chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neck soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Jun-2021, the patient experienced NECK PAIN (Neck soreness). At the time of the report, NECK PAIN (Neck soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient did not received any treatment. Patient allergies and medical history was not provided. After one day of receiving vaccine patient felt sore in the base neck and left side of the neck.   Reporter did not allow further contact
Per Agency Immunization Healthcare Division guidance we are to  discontinue monovalent mRNA boosters> All such boosters  administered to 12+ year-old patients, after 31 AUG 2022, will need to be reported in VAERS as administration errors.
Blurred vision in periphery of left eye.  Came on suddenly and lasted for about 30 minutes.  Had never experienced anything like this before.  No eye pain, no dizziness, no nausea.  Cleared up on it's own.  Did not require medical attention at the time but make an appointment with my Optometrist at his earliest convenience.  By process of elimination, he believes it was a Migraine with aura.  I did not mention my vaccine status and have no idea if this and the vaccine are related.  I did not experience this in my previous 3 vaccine doses.  It seemed like the right thing to do by reporting it.
Received the Moderna booster on 11/16/21. Broke out with hives on my head, back, hips with severe itching on 11/26/21. I have been treating with Dr since Dec , 2021 until present.  I also went to my Endrocrincologist. He felt it was Covid Booster related. Also, went to an Allergist. H ran blood tests & found only a minimum amount of allergy to Timothy grass. No other allergies. What can be done to get rid of the itching & rash that I'm still dealing with 9 months plus.  I have been on presisone twice. I have been on steriods almost 9 plus months; Fluocinonid Topical Solution .05% & Betamethasone Valerate .01%. I don't believe long-term steroids are a good idea.
While there was no pain when shot was given, the next day there was a lot of pain in the arm at the injection location.
Information has been received from a pharmacist concerning a 71 year old female consumer with no known drug allergies who on 17-APR-2008 was vaccinated SQ with 0.65 mL of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). Subsequently, on an unspecified date the patient developed redness, swelling, and tenderness at the injection site after immunization with the vaccine. It was also reported that on 24-APR-2008 the patient also developed itching at the injection site. Medical attention was sought, the patient called the pharmacist. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Patient came in to get M-M-R II Live vaccine and Varivax  at our pharmacy  on 8/22/23.  She called today and complained about her left arm being super itchy.
Pt felt dizzy, sweating, ears were ringing, spots before her eyes. Gave pt water, had her elevate her legs and recline, started to feel better after about 5 minutes.
Consumer wants to know if one is considered contagious once they have a fever after receiving the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Consumer wants to know if one is considered contagious once they have a fever after receiving the Pfizer-BioNTech Covid-19 Vaccine".  Additional Information: Reported wanted to know if one takes the vaccine and gets the symptoms is one allergic at that point when they get the fever.   Follow-up attempts have been completed and no further information is expected.
p/recv vax pt exp sore arm, elevated temp 99, weak, achy all over the next morning. took aspirin, felt better
had pain and swelling in my left hand; had pain and swelling in my left hand/swollen rash covering my limbs.; It developed into hive rash on finger. Now it has developed into swollen hives on my scalp, ears, chest, arms, back, legs, and feet.; finger then started blistering up with open sores and peeling skin.; finger then started blistering up with open sores and peeling skin.; That then developed into a complete swollen rash covering my limbs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 14:00 (Lot number: FD0809) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD0808, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 03Sep2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "had pain and swelling in my left hand"; PERIPHERAL SWELLING (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "had pain and swelling in my left hand/swollen rash covering my limbs"; URTICARIA (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "It developed into hive rash on finger. Now it has developed into swollen hives on my scalp, ears, chest, arms, back, legs, and feet"; BLISTER (disability, medically significant), SKIN EXFOLIATION (disability, medically significant) all with onset 13Oct2021 01:00, outcome "not recovered" and all described as "finger then started blistering up with open sores and peeling skin."; RASH (disability, medically significant) with onset 13Oct2021 01:00, outcome "not recovered", described as "That then developed into a complete swollen rash covering my limbs". The all the events were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of all events (antibiotic, steroid topical, 7 different).  No follow-up attempts are possible. No further information is expected.
Neuropathic pain (peripheral) in the left arm above the elbow; Sensitive to touch; painful to have clothing rub against it or to roll over in bed; This case was reported by a nurse via sales rep and described the occurrence of peripheral neuropathic pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced peripheral neuropathic pain, touch sensitivity increased and tenderness. On an unknown date, the outcome of the peripheral neuropathic pain and touch sensitivity increased were unknown and the outcome of the tenderness was not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathic pain, touch sensitivity increased and tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 65 years or 66 years. About 1 month after receiving Shingrix, the patient experienced neuropathic pain (peripheral) in the left arm above the elbow (injection arm). It was sensitive to touch and painful to had clothing rub against it or to roll over in bed.  The pain was ongoing. The reporter gave consent for follow up.
Very cold, fever over 101 body aches, feet tiredness and headache. Tiredness.
No additional AEs; Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information on patient' pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 24-JAN-2023, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # W02294 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX), expiration date reported as 13-JUL-2024, strength and route were unknown) for prophylaxis (product storage error). The vaccine was exposed to 6.9 degrees Fahrenheit (F) for 15 minutes. Previous temperature excursion included 7.1F for 0 hours 30 minutes 0 seconds and 11.6F for 1 hour 0 minutes 0 seconds. No additional adverse event was reported.
Redness from injection site, down left arm, warm to touch and slightly swollen. Advised ibuprofen and ice.
11/02/09 Intranasal H1N1. 11/03/09-Fever 104, c/o leg pain, headache and joint pain, vertigo.
Body-aches, dizziness, diarrhea, fever (no temp was relayed to front office staff or to triage nurse. patient was advised to use tylenol as needed for body aches and fever, patient advised to hydrate and to report to the ER if symptoms worsen.
mom verbalized pt cried from time vax for several hrs; cranky, high pitched cry for several hrs; temp ranged from 103 to 104 R;
Burning pain in his arm and all over his body; Could not move to reach the phone; Headache; Myalgia; Temperature of 99.9 F; This spontaneous case was received on 01-Sep-2020 from a physician via Med Communications (reference number SEQW20-01130) and concerned a 70-year-old, male patient.  The patient's concurrent conditions included atrial fibrillation, atherosclerosis, dyslipidemia, benign prostatic hypertrophy, insulin resistance, gastroesophageal reflux disease (GERD) and gout.  The patient's concomitant medications included Indocin (indometacin), Aspirin (acetylsalicylic acid), chloroquine, magnesium, Crestor (rosuvastatin), Prevacid (lansoprazole), fish oil, carvedilol, irbesartan, chromium picolinate, tadalafil, Nature's Bounty probiotic, Vit D3 (colecalciferol), Mulivitamin unspecified, all used for unreported indications.   On 31-Aug-2020 at about 3:30 pm, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, dose: 0.5 ml, indication: influenza prophylaxis, route of administration: intramuscular, anatomical location: deltoid). The batch number was 279798, expiry date: 15-Jun-2021.   On 01-Sep-2020, at around 2 am, about ten and a half hours after receiving Fluad Quad, the patient woke up with burning pain in his arm and all over his body and headache. The patient reported it was hurting so much he could not move to reach his phone. In the morning, when the patient woke up the burning pains and headache were gone, the injection site was not tender nor red. The patient felt only mild myalgia that was getting better by the hour. The patient also had a temperature of 99.9 F but he did not retake his temperature.   At the time of initial reporting on 01-Sep-2020, the patient recovered from the events pain burning', movement disorder' and headache' and was recovering from the event myalgia'.  The outcome of the event fever' was not reported.  The reporter did not provide a causality assessment.  Company comment:The patient developed pain, movement disorder, headache, myalgia and pyrexia one day after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed pain, movement disorder, headache, myalgia and pyrexia one day after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Starting early May: Digestive issues. Ongoing.  Insomnia. Starting late May: Belly bloating. Loss of appetite. Weight loss. Contractive sensation in lower right abdomen.Numbness/muscle spasm in toes, sometimes leg, and left arm. Back pain-sometimes mid back, sometimes lower back and neck.  Neck stretches result in pain and tightness the following day. Muscles in legs are very tight and nothing relaxes them.  Malaise. Fatigue  and sleepiness beginning  in afternoon. Sleeping in most positions bring on numbness in limbs.
Detached Retina in left eye. If blood clot caused this, it needs to be looked into.
Flush face, numb face, cold feeling left arm with slight numbness, pain at injection site, warmth at injection site, sensation of facial warmth, dizziness, lightheadedness, feeling similar to "a slight buzz after an alcoholic drink or two, diarrhea, tachycardia
ended up in the ED later that day with a flare up of covid symptoms, I stated hurting all over as expected, but also got lightheaded, nauseated, sugar kept dropping, felt short of breath due to coughing, head started pounding, and got very weak.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).The outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.  It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got his/her RSV shot and only a slight sore arm for a day. The patient felt great no after affects.  The reporter stated that better the shot than getting the virus. The follow up would not possible as no contact details were available.
Fatigue; weak; chest pain; decrease appetite; cold; hot flashes; Dose 1: Pfizer bivalent; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Mar2023 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Anxiety anemic and ibs" (unspecified if ongoing); "anemic" (unspecified if ongoing); "ibs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Mar2023, outcome "unknown", described as "Dose 1: Pfizer bivalent"; FATIGUE (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered"; CHEST PAIN (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered"; NASOPHARYNGITIS (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "cold"; DECREASED APPETITE (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "decrease appetite"; HOT FLUSH (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "hot flashes"; ASTHENIA (non-serious) with onset 22Mar2023 at 12:00, outcome "not recovered", described as "weak". Therapeutic measures were not taken as a result of fatigue, asthenia, chest pain, decreased appetite, nasopharyngitis, hot flush. Additional information: The patient has no other vaccine in four weeks, no other medications in two weeks, no COVID prior vaccination, and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   On 25th August 2022, the patient received Menveo. On 25th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: The nurse reported that a staff member most likely administered a dose of Menveo powder after reconstituting it with a non-GlaxoSmithKline diluent. They had a leftover diluent. It was unknown which patient out of a group of five patients it was.  All five patients were 11 years of age.  The reporter consented to follow up by email. Additional supportive information: The nurse reported that the patient received a dose of Menveo powder after reconstituting it with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Initial solicited case received on 20 October 2015 from the investigator in a trial. Seriousness criteria-other: important medical event. This case involves a 34-year-old male subject who developed non-specific myocarditis during the study participation. The subject had medical history of numbness or paralysis. The subject received a first dose of anthrax vaccine concomitantly on 27 August 2015 and Japanese encephalitis vaccine on 27 August 2015. On 29 September 2015, 11 days after receiving a dose of ACAM2000 on 18 September 2015 (batch number, route and site of administration not reported), the subject had non-specific myocarditis and on 30 September 2015, 12 days after receiving a dose of ACAM2000 on 18 September 2015, the subject had acute myocardial infarction, unspecified site. The subject's blood test done on 30 September 2015 recorded the highest value of Troponin I as 03.79 which was abnormal. The subject had an electrocardiogram (ECG) done on 29 September 2015 was normal and echocardiogram done on 30 September 2015 was normal. MRI (brain, spinal cord and heart) and lumbar puncture (spinal tap) was not performed. The subject's corrective treatment was not reported. Outcome of the event non-specific myocarditis and acute myocardial infarction, unspecified site was not reported. Relationship to investigational product according to Reporter: not reported. Relationship to investigational product according to company: associated. Whether the serious adverse event led to the termination of the subject from the study or not was not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Chills, 101 temp, extreme fatigue but unable to sleep, chills, sweating, gas, bloated stomach, extreme headache - redness, heat itching at injection site - redness on injection sight move from 1.34 ? to 4? length in 48 hours
Head cold; Running nose; Cough that has continued until today; Very painful; Inflamed; Itch a little; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose), COUGH (Cough that has continued until today), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INFLAMMATION (Inflamed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Very painful), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Itch a little). On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose) and COUGH (Cough that has continued until today). The patient was treated with PARACETAMOL (TYLENOL) on 09-Feb-2021 at an unspecified dose and frequency. On 22-Feb-2021, VACCINATION SITE PAIN (Very painful), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Itch a little) had resolved. At the time of the report, NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose) and COUGH (Cough that has continued until today) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Upon internal review on 04-Aug-2021, the age was corrected to 65 years.
This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that the patient had been receiving every five years (dates unspecified), a dose of PNEUMOVAX23 injection 9doses, administration dates, route and lot # were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. Additional information has been requested.
Went to the pharmacy for vaccination, got the first one in December, got the second shot in January. On January 18th i brgan to have extreme chest pains, went to the hospital and was diagnosed with pericarditis. Effects of pericarditis still occuring after nearly a year even during treatment.
3min 16s after injection: dizziness, weak and extremely tired, nauseous; flush face and headache (forehead) drank power ade (10oz), moved to cool/cold area; remained inactive;  after several minutes (3-6min) symptoms improved, then repeated (symptoms returned but less severe, then mitigated) two more times over next 18 min  stayed at dr. office for another 20 minutes with no more adverse reactions (mild headache and slight tiredness; no other symptoms)
Headache, Myalgia & Arthralgia Narrative: Employee reported "severe head ache and body aches." Complaints resolved on their own within 24 hours