chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case, was received from a Pharmacist on 18-Oct-2017, concerns 8-year-old male patient. This report was 1st out of 03 reports. On 16-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 1618701, and expiry date: Apr-2017). On 16-Oct-2017, the patient was administered with influenza vaccine which was explicitly coded as expired vaccine used. The patient did not experience any adverse event later. It was reported that, the patient was revaccinated. The reporter considered the case as non-serious. Non-significant follow up received on 30-Oct-2017: It was reported that, the patient did not experience any adverse event later and was revaccinated.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Lot number: Fm7553), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Nov2021 as dose 2 (booster), single (Lot number: 066F21A), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 07Apr2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; HYDROXYCHLOROQUINE; LUTEIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26May2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (22Apr2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2023) Negative; (24Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 17Apr2023 to 22Apr2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175542 same patient, different drug and event.;
I was feeling nausea. I developed anxiety and depression. I got really dehydrated and I was light headed. I didn't eat for awhile.  I had a brain fog. I was prescribed anxiety and depression medications.
24 hrs after vaccine red goose egg - hot at the site - itching - over the next week the swelling & itching spread around & down the upper arm. Ice helped. Lasted 8 days - also scalp itched after several days.
FIVE MINUTES AFTER RECEIVING HER PFIZER VACCINE, PT SAID SHE HAD TINGLING AND NUMBNESS IN HER JAW AND FELT LIKE HER LYMPH NODES WERE SWOLLEN. GAVE PATIENT 10ML LIQUID BENADRY. WAITED FIFTEEN MINUTES. PATIENT SAID SHE FELT LIKE IT WAS A LITTLE WORSE, SO WE GAVE HER ANOTHER DOSE OF BENADRYL. SHE WAITED ANOTHER 15 MINUTES AND SAID SHE FELT BETTER AND HAD A FRIEND TAKE HER HOME.
Narrative: Patient received three doses of Pfizer COVID 19 Vaccine. The patient tested positive for COVID 19 on 23 April 2022. The patient presented to the ED with cough, malaise, wheezing and decreased appetite. The patient was admitted to the hospital with acute kidney injury, covid pneumonia, and hyperglycemia. The patient was treated with supportive care, antitussives, and bronchodilators. The patient was discharged on 2 May 2022 in stable condition. Reported per EUA.
Pt recv vax on 3/3/99; 1-2 days post vax pt exp local swelling, tenderness & erythema of LA
pt recv vax 28NOV98 & 25DEC98 pt appeared very pale;17FEB99 pt devel URI;22FEB99 fever associated w/infect peaked so visited MD:26FEB99 pt hosp for encephalitis;per MD when pt adm was status epilepticus & had been tx for mult sz;Annual follow-up received on 11/27/00 provides no additional data.
Received a flu vaccine and Shingrix vaccine at the same time. By evening had joint/muscle pain and shivering. Got up feeling fatigued and weak, slight nausea. At approximately 8:00 a.m., felt dizzy and clammy, then passed out and hit forehead on marble floor. No further dizziness after that event. Fatigue and joint/muscle pain continued throughout that day but subsided by evening. On 09/16/2019 (four days after the shot), experienced nausea and diarrhea. Have never had an adverse reaction to a flu shot.
Hallucinating at about hour 9; He had a high temperature; This is a spontaneous report from a non-contactable consumer. A 14-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on 21Jun2021 12:00 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies and other medical history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 15Jun2021 04:30, the patient experienced hallucinating at about hour 9, he had a high temperature. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. No treatment was received for events. The outcome of events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 3/24 patient received J&J COVID-19 vaccine Started to feel soreness in arm x 2 days, got better, went back to her usual exercise routine (heavy lifting, kettle bells)  but then a week after receiving the vaccine, she started noticing some pain in the injection site, R deltoid Feels like a nerve pain. Localized. Feels like a shock sensation.  Started lifting weights and has noticed she doesn't have as much strength in that area as well. c/o weakness of affected deltoid muscle Can't lean on the area for a prolonged or put any pressure on it
This spontaneous report was received from a Registered Nurse refers to a 14 month old patient of unknown gender. Medical history and concurrent conditions were not provided. On 22-DEC-2015 (reported as yesterday), the patient was vaccinated with a dose of ZOSTAVAX instead of VARIVAX (dose, route, lot number and expiration date were not reported). No adverse effects reported at this time. There was no concomitant medication provided and no Product Quality Complaint (PQC) involved. Additional information is not expected because the reporter refused additional contact.
What happens if I miss the second dose?; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was asking what happens if miss the second dose. The health care professional was using chat and able to confirm the product in question was Shingrix, patient or HCP demographics, whether or not the patient was indeed past due for the second dose of Shingrix. This adverse event filed out of the abundance of caution. No additional information to provide.
continued nasal drainage that turned into a sinus infection. Ulcer in left nostril. Chest pains (still, have  however not as bad),. Overall exhaustion.  Lethargic. Still have dizziness since the first shot.
Blotchy Area (2" wide) Injection Site; Rash (2" wide) on the Injection Site; Itchy Injection Site; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), VACCINATION SITE IRRITATION (Blotchy Area (2" wide) Injection Site), VACCINATION SITE RASH (Rash (2" wide) on the Injection Site) and INJECTION SITE PRURITUS (Itchy Injection Site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm). On 22-Apr-2021, the patient experienced VACCINATION SITE IRRITATION (Blotchy Area (2" wide) Injection Site), VACCINATION SITE RASH (Rash (2" wide) on the Injection Site) and INJECTION SITE PRURITUS (Itchy Injection Site). On 16-Apr-2021, PAIN IN EXTREMITY (Sore Left Arm) had resolved. At the time of the report, VACCINATION SITE IRRITATION (Blotchy Area (2" wide) Injection Site), VACCINATION SITE RASH (Rash (2" wide) on the Injection Site) and INJECTION SITE PRURITUS (Itchy Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient used for treatment Benadryl and ice Pak on the rash area.
was administrated  with the powder component of Menveo with sterile water; was administrated  with the powder component of Menveo with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient was administrated with the powder component of Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No other information was provided. The reporter consented to follow up.
The patient developed a rash over her body including arms and legs, and pt says she visited her dr. who have her prednisone and PROAIR inhaler. Pt has existing lung condition. Unclear if vaccine made it worse.
Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi at vax site.  Taken to ED from vax site. Started on epi drip. Admitted to SHC.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Concomitant therapy included MENACTRA. The physician heard that the patient fainted after receiving GARDASIL. The physician does not wish to be contacted. The patient sought unspecified medical attention.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency  consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
The patient arrived at Hospital via EMS with CPR in progress.  The patient was found in asystole upon arrival.  The patient was intubated and was given Epi x 5, and bicarb x 1.  The patient was recently discharged from the hospital on 3L O2, and COVID positive.  The patient expired with a cause of death: cardiopulmonary arrest.
Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to be lessening now
By evening, general fatigue. Overnight, nausea. 6:00am next morning had 101.5 fever, dizzyness, overwhelming fatigue. 500mg Tylenol taken. Drank 72 ounces of water throughout day. Fever of 100.3 at 7pm same day. Extreme fatigue. Dizzy spell gone. By 6 am on second day, all symptoms gone.  Soreness of arm for 48 hours.
This spontaneous report was received from a 36-year-old female consumer regarding herself with double bypass surgery and drug reaction or allergies to acetaminophen, propoxyphene napsylate (DARVOCET) and penicillin. The patient's concomitant therapies included rosuvastatin calcium(CRESTOR), aspirin(manufacturer unknown) and isosorbide. On 13-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, (dose, anatomical location, lot number and expiration date were not reported) for prevention of shingles. On the same day, the patient was experiencing bumps on her arms and legs that were bleeding and itchy. The patient was unaware if they were bleeding because she was scratching them (skin haemorrhage, rash papular and rash pruritic). The patient sought  medical attention and the physician prescribed prednisone (manufacturer unknown) for the events, no laboratory diagnostics studies were performed. At the time of the report, the patient stated that "it got a little better" but she did not recovered from the skin haemorrhage, rash papular and rash pruritic  and when she ran out the medication, the symptoms fully returned. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Bad injection site reaction (arm got red); Bad injection site reaction (arm got red); Hypersensitivity; This spontaneous case was received on 26-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-05058) and concerned a 90-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date in 2022, an unspecified amount of time after receiving Flucelvax Quadrivalent, the patient experienced bad injection reaction/hypersensitivity (arm got red).  At the time of reporting, the outcome of the events was not reported.  The reporter assessed the events of hypersensitivity, vaccination site erythema and vaccination site reaction as related to Flucelvax Quadrivalent, as it was reported that the patient had bad reaction to the Flucelvax.  The case was assessed as non-serious.  Company comment: The events of hypersensitivity, vaccination site erythema and vaccination site reaction are assessed as related to Flucelvax Quadrivalent due to plausible temporal relationship.; Reporter's Comments: The reporter assessed the events of hypersensitivity, vaccination site erythema and vaccination site reaction as related to Flucelvax Quadrivalent, as it was reported that the patient had bad reaction to the Flucelvax.; Sender's Comments: The events of hypersensitivity, vaccination site erythema and vaccination site reaction are assessed as related to Flucelvax Quadrivalent due to plausible temporal relationship.
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache.  12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness.  12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness.  1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
patient got sick; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a unknown demographics patient who got sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was illness.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
p/vax pt devel a papular erythematous rash which looked like attenuated lesions;the lesions were on trunk & scalp & were very itchy;
The swollen lymph nodes is on both sides, but is subsiding; On the side where she got her shot the swelling has come down to her collar bone.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number and expiry was not reported) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunization. Medical history included 2 Autoimmune diseases. The patient's concomitant medications were not reported. On an unspecified date, after receiving the vaccine she noticed her lymph nodes were swollen. The patient reported the swollen lymph nodes is on both sides but is subsiding. The patient questioned if second dose should be taken as it is scheduled for 24Mar2021 and enquired if it will get worse.  Follow up letter has been generated for lot/batch number and for further information  Follow-up (22Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported for herself that:   Follow-up (22Mar2021): Follow up information included. The patient reportedly noticed 5 days later that she had swollen glands around her neck. She has autoimmune problems, Sjogren's, which affects the lymphatic system. When she asked her doctor he said it was a side effect from the vaccine. She is supposed to go on 24Mar2021 for her second dose. The swollen glands have calmed down now. On the side where she got her shot the swelling has come down to her collar bone.  No follow-up attempts are possible; information about lot/batch number cannot been obtained  This follow-up report is being submitted to amend previously reported information: The classification of at risk was removed as true event PT Lymphadenopathy is reported.
Severe body aches, muscle pain,  severe feeling of unwell, Mental fog/difficulty thinking/cognitive impairment, difficulty with speech, severe headache, chills, shaking, flu like symptoms, Severe lethargy, dizziness, nausea and odd feeling in chest.  Nausea started within three hours of booster  (7pm) and no other symptoms until 24 hours after booster (4pm following day). Symptoms worsened over the course of the next three hours and peaked about 27-28 hours after booster lasting severe until the next morning around 11 am.  Moderate symptoms lasting until late afternoon on second day and mild symptoms lasting until third and fourth day.  Almost needed emergency room care.
Can not use left arm after 2nd dose; Terrible pain left shoulder to hand, when using left arm, after 2nd shot; Hard time hearing even with the hearing Aid, after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Can not use left arm after 2nd dose), PAIN IN EXTREMITY (Terrible pain left shoulder to hand, when using left arm, after 2nd shot) and HYPOACUSIS (Hard time hearing even with the hearing Aid, after 2nd shot) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056H21A and 032H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing aid user.   On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced HYPOKINESIA (Can not use left arm after 2nd dose) and PAIN IN EXTREMITY (Terrible pain left shoulder to hand, when using left arm, after 2nd shot). 11-Jan-2022, the patient experienced HYPOACUSIS (Hard time hearing even with the hearing Aid, after 2nd shot). At the time of the report, HYPOKINESIA (Can not use left arm after 2nd dose), PAIN IN EXTREMITY (Terrible pain left shoulder to hand, when using left arm, after 2nd shot) and HYPOACUSIS (Hard time hearing even with the hearing Aid, after 2nd shot) outcome was unknown.            No concomitant medication reported No treatment medication reported
"Pfizer-BioNTech COVID-19 Vaccine EUA": Acute onset of tongue swelling, throat tightness, and diffuse erythema approximately 5 minutes after receiving COVID-19 vaccine. Patient transferred to emergency department. Patient treated with Epinephrine 0.3 mg IM X1 dose, Dexamethasone 10 mg IV x1 dose,  Diphenhydramine 25 mg IV x1 dose. Patient discharged same day with resolution of symptoms.
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid.  On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
Severe vomiting  Severe diarrhea  Temperature up to 103.6F Severe chills/shaking  Moderate joint pain Severe headache