chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection arm became sore; Knot at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Injection arm became sore) and VACCINATION SITE NODULE (Knot at injection site) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection arm became sore) and VACCINATION SITE NODULE (Knot at injection site). At the time of the report, VACCINATION SITE PAIN (Injection arm became sore) and VACCINATION SITE NODULE (Knot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
7:55pm ? Patient entered with her boss, who translated for her. Patient sat down and was screened prior to vaccination; patient disclosed a history of anaphylaxis when receiving a vaccine previously. The patient could not recall the vaccine she received.  8:00pm ? Patient was given the Moderna COVID-19 vaccine 0.5ml  IM in her left deltoid. Lot #050C21A exp 11/6/21. Due to her history, the patient was asked to stay in the screening room until 8:30pm. 8:13pm ? Patient relayed that her throat felt itchy, and her lips were puffy. 8:17pm ? Patient was given Benadryl 50 mg orally with water. A translator was called to help relay information to the patient.  8: 22pm - On site EMS who could translate arrived, questioned patient, then called 911. Patient said her lips tingled and her throat felt like it was closing. Patient was audibly wheezy. 8:27pm ? Patient HR 76, O2 sat 99.  8:30pm ? Patient?s blood pressure measured manually at 130/70, directed to give epinephrine by 911. Patient was moved to a more private location and layed flat. 8:32pm ? Epinephrine 0.3 mg (TEVA, lot 012c20aa, exp 1/2022) was given in patients left upper thigh. Patient was laying down when the dose was given. 8:35pm ? EMS arrived, and all information was relayed to the team. Patient was taken to Hospital via Ambulance for further monitoring.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 05-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended at a pharmacy for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On or about 01-JUN-2015, the patient was treated at a clinic for the onset of a severe vesicular rash which was diagnosed as shingles. The patient was prescribed prednisone and hydroxyzine for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Patient called complaining of hives from head to toe, itching, wheezing, and difficulty breathing. Advised patient to immediately go to emergency room for evaluation. Requested patient to call back after treatment for resolution.
pt c/o severe pain in her (r) head, numb (r) face two days.   O: (r) eye doesn't open as well (L) eye, flattening of the (r)    nasal facial grove. these signs/symptoms noted in accupuncture clinic.  Pt. seen in Emergency Department the following day with loss of nasal facial grove, facial pain & difficulty in opening eye noted. Dx of Bells Palsy made & patient started on course of acyclovir & prednisone.
Slight Head Ache and sore Throat 10/30/2016 12:00 PM Back muscle ache and Flu Symptom congestion 10/31/2016 10:00 AM Fever 99.5 and no more muscle ache 11/1/2016 Fever 100.
sore arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and FATIGUE (felt tired) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced MYALGIA (sore arm) and FATIGUE (felt tired). On 18-Aug-2021, FATIGUE (felt tired) had resolved. On 19-Aug-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Redness & swelling of L arm form shoulder to elbow since 10/23/01, decreased swelling today as per mom. Cool compresses & ibuprofen.
1st dose, I had fatigue and projectile diarrhoea for 24 hrs.  Thought it was a fluke.  2nd dose gave me the same effects.; 1st dose, I had fatigue and projectile diarrhoea for 24 hrs.  Thought it was a fluke.  2nd dose gave me the same effects.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01May2021 12:30 (Lot number: EW0158) as dose 1, single and intramuscular, administered in arm left, administration date 22May2021 12:30 (Lot number: ER8736) as dose 2, single for covid-19 immunisation. Relevant medical history included: "type 2 diabetes" (ongoing); "COPD" (ongoing); "cholesterol" (ongoing); "BP" (ongoing); "acid reflux" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); VICTOZA taken for diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); PANTOPRAZOL [PANTOPRAZOLE] taken for gastrooesophageal reflux disease (ongoing); MONTELUKAST taken for hypersensitivity (ongoing). Past drug history included: Demeral, reaction(s): "known allergies: demeral"; Soma complex, reaction(s): "known allergies:soma complex". The following information was reported: FATIGUE (non-serious), DIARRHOEA (non-serious) all with onset 01May2021, outcome "recovered" (25May2021) and all described as "1st dose, I had fatigue and projectile diareha for 24 hrs.  Thought it was a fluke.  2nd dose gave me the same effects.". Therapeutic measures were not taken as a result of fatigue, diarrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 1.Diarrhoea, onset date:01May2021, onset time: next day, lasted 2 days. seriousness criteria: not serious.AE outcome: recovered. Date of recovery:04May2021. Treatment: No 2.Diarrhoea; onset date:22May2021.onset time: next day, lasted 2 days. seriousness criteria: not serious. AE outcome: recovered. Date of recovery:25May2021.Treatment: No Ended up with projectile diarrhoea the day after each dose, that lasted 2 days and then went away on its own. Been fine since then.  No follow-up attempts are needed. No further information is expected.
Patient reports having had occasional eczema on and off for several years localized to cheeks and around eyes, but after she got her first Moderna COVID vaccine, she started having outbreaks of eczema all over face and neck and by the second vaccine she had eczema on her forehead, neck, and face and it was peeling off and causing excruciating pain. Patient reports she had never had this peeling or pain associated with her limited eczema before. Patient is very hesitant to get the booster and is starting a biologic therapy for her eczema now. Patient did not provide a specific timeline of when she received the first and second Moderna COVID vaccines, however there is a claim processed 11/2021 for the Moderna vaccine visible to the reporting pharmacist (I am reporting from a specialty pharmacy unrelated to the site of vaccination; patient's report of the potential adverse reaction to the Moderna COVID vaccine was discussed during a call regarding questions about her specialty medication).
-SOB approx 30 mins after vaccine along w/itchy eyes This continued through the night and then improved over next few days. - itchy eyes lasted approx. 1 mos. - patient did not seek medical attention
3 blisters above the vaccination site. Administered diphenhydramine 25 mg and held for additional monitoring.
hypertension upon standing (up to 165/120) which can resolve upon sitting; eye pain; tingling in hands and feet; ringing in her ears; crushing chest pain; pain in her neck; pain in her back; pain in her hands and feet; lymphadenopathy in her neck on the same side as the injection; lymphadenopathy in her neck on the same side as the injection, which is painful to touch; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). A female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperadrenergic POTS" (unspecified if ongoing), notes: living for years with Hyperadrenergic POTS (Postural tachycardia syndrome); "Thoracic Outlet Syndrome" (unspecified if ongoing), notes: living for years with Thoracic Outlet Syndrome. The patient's concomitant medications were not reported. The following information was reported: ORTHOSTATIC HYPERTENSION (non-serious) with onset Jan2022, outcome "unknown", described as "hypertension upon standing (up to 165/120) which can resolve upon sitting"; EYE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "eye pain"; PARAESTHESIA (non-serious) with onset Jan2022, outcome "unknown", described as "tingling in hands and feet"; TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "ringing in her ears"; CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "crushing chest pain"; NECK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her neck"; BACK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her back"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her hands and feet"; LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection"; LYMPH NODE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection, which is painful to touch"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received the Pfizer Covid Vaccine for the first time about a week ago (06Jan2022). Post-vaccine (ranging times of onset) she developed symptoms. She reported that some symptoms started within 3-4 days of the vaccine, and some started earlier. She was obviously quite upset and was in tears on the call.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Experiencing vertigo and nausea, I sought care from a local immediate care facility. There I had a physical and a COVID Test. Test came back negative. They came to the conclusion that I may have an acute maxillary sinusitis.  Was prescribed an antibiotic but it was delayed at pharmacy and didn't receive it. I was recovered by the time I was able to pick up medication.  Currently feel that I have recovered.
Caller mentioned that at the end of the year 2020 she began exhibiting signs of IBS (clarified as irritable bowel syndrome) and fibromyalgia.; Caller mentioned that at the end of the year 2020 she began exhibiting signs of IBS (clarified as irritable bowel syndrome) and fibromyalgia.; This spontaneous report was received from a consumer and refers to an approximately 37-year-old female patient. The patient's pertinent medical history, concomitant medications, and drug reactions/allergies were not reported. The patient was not pregnant.  On an unknown date in June 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose/3 total, administered intramuscularly (IM) (strength, lot#, expiry date, and anatomical location were not provided), vaccination to prevent 9 types of HPV related cancer.  On an unknown date in 2017, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose/3 total, IM (strength, lot#, expiry date, and anatomical location were not provided).   On an unknown date in December 2017, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose/3 total, IM (strength, lot#, expiry date, and anatomical location were not provided). The patient stated that she received the three doses at the recommended intervals per the prescribing information.   During year 2020, on an unknown date, the patient started therapy with lentinus edodes mycelium (AHCC), daily, as an immune boosting supplement (strength, formulation, dose, lot#, expiry date, and route of administration were not provided).   On an unknown date in 2020 (reported as at the end of the year 2020), the patient began exhibiting signs of irritable bowel syndrome (IBS) (Irritable bowel syndrome) and fibromyalgia (Fibromyalgia). The patient sought medical attention at unspecified time for treatment (treatment was unspecified), and her healthcare provider recommended that she stop taking the supplement. At the time of reporting, the patient was recovering from the events of IBS and fibromyalgia. It was reported that she had mostly recovered from the symptoms of IBS and fibromyalgia as the symptoms had minimized. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable; while, with lentinus edodes mycelium (AHCC) was considered as withdrawn with positive dechallenge result.  The reporter considered the events were not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The causal relationship between the events and lentinus edodes mycelium (AHCC) were not provided.
Initial report was received from a health care professional staff member on 30 September 2011. A 78-year-old male patient had received a FLUZONE Intradermal injection; lot number UH458AA in right deltoid on 19 September 2011. On 22 September 2011, the patient experienced nausea, vomiting, chills, diaphoresis and unstable balance which lasted twenty four hours and resolved. He also developed an unknown local reaction at injection site. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 24 January 2012. The patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH458AA in right deltoid. No additional information available. Documents held by sender: none.
no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
Patient c/o headache, dizziness, and triedness after receiving H1N1 shot.  Mother to take to ER.  No other symptoms.  11/10/09 - T.C. to School Nurse.  Patient went to ER on 10/30/09, and released home with no further problems.  Patient went to school the next day.
Immediately post partum, neonate was administered Hep B vax & Hep Immune globulin & 24 hrs later the neonate was found in crib postioned on abdomen w/head turned to lt side, color was cyanotic; no resp, pulse, or spontaneous movements;
Significant hair loss potentially caused by vaccine; Injection site pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 2955291-06152) via an unspecified route of administration in the left arm on 31Mar2021 at 08:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included seborrheic dermatitis, hair thinning, COVID-19 and known allergies to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), ketoconazole (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and minoxidil (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 19:30, the patient experienced injection site pain, chills and fever. On 13Apr2021, the patient experienced significant hair loss potentially caused by the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, chills, fever and significant hair loss were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body aches) and CHILLS (Chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body aches) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was pre-medicated with Tylenol and Benadryl two hours prior to vaccine and took again 6 hours after the vaccine.   This case was linked to MOD21-061231, MOD-2021-056044 (E2B Linked Report). This case was linked to MOD-2021-056031 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up was received contains no new information; Sender's Comments:  MOD21-061231: MOD-2021-056044:Wife's Case
Pt did not respond to vax series; 21JAN92 neg HBSAB titer result; booster dose administered;
Breakthrough Covid. Patient Developed symptoms of Covid starting August 6th (12 days of progressive symptoms) despite getting Covid Vaccination (2 doses, one in March and one in April).  She developed loss of taste and smell, bodyaches, nausea, nasal congestion, general weakness, shortness of breath. Respiratory panel positive for SARS-CoV-2.