chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty lifting her left arm, and difficulty lifting objects to a certain point with her left arm; Since the vaccine was administered, pain in the left deltoid (the site of administration); Initial information received on 28-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves 27 years old female patient who experienced (since the vaccine was administered) pain in the left deltoid (the site of administration) and difficulty lifting her left arm, and difficulty lifting objects to a certain point with her left arm while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Pregnancy: No   On 20-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE , formulation: injection, (dose, strength, expiry date and lot number not reported via unknown route in left deltoid administration site) as prophylactic vaccination.  On 20-OCT-2021 the patient developed a non-serious event "since the vaccine was administered, pain in the left deltoid" (the site of administration) (vaccination site pain) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 20-OCT-2021 the patient developed a non-serious event "difficulty lifting her left arm, and difficulty lifting objects to a certain point with her left arm (limb discomfort) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "The patient received FLUBLOK QUADRIVALENT on 20OCT2021 by a nurse at her place of employment. Since the vaccine was administered, the patient has experienced pain in the left deltoid (the site of administration). The pain started immediately after the injection. The patient complains of pain in her left arm, difficulty lifting her left arm, and difficulty lifting objects to a certain point with her left arm. The Chiropractor stated that he has tried to work with her, but there has not been any improvement. The Chiropractor was not sure of any other treatment or if the patient has seen her Primary Care Physician for treatment. The caller stated that the patient may have tried pain medication and that it would have been all over the counter, but he was unsure."  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  Corrective treatment (pain medication) was received for the event (Since the vaccine was administered, pain in the left deltoid (the site of administration)). It was not reported if the patient received a corrective treatment for the event (difficulty lifting her left arm, and difficulty lifting objects to a certain point with her left arm).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event since the vaccine was administered, pain in the left deltoid (the site of administration) and was Not Recovered / Not Resolved for the event difficulty lifting her left arm, and difficulty lifting objects to a certain point with her left arm.
TIREDNESS; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 04-FEB-2022) dose was not reported, administered on 17-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported. On 18-MAR-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20220752348. This case, from the same reporter is linked to 20220754682.
Swelling / redness with 3 cm x 2 cm red area L post 1 cat aspect
had severe diarrhea for 5 days  I took pedialyte and drank lots of water
Medical professional drawing up vaccine dosage drew up 1.0ml instead of the recommended dosage of 0.5ml
Pt received a MMR vaccine on Wed around noon - 4/15/12. Throughout the night, after midnight dev. itching 4/26/12. Dev blistery rash on (L) elbow/wrist 4/26/12 at work. Fine flat rash dev on neck, breast & abd. Today feeling worse - body aches, itchy, no fever, "red all over". Enc. BENADRYL & seek emergency care if hives, etc.
Pfizer on 3/8 and 3/29. Positive on 9/23
Patient reported painful swelling on her left upper arm.  She said it was extremely red...tight and the muscle was very hard.  The reaction was more than she's ever had with any vaccine.  It did get better over the next week few days.  It was still red over the upper arm at 6 days...but the swelling had come down.
On the next day after receiving the shot, I became extremely cold late in the evening about 7:30 p.m. but, later at 1:00 a.m. until about 6-8 am, I experienced mild fevers, mild headaches, swollen and sensitive arm.
got both Pfizer boosters; got both Pfizer boosters; SARS-COVID RNA U01.7, she got the delta [variant]/diagnosed with Omicron; SARS-COVID RNA U01.7, she got the delta [variant]/diagnosed with Omicron; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "unknown" and all described as "SARS-COVID RNA U01.7, she got the delta [variant]/diagnosed with Omicron"; OFF LABEL USE (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "got both Pfizer boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive, notes: diagnosed with Omicron.  Additional information: The patient was diagnosed with Omicron yesterday and was told Paxlovid could help her. However, she can't swallow pills. She needed to crush it in applesauce. She just went this morning for monoclonal antibodies [instead of PAXLOVID] because she did find out she cannot crush or open [PAXLOVID] in any way. She was hoping the antibodies work. She got vaccines, the first to get them in Jan and then she got 3 months later or a month later whatever, the second vaccine and then they got both Pfizer boosters and they were happy they didn't have any side effects from it at all. They felt really good and they felt very safe. She got SARS-COVID RNA U01.7, she got the delta [variant] and when she came down with this she was really surprised because they thought they were protected and they were also happy that labs such as Pfizer were coming out with ways to help them. She had a car accident because of that she had a concussion and it left her with a problem swallowing pills so she had to opt for the monoclonal antibodies. Stated the scientists that have done so much, labs that have done so much to help the whole world to survive this horrible pandemic.
Breaking out on her upper thighs/ big lesions then spread to arms, chest and whole body; Having trouble picking things; Fatigued; 2 different types of eruptions; Hyper reaction to flu vaccine; This spontaneous case was received on 05-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-02890) and concerned a 76-year-old female patient.  The patient's concurrent conditions included allergy to sulfa which caused her muscle paralysis, and meloxicam allergy. The patient was not taking any concomitant medications and stated she was very healthy.   On 08-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml; anatomical location: deltoid; route of administration: not reported) for influenza prophylaxis. The batch number and expiry date were not reported. The patient had no problem at the time of administration.  On 10-Sep-2020, two days after receiving Afluria Quadrivalent, the patient was fatigued, had trouble picking things up and started breaking out on her upper thighs, it was tiny at first, then by the second week had developed into big lesions then spread to arms, chest and whole body.  On an unknown date in 2020, the patient saw dermatologist that reported the patient had two different types of eruptions and diagnosed her with hyper reaction to flu vaccine. She was prescribed prednisone, at dose of 40 mg, for two weeks and a return appointment on 29-Oct-2020.  On 02-Oct-2020, the patient started treatment with prednisone, at dose of 40 mg.   At the time of initial reporting on 05-Oct-2020, the patient had not recovered from events 'fatigue' 'hypersensitivity reaction' and 'movement disorder' but was recovering from events 'skin lesion' and 'skin eruption', as it was reported that the rash was much improved.  The events 'hypersensitivity reaction', 'skin lesion' and 'skin eruption' were considered to be medically significant by a Physician within Seqirus's Department.  The reporter assessed the event of 'hypersensitivity reaction', 'skin lesion' and 'skin eruption' to be related to Afluria Quadrivalent. The reporter did not provide a causality assessment for other events.  Company comment: Hypersensitivity, skin lesion, rash, movement disorder and fatigue were associated with the use of the suspect product - Afluria Quadrivalent. Causality was assessed as possibly related  for all events due to plausible chronology and absence of any other confounding factor.; Reporter's Comments: The patient saw dermatologist that reported the patient had two different types of eruptions and diagnosed her with hyper reaction to flu vaccine.; Sender's Comments: Hypersensitivity, skin lesion, rash, movement disorder and fatigue were associated with the use of the suspect product - Afluria Quadrivalent. Causality was assessed as possibly related  for all events due to plausible chronology and absence of any other confounding factor.
Felt like flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Felt like flu) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 027B21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA (Felt like flu). On 03-Apr-2021, INFLUENZA (Felt like flu) had resolved.            No relevant concomitant medications were reported. No treatment details were reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-127980 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non-significant follow-up appended. On 22-Jul-2021: Follow  up information contains Reporter's Address. On 28-Jul-2021: Follow-up information include no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127980:Case for husband
18 months stopped sleeping through night. 18 months started losing speech-stopped saying words, only said sounds like "da, ga, woo." Diagnosed with autism.
I noticed sudden, profound symptoms of Tinnitus within a few days of receiving this booster. Loud ringing in the ears that had no relief. I've since been exhaustively tested to eventually get some relief when wearing hearing aids with a tinnitus masker. However, I still cannot sleep as I don't wear the hearing aids at night and other sound maskers are insufficient. I am told this is now permanent.
This case was reported by a healthcare professional (pharmacy student) and described the occurrence of swelling injection site in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included Tdap; GlaxoSmithKline; unknown; unknown given on an unspecified date. On 8 March 2013 the subject received 1st dose of BOOSTRIX (.5 ml, unknown details). In March 2013, within days of vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site pain. The reporter stated that the subject experienced "localized swelling and pain at the injection site after he received his shot of BOOSTRIX. The patient came back to the hospital" on 11 March 2013. The subject was treated with BENADRYL and ibuprofen "to treat his reaction." At the time of reporting the outcome of the events were unspecified.
Hard, swollen, hot, itchy, red.   Size evening of injection was approximately 1" diameter.  Next morning was 3" diameter and now 48 hours later, spreading has grown to 5" diameter.
She received her vaccine on 12/28/2021. After the vaccine, her right arm arm was extremely sore and then around 01/07/2022 she started having mild headaches and a bit of a cough. She felt like she needed to clear her throat and felt fatigued. I took her to a local health care facility. No exams were performed. She tested positive for Covid on 01/15/2022 and retested on 01/20/2022 where she tested negative. As for today, she has severe headaches and extremely fatigued, coughs and gets congested out of the blue.
Patient is an employee of the hospital and arrives to the vaccination area requesting to get the third dose PFIZER. Patient fills out the document. PFIZER vaccine is administered and when requesting the CDC card we realized that she had the first two doses of MODERNA. Patient reports not knowing that it was not PFIZER. We follow up by phone and she reports feeling good. Booster dose (third) PFIZER was administered to patient with MODERNA primary series without presenting adverse affects.
Received 2nd shot on April 24. Started having adverse reaction on April 27. Itchy rash, swelling and hot to touch.
pt states that she has developed a itching red rash  with swelling of the face, eyes, neck, and forearms.  She is also has fatigue.
lymphedema under arm, collarbone; Fatigue; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 11:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 20Apr2021 at 11:15, the patient experienced lymphedema under arm and collarbone, fatigue, headache, chills and fever. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events lymphedema under arm and collarbone, fatigue, headache, chills and fever were unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by other health professional via sales rep and described the occurrence of generalized rash in a female patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance to the previous dose of Flu vaccine refer case US2016GSK169577). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. The reporter considered the generalized rash to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not provided. The patient had injection site rash which spread to chest and body. This was 6th case of 6 cases reported by the same reporter. This case was linked with US2016GSK169577 for the same patient.
Patient received an Measles, Mumps, Rubella, and Varicella in a combo injection and a separate varicella. Resulting in two varicella vaccines on the same day.
I tested positive for COVID-19 on 2/27/23. I had a bad headache first, coughing, fatigue, runny nose, and loss of appetite. I contacted my doctor and was prescribed PAXLOVID, doxycycline hyclate, albuterol, and prednisone. I also took vitamin B12 and vitamin C. It took me about four weeks to get over the cough.
Fever NOS on 2013-01-16, clinician comment: Fever less than 24 hrs after vaccination, no focus, no sign of illness.
On or about  August 13, 2022, I began noticing in the mid day I had serious aching pain and tenderness in my groin area on both sides.  It was very tender to touch.  I tried to ignore it.  It gradually got worse.  It continued to get worse even when I was sitting.  This lasted about a day and a half.  It didn't keep me from sleeping.  The tenderness just gradually faced away.  I visited the doctor at my scheduled appointment on August 19, 2022, but the problem had resolved by then.
Severe migraine lasting several weeks.   Re-onset of severe inflammatory response in lower extremities, causing muscle tightness and pain, including plantar fasciitis and athletic pubalgia (previously diagnosed one week following first COVID booster shot).  Prior to the boosters, I never experienced plantar fasciitis or pubic pain.  Before the boosters, I ran 6 miles per day, but due to the inflammation and muscle tightness, I am unable to run for more than 2 minutes at a time without further aggravating the inflammation.    My orthopedist prescribed Diclofenac 75 mg for 2 weeks to address the inflammation since I am not able to take prednisone.  The Diclofenac has helped, but not fully resolved the issue.
booster dose given to patient too soon. 2nd dose received on 05/14/21. patient ineligible until 11/10/21 at earliest.
Shortness of breath, tingling sensation starting in legs and slowly moved up my body, rapid heart beat, high blood pressure, breathlessness, severe uncontrollable shaking
EXTREME THIRST THAT COULD NOT QUENCH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, after 8 to 12 hours the subject experienced extreme thirst that could not quench. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme thirst that could not quench on MAR-2021. This report was non-serious.
Pt was given adult dose COVID vaccine instead of pediatric dose.  She did not have any reported side effects or adverse events.  Mother notified of event.
Information has been received from a physician concerning a male infant who was born from a 17 year old female with history of anger issues, who on 03-DEC-2008 was vaccinated with the second dose of GARDASIL (Lot 660553/0070X). It was reported that the patient's mother received her first dose over a year ago. Concomitant therapy included HAVRIX and hormonal contraceptives (unspecified). It was reported that the patient's mother (G2P1) got 2 doses of GARDASIL prior to delivery (WAES0812USA00560). On 24-JUN-2009, the patient's mother delivered the infant weighing 3308g with an Apgar score of 9/9 via C-section due to decreased fetal heart rate. His newborn metabolic screen was normal and his newborn hearing screen was normal. He received his first immunization of HBV on 26-JUN-2009. At his first well child visit on 01-JUL-2009, his physical examination was within normal limits including his heart and pulses. No murmurs were heard. The patient was considered a well "FI" newborn. Additional information is not expected.
Patient DOB 11/25/1942 passed away at Hospital on 11.3.22.  He was admitted to another Hospital on 10.31.22 and diagnosed with COVID-19 on 10.31.22.
felt warm; shortness of breat; running fever; Dizzy; red face and flushing about 6 hours later; red face and flushing about 6 hours later; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red face and flushing about 6 hours later), FLUSHING (red face and flushing about 6 hours later), SKIN WARM (felt warm), DIZZINESS (Dizzy) and DYSPNOEA (shortness of breat) in a 66-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.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ERYTHEMA (red face and flushing about 6 hours later), FLUSHING (red face and flushing about 6 hours later) and DIZZINESS (Dizzy). On an unknown date, the patient experienced SKIN WARM (felt warm), DYSPNOEA (shortness of breat) and PYREXIA (running fever). At the time of the report, ERYTHEMA (red face and flushing about 6 hours later), FLUSHING (red face and flushing about 6 hours later), DIZZINESS (Dizzy), DYSPNOEA (shortness of breat) and PYREXIA (running fever) outcome was unknown and SKIN WARM (felt warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient fully vaccinated with Moderna COVID 19 vaccine. First dose was 12/29/20 and 2nd dose 1/27/2021.  Patient was tested routinely with COVID 19 PCR test on Friday 3/12/2021 per facility protocol. No COVID S/S reported or observed. Result came back presumptive positive on Saturday, 3/13/2021. Was retested on 3/13/2021. Result came back positive on Sunday 3/14/2021. Patient was transferred out to a COVID CRC facility.
Chest pain within 12-24 hours of second Moderna Vaccine with associated fevers/chills & myalgias
mom states pt became ill w/fever, h/a in the PM p/receiving hep B #1 t101, nausea/no vomiting;
Patient received booster 5 days before he should have. 1 day before the allowable 4 days.
After immunization patient sat down and after a few minutes lay down on the floor on his side on his own. He began to snore for at most five seconds then his body jerked back and forth for at most five seconds then he became conscious. He lay down for ten minutes, and sat upright for thirty minutes. An ambulance was called but he refused to be taken to the hospital.