chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in muscle in left arm. Cannot lift arm (left). Has been in pain for 1 month. Felt pain at injection, had gotten worse by 07/01 and could not lift arm.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 02/17/2021 and 03/10/2021. They became symptomatic for COVID-19 disease approx 12/27/2021 and tested positive via PCR test on 12/29/2021. They were hospitalized 12/29/2021-01/06/2022. They died at home on 01/12/2022. The individual had numerous underlying medical conditions.
Vaccine admin at 04:15pm on 03/17/2021. Patient began to have difficulty breathing and cold sweats at 04:20pm.  Paramedics were alerted and arrived at 04:31 pm.  They treated her for high CO2 level with oxygen and let her go.
Vaccine given on 11/19/08, on 11/20/08 patient presents with urticaria all over body. No distress.
Pt noticed erythematous papules around the injection site of the PNEUMOVAX on 9/14/12. The next day the area became warm and red.
Flu like symptoms- aches/headaches/chills for 36 hours. One and 1/2 week after, diffuse shifting burning pain back. Chills, very cold hands. Tingling in hands and legs, weakness in legs. She went to ER and put on prednisone which helped resolved symptoms.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756543A, A0756545A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA, and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
I came to see my Mom today and found her in bad shape. She was weak and had chills and said she felt on a cloud like she was dying. Her home health spoke to the Doctor on call who advised her to go to the hospital. The wound on her head may have been infected, or a possible UTI, or a vaccine reaction. But she had a marked difference in her wound per the home health nurse. She had chills and chest pain. She also had zero energy and felt like she was going to pass away. All I know is that isn't was a Pfizer vaccine given.
C/O redness, itchy and swelling around injection site 10/18/07 am. Seen by MD 10/19/07 at 400 pm. "Vaccine rx with hives may also represent Amoxil Rxn but coincident with vaccine". Benadryl and cool compresses.
Lasting side effect three months after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Lasting side effect three months after second shot) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Lasting side effect three months after second shot). At the time of the report, VACCINATION COMPLICATION (Lasting side effect three months after second shot) outcome was unknown.            No concomitant medications was provided. No treatment medication were provided.
Patient presented to the pharmacy on Monday 10/09/2017 with redness at site of injection. Area was warm to the touch. We suggested warm heat compresses and to have him draw a line around the red area to see if the area of redness spreads. Patient then returned to the pharmacy on 10/10/17 and the area of redness had spread beyond the outline. He decided to seek medical attention as he indicated the area was starting to tingle.
2) HPV vaccine reaction After she received the first HPV vaccine she shortly thereafter had vomiting, felt very faint, and felt very sleepy. She slept for about 3 hours and remained sleepy for the next 24 hours. She is wondering if it is safe for her to get the second HPV vaccine.
Mother states re-occurrence of "shingles" lesions below Rt eye 8 days after Gardasil #1 given. Child had not had outbreak in 2 yrs.
Eye floaters, blurry vision, black spots, flashing lights - left eye for nearly a month now
This spontaneous report as received from a registered nurse (reported as office manager) refers to a male patient of unknown age. The patient medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unkonwn date, 5 years after vaccination the patient experienced canker sores on his lips. The outcome of canker sores on his lips was unkonwn. The causality of canker sores on his lips was not reported. Additional information has been requested.
diagnosed with cancer after the first dose; patient received her first dose of Shingrix in August of 2019; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the cancer and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient receoved 1st dose of Shingrix and some point after vaccination diagnosed with cancer. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. This case was linked with case US2020202323, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202323:same reporter
Bursa; neck swelling and pain in arm become worse.; Pain in arm; shoulder area hurting; my neck area around is swollen/swollen neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURSA DISORDER (Bursa), SWELLING (my neck area around is swollen/swollen neck), CONDITION AGGRAVATED (neck swelling and pain in arm become worse.), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (shoulder area hurting) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced SWELLING (my neck area around is swollen/swollen neck), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (shoulder area hurting). On 16-May-2021, the patient experienced CONDITION AGGRAVATED (neck swelling and pain in arm become worse.). On an unknown date, the patient experienced BURSA DISORDER (Bursa). The patient was treated with Physical therapy for Bursa disorder. At the time of the report, BURSA DISORDER (Bursa), SWELLING (my neck area around is swollen/swollen neck), CONDITION AGGRAVATED (neck swelling and pain in arm become worse.), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (shoulder area hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   CT scan and blood clot test was performed but results were not provided.  on 16-May-2021 the neck swelling and pain in arm became worse.   Treatment medication includes Steroids   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received Patient demographics and clinical course updated, New events added, event terms updated. On 31-Jul-2021: Non signi ficant followup; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Croup  Bacterial Viral Infection  Sinuses/ Wheezing/Nasal Congestion   prednisoLONE 15 MG/5ML Oral Solution Instructions: Take 7.50 mL 1 times per day for 3 day(s) Inactive November 23 , 2022 Amoxicillin 400 MG/5ML Oral Suspension Reconstituted Instructions: 5 ML BY MOUTH TWICE DAILY FOR 10 DAYS Inactive  October 12 , 2022 Childrens Ibuprofen 100 MG/5ML Oral Suspension Instructions: 5 ml by mouth every 6 hours prn pain Inactive  October 12 , 2022 Culturelle Kids Oral Packet Instructions: once a day 1 pack po q day Dose: 1 Frequency: once a day
Can shingles vaccine cause pain in area of injection; Can shingles vaccine cause/shivering; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and shivering. On an unknown date, the outcome of the injection site pain and shivering were unknown.   It was unknown if the reporter considered the injection site pain and shivering to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient reported and enquired if the administration of Shingles vaccine could lead to pain in the area of injection and shivering.
Approximately 24 hours after injection, I developed a red blotch two inches below the injection site. It is painful and hot to touch . As of now (57 hours later) it is expanding in size, hot to touch, but is expanding downward toward hand.
Called back into room after visit by Nurse that patient's mother was concerned after vaccination. Pt re-examined immediately -found to be vomiting, wheezing throughout, sleepy/lethargic, tachycardia, no skin changes, no grunting, no nasal flaring. Nurse obtained vitals 02 Sat low 90's EMS called for presumed anaphylaxis -child was perfectly well prior happy and smiling prior to vaccination EPI PEN JR administered by writer Oxygen was obtained but not given as EMS arrived Albuterol given via continuous nebulizer by EMS while in route to ED. Hives noted in ED Patient discharged from ED.
Pt. experienced explosive episodes of diarrhea 6 days after administration of ROTARIX. Mother described as large, yellow, no blood, foul smelling stools for over 48 hours. Evaluated by medical provider.
Redness, and Pain at injection site. Fever. S/S for 24 hours. No cellulitis.
Pt recvd 3 doses of Hep B & titer was checked w/in last month & was neg; pt was a non-responder; reporting MD may recommend an addtl dose or doses;
07/21/2022  I woke up early and was sweating through my clothes. My clothes were damp.  I felt cold.  For a  half an hour to an hour I continued to sweat and feel cold. This continued for about 3 times a week.  I have an appointment to see my doctor about this.
The following afternoon after receiving experienced deep/extreme confusion. Now going in and out of stages of deep confusion.
12 hours after vaccination developed Palpitations, Tachycardia, Trouble breathing, Chest pain, and dizziness went to the Emergency room
Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Patient reported feeling throat closure feeling, throat scratchiness, tingling, and mild shortness of breath 12 minutes after vaccine. Patient chair also beside table with wrapped muffins containing nuts, doctor discussed possibility of peanut particles around but more likely a vaccine effects.
red pus filled bumps; fever of 100 degrees; It did wipe me out about 7 hours; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (red pus filled bumps), PYREXIA (fever of 100 degrees) and FATIGUE (It did wipe me out about 7 hours) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 303B21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid nodule (More nodules discovered on 4/21/21 via ultrasound.) in October 2016, Herpes simplex virus test positive (fewer cold sores) in 1965 and Vasovagal symptoms in 1980. Concurrent medical conditions included Penicillin allergy. Concomitant products included BORAGO OFFICINALIS OIL, FISH OIL, LINUM USITATISSIMUM OIL (OMEGA 3-6-9 [BORAGO OFFICINALIS OIL;FISH OIL;LINUM USITATISSIMUM OIL]) for Heart disorder and Inflammation, TURMERIC [CURCUMA LONGA RHIZOME] and ACHILLEA MILLEFOLIUM, CINNAMOMUM VERUM, HAMAMELIS VIRGINIANA (CINNAMONUM HOMMACORD N) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021 at 1:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (fever of 100 degrees) and FATIGUE (It did wipe me out about 7 hours). On an unknown date, the patient experienced PUSTULE (red pus filled bumps). On 08-May-2021, PYREXIA (fever of 100 degrees) and FATIGUE (It did wipe me out about 7 hours) had resolved. At the time of the report, PUSTULE (red pus filled bumps) outcome was unknown.            Concomitant medication include Sundown Omega 3-6-9 and used for Heart, Health, Skin. No treatment medication information. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   This case was linked to MOD-2021-076646 (Patient Link).
I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were being ripped apart, tired/fatigue, blurry vision, dizziness, my body felt hot from the inside out, tingling sensation in feet and hands.
shortness of breath and difficulty breathing; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 02Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced shortness of breath and difficulty breathing on 03Mar2021. Therapeutic measures were taken as a result of shortness of breath in the ER with Prednisone. The Patient wanted to know whether she could take second dose after this. The outcome of the event was unknown.   No follow-up attempts are possible. No further information was expected.
This patient came in for a flu shot.  I had previously picked flucelvex for this 4 year old patient, however, after talking to his mother, I decided to change to flublok due to his allergy to eggs.  I didn't realize that flublok was not age appropriate until after the vaccine was already administered.  There were no adverse effects that I am aware of.  I contacted the manufacturer and they told me that the dose doesn't need to be repeated and there are no safety concerns.  They do have data on pediatric patients.
Perhaps slight numbing of upper lips anxiety attack (dizziness, lightheaded, increased blood pressure, racing heart, shaking.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), on 29Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ibs" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clexa, reaction(s): "Drug Allergy: Clexa", notes: Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 23Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
as they were administering the vaccine half of the product leaked out with no reported adverse event; needle broke off the syringe at the tip with no reported adverse event; Initial information received on 22-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 77 years old male patient who experienced as they were administering the vaccine half of the product leaked out with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Dec-2021, the patient received 0.7mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ766AA, expiry date: 30-Jun-2022  via intramuscular route in upper shoulder right administration site (formulation and strength not reported) as prophylactic vaccination. First time product used : Yes   On 22-DEC-2021 the patient developed a non-serious event "needle broke off the syringe at the tip with no reported adverse event "(needle issue) (latency same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 22-DEC-2021 the patient developed a non-serious event "as they were administering the vaccine half of the product leaked out with no reported adverse event" (product leakage) (latency same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Caller states that as she was administering the product the needle broke off the syringe at the tip. Caller states that more than half the product leaked out and at least three drops splashed onto the HCP's (healthcare professional) glasses"  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (needle broke off the syringe at the tip with no reported adverse event, as they were administering the vaccine half of the product leaked out with no reported adverse event).  At time of reporting, the outcome was Unknown for the event needle broke off the syringe at the tip with no reported adverse event and was Unknown for the event as they were administering the vaccine half of the product leaked out with no reported adverse event.
Patient presented to the health department requesting flu shot. Patient wrote her age as 63 and then her DOB differently. When selecting type of flu shot I chose Fluarix for patient under 65. Patient may have requested Fluarix, but I have been unable to reach her by phone to confirm. Patient was eligible for high dose flu and did not receive one.
patient came back to pharmacy today as his md advised him to report to us rash on upper left chest, swollen lymph nodes on left under arm,  and lower right side stiffness
Severe chills within 5 hours of shot. Awoke at 2:30 AM (about 9 hours after shot) with fever of 101.5 that climbed as high as 101.8 by morning. Accompanied by body aches, mild headache. Took Acetaminophen occasionally over 24 hours, but lower fever (100.8) persisted each time after medicine wore off. Limbs are sore. Slight soreness at injection site but more soreness in ankles/lower limbs. About 24 hours in, I noticed 2 faint red splotches on my stomach and chest.
Teeth Chattering Chills, possible fever, Muscle Ache, Headache, queasiness-treated with ibuprofen.  Listed symptoms started at approximately 12:30 am and did  not break until approximately 5:45 am.  Continued Headache and Muscle Ache as well as queasiness throughout the day on 4/24 and now thru 5:30 pm on 4/25.   Treating with Aleve at this time.
Fainting, blackouts,( stroke symptom of left  eye blackout) , fatigue, dizziness,  inability to focus , headaches
pt recvd vax w/no apparent adverse local rxn when given vax on 21DEC95; pt exp 2cm reddened area w/hard knot
Patient got her first dose of COVID -19 vaccine Moderna at 11;16 am. She stated feeling like her tongue was swelling. She was alert, able to talk and vital sign stable.  Denies any SOB, chest pain and palpation. Administered Epi x once and Benadryl IM 50 mg and Pepcid 40  mg oral. 1 liter of fluid bolus given, vitals taken frequently, an d EKG done. Patient monitored and stable.
Erupted with pox on 03/12/2002. Had received varivax on 09/28/1998 and had about 30 lesions on 03/13/2002. When seen by PCP, mildly pruritic, afebrile.
Received 2nd dose Moderna on 1/26 next day on 1/27 reported left arm limited strength to lift arm above shoulder On 1/27 assessed to able to move LUE with full ROM, warm to touch, pink, denies numbness tingles  On 1/27 encouraged to see doctor if continues with concern or decline On 1/28 offered no c/o as using left arm without noted difficulty
Dizziness, light headed ness and racing heart one minute after vaccine. The occurred again another 40 minutes later. Symptoms resolved but now chest pain and dizziness occurring each night when trying to sleep with chest pressure and dizziness upon awakening.0