chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 008C21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure abnormal, RIVAROXABAN (XARELTO OD) for Clotting disorder.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was really sore). At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown.            Patient medical condition knee disorder. Patient had a knee replacement surgery on 07 Nov 2021.   This case was linked to MOD-2021-403388 (Patient Link).
Patient states that approximately 12 to 24 hours following vaccine administration, she experienced generalized weakness, chills, body aches, and felt feverish however could not confirm a true fever via thermometer. Pt did not indicate that she sought treatment or took any medication to treat these symptoms. Unable to provide outcome as at the time patient notified us she only had the symptoms less than 24 hours.
Motor Tics including clenching of hands, face twitching, eye blinking, shoulder shrugging and leg movement with pointing of the toes. Started while watching TV and occurs multiple time per minute - very often.
having menstrual periods; booster; 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 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 11:15 (Lot number: D7248) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, around midday, in left arm, Lot: EP6955, Expiration: unknown), administration date: 16Mar2021, when the patient was 66 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number:02, around midday, in left arm, Lot: EWD162, states she cannot read it on the vaccination card, Expiration: unknown), administration date: 13Apr2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "having menstrual periods". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 11:15, outcome "unknown", described as "booster"; MENSTRUAL DISORDER (non-serious) with onset 20Dec2021, outcome "unknown", described as "having menstrual periods".  Additional information: It was reported that after receiving the booster dose on 17Dec2021, she had a period 3 days ago. Patient took the vaccine for the prevention of serious disease, age and since she was overweight, and lives in a packed community. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts completed. No further information expected.
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 19:57. At 20:03 he reported feeling lightheaded, dizzy and nauseous. He lowered himself to the ground and laid down. Patient was given Benadryl 25 mg. He was advised to take deep breaths, drink water, and eat saltine crackers. He was kept for additional observation and began to sit up within 15 minutes after receiving the Benadryl, drinking water and eating crackers.
Headache, migraine, nausea, malaise, extreme fatigue, weakness, generalized body pain, fever, out of body experience, weird dreams, and feeling not self.
Patient stated she had lots of pain at sight of vaccination the day of administration but it was gone by the next morning. In the afternoon the day after the shot, the patient had tingling and numbness in her fingers and discomfort on the underside of her arm and shoulder blade. She states that the pain decreased when pressure was applied at the base of her armpit or if she held her arm up. On the 18th the patient went to the ER. MD told her that the vaccine affected her muscle and prescribed Percocet, cyclobenzaprine and prednisone. The MD told her that other patients had come in with the same issue.  The medications have decreased her symptoms but have not fully resolved them.
Friday a.m. a rash started on the thigh and progressed down both legs.  Pt. was given 4 dispersed doses of Benadryl, 25 mg. P.O. and then on Saturday taken to an Urgent Care Center where she was administered steroids.
A 18 year old female pt experienced abdominal pain, headache, arthralgia, myalgia, and rash while receiving RabAvert. She received four doses of Imovax Vaccine on 03Jun03, 06Jun03, 10Jun03, and 17Jun03 as well as a fifth dose of Rabies vaccine with RabAvert on 01Jul03. The pt had no illnesses at the time of vaccination and was on no concomitant medications. The pt was exposed to a rabid horse on 01Jun03 and the first dose of Imovax was initiated on 03Jun03. She then developed abdominal pain, joint pain, muscle pain and headache. Following each dose of Imovax and RabAvert the symptoms reappeared and increased in severity with each subsequent dose. The pt also developed a rash, described as a bumpy red rash on one finger and her eyelids. The outcome of the events is not known.
No adverse event; dose administered after expiration date. Dose administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered after expiration date. Dose administered today. Bivalent vaccine).    It was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text of the suspect product was reported as unknown. It was reported that 5 doses administered after expiration date.. There were no reported symptoms at this point. No treatment medication was reported.   This case contains information about patient 2nd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Swollen lymph node under left armpit for four days starting 01.01.2021.
Within 3hrs developed fever 102 HA, myalgias, then conjunctivitis, coryza, cough then typical measles rash lasting 5 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN, start date: Jan2008; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2008. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Negative; (15May2022) Negative; (17May2022) Positive; (19May2022) Positive; (20May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Completed Paxlovid treatment 11May. Symptoms were obviously improving and patient tested Negative on 14May afternoon, and Negative again May 15 morning. On the morning of 17May patient had a runny nose and a light cough. He tested POSITIVE again that morning. Symptoms of runny nose, light cough, fatigue (but no fever) continued for about 4 more days. He tested POSITIVE 19May and 20May. If patient recovered: Recovered. Adverse event stop date: 21May2022  No follow-up attempts are possible. No further information is expected.
Vaccine was on the 8th of January  - Headache, rash on the top of my head and down on to my forehead and around my right eye. Doctor visit on 11th.  Diagnosed as Shingles. They put me on an anti-viral - Valtrex -  for 10 days. It prevented it from spreading. I had the symptoms until about the January 27th.
This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's historical drug included vaccination with two doses of GARDASIL on 18-JUL-2013 and on 13-AUG-2014 respectively with no adverse effects reported (MARRS# 1508USA011661). The physician reported that on 18-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 and on 25-AUG-2015, a second dose of GARDASIL 9 was administered (doses, route, lot numbers and expiration dates were not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two cases linked by the same patient. Additional information has been requested.
Pt felt dizziness, tiredness & chills right after FLUZONE administration (BP 67/33, pulse=71) paramedic was called in. Pt felt already better by the time ambulance came in.
Patient experienced dizziness, sweating, cold chills, achy muscles, nausea, hives on face and neck, swollen red arm at injections site
vomiting hourly fever of 101.4+ Treated with Tylenol, Zofran
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 20-JAN-2015 the patient was inoculated with ZOSTAVAX vaccine at a family medicine clinic for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 29-JAN-2015 the patient was treated by a physician at a medical clinic for onset of a persistent and severe vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Patient received Moderna vaccine second dose. While pt being monitored, pt began having palpitations. Medical emergency response team called and patient brought to ED for eval.
Pt. says immediately after vaccine administration, her arm hurt "pretty bad". She was unable to move her arm the next day so she called the MD and they said "don't worry." It has now been one month and she has no relief yet.
Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb stairs. Out of work for 5-6 weeks. Went to primary care doctor and a cardiologist. Still experiencing severe fatigue
This spontaneous report as received from a physician assistant refers to a 12 month old patient. Physician assistant reported that patient was given a dose of VARIVAX (merck) (strength, formulation, lot#, dose/frequency, route and duration were unspecified) in one arm and a dose of PROQUAD (merck) (strength, formulation, lot#, dose/frequency, route and duration were unspecified) in the other arm during one office visit (date unspecified). No adverse effect reported. Outcome was unknown. Additional information has been requested.
40 mins after inoculation, my left arm and hand felt tingly like my arm went to sleep. Lasted for about an hour. Left arm sore at the injection. 4 hours after inoculation, eyes were extremely heavy, felt tired and had a slight headache.
her tongue got tingly for several hours; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (her tongue got tingly for several hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA ORAL (her tongue got tingly for several hours). On 23-Jan-2021, PARAESTHESIA ORAL (her tongue got tingly for several hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were also not reported  Treatment for the event was not reported.
Anaphylaxis; swelling of lips, face, eyes; throat swelling as well.
Patient's Mom noticed "bumps" on pt. 9/5/16. Pt. was seen 9/6/16 and DX with chicken pox by Dr.
Redness at site, itchiness, swelling. Pt. went to E.R.
Mom says she took child to Emergency Room following vomiting, not eating, irritable, pain in leg, fever. Mom does not report redness or swelling at the injection site. Child has had seasonal influenza vaccine in the past with no reactions and has no known allergies. On date of form completion illness continues, fever has broke, child sleeps frequently.
pt complaining of still having arm pain in the arm of vaccine. pain is about 1-2 inches below where he had his vaccine given according to patient.  Patient claims it is more of a muscle pain .   ( shot given 23 days ago)
Information has been received from a physician referring to an approximately 15 year old male patient (16 year old at the reporting time). Information regarding relevant history and concurrent condition were not reported. "2 years ago", in approximately August 2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). "1 year ago", in approximately August 2014, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # not reported) and at the reporting time of 13-AUG-2015, the patient would receive the third  dose of GARDASIL (dose, route and lot # not reported) (inappropriate schedule of drug administration). No adverse event was reported. Additional information has been requested.
For 2.5 days after 1st immunizations (08/21/2003) parents describe child as excessively sleepy and "out of it" did awake to eat but without enthusiasm.  No fever, no obvious redness, swelling etc.  No abnormal movements "severe drowsiness" then "fine".  No treatment.
Reported generalized pruritus, diffuse rash: face, neck, BUE, torso.  Lethargic anxious  HR 90, RR 20, Administer Epi injector right thigh.  Given IM Benadryl.  Transported to ER.
Immediately after shot, tip of tongue was numb. After an hour or two, I also noticed tingling in right foot and hand. Next day, (today) I have tingling in top of both hands, up right forearm, tops of both feet, up to both shins and on my face - mostly right side of face and onto lips.
Initial information received on 29-Apr-2021 regarding an unsolicited valid non-serious case from other health professionals via Agency (inquiry number 00582945).  This case involves a patient with unknown demography who was administered with an expired 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number was not reported and expiry date: 19-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 20-Apr-2021.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   The reporter asked if it counts as a valid dose.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, it was unknown whether the patient had any adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
soreness around the site of the injection; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 01Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received annual flu vaccine and experienced soreness. It was reported that starting 01Mar2021 (reported as yesterday night), patient began to experience shoulder pain/soreness around the site of the injection; the pain has continued up to now though has been localized to the upper shoulder. Patient was aware that pain and swelling of the arm are common side effects of the vaccine, but as this is more soreness than patient had experienced with other vaccines (eg, annual flu vaccine), patient wanted to report out of an abundance of caution. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Received pneumonia vaccine at about 1:45 PM in left deltoid on 10/15/05. Site red and swollen by evening. Monday, progressed down to left forearm, red, swollen, painful. Going to urgent care after phone call. I asked for follow up call.
pt recv vax 11/26/97 & became preg LMP 11/12/97, EDC 8/20/98;pt induced @ 36wk d/t hx of prev shoulder dystocia;
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date 3 to 4 yeas ago the patient was vaccinated with GARDASIL dose 1 and 2. On an unknown date the patient and her sister (see linked case 1401USA005969) were about to receive their 3rd dose of GARDASIL and had received their 2nd dose of GARDASIL 3 to 4 years ago. No adverse effect was reported. Additional information has been requested.
12 noon - 8/31/2000 Mother bringing child into house from outside child in car seat, head jerking. Several seconds then seemed drowsy x 30 minutes vomited 1-2 times that afternoon then ok.
Flu and Pneumonia vaccine given in same syringe currently in process of re-vaccinating Per CDC.
Vax administered @ 9AM; t102, tremors & vomiting by noon;  Convuls @ noon; Seen by MD; Lasted 24hrs;
This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  Consumer stated, patient just received Covid-19 vaccine, patient took it just today (15Jan2021) and patient didn't get (word not clear) but patient was supposed to have patient's menstruation. Patient had Covid vaccine, patient worked with a (City name) (state name) (not clarified). After 15 minutes, it is a time that patient was supposed to see patient's menstruation and patient's menstruation came out in one hour time. After that patient didn't take up anything and when patient woke up this morning on 15Jan2021 patient felt that patient had lumps on patient's right breast and very painful and big. Patient had lumps (sentence incomplete). When probed to clarify if consumer wants some information, consumer stated, "Yes, because I developed lump immediately, so I want to find the issue. I want to know what would be the next step to do.".  Consumer stated, "I don't know if vaccine has expiration date. I saw something written as Pfizer Covid L and then they wrote a number and the number is 3302. Then they wrote Healthcare professionals at (Pharmacy name)." The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained.
9:08 am, 5 minutes after receiving vaccine, c/o numbness starting in the upper arm and spreading to fingertips and injection site soreness.  Vitals stable, AAOX4, good pulse, skin warm to touch, moving extremity with ease, no burning, tingling or skin discoloration.  ongoing monitoring in the recovery area for add'l 15 minutes, stated, numbness was lessening, continue to move extremity freely, dc to self care at 9:35am.
On 4/19/21 Patient experienced symptoms of swollen, watery eye, and then facial numbness that progressed to drooping. Patient was diagnosed with Bell's palsy. Patient was given a Medrol Dosepak and Acyclovir and had to be off work for 6 days. She is slowly getting better.
have issues with my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: have issues with my arm). The outcome of the arm discomfort was not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt date:16-JUN-2023 The case was received from  the patient via interactive digital media. The patient received first Shingles vaccine over three months ago and still had issues with his/her arm.
Hair falling out ,neo partials itching and pertaining out on arm , itching scalp before hair falls out ,neo partials filmed on roots of hair.blood clots and chest pain,
Admitted after 1 day of epigastric pain with associated nausea and vomiting, since resolved without recurrence, admitted with markedly elevated LFTs with AST 1701, ALT 2980, Alk phos 219, T bili 3.92, with mildly elevated INR to 1.2.