chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 patients were administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event; Initial information was received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA288625.  This case involves 65 years old male patient who experienced 2 patients were administered the influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] rather than the influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine (Suspension for injection) (strength, lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the 2 patients were administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event (wrong product administered) (latency : same day) following the administration of influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 2 patients were administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported 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 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.
cant walk; can't stand/cant set up; 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 GAIT DISTURBANCE (cant walk) and DYSSTASIA (can't stand/cant set up) 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 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 GAIT DISTURBANCE (cant walk) and DYSSTASIA (can't stand/cant set up). At the time of the report, GAIT DISTURBANCE (cant walk) and DYSSTASIA (can't stand/cant set up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication information was provided.
Patients wife phoned 11-3-06 said flu shot site reddened and swollen. Check up 11-6-06-redness lateral surface left arm; check up 11-9-06 redness Left posterior arm (abrasion); check up 11-14-06 left arm area healing nicely; check up 1-5-07 left arm posterior red. Note: Site of redness is not exact location of injection site.
Pain in shoulder joint, possibly as result of incorrect placement of injection. Acute pain in shoulder joint for 3 days post injection with severe range of motion deficits. Ongoing pain in shoulder joint at 10 days post injection with minor range of motion deficits. Internal Medicine consultation at one week post injection. Prescribed an NSAID (naproxen) and lidocaine patch. This event is ongoing and has not resolved at time of report.
Each vax resulted in one week bedridden, fever only first 3 days, inflammation  since first vaccination. Extreme fatigue, memory fog,  hot flashes (previously went away by 2018). Two major health conditions arose after vaccinating between the first and second: undiagnosed IBS diarrhea (unable to work full time, 25+ visits to toilet per day); bloodwork, thyroid and fecal tests at lab; diagnostic and excision biopsies both EGD and colonoscopy; diagnosed collagenous colitis 4/29/2022; undiagnosed breast tumor from mammogram 4/25/2022; primary dr referred me to oncologist for more scans and another outpatient diagnostic excision biopsy on one breast. I am unable to work full time despite Collagenous Colitis drug therapy, I?m always tired, I?m unable to focus at work and home, I?ve been healthy without disease prior to 2018 having one bad cold November 2019 which is rare.
On day four 1/2 vaccine site is itchy and red almost all around arm and 2-3 inches high.  Day after shot had slight headache and fatigue.
From initial information received on 7/3/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a patient (age and gender not provided), received a dose of IMOVAX RABIES as part of a pre-exposure series in January or February 2004. The initial doses were part of the recalled lots and the patient had to receive two more doses on unspecified dates. No lot numbers were reported for any of the products. An unspecified amount of time later, the patient developed hypothyroidism. No specifics were provided regarding the adverse event nor the patient's recovery status.
No adverse effects reported.; The patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.    On 22-APR-2019, the patient as inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) with lot # N030111 and expiration date 21-APR-2019  for prophylaxis.
L upper arm + swelling and redness, since yest, day after received vaccines can use arm, but c/o pain, no itching swelling and redness less than yest as per mom received KINRIX in affected arm 2 d ago.
Headache, Myalgia, Fever, NauseaVomiting, fatigue,chills Narrative:
Tested positive for covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical 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 COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Tested positive for covid 2 days later..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided   Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.
Fever 101.3 with severe  body aches and terrible headache since last night until now. It has been more than 24hrs since I received a vaccine.
Exactly one week after my first Moderna COVID vaccination, I developed itching at the injection site.  The area is about 3" found, red and inflamed and a bit painful to the touch.  Today is the second day so I can't speak to the duration.   I understand that this is being called COVID arm.
local pain, swelling, fever, malaise, diarrhea, palpitations x 2 wks;
being sick; has not been able to get the second dose due to her being sick and also the weather; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (has not been able to get the second dose due to her being sick and also the weather) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (has not been able to get the second dose due to her being sick and also the weather). At the time of the report, ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (has not been able to get the second dose due to her being sick and also the weather) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
pt presented with covid and encephalopathy.  neuro workup done. pt discharged home.
New white spot and under the arm in the lymph node area; headache; vertigo; UTI; I did not feel like myself, I was not as upbeat. I was rundown; Rotator cuff syndrome; chills; Sore arm at injection site; Tired / Fatigue/more tired; Malaise/didn't feel good; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rotator cuff syndrome. Concurrent medical conditions included autoimmune disorder (which attacks the mucus in her mouth). Concomitant products included dapsone.   On 4th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced injection site pain, fatigue, malaise, chills, feeling abnormal and rotator cuff syndrome. In December 2019, the patient experienced urinary tract infection. On an unknown date, the patient experienced skin discoloration, headache and vertigo. On an unknown date, the outcome of the injection site pain, skin discoloration and vertigo were not recovered/not resolved and the outcome of the fatigue, urinary tract infection, chills and headache were recovered/resolved and the outcome of the malaise, feeling abnormal and rotator cuff syndrome were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, malaise, urinary tract infection, chills, headache, vertigo, feeling abnormal and rotator cuff syndrome to be related to Shingrix. The reporter considered the skin discoloration to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm deltoid. She did not recall if it was intramuscular or not and had sore arm at injection site arm got progressively worse first couple of weeks and at the time of reporting it was starting to get better.  The injection site arm and felt that it was possibly a rotator cuff issue like what she had with her other arm.  The patient had Tired, Malaise, Fatigue and did not feel good and was more tired. The patient did not feel like myself and was not as upbeat. I was rundown on and off. The patient had Urinary tract infection she had never had one before. The patient finding on mammogram and she had a yearly physical and mammogram and was called back because of a new white spot and under the arm in the lymph node area. She spoke to the nurse about how she thinks it could be related to the Shingrix shot.  The reporter told her that the shingles shot can cause pain problems, chills, headache, Vertigo. The caller was joking about how she could not find the paperwork which she had which had the information about the injection. She jokingly said it's not fun getting old and losing things. The reporter consented to follow up.      Lab Comments: she had a yearly physical and mammogram  and was back because of a new white spot and under the arm in the lymph node area.
URI, low grade fever, conjunctivitis and severe rubella/measles-like rash covering entire body with red papules, worse no trunk, confluent on face.
Initial report received on 05 March 2008 from a nurse. A 13-year-old female patient, with no pre-existing medical conditions, had received an intramuscular right deltoid injection of Menactra (lot number U2403AA); and an intramuscular left deltoid injection of Gardasil (manufacturer Merck, lot number 1267U) on 09 November 2007. The patient received the vaccinations and fainted when leaving the office. The patient was then brought back into the office and put in a reclined position for about 16 minutes; vital signs were stable. The patient left the office without any further symptoms and had recovered from the event. No other relevant medically significant information was provided. The reporter for this case is the same as reported in case 2008-00497 (Case reported in a 17-year-old female patient, who fainted five minutes after she received a concurrent immunization with Menactra vaccine and Gardasil.).
pt recv vax 5JAN99 & broke out in a rash on 29JAN99;went to ER on 31JAN99 rash became worse, blisters appeared, itching & swelling;given atarax, DPH & pred;5FEB99 same blister rash w/itching;
5/3/16- Nausea, vertigo, photophobia, urticaria, low grade fever.
Left hand felt stiff and then became red, wrinkly, and dry with small amount of skin chafing, no symptoms in right hand. - vaccination was administered in left arm
Pain, numbness, redness at site, chills and night sweats. DX: Cellulitis vs. different sort of pneumococcal vaccine reaction. Given BIAXIN 500mg BID x 7 days.
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch.  I left facility 1 hour later.  After 2 hours of the shot, the left arm began to be noticeably sore.  12 hrs post vaccine, I had flu-like symptoms.  24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced  considerable  lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area.   36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area.  Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm).   Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
Fever of 101.2; 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 PYREXIA (Fever of 101.2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101.2). At the time of the report, PYREXIA (Fever of 101.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.. No Treatment information was reported.
Systemic: Seizure-Severe, Additional Details: Pt called on 08/28 complaing about the seizure
Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; Several redness and rashes and itch all body every day; A lot of thread veins are visible.; It's like an insect crawling inside the skin; Daily life is difficult and very stressful; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Apr2021 15:15 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for covid-19 immunisation, age at vaccination 47 years old. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of BNT162B2 (Lot/batch no: EW0165) on 03Apr2021, 15:00 at Arm Left for covid-19 immunization. Patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications the patient received within 2 weeks of vaccination. Patient had been getting several redness, rashes and itch all body every day even 2 months have passed. It's like an insect crawling inside the skin. Also, a lot of thread veins are visible. Patient mentioned that It's been two months and he was not the only one who still has these symptoms. Because of this, daily life is difficult and very stressful (He didn't have any allergies to food or vaccines). Patient had antihistamine injections, took antihistamine pills and medicine for several weeks. However, when he stopped taking the medicine, the symptoms recurred. Physician office was visited. Outcome of the events was not recovered.  Information on batch/lot number was available. Additional information has been requested.
This is a spontaneous report from a contactable physician. A 18-year-old female patient received the 2nd dose of TRUMENBA (lot# S58879CVX, exp date 30Jun2019, NDC 0005-0100-01), intramuscular in left arm, on 28Feb2018 at 07:30 PM, at 0.5 ml single, for immunisation. Medical history included ongoing attention deficit/hyperactivity disorder and ongoing headache. Concomitant medication included dexamethasone, ofloxacin hydrochloride (FOCALIN) from some years before and ongoing for attention deficit/hyperactivity disorder (prescribed by the neurologist). The patient previously took the 1st dose of TRUMENBA (lot# S58879CVX, exp date 30Jun2019) on 28Feb2018, for immunisation. The patient experienced headache and dizziness both on 11Mar2019, with outcome of recovering. Therapeutic measures were taken as a result of headache. The patient waited 10-15 minutes in physician's office before going home. When she was at the car she then started feeling dizzy and had a severe headache. She was asked to come back in and checked her vital signs, and they were stable. She was interacting and talking with her eyes closed like the lights were bothering her. She had her hand on her forehead like her head was hurting really bad. After 45 minutes the headache persisted all the way through. They gave her Pedialite and she took a few sips. The doctor asked if the patient eat and the patient said yes. The parents brought her to the emergency department and 1 hour later they went home. The patient slept through the night. Her headache reduced significantly. The events were considered serious as per medically significant by the reporter. Causality: This happened after giving the vaccine and there was nothing else to account for this. Her exam was normal.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events dizziness and headache.
Took Tylenol PM to help with aches.  Went to bed about 10:00PM and very quickly developed chills then vomited 3 times.  Event lasted about 3-4 hours.  Was fine in the morning with only a little weakness.
Could not lift Right Arm; Muscle Pain; Joint Pain; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), LIMB DISCOMFORT (Could not lift Right Arm), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Sick). On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Could not lift Right Arm), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain). At the time of the report, ILLNESS (Sick), LIMB DISCOMFORT (Could not lift Right Arm), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
After a few days, my daughter developed a rash. The bumps are very fine and are on her chest, back and arms mostly. (Upper trunk). The bumps have been there ever since and it's been serveral weeks since the injection. Baths, lotions, oils don't make a difference.
3-4 day hours of fever followed by outbreak of diffuse rash, erythematous papular rash.  Rosacea vs post vaccine measles/rubella reaction.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or drug reaction reported. The reporter read an article on the Internet pertaining to the patient who was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expired date were unknown) on an unknown date. No concomitant therapy was reported. It was reported that the patient had a "tennis ball size lump" at the injection site when he/she woke up on the day after the vaccination. The outcome of the event was unknown. Additional information has been requested.
Warm, raised, red welt at the site of injection.  At report, welt measured 2.8cm x 3.9cm. Welt has been outlined to determine size change. Fever recorded at 100.4 with body aches, fatigue, and swollen glands.
Patient came in for weakness and multiple falls the past week. BP in triage is 86/52. An 85-year-old male with PMH of HTN, HLD, CAD s/p CABG and AICD, CHF and BPH presented to the ED with generalized weakness and multiple falls over the last week. Patient stated he feels generally weak. He stated he has fallen a few times over the course of the last week, but denied any head trauma. No loss of consciousness. He denied any other focal symptoms. No fever or chills. No chest pain or palpitations. He noted some mild orthopnea, but felt this is chronic from his CHF. He has chronic unchanged lower extremity edema. No asymmetry. No hemoptysis. Abdominal pain, nausea, vomiting, diarrhea, constipation, dysuria, hematuria or increased frequency. Vaccinated for COVID-19 (had 2 doses without a booster).
10:10am Vaccine given for booster on 6/14 was drawn up in syringe in refrigerator since 6/11.  Unknown to nurse giving vaccine.  Primary vaccination nurse alerted this nurse to situation.  Notified Public Health who advises to offer new vaccine.  Situation explained to patient and wife (other patient).  Consent to new vaccine injection (same lot).  Asked patient to call if any problems or concerns.
fever, chills, cold sweats, body aches, headache, fatigue. Symptoms lasted the entire night into 9:00am this morning after taking Advil and Tylenol.  I am still experiencing a headache and fatigue 9:30am 11/4.