chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain in left arm; Patient could not use or lift her left arm; Sensitivity and pain in top of head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme pain in left arm), MOBILITY DECREASED (Patient could not use or lift her left arm) and HEADACHE (Sensitivity and pain in top of head) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Extreme pain in left arm), MOBILITY DECREASED (Patient could not use or lift her left arm) and HEADACHE (Sensitivity and pain in top of head). At the time of the report, PAIN IN EXTREMITY (Extreme pain in left arm), MOBILITY DECREASED (Patient could not use or lift her left arm) and HEADACHE (Sensitivity and pain in top of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 and contain no new information.
No additional AE reported; HCP reported VARIVAX was administered to patient after a temperature excursion.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U020238, expiration date: 28-JUN-2023 (dose regimen, route of administration and anatomical location were not provided), as prophylaxis (Product storage error). No adverse events (No adverse event) or product quality complains were reported.  The improper storage lot # underwent a temperature excursion of -8.3 degrees Celsius (C) for about 1 hour and 1 minute without previous excursions.  This is one patient of three received from the same reporter.; Sender's Comments:  US-009507513-2207USA003330: US-009507513-2207USA003332:
Initial report was received from a pharmacist on 21 Dec 2009: This patient (3 year old child) was vaccinated with H1N1 (batch no. 101326) on 15 Dec 2009. No adverse event was reported.
This spontaneous report as received from an office manager refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and historical drugs were not reported. On 16-NOV-2017, the patient was vaccinated with improperly stored dose of M-M-R II (rHA)lot # N010495, expiration date 31-MAR-2019 (dose and route were not reported) for prophylaxis; reconstitute with sterile diluent which was properly stored. No adverse effects reported. The temperature involved was 9 degrees Celsius to 25 degrees Celsius for 3 hours and 8 minutes. Previous temperature excursion was not reported, and a data logger was involved.
This initial spontaneous case, was received from other non-health professional, concerns a 58-year-old, adult female patient. On 17-Oct-2017, the patient was administered with AFLURIA QUAD (dose: 0.5 ml, route of administration: subcutaneous, anatomical location: right deltoid, batch no: XT59906, and expiry date: not reported). On 17-Oct-2017, the patient was administered with flu vaccine through subcutaneous route of administration which was explicitly coded as inappropriate route of vaccination. The patient did not experience any symptoms afterwards. The reporter considered this case as non-serious.
The patient had muscle aches/fatigue as expected that lasted about 36 hours.  However, she developed red raised, itchy hot rash localized rash in  the area of vaccine 6 days after vaccine.  There was some heat to the area and some streaking below the circular rash.  We discussed that a red rash at the injection site can be a side effect (benign) of the Moderna vaccine.  However, based on the streaking and the delay in the rash beginning we did also cover with a short course of antibiotic and patient requested this be reported to VAERS.  She did not receive the vaccine at our facility and so I do not know the lot number or other specifics.
Had come back from a trip and that Sunday I was feeling crappy. I thought it was a sinus infection, I had congestion, drainage and was feeling poorly. I took a COVID-19 test and it was negative on that Monday. I took a Z-Pak and by Friday still felt poorly. I called my PCP and tested again and I was positive for COVID-19. My doctor gave me more of the Z-Pak and by end of that I was doing much better. I did have a cough after eating and drinking and that lasted for a few weeks after I recovered.
10/31/13 4 AM - shaking, twitching arms, legs > 1 hour, EMS came, advised to see MD.
It started about four days after I got the vaccine. My right arm approximately 4-5 inches below the injection site, got very red, raised, and hot to the touch. The area was about 2 inches wide and about 6 inches long. It would go always for a few hours, then come back, go away, come back, etc. This lasted up to three days ago.  Along with it I would sweat profusely, and be hot but not running a temperature above normal. The temperature of the area when it was red, would range between 99.4-101.0
racing resting heart rate; dizzy; sore arm; chills; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 14:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic neck pain" (unspecified if ongoing), notes: other medical history: Chronic neck pain. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in Sep2022 as dose number unknown, single; LYRICA. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHILLS (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown"; DIZZINESS (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "dizzy"; NAUSEA (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "nauseous"; HEART RATE INCREASED (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "racing resting heart rate"; PAIN IN EXTREMITY (medically significant) with onset 29Oct2022 at 01:00, outcome "unknown", described as "sore arm". The events "racing resting heart rate", "dizzy", "sore arm", "chills" and "nauseous" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (29Oct2022) racing resting. Therapeutic measures were taken as a result of heart rate increased, dizziness, pain in extremity, chills, nausea. Clinical course: Other medications in two weeks: Lyrica, Mounjaro 5 mg. Within 10 hours post vaccine she experienced a sore arm, chills, and a racing resting heart rate that was picked up 6 times by (name withheld) watch. She was unable to get her heart rate to lower and began to feel nauseous and dizzy. She then went to the ER. AE treatment: IV fluids and Tylenol. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19.
Pt received 1st covid shot on 3/29/21. He started having a rash on the front and back of his torso 4-6 days after the injection. Rash is itching and seems to be worse at night. He is also having digestive issues (bloating and discomfort). Pt did have a dr's appt for a different issue and the doctor prescribed allegra.
painful burning; low grade fever; Migraines; Headache; small raised bump/ large raised lump; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), BURNING SENSATION (painful burning), INJECTION SITE MASS (small raised bump/ large raised lump), HEADACHE (Headache) and PYREXIA (low grade fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A2IA) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia, Arthritis and Anxiety. Concomitant products included CLONAZEPAM (KLONOPIN) and NAPROXEN (MOTRIN [NAPROXEN]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE MASS (small raised bump/ large raised lump). On 27-Feb-2021, the patient experienced MIGRAINE (Migraines) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced BURNING SENSATION (painful burning) and PYREXIA (low grade fever). At the time of the report, MIGRAINE (Migraines), BURNING SENSATION (painful burning), INJECTION SITE MASS (small raised bump/ large raised lump), HEADACHE (Headache) and PYREXIA (low grade fever) 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.
The site is warm to the touch; Redness 2x2 inch below the inject site; The rash didn't get worst but it still there; This spontaneous case was received on 29-Sep-2022 from other healthcare professional (pharmacist student) via Communications (reference number: SEQW22- 03682) and concerned an 84-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included Eliquis (apixaban), lisinopril, cyanocobalamin, atorvastatin, metoprolol and levothyroxine sodium, all used for an unreported indication.  On 26-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 346346 and expiry date was 21-Apr-2023.  On 28-Sep-2022, two days after receiving Fluad Quadrivalent, the patient experienced redness 2x2 inch below the inject site. The site was warm to the touch. Also, the patient experienced rash. The patient did not received any treatment measures.   At the time of initial reporting on 29-Sep-2022, the patient had not recovered from the events. As reported, the rash did not get worse, but it was still there.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: An 84-year-old, female patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient developed vaccination site warmth, localised erythema and rash. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: An 84-year-old, female patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient developed vaccination site warmth, localised erythema and rash. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
fatigue; malaise; severe headache; chills; myalgia; arthralgia; temperature fluctuations; lightheaded ness; diaphoresis; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 34-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, on 17Dec2020 at 17:00 (Lot # EK5730) via intramuscular route in right arm and the second dose on 07Jan2021 at 17:30 (Lot # EK9231), at 34 years of age, via intramuscular route in left arm, both at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination and had no relevant medical history and no known allergies. She was vaccinated in hospital. Concomitant medication included sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC) and mometasone furoate (FLONASE). On 08Jan2021 at 16:00 the patient experienced fatigue, malaise, severe headache, chills, myalgia, arthralgia, temperature fluctuations, lightheadedness and diaphoresis. No treatment was received for the reported events. At the time of the report the reported events had not resolved yet. The patient commented that these events may still be considered normal, but she still had been experiencing them 3 days post vaccine, they have persisted long enough and she thought she should report them.
Information has been received from a physician concerning an adult pt aged 20-25 who was vaccinated with hep A virus vaccine inactivated. The physician reported that the pt had been previously vaccinated with hep A virus vaccine inactivated (Havrix) for their first hep A dose and then received hep A virus vaccine inactivated for their second dose. Subsequently the pt experienced fever. The physician reported that the pt sought unspecified medical help. Additional information has been requested.
My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; My daughter said her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching; This is a spontaneous report from a contactable consumer (patient's parent). A 12-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) as single dose for COVID-19 immunization. 1 day post 2nd covid vaccine, her legs felt tired, she had trouble breathing, and passed out. She also ran a fever of 102. Her joints were aching. Her symptoms improved after 1 does of Advil. Event took place after use of product. The outcome of events was unknown.  Information about lot/batch number is requested.
Teeth chattering chills, headache, neck ache, ear ache, fatigue,  brain fog, confusion, vision not right, sensitive to light, diarrhea,  falls, clumsy, don't feel safe to drive or leave the house
On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck.  Left side wit ear and base of neck was tender and painful to touch.  Client has been taking tylenol, lemon candy lozenges, hot packs, and herbal tea.  These have provided short periods of relief.
Shingles (R) scalp: within a week of my vaccinations I had symptoms of shingles; tingly (R) scalp, hive-like line of "rash" base of scalp, pain to elbow (R) arm; this progressed to pain and redness of (R) scalp, another breakout (R) anterior neck; soreness (R) eye. No known fever but malaise and sx of general illness. MD - 11/25/15 misdiagnosed. M.D. 11/29/15 started Famciclovir and Gabapentin. Shingles ongoing. Had shingles vacc. in 2007.
pt has hx of thrombocytopenia, tx w/Vincristin; 7/98 pt recurrent episodes of thrombocytopenia, tx w/Vincristin; pt had painful rash lower extremities, severe myalgias& leg pain, dx=urticarial vasculitis; abd pain; low immunoglobulins Per follow-up dated 9/18/00, the pt continues to have severe recurrent vasculitis, thrombocytopenia, headaches, arthralgias, chronic pain, and immune suppression.  Doc #201751 states that patient continues to have severe recurrent, vasculitis, thrombocytopenia, headaches, arthralgias, chronic pain and immune suppression
rash on the spot where the shot was; swelled up a little; red; itchy; hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on the spot where the shot was), VACCINATION SITE SWELLING (swelled up a little), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE WARMTH (hot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the spot where the shot was), VACCINATION SITE SWELLING (swelled up a little), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE WARMTH (hot). At the time of the report, VACCINATION SITE RASH (rash on the spot where the shot was), VACCINATION SITE SWELLING (swelled up a little), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE WARMTH (hot) 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.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
stomach feeling funky; Dizziness; Fatigue and run down; Nausea; heat on the chest with discomfort; A spontaneous report was received from a consumer concerning a 36-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, fatigue and run down, nausea, heat on the chest with discomfort, stomach feeling funky.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) dizziness, fatigue and run down, nausea, heat on the chest with discomfort. On 28 Feb 2021, the patient experienced the event(s) stomach feeling funky.  Treatment details included Meltrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizziness, fatigue and run down, nausea, heat on the chest with discomfort, stomach feeling funky was unknown.
Redness soreness swelling at injection site. Pt treated with BENADRYL.
02/18/2021 I had a light red rash on my left arm below the injection site. It lasted three days.
This is a spontaneous report from a contactable consumer. A consumer reports that her 3 year old daughter received a dose of PREVNAR 13 and a dose of a flu with H1N1 vaccine (manufacturer unknown) for her 3-year immunization, intramuscularly, one in each upper arm, on 09Nov2010 at an unknown dose. The patient, with no drug allergy, received three or four previous doses of PREVNAR 7 with no problems, and in 2009, she was given a flu vaccine and nasal H1N1 with no problems. Relevant concomitant medications included vitamins with fluoride. On the morning of 13Nov2010, the patient experienced an allergic reaction as when she woke up, she was covered from head to toe with a rash. She was seen by her physician and was given prednisone and BENADRYL. On 14Nov2010, the patient was seen by her physician again because the rash had not improved and was then taken to the emergency room where she was diagnosed with erythema multiforme and treated with intravenous prednisone and oral diphenhydramine. Basic blood work was taken and results were assumed to be normal. As of 16Nov2010, the erythema multiforme was still ongoing and had not improved. Follow-up (15FEB2011): New information was received from a contactable physician regarding a 3-year-old female patient who received a dose of PREVNAR 13 on 09Nov2010. On 13Nov2010 the patient experienced erythema multiforme. The patient was taken to the emergency room on an unspecified date and treated with steroids. The physician reported the patient is recovering. The physician believes there is a reasonable possibility that the event is related to PREVNAR 13. No concomitant medications. The physicians reported no prior medical history, no relevant drug history, no drug allergies, and no family history. The reported event might be compatible with the known adverse event profile of PREVNAR 13; a causal relationship therefore cannot be excluded.
Feverish, cranky and rash started 11/9/04. Plan: Motrin or Tylenol , cool baths, diet and activity as tolerated. Follow up with PCP this week.
3/7/21 late at night:  Livedo Reticularis... dark purple veins in both legs & wrist/hand, shaking, teeth chattering, increase heartrate - went away within 30min...aches in legs & left chest lingered afterwards  3/18/21 late at night:  Livedo Reticularis... dark purple veins in both legs & wrist/hand, shaking, teeth chattering, increase heartrate - went away within 30min...aches in legs & left chest lingered afterwards
Narrative:  Patient received first Moderna vaccine on 03/08/2021 and second Moderna vaccine on 04/05/2021. He presented to the ED via EMS on 11/16/2021 for shortness of breath. He tested positive for COVID-19. He was placed on oxygen on 11/17/2021. Remdesivir therapy was deferred due to history of cardiac sarcoidosis and bradycardia. Dexamethasone was initiated on 11/17/2021. Oxygen was weaned off on 11/18/2021. Plan is to discharge home on 11/19/2021.
Palpable lump to left arm with pain with palpation. Happened 2 weeks after administration of vaccine but reports pain prevents her from lying on that aspect of her arm when she sleeps. Otherwise, not bothersome. Advised warm compresses and massaging are since lumps following vaccine administration can happen.
p/vax area was swollen immed larger than a tennis ball;pt became flushed & jittery;was transported by wheel chair to hosp;developing ascending hives, both arms, chest & up neck;felt faint;
This is a spontaneous report from a contactable consumer. A female consumer of an unspecified age reported for herself, who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EM9810, expiry date: 30Jun2021) via an unspecified route of administration on 05Feb2021, as SINGLE dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination on Feb2021, patient stated that next day or so or may be that same day on 05Feb2021 she had developed onset of sniffles, a little running of nose and watering of the eyes. On the second day, on 06Feb2021, she got some chest congestion and cough. She coughed every now and then but not terribly. She took cold tablets for probably about 6-7 days until they ran out. She was taking the second bottle of cough syrup which was almost finished, but still coughs every now and then. She wondered since it seems to her, she got those events after the Pfizer COVID-19 Vaccine, and she was supposed to get the second dose of Pfizer COVID-19 Vaccine tomorrow but had a doubt whether she should or should not get the second dose as scheduled relative to these events. The outcome of the events sniffles/ runny nose and cough were not recovered; chest congestion was improved (recovering) but it was almost gone but not completely and she no longer had watery eyes, recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.