chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described a 2-month-old female pt who inadvertently received diphtheria and tetanus toxoids and acellular perrtussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) plus a separate injection of poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 10/13/2003, the pt received her 1st dose of Pediarix. The pt then inadvertently received an injection of IPOL. The pt also received Haemophilus influenzae type b conjugate vaccine (Hib-Titer, Lederle Labs). At an unspecified time following the immunizations, on 10/13/2003, the pt experienced crying.
patient received an expired dose of Fluzone / no AE; 56 year patient receive Fluzone HD dose/ no AE; 56 year patient receive Fluzone HD dose / no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56 years old male patient who received 0.5 ml dose of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ000AB (Expiry date Mar-2019) via intramuscular route in the left deltoid on 20-Sep-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used, inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  List of documents held by sender: none.
I have mild pain, burning, and itching at the injection site along with a rash and mild swelling.  Symptoms started today, 9 days after vaccination.
All of my chronic degenerative soft tissue seemed to be exacerbated from the (intense) immune response from the vaccine. The normal chronic pain levels were elevated and unrelenting causing unusually chronic fatigue, depression, headaches and generally a malaise that continued to intensify daily until I received a scheduled cervical epidural steroid injection on May 5th 2021 at 9;00 am by MD at a medical office. Location in a state. After that treatment was completed all my adverse symptoms subsided entirely by the end of that day, May 5th. I am hesitant and nervous about getting my second shot.
There is an itchy rash all over my body, including legs,  arms, belly, and back.  It started the day after my shot on my legs and arms.   The next day it had spread to my back and hips/thighs, and the day after my belly and chest.   The rash is still evident on all parts, but the itchiness is starting to subside on my lower legs and arms.  I have been treating with calamine lotion, ice packs, and benadryl or the itch.  The sun and heat seems to exasperate it.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (unknown age and gender). On an unknown date, the patients were vaccinated with LIQUID PEDVAXHIB (dose, route of administration and lot number were not reported) GARDASIL which were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Lymph node(s) in left armpit were swollen, red and warm to touch.  Infection suspected, but not confirmed by laboratory tests.  CEFUROXIME 500 mg 2/day for 7 days was prescribed and taken.  Swelling and redness of lymph node(s) returned to normal approximately 48 hours later.
Pt tolerated vaccination well, ten minutes after administration pt became flushed to face. Temp 99, P-87, R-14, B/P-120/82, oxygen sat 99% at room air, denied pain, dizziness, or SOB. Given water, crackers, and ice to neck; flushing unrelieved. Phoned Dr.'s office whom was unable to see pt today, pt encouraged to go to urgent care.
The patient stated that every since she received the vaccine she has had pain in her left and right shoulder. She can not lift up and she can not move her  arm in certain motions with out discomfort.
Info has been received from a health professional concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #641027/1051L). Subsequently the pt experienced arm swelling from shoulder to elbow, heat and erythema. The experience "lasted 2 to 3 days and resolved without intervention". The pt sought unspecified medical attention. The health professional also described the experience of another pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot #641027/1051L, exp. 05/18/2003), WAES #0211USA01918. Additional info has been requested.
Pt recvd 3 doses Hep B on 2MAY91, 3JUN91 & 26NOV91 & DEC91 lab eval showed elevated liver enzymes; no futher details were provided;
injection site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported, however it could be over 50 years. The reporter stated that the patient had pain at injection site after vaccination. The patient refused second dose due to the adverse event. This case has been linked to US2019AMR222641, reported by the same reporter.
sore arm; neck pain; difficulty moving his head side to side; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction to the Pfizer covid vaccine and wanted to know if it is normal or not. He received the vaccine on Friday afternoon (unspecified date) and experienced sore arm lasting 2 days which he expected, but by the end of this time experienced neck pain and difficulty moving his head side to side. "Can I take Tylenol for this reaction?" Outcome of all the events was unknown.   Information about lot/batch number has been requested.
hives to affected arm soreness starting 2 days post injection   pt reported using aniitch cream and benadryl  with relief of symptoms
blood sugar started creeping up again; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (blood sugar started creeping up again) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERGLYCAEMIA (blood sugar started creeping up again). At the time of the report, HYPERGLYCAEMIA (blood sugar started creeping up again) outcome was unknown.            No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-035936 (Patient Link).
Information has been received from a physician concerning a 56 year old female,also reported at 57 years old, who on Oct 18, 2002, reported as Oct 18, 2003, was vaccinated in the left thigh with a first dose of pneumococcal vaccine 23 polyvalent (Lot# 643251/0445M). On Oct 18, 2002 in the PM, reported as Oct 18, 2003,on the night of vaccination, the patient developed local swelling, redness, and itching at the injection site, which was 5 inches by 4 inches in size. The reporter indicated that the patient recovered. Unspecified medical attention was sought. The reporter indicated that five or six patients experienced a sever injection site reaction after vaccination (WAES0303USA01861: WAES0303USA01727: WAES0303USA01728: WAES0303USA01730). No further information is expected.
Post vax, pt walked to waiting room, where pt had syncope and landed on his back, hitting back of head on floor. BP 154/80, Pulse 60. Complaining of pain to back of head. BP retaken, 152/80. Pt ambulated with assistance to room for repair of 2 lacerations above left eye, during fall. BP 120/84. Gave Benadryl IM in left arm. BP 120/80, Pulse 72. Pt given Adrenalin, SC in left arm. BP 120/80. Pt did complain of tightness of his chest and some shortness of breath. At that time, is when the doctor ordered the injection of the Benadryl and Adrenalin. Pt and mom left ER, AMA.
Pneumococcal given 4/18/2022  - same date as Covid Booster #2, 4th Pfizer Covid shot  I got inflamed lymph nodes from Covid vaccines on left side armpit. I ended up with breast cancer on left side.
I have recieved both vaccines including booster and monoclonal antibody infusion because i am a healthcare worker and it is mandatory. Since i recieved first vaccine in Dec 2020, i started having hypertension , which progressively got worse. Muscle weakness, rashes over my body which hurt and itch. I have caught covid twice , missed work multiple times due to ongoing tests , at present i have been exposed to Covid again and have this reccuring Shortness of breath with Hypertension. I am now seeing a Cardiologist and Pulmonologist. I am so tired, I have done the v-safe check in, i thought someone would reach out to me to explain whats going on. I now have anxiety, depression and so fearful of what is coming next.
Immediately after administering MMR and DTAP vaccine patient broke out in very small hives under both eyes and along sides of his face. He later had some swelling around his eyes and complained of itchy eyes 2 doses of BENADRYL given and oral steroid given and prescribed.
Information has been received from a physician concerning a 74 year old female with reportedly no adverse drug reaction or allergy, who on 4/28/2006 the patient experienced deep vein thrombosis DVT and was admitted to the hospital. It was reported that the patient had blood work performed. The patient was given intravenous IV heparin. It was reported, that the patient was on enoxaparin sodium Lovenox therapy until the patients warfarin sodium Coumadin became therapeutic. Additional information has been requested.  Follow-up: This WAES number was voided, as it was determined to be a duplicate of WAES number 0606USA01896.
This case was reported by a physician via sales rep and described the occurrence of myalgia in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was immunized at the pharmacy and experienced significant myalgias. The physician did not have any additional details regarding the patient. The reporter did not agree to receive mails of follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK082075 reported by the same reporter.
approximately 10 minutes after she received her vaccine she became dizzy,  shaky, diaphoretic, couldn't stand up, pallor, hot flashes through entire body, speech slightly slurred.  50mg PO benadryl given, and took her to ED to be seen, as symptoms did not improve.    She is  approximately 9 weeks pregnant.    ED gave her: Diphenhydramine 25mg IV once Famotidine 20mg IV once Methylprednisolone Sodium Succinate 125mg IV once Onedansteron 4mg PO once  Symptoms improved, Discharged home stable Instructed to follow up with her OB and PCP 1/20/21.
On 6/9/2005 this patient received the Menactra Vaccine. Her mother called our office on 6/17/2005 stating she wasn't sure if it was a reaction but wanted to let me know.  On 6/15/2005 she developed generalized myalgia and arthrolgia with definite skin sensitivity telling her mom " don't touch me, my skin even hurts". She had a temp of 101 with other sypmtoms of headache, sore throat, fatigue and general malaise.  Symptoms lasted a couple of days.  Mother is an RN and wanted it noted.
GI and neurologic symptoms; GI and neurologic symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), NEUROLOGICAL SYMPTOM (non-serious), outcome "not recovered" and all described as "GI and neurologic symptoms". The events "gi and neurologic symptoms" required physician office visit. Additional information: The patient is currently followed by neurology, primary care, emergency medicine, Gl consultants, otolaryngology, audiology, and ophthalmology.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (First dose) on 10-Apr-2021 and Pfizer (Second dose) on 10-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Hospitalized for some other reason. pt incidentally tested positive at admission and received oxygen as well as Decadron and Remdesivir
Sore left arm for one hour; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 22Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician, the patient.  A 59-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in the left arm on 08Apr2021 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 59 years-old), dose 2 intramuscular, administered in the left arm on 29Apr2021 (Batch/Lot Number: ER8735) as dose 2, single (at the age of 59 years-old) for COVID-19 immunisation.  Medical history included hyperlipidaemia from 2008 and ongoing, cerebral palsy from 1961 and ongoing (Orthopaedic surgery left arm and leg 1970's and 1960's), and ongoing unusual eye anatomy (from birth). Concomitant medications included atorvastatin taken for hyperlipidaemia from 2008 and ongoing; dorzolamide (DORZOLAMIDE) taken for an unspecified indication from an unspecified start date and ongoing; inositol nicotinate (FLUSH FREE NIACIN) taken for hyperlipidaemia from 2008 and ongoing.  The patient experienced sore left arm for one hour on an unknown date in 2021. The event was reported as non-serious. The outcome of the event sore left arm was recovered on an unknown date in 2021.
Patient got COVID-19 Vaccine and was sick with infection after first shot.; Patient got COVID-19 Vaccine and was sick with infection after first shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), INFECTION (non-serious), outcome "unknown" and all described as "Patient got COVID-19 Vaccine and was sick with infection after first shot.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt states recv vax 6MAY96 430PM & later noted pain lt side of neck, Tues AM, took ASA & called MD told to call hlth dept-arm a little sore, small bruise @ site size of penny, upper arm swollen & warm to touch;inj site became hard & black
Fever, hives 7/27 went to ER CXR NL U/A - Cx- negative - Went to clinic u/c 7/27 sent to another clinic seen by doctor 7-29-09 - Hives under neck, diarrhea, vomiting x 5 days - Referred to allergist - allergic reaction to vaccination - also had banana that day - 7-31-09 Rash improving - *Mom said 7-31-09 had a similar reaction after 1st immun but not as much - did not tell doctors.
This spontaneous report was received from a registered nurse referring to unspecified number of unspecified patients. Patients' medical history and concurrent conditions were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored VARIVAX (Merck), (lot # L031065 and expiry date on 18-AUG-2017) and (lot # L035128 and expiry date on 14-SEP-2017), (strength, route, dose and frequency were not reported). Concomitant mediations were not reported. No adverse effect was reported and no product quality complaint was involved. The stored temperature reported as 7 F degrees for 10 minutes and temperature excursion was reported as 18.2 F degrees for 5 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Hurt when he would raise his arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Hurt when he would raise his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurt when he would raise his arm). At the time of the report, PAIN IN EXTREMITY (Hurt when he would raise his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Hurt when he would raise his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurt when he would raise his arm). At the time of the report, PAIN IN EXTREMITY (Hurt when he would raise his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Flu vaccine given in LD (12:15pm) LOT #UJ711AB   Patient not due for flu vaccine as she received it 10/16/21   RN alerted staff to vaccine error   Pt waited 15 mins after vaccine w no adverse reaction   Pt instructed to take Tylenol or Motrin if side effects arise and to call the clinic with any questions or concerns
Headache, Myalgia, Fever, NauseaVomiting, Awoke 17 hrs post 2nd COVID vaccine with fever,HA,nausea,and myalgias. Narrative:  Awoke 17 hrs post 2nd COVID vaccine with fever,HA,nausea,and myalgias causing her to miss 1 day of work.
Employee here for COVID vaccine reaction, Left upper arm in deltoid area is red, swollen, warm to the touch. States this reaction started 01/05/21 with redness and itching area was outlined in pen at that time measured 7 X 9cm. The area has now expanded and is 11.5 X 11.5cm. States it is itching tender to the touch, swelling seems to wax and wane. No medication taken at this time. Redness does appear to be spreading toward collar bone and streaks are noted extending up shoulder. Recommending that the employee get seen for this reaction by PCP or walk in clinic to rule out possible cellulitis. Employee verbalizes understanding and agrees.
Patient departed from vaccination clinic in no distress with no changes. Presented to ER  with  left sided facial droop which started on her drive home. Per ER note, patient did have aphasia and shortness of breath.  Patient had quick change of respiratory sounds with suspected flash pulmonary edema.  Noted to also have facial swelling. Anaphylaxis suspected. Patient intubated and admitted to ICU with guarded condition.
Received PCV7, HIB in left thigh, and flu shot in right thigh.  MMR in right arm subcutaneously, and VAR in left arm subcutaneously.  Immediately after vaccines given, nurse noticed a dollar sized reddened area at injection site.  Two inches in size on both arms extending to elbow, warm to touch on both arms.  Baby had no signs of Physical assessment done in ER.  Vital signs normal, pulse ox 98%.  No treatment needed.  Diagnosis:  Allergic reaction resolved.  Referred to Pediatrician.
It was a few days after the vaccine, and in the shower I noticed a lump on the inside of my collarbone on my right side and I saw my doctor. She thought it was a swollen lymph node from my vaccine. It resolved within 10 days and was completely gone a bit after that.   Note: I got a tetanus shot around the middle part of March. I don't know the name of it for a bad cut on my foot.
Worse menstrual cycle of my life. One week late. Cramps so bad for three days that my back and hips hurt and couldn?t get off the couch. Normally I am twenty eight days and have no cramps.