIA (body ache). On 01-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PYREXIA (fever 101.6), HEADACHE (headache), FEELING HOT (warm sensation through neck and shoulder) and MYALGIA (body ache) 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.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Adult patient was given a pediatric vaccine (proquad). Per CDC, dose may be counted towards her MMRV vaccine series and does not need to be repeated.
No adverse reactions observed until 12th Day.  On 12 th day 1/31/21, Started becoming very Sleepy , Tired . Two days later brought  attention brought to caregiver for Fever, (showed 99.3) feeling very Cold - 3 blankets. Hello pee. No appetite. Just wanted to sleep like very Fatigued.  2/5/21 - Temps 101.9 -    Gave 1 Tylenol 500mg tab. Fever down after 4 hours. Stayed down. 2/6/21 - 99.7 at 3 pm. Should I take to the Urgent Care if temp goes up????  I can't get to her doctor. No RESPONSE
patient was vaccinated at 0801. After 15 minutes patient started feeling light headed and weak. Vital taken. patient was monitored until 0842 with little improvement in symptoms and pulse was low. Patient was transferred to urgent care , and checked in for further evaluation,
pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 300042698 and 3000489) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Vision loss (Lost eye sight on the right one.) since 1967, Cataract operation (Cataract surgery of left eye) in 2013 and Bypass surgery. Concurrent medical conditions included Diabetes since 2003. Concomitant products included INSULIN, METFORMIN HYDROCHLORIDE (SIOFOR), SULODEXIDE (VESSEL DUE), ROSUVASTATIN CALCIUM (CRESTOR), GLICLAZIDE (DIAPREL), FENOFIBRATE (LIPANTHYL) and ACETYLSALICYLIC ACID (ASPIRIN CARDIO) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: Normal. On an unknown date, Blood sodium: Normal. On an unknown date, Glycosylated haemoglobin: (High) 11.3 Higher than normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications include, Resveratrol, Vitamin C, Multivitamin, Milgamma N, Actovegin, Thioctic acid.  On an unknown date, laboratory data include tomography, optic nerve echography, eye fundus examination, result unknown. On 12 Mar 2021 had an angiotomography, result unknown.
COVID-19 breakthrough. The symptoms were like a mild cold. I had a runny nose, fatigue, sneezing and muscle aches. The cough was very severe, I seemed to be coughing all the time. I think I remember taking Ibuprofen.
got COVID-19 after receiving the first vaccine; got COVID-19 after receiving the first vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. The patient was wanting to get the second dose of the COVID vaccine 5 months after receiving the first vaccine. Caller wanted to know if there was any harm in giving the vaccine after five months and if the series needs to be repeated. Caller stated that the patient did not receive the vaccine because the patient got COVID-19 after receiving the first vaccine. The outcome of event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Patient developed reddness and swelling at the site of DTaP.  Left deltoid.  Reportedly tender erythema on of arm.  Diagnosis: Adverse reaction to Immunization obersevance.  Advil prn if no inflammation.
it was rpt p/vax pt exp intussusception requiring surgery & resection of 15cm of intestines.
No adverse effects reported.; expired dose of ROTATEQ which was administered on 4/8/2019; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 08-APR-2019, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose and route were not reported; lot # N030366 and expiration date 13-MAR-2019) for prophylaxis (expired product administered). No adverse effects were reported.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AJMALINE (CARDIA), LOSARTAN, ATORVASTATIN, ALENDRONATE SODIUM (ALENDRONATE), CINNAMON [CINNAMOMUM VERUM], VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM 600 WITH VITAMIN D3) and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided          The patient reported that her sore arm was on the left non dominant deltoid where she received the second shot. No treatment information was provided.
Received 2 doses within 7 days Narrative:  Patient received dose of Moderna vaccine at hospital on 1/29/21, then received another dose of Moderna vaccine at another hospital on 2/5/21. No adverse effects noted.
Autoimmune hepatitis.  Started getting symptoms 3-4 days after vaccination.  Nausea, itching, fatigue, abdominal pain.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart beat which happens when I get a cold), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen lymph nodes in underarm on left side) and PYREXIA (Fever for second and third day after vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.  Concomitant products included DILTIAZEM and PRAVASTATIN for an unknown indication. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ASTHENIA (Weakness) and FATIGUE (Fatigue). On 08-May-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat which happens when I get a cold) and PYREXIA (Fever for second and third day after vaccine). On 09-May-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in underarm on left side). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 09-May-2021, ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart beat which happens when I get a cold), FATIGUE (Fatigue) and PYREXIA (Fever for second and third day after vaccine) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in underarm on left side) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Lightheaded, pulse rose from 72 bmp to 100 bmp 10 minutes after vaccine. Hives and red rash on face, right arm, back, scalp, lips, inner lips/gum line, and back. Rash got worse the day after the second dose and caused an itchiness/ tightness of the chest and throat. Did not feel like my life was threatened so I nursed it at home with antihistamine.
Vomited dinner last night at 10 pm,  have fundoplication and shouldn?t be able to vomit. Severe chills, fever, dizziness, muscle pain all over, balance issues walking, difficulty taking in liquids today.
Maladministration into a 4 months old female patient.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7T5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Kinrix at 4 months old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
On day 8 I woke up with arm redness and swelling which lasted about a week. Closely the size of a softball.
Pt c/o headache after flying to another state that day. Took MOTRIN 400 mg and felt better 2 hr later. Sore arm as well 6/14/08 c/o headache again/low grade temp. MOTRIN again with relief.
Patient experience rash with blister to left calf, sensation of pins and needles all over body. provided hydralazine and muprocin for blister and rash.
Weakness, fatigue, body aches, injection site soreness/became hot, fever rushes, lack of appetite, sinus pressure, post nasal drip
I tested positive for Covid-19 on April 4, 20223 I experienced headaches, sore throat, cough, fever, nauseated; body aches; extreme fatigue; I was taking Tylenol and was also prescribed Paxlovid for my symptoms.
Left knee full of pain and swelling above knee, shoulder, hip, knee and wrist joints stiff and painful.  Shoulder and neck muscles tense and full of knots.
Throwing up; Fever; Sleeping all day; Just miserable; Very dizzy; Little off balance; Sick; This is a spontaneous report from a contactable consumer or other non hcp. An 86-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 14Feb2021 (age at the vaccination 86-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medication were none. The patient experienced very dizzy on 14Feb2021, and on 15Feb2021 throwing up, fever, sleeping all day, just miserable. little off balance and sick on an unspecified date in Feb2021. Today is the first day because he just got the injection yesterday. She waited an hour for someone to answer. This department must be understaffed. The doctor said cold compresses so that is what she is doing for him right now. He was a little off balance last night and slept all night. Patient was never sick at 86 so it is troublesome to her to see him sick. They both knew it could happen, but it is worth it. She will not go around and tell people not to get it. She wants people to get it. She was going to keep pushing fluids and try to get him to take Tylenol. The patient underwent lab tests and procedures which included blood test: good and investigation: they were well on an unspecified date. The outcome of the event very dizzy, throwing up, fever, sleeping all day, just miserable was not recovered and other events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Patient received Covid 19 vaccine on 3/25/21 in Oregon city. 10 days later she had a syncope episode and another syncope  episode on 4/11/21
09:45 received her 1st dose of FLULAVAL ever. 45 minutes later, started itching all over. Reported to Emp Wellness, Dr order nurse to give her 50 mg BENADRYL IM. Pt had epi-pen for other allergies but did not use it or want us to use ours.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was inadvertently vaccinated an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # H014977, expiration date: 09-AUG-2014). Dose was supported. No adverse experience reported. Additional information has been requested.
Headache; itching at injection site; pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), INJECTION SITE PRURITUS (itching at injection site) and URTICARIA (pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O27V2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TAMSULOSIN, AMLODIPINE, POTASSIUM CHLORIDE (KLOR-CON), LISINOPRIL, APIXABAN (ELIQUIS), GABAPENTIN, ACETYLSALICYLIC ACID (ASPRIN), ATORVASTATIN, FUROSEMIDE, CARVEDILOL and SOFOSBUVIR for an unknown indication, Belpatra.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (Headache), INJECTION SITE PRURITUS (itching at injection site) and URTICARIA (pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the). On 13-Jan-2021, INJECTION SITE PRURITUS (itching at injection site) had resolved. At the time of the report, HEADACHE (Headache) and URTICARIA (pretty big rash/hives started that went down to the leg from the same side, mid calf, then to the) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient applied alcohol on itchiness   This case was linked to US-MODERNATX, INC.-MOD-2021-006272 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-006272:Crosslinked with MOD21-05193
pt recvd vax 17JAN95 pt died on 20JAN95 preliminary autopsy finding consistent w/SIDS; final report pending; parents report pt was cranky p/vax slep more following day; on 20JAN95 seem well; PMH pos agenesis corpus callosum; balanced trans
Itchiness to right arm, opposite of arm injected then itchiness spread to neck, bilateral cheeks, chest, knuckles, forearms and feet.  Redness to all sites noted.
Dizziness, patient did not eat breakfast. Patient assessed, Vital signs WNL. Patient refused transport.
May 1 - Room would spin when I rolled over.  Vertigo, sense of dizziness throughout the day, felt slightly nauseated due to it.  May 26 - felt like I was going to pass out when I was walking into a store - legs heavy, vision closing in, had to sit down.  June 3 - slightly nauseated - still sort of a sense of things being off spacially, dizzy June 12 - standing with a group at an celebration of life, suddenly felt hot, vision got a bit blurry, felt like I was going to pass out.  Went into another room and sat and drank water. June 19 - when I close my eyes while praying for someone I feel dizzy have to open them. June 21 -  another much worse bout of vertigo, couldn't walk, everything tilting,  Lasted a while. June 24 - Felt like I was going to pass out in the morning, bp up to 151/103  Basically VERTIGO (which I have never had), DIZZINESS and a sense of PASSING OUT.   All bloodwork fine, Dr. saying next step is ENT if this doesn't stop.
No additional AEs; temperature excursion and also reported that the vaccine, VAQTA was administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 01-AUG-2022, the patient was vaccinated with a dose of improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) lot # U033212, expiration date 07-NOV-2022 (dose and exact anatomical locations were not reported). Administered dose of vaccine experienced an unspecified temperature excursion (product storage error). No additional adverse events were reported.
Patient states she had 101 degree fever, headache, chills, malaise, lethargy for 48 hours.
Patient had broken out in a red stinging/burning rash on the inside of her (R) arm all the way down starting on 9/5/19. Patient came into the clinic on 9/6/19 was evaluated and given a kenalog shot and told to go to ER if she got woRse.
Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter) and PAIN IN EXTREMITY (Arm was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced CONTUSION (Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter) and PAIN IN EXTREMITY (Arm was sore). At the time of the report, CONTUSION (Bruise started developing with black and blue spots in the middle (about 1.5 inches diameter) and PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient reports swollen glands, blisters inside nose and mouth, achy body, and pain similar to his past shingle infections. Patient believes he is now having an outbreak of shingles. Patient also reports feeling overall very weak 48 hours after the vaccine.