chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received severe pain I can't walk; I received severe pain I can't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FK9896) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: Verbatim: Lupus; "blood pressure stable" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for systemic lupus erythematosus; OLMESARTAN taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization, reaction(s): "I had no reactions from the first two shots"; Bnt162b2 (Dose:2), for Covid-19 Immunization, reaction(s): "I had no reactions from the first two shots". The following information was reported: PAIN (non-serious) with onset 29Jan2022, outcome "unknown", described as "I received severe pain I cant walk"; GAIT DISTURBANCE (non-serious) with onset 29Jan2022, outcome "unknown", described as "I received severe pain I cant walk". The events "i received severe pain i cant walk" and "i received severe pain i cant walk" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.   Additional information: NDC number, UPC number and Expiry Date  of Covid 19 Vaccine was unknown. Concomitant products Hydroxychloroquine and Olmesartan Start and Stop date was unspecified. It was reported Investigation assessment was yes. On Thursday she received the booster shot. By Saturday evening she had received severe pain she cant walk. On Sunday she could not walk. Today Is Saturday almost a week later, the pain are so severe she cant walk. Patient have been to the hospital (further clarification unknown) they cant do anything. She had gone to a doctor he gave some information nothing is working (further clarification unknown), the pain is preventing from walking, so she don't  Know what else to do the pain is so severe. She had to be in pain until Monday. There is nobody can help she with she cant walk the pain is so severe. She will try as she said she was in extreme pain here but she will try because nobody should have to go through this, she followed all the directions she took the shots and now she suffering so badly loosing time from work it is just painful. Consumer stated, you want the number where it was done. RA10648 (further clarification unknown) the first two vaccines were done at withheld, the third one was done at withheld drug store. Patient started treatment yesterday it was Meloxicam because the pain is so bad. Dose of Meloxicam 7.5 mg 1 tablet every day. she just started last night. Consumer stated they went for at the hospital they did a blood work. They did a CAT scan and she also had an MRI done to find out what is causing this pain.  No follow-up attempts are possible. No further information is expected.
Within 30 minutes of receiving vaccines the child developed face, lip and mouth swelling, full body rash.  Went immediately to the ER (which is in the same building as the Dr. Office) received IV Benadryl, IV Decadron IM epinephrine, HHN Albuterol observed until 8pm, swelling decreased and discharged with Decadron and Benadryl po for 24 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 5 (booster), single (Lot number: 693274), in right arm and on 09Aug2023 as dose 6 (booster), single (Lot number: GK4974) at the age of 77 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in right arm, on 15Dec2021 as dose 3 (booster), single (Lot number: 303308D), in right arm and on 12Jul2022 as dose 4 (booster), single (Lot number: FP7139), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes B" (unspecified if ongoing); "reflux" (unspecified if ongoing); "unable to metabolize folic acid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: milk protein" (unspecified if ongoing); "Known allergies: gluten" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR], start date: 01Jan2017; METANX, start date: 01Jan2019; DEPLIN [LEVOMEFOLIC ACID], start date: 01Jan2019; PANTOPRAZOLE MYLAN, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment". Clinical course: Symptoms started 01Sep2023, felt like a chest cold. Felt ill and got tested for Covid and flu on 03Sep2023 at (withheld) (Labor Day weekend). Was prescribed Paxlovid and started taking it that night. The patient underwent the following laboratory tests and procedures: Influenza virus test: (03Sep2023) Positive; (09Sep2023) Negative; SARS-CoV-2 test: (03Sep2023) Positive; (09Sep2023) Negative. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 03Sep2023 to 07Sep2023.
Pain started in left arm & moved to right arm on 9/30/12 joints in hands, wrist were swollen, achy & red. Gradually dissipated was completely resolved by 10/3/12.
2nd dosage but similar side effects as the first dose:  Chills, body aches,  nausea
Tinnitus in right ear. Constant fluttering and pulsing sound. Have never had this occur prior to getting the vaccine.
Patient returned to clinic on 9/3/08 stating that her private physician thought she might have had on adverse reaction to MENACTRA due to ? latex allergy - she reports nausea, vomiting, and decreased appetite with onset about 24 hours after vaccination which was resolved in - 10 days-
Had the shingles shots / shingles in eye/s uspected vaccination failure; shingles in eye / excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and still got shingles in the eye. It was excruciating even with antiviral and antibiotic. The patient stated that he/she thought that the shots prevented shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fatigue, dry skin, extreme fatigue, light headed, headache, increased menstrual cramps, Raynaud's disease, weight loss, hair loss, joint pain, facial rash, extreme joint pain, body rash.  9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. Assesment: Systemic Lupus Erythematosus. Vitiligo. Patient presented with progressive fatigue and weight loss with impaired functional capacity. Joint pain, swelling, and stiffness at PIPs, MCPs and wristes. Malar rash and Raynauds of feet. Leukopenia, anemia. Inflammatory polyarthropathy.
Narrative:  Patient received Moderna Covid vaccine #1 on 2/25/21. There are no notes in database system or scanned records to indicate what happened from that date until his date of death on 3/19/21. There were 22 days from vaccine to date of death, no autopsy report available.
One patient 14 years old received their first dose of the Moderna vaccine; A spontaneous report  was received from a pharmacist concerning a 14-year-old patient who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273) at the age of 14.  The patient's medical history was not provided. Concomitant product use was not provided.  Between 11 Jan 2021 and 21 Jan 2021 (date not specified), the patient received their first of two planned doses of mRNA-1273 (No Specific Batch numbers provided: 011L20A - 013L20A - 039K20A)  intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date in Jan-2021 (between 11/Jan/2021 and 21/Jan/2021), at the age of 14, the patient received their first dose of vaccine.  Action taken with mRNA-1273 in response to the event was not provided.  The event, one patient 14 years old received their first dose of the Moderna vaccine was considered resolved on an unspecified date in Jan-2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011617: US-MODERNATX, INC.-MOD-2021-011581:
11/01/2021 thru 11/11/2021..  Daily sore muscles, mostly upper legs and calves, but could also be shoulders and forearms.  Eventually required Tylenol 1000mg every 6 hours and Lidocaine gel.  This daily pain increased daily until I feared standing or walking because this would intensify the pain.  After several days, I developed chills/shakes and severe sweating.  Temp ranged from normal up to 101.8.  ER visit on Saturday, 11/6  and sent home after labs done.  Saw PCP on 11/9, labs ordered.  Cardiac ablation (scheduled) done on 11/11.  Prednisone started 11/12 per PCP for abnormal lab.  Aching muscles was gone until prednisone X 5 days done, then returned but more mild in forearms and upper legs.  Now also severe fatigue.  No temps.
Systemic: PT STATES NUMBNESS IN HAND CANT MOVE THUMB-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium.
Soreness at injection site; Flu like symptoms; Lack of energy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2019, the patient received the 1st dose of Shingrix. On 1st June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms and loss of energy. On 2nd June 2019, the outcome of the injection site pain, influenza-like symptoms and loss of energy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and loss of energy to be related to Shingrix.  Additional information received were as follows: The patient received the Shingrix in right arm. The patient had injection site pain, influenza-like symptoms and loss of energy. The patient planned to follow up with her physician on an unknown date. The reporter did not consent to follow up. Limited information was provided.   The patient did not want to answer questions for this report and wanted to remain anonymous.
This initial spontaneous case, was received from other health professional on 29-Sep-2017, concerning a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On unspecified date in Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 186866, expiry date: May-2017, route of administration and anatomical location: not reported). The patient received the expired vaccine (explicitly as expired vaccine used). The reporter assessed  the report as non-serious.
immun 23AUG94, sleepy 24AUG94 almost exactly 48 hrs p/vax devel erythema on neck, cheeks, forehead & temples & irritability;
This spontaneous report was received from a registered nurse, and refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On multiple unspecified dates, the patients received improperly stored doses of RECOMBIVAX HB, lot number M036156, expiration date 23-FEB-2019, for prophylaxis (routes of administration were not provided). On unknown dates, the doses of RECOMBIVAX HB underwent temperature excursions of 9 degrees Celsius (°C) to 25°C for a time frame of 1 hour and 9°C to 25°C for 10 minutes, which were detected by the data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA010721: US-009507513-1709USA012219: US-009507513-1709USA010721: US-009507513-1709USA012222.
Information has been received from a physician and a licensed visiting nurse concerning an 18 month old hispanic male with asthma and an egg allergy who at 11:03 on 29-NOV-2006 was vaccinated SC in the left leg with a "half dose" (also reported as 0.3) of MMR (lot # 649818/0729R) and was vaccinated with the other "half dose" (also reported as 0.3) of MMR (lot # 649818/0729R) at 11:30 on the same day. The patient returned to the clinic two hours later with a generalized urticarial rash all over his body and bronchospasm. The patient was given epinephrine and BENADRYL. On an unspecified date a serum multiallergen radioallergosorbent test showed a class IV egg allergy. On 30-NOV-2006 the patient recovered from the urticarial rash. On an unspecified date the patient recovered from bronchospasm. There was no product quality complaint involved. No other information was provided. Additional information is not expected.
Within ten days of receiving the vaccine, the patient began experiencing excruciating headaches. She described the pain stating, "It feels like my head is in a vice and someone is turning the crank." She has headaches nearly everyday. She has been seen by her family doctor, neurologist, & neurologist. To date she has not gotten any relief from her headaches.
Fever, vomiting, pink swollen area surrounding vaccine scab. No induration, right leg.
SICK; WICKED HEADACHE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (dose series 1, manufacturer not specified) for prophylactic vaccination. No adverse events associated with past vaccination (dose series 1,manufacturer not specified) were reported. The patient received an additional company suspect covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: 204B21A expiry: Unknown) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-OCT-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose series 2), the patient was sick and was having a wicked headache. On an unspecified date in OCT-2021, the patient took Tylenol (paracetamol) for the headache The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and wicked headache. This report was non-serious.
Patient states that after her 2nd shot, her arm is red and swollen. Has subsided but overall hasn't gotten better.
Initial report received from a healthcare professional on 19 September 2013. A female patient who had history of nickel allergy and concomitant medication were not reported, had received a dose of Tetanus toxoid (Manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient had reaction due to nickel allergy. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Fevers high as 104.4 Came down with Tylenol x3 Severe body aches  Headache  Dizziness  Baseball size lump under armpit of injection site arm 2 days post injection.
Initial unsolicited report received from a Consumer (patient mother) on 04 October 2016. This case involves a five-year-old female patient who was vaccinated with a dose of FLUZONE (batch number-U2169NA, expiry date not reported) by intramuscularly in thigh on 25 October 2006. The patient had allergy to penicillin and illness at time of vaccination was none as per reporter. Concomitant medications was not reported. On an unspecified date following the vaccination, the patient had experienced a large amount of swelling, redness, and pain from knee to hip. Lab data and corrective treatment were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
shaking; fever; arm started to hurt; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm started to hurt), TREMOR (shaking) and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, DICLOFENAC SODIUM, LINUM USITATISSIMUM, MENTHOL, METHYL SALICYLATE, THIOCOLCHICOSIDE (INSTAFLEX) and CETIRIZINE HYDROCHLORIDE (ALLERTEC) for an unknown indication.    On 31-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt). On 01-Feb-2021, the patient experienced TREMOR (shaking) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm started to hurt) and TREMOR (shaking) outcome was unknown and PYREXIA (fever) was resolving. Not Provided      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.
local skin rash, +induration, + erythema,  Full ROM, 2+ pulses
Patient felt faint right after receiving the COVID-19 Pfizer vaccine. He laid down with legs elevated. He did not loose consciousness and talked to us the whole time. After 15 minutes or so, he felt it was okay to sit up, so he did. He drank some water but then immediately vomited. Paramedics were called after this occurred. They came, assessed the patient and declared him healthy/well. Patient walked out of the pharmacy with no help. He went home with his family who was there with him.
This spontaneous report as received from a nurse refers to a 66 year old male patient. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On 22-OCT-2015, at the age of 65 year old, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot number, expiration date were not provided). The patient did not recall receiving that dose and did not have documentation. As a result, on 24-FEB-2017, at the age of 66 year old (two months before his 67th birthday), the patient was vaccinated with a second dose of PNEUMOVAX 23 (dose and route of administration were not provided, lot # M013156, expiration date 15-OCT-2017). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.
3/11 (day of vaccination): Very sore arm, tenderness at the injection site 3/12: sore arm, tenderness at the injection site, headache in the afternoon, tiredness all day 3/13: mild arm soreness and tenderness at the injection site  First pregnancy, due 9/10/21
Substantial body aches, unrelenting headache, fatigue, negative thinking,  general malaise. Had to close my shop and lose business (would only do that if it knocked me off my feet)!
The top of child's right thigh became slightly red one day after vaccines given. Reddened area became progressively bigger area over next 2 days. Came for office visit and area was up to 8 cm at largest point. Area was hot to touch and tender as well.
lightheaded; tired; fuzzy-minded; weak feeling; This is a spontaneous report from a contactable consumer (Patient). A 75-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on 26Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date patient experienced lightheaded, tired. On 30Aug2021 patient experienced fuzzy-minded, weak feeling. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial misuse report received from a healthcare professional on 20 November 2013 and on 21 March 2014. A '02-weeks-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE, PREVNAR, PEDIARIX on an unspecified date, and no adverse event was reported, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
After vaccine in May 2021, June and July started getting serious headaches for weeks, pressure in head stopped me from thinking. Went off work on disability for 3 months, lost sense of taste, couldn't speak probably, couldn't concentrate.
Pregnant with due date of November 11, 2021 Red, itching, and hard nodule at injection site Pain throughout arm
This spontaneous report as received from a pharmacist refers to unspecified number patients of unknown age and gender. The pharmacist reported that on unknown dates other unspecified pharmacist administered ZOSTAVAX (strength, dose, lot # and route were unknown) to an unspecified amount of unspecified patients "behind the arm," clarified as in the back of the arm, lower than the deltoid region. Pharmacist reported he had never done this himself, but reported he and other unspecified pharmacist had all been specifically trained to administer ZOSTAVAX in this manner. It was unable to be asked whether any patients experienced adverse effects as a result. No additional information provided. The outcome of the event was unknown. Additional information has been requested.
My feet and legs became very swollen around day 4 after taking vaccine dose 1 and day 5 after taking vaccine dose 2. I went to my primary care doctor the first time they were swollen and he did blood work, but couldn't determine a cause. He prescribed a medication that helps remove fluid. The swelling went down and came back after taking the 2nd dose of the vaccine. It has been over a month since last dose and my feet and legs constantly swell and then go back down. I haven't gone back to my doctor, but I plan to make an appointment this week.
Sudden fatigue and lightheadedness. Patient leaned back in car seat and AC turned on. Drank water. HR 70s, O2 98%. CV and lung exam nl. R facial numbness. CN II-VII o/w nl.  Symptoms subsided after interventions above.
i hour post vaccination describes feeling distended, gassy, hiccups for 15 minutes followed by flush and sweats.  To OHS where placed on O2 with rebreather bag; BP 140/90, O2 Sats continued at 93 and removed from o2. Observed for 1 hour 30 minutes.  breath sounds clear, respirations 1, Temp 98.1.  Released to home per Taxi.  Referred to PMD.