chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles along my spine wrapped around my right side; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th December 2022, the patient received Shingles vaccine. In December 2022, less than a week after receiving Shingles vaccine, the patient experienced shingles and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shot on a Friday and on Tuesday was at the doctor getting the anti viral drug broke out in shingles along spine wrapped around patients right side. The symptoms luckily stopped it before it got to bad, but was very painful. The follow-up could not be possible as no contact details were available.
Grand mal seizure-pt home approx 12-13 hrs after immunizations IV Diazepam given.  12/07/2007 ER report received for DOS 10/26/07 with Final DX:  First time seizures.  Pt developed seizure at home described as whole body shaking and eye rolling with perioral cyanosis on pm of vax.  PE WNL except for (+) irritability.  Observed for 23 hrs and D/c.
Red, blotchy, oval, slightly raised rash at injection site 9 days after injection, 2/19/21, did not itch, slightly warm to the touch, about 4" in diameter.  No treatment taken.  Disappeared on 2/24/21.
This spontaneous report as received from a nurse practitioner refers to 8 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 18-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician, via a company representative, concerning to a male patient in his 60s. The patient's pertinent medical history and concurred conditions were not provided. It was reported that in 2012, reported as "4 years ago", the patient was vaccinated with one time injection of ZOSTAVAX (lot #, dose, route and expiration date were not provided). Concomitant therapies were not reported. On an unknown date, the patient got shingles and he sought unspecified medical attention on an unreported date. The outcome of shingles was unknown at the time of the report. Additional information is not expected as no consent for follow up was given.
For the 36 hours after my vaccine, I had commonly listed side effects; chills, aches, and shivers. These subsided, and I developed a cough for the next 3 or 4 days. This developed into more of a chesty feeling and lethargic feeling. On the 8th day after my vaccine, my symptoms were similar to those in Covid positive cases; chest tightness, dry cough, and chills. I went to get tested, and was found to be Covid-19 positive. Since then, I have experienced severe headaches, continued tight chest, cough, chills, and sweats.
This spontaneous report as received from a medical assistant refers to a 2 year old patient. On an unknown dates, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) at 1 and 2 years old which was not included in the prescribing information. No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
Batch of Vaccines drawn up may of had expired doses outside of the 6 hour window. This patient may have received a dose that was outside of that window but within 24 hours of been drawn up.   No adverse events reported to the patient.   Patient was informed.
tiredness; Headache; Muscle pain; Some chills; fever; Nausea; just feeling not well; This is a spontaneous report from a contactable consumer.   A 59-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (age at vaccination: 59 years), as dose 1, single dose for COVID-19 immunisation. The patient's medical history included Rheumatoid arthritis. The patient's concomitant medication included lisinopril, sulfasalazine and hydroxychloroquine, all from unknown dates for unspecified indications. The patient stated that the patient was having reactions to the COVID19 vaccine. On an unspecified date, the patient experienced tiredness, headache, muscle pain, some chills, fever, nausea and just feeling not well. The patient was just wondering what to do. The patient had two doses and it's been about 3 weeks out on second dose and was still having tiredness, headache, muscle pain, some chills, fever and nausea and discriminant well basically. The patient stated that the patient had in both times, and it seems like second dose has been more severe. The patient asked that what do I need to do for, whether the patient needs to go to the doctor or needs to go to the hospital. The patient asked for treatment taken in response to adverse events and the patient said that just resting. The patient underwent lab tests included blood test for anemia on an unspecified date. Outcome of the events tiredness, headache, muscle pain, some chills, fever, nausea were not recovered and for just feeling not well was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It was Saturday but he may have been a little more fussy because mom was away. Saturday around noon dad notices the baby wouldn't eat or drink and had fever of 101. Dad then call doctors and the doctors told him to come to the campus. No medication was given from the doctor. We were just instructed to give him Tylenol. Today he seems happy and back to normal but yesterday was pretty rough.
Extreme fatigue set in just shy of 2 days after injection.  Remained fatigued for 4 days afterward
GENERALIZED SWELLING, TENDERNESS, FEVER, PAIN/SORENESS AT INJECTION SITE
Dizzyness-Unsteady 2/4 doctor visit (cardiology) ecg set up 2/10 doctor visit (gp) brain scan set up reduced tamsulosin, changed metoprolol succinate to tartrate
Near syncope. Pt asked for help as she felt faint and the feeling worsened over the next two minutes. Had pt recline in her automobile. Called EMS and they arrived at 10:10am and evaluated her. She recovered quickly and by 10:30am was able to leave the facility by herself.
Pt almost passed out after giving Tdap vaccine. For about 1 min. I kept talking to her and put her feet up. Washed her face with water.
Moderna COVID-19. Vaccine EUA Exactly 12 hours after my injection, 1:30 am, I awoke with a severe coughing attack. In addition, my chest was wheezing and felt as if "bubbles" were in my chest. My arm felt very hot and tender at the injection site. This attack lasted for half an hour. I went back to sleep and awoke the following morning feeling very weak and confused. Feeling extremely fatigued, all I wanted to do was sleep. I also lost my appetite. The next day, I had occasional coughing which subsided with my over the counter cough medicine.
Patient reports swelling in her arm, starting the evening of her vaccination.  Her arm had a puffy, raised, red patch covering most of her shoulder.   She had a headache and checked her blood pressure.   She reports it was 157/93, higher than normal for her.  She also said she felt like her blood sugar was low but did not report testing it.  She continued to feel ill off and on but reports feeling better with time.  Her arm today (Monday) still had a red raised patch spanning several inches acrossed her deltoid.  She said it itches but looks better than it had on Saturday evening.  She has not taken any medication during this time.
shingles on my face; Shingles on my face and in my mouth; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 at 17:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 01Mar2021 at 17:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced "shingles on my face and in my mouth". The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events shingles on my face and in my mouth which included treatment with anti-viral drug from an unknown date. The clinical outcome of the events shingles on my face and in my mouth were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
flared up joint pain; flared up joint pain; Breathing difficulties; heavy fatigue; This is a spontaneous report from a non-contactable other HCP. A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Left Arm on 12Feb2021 as DOSE 2, SINGLE (at the age of: 28-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number: Unknown) on 12Feb2021 for covid-19 immunization. Medical history included lyme disease. The patient's concomitant medications were not reported. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies reported for the patient. On 13Feb2021, the patient experienced flared up joint pain, flared up joint pain, breathing difficulties and heavy fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA - I had a raging headache for 30 hours - I took Excedrine Migraine as directions allowed.
Soon after giving H1N1 inj.   patient felt faint said she seen black for a second, and then began to cry, nausea
Injection site swollen, hot, and red. Nausea, headache, chills. Fatigue.
Client fainted.  Client's mother stated client had a seizure not witnessed by staff.  Client stated after hepatitis A, she felt pain in Lt arm.  After MENACTRA she felt like she had to sleep.
Wheezing and congestion along with Atopic Dermatitis/eczema around injection site in Left lateral thigh and several patches around left posterior elbow.
Toothache; Aches and pains; Could not eat; Arm pain; lost of strenght, could not held a glass of water; Really really high fever; Nausea; Joint pain; Muscle pain; Fatigue; chils; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Really really high fever), PAIN (Aches and pains), NAUSEA (Nausea) and FEEDING DISORDER (Could not eat) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Really really high fever), PAIN (Aches and pains), NAUSEA (Nausea), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), ASTHENIA (lost of strenght, could not held a glass of water), FATIGUE (Fatigue), TOOTHACHE (Toothache) and CHILLS (chils). On 23-Jan-2021, CHILLS (chils) outcome was unknown. On 24-Jan-2021, PYREXIA (Really really high fever) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (Aches and pains), NAUSEA (Nausea), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), ASTHENIA (lost of strenght, could not held a glass of water), FATIGUE (Fatigue) and TOOTHACHE (Toothache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen muscles upper left arm, skin red on upper left arm, very painful to touch or to extend arm at elbow. Light headed with headache. Had an episode of being very cold and unable to get warm, lasted 1-2 hours. No temperature. Symptoms slowly abated over 3 days.
Imm given at 1340. Flushing and SOB started at approx 1400. Taken to ER. Presented with SOB, tachycardia, increased B/P. Given solu medrol IV and albuterol inhaler.   EKG, CXR and cardiac enzymes preformed, all WNL.  SOB resolved slightly at rest after approx 4-5 hrs. SOB continues with activity and talking.
a patient received IPOL vaccine third dose on 6 year of age and fourth dose on 16 years of age/ No AE; Initial information received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via Medical Information number: 00767893 via phone.  This case involves a six-year-old male patient who received a third dose of IPV (VERO) [IPOL] and fourth dose of the same vaccine at 16 years of age (inappropriate schedule of product administration).  The patient's past vaccinations included first dose of IPOL [POLIO VACCINE INACT 3V (VERO)] in Jul-2005 at three month of age and second dose of the same vaccine in Sep-2005 at five month of age for prophylactic vaccination respectively.  The patient's medical history, past medical treatments and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and MENINGOCOCCAL VACCINE B [Meningitis B vaccine] for prophylactic vaccination respectively.  On an unknown date in January 2011, the patient received a third dose of suspect IPV (VERO) lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  On 17-Aug-2021, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) lot number: R1F972M, expiry date not reported, strength: standard, frequency: once via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency same day).   It was reported "Caller states that a patient has already received a full series of IPOL vaccinations and that the practice accidentally began a second series starting on 17-Aug-2021. Caller states that the patient is scheduled to come in for their second dose of their second series of IPOL and wanted to know if there was any risk in this and how to proceed. Caller states that the patient previously received IPOL in July and September of 2005 at ages 3 and 5 months as well as in January of 2011 at age 6 years and most recently on 17-Aug-2021 at age 16 years. Caller asked about safety of the vaccine. Fifth dose was scheduled."  At the 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 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.   There will be no information on the lot number of the third dose of vaccine in this case.
RECEIVED VACCINE FEBRUARY 9th AROUND 11:10 AM.  AT AROUND 2:30 AM ON FEBRUARY 10th STARTED HAVING CHILLS AND BODY ACHES.  THE BODY ACHES CONTINUED THROUGHOUT THE DAY ON FEBRUARY 10th ALONG WITH NAUSEA, LOSS OF APPETITE, FATIGUE AND LIGHT HEADACHE.  SYMTOMS WERE GONE ON FEBRUARY 11th.
Injection arm was very sore for first 3 days, but felt better and only bothered me to touch injection site. Starting day 8, I noticed my arm was itchy and more tender and hot to touch. Looked in the mirror and have a red splotch that I didn?t have before today.
Day 1 Chills, malaise, headache.   Overnight low grade fever (<100),  body ache, headache.  Day 2 low grade fever, extreme lethargy, body ache, mild headache  Overnight body ache, low grade fever, mild headache
I got sick shortly after the shot with on and off fever chills severe pain in legs and arms.. Severe back pain head ache cough soar throat dehydrated weak tired on the sat following the 8th i coughed up blood. My arm that i got the shot in still has pain and so does my back, i also still have a lingering cough every morning
Went for audio hearing test and normal hearing; Tinnitus following 2nd injection; This is a spontaneous report from a contactable other HCP, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 07May2021 at 18:15 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, for many years which was regular and no problem. The patient had allergy to wheat gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 18:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021, following the second injection, the patient experienced tinnitus. The events resulted in doctor or other health care professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported event. On an unknown date in 2021, the patient underwent audio hearing test and the result was normal hearing. The clinical outcome of the event tinnitus following second injection was not recovered at the time of this report.
Patient was found unresponsive with pinpoint pupils in the hotel room. She was given intranasal and intravenous naloxone improvement in mentation but reportedly hypoxic with SpO2 in 80s patient placed on non-rebreather mask switched to BiPAP but agitated restless required intubation in the emergency department.  Initial ABGs pH 7.19 PO2 236 PC O2 67 PF ratio 236 .SARs Cov2 screen positive.  Chest x-ray bibasilar airspace disease.  UDS positive for cannabis.  Patient admitted to ICU on 02/10/2022 with acute hypoxic hypercapnic respiratory failure, pneumonia, acute toxic metabolic encephalopathy acute kidney injury and lactic acidosis. Patient required vasopressors for hypotension in ICU 2/11 patient extubated.  BiPAP 2/12 patient restless agitated-olanzapine p.r.n. added taken off BiPAP placed on high-flow nasal cannula.  Requires intermittent diuresis with Lasix.percedex drip weaned off 2/13-oxygen wean to nasal cannula. Patient restarted on Toprol-XL and spironolactone and received Lasix 40 mg x1.  Tolerated p.o. Transferred out of ICU 2/13    Patient required high-flow nasal cannula 2/14 night shift but able to be weaned to nasal cannula  6 L.  Patient started on barcitinib  by Infectious Disease 2/14. Continues on Decadron. Oxygen wean to nasal cannula 4 L on 02/16. Oxygen wean to 2 L on 2/18  Discharge on oxygen 1 L nasal cannula  Discharge Diagnoses:  Acute respiratory failure with hypoxia and hypercapnia -extubated 2/11 COVID-19 Acute COPD exacerbation-  Improved  Chronic hypoxic respiratory failure-on 2L home oxygen at baseline "as needed" Leucocytosis- likely secondary to steroids- better  - Weaned off to room air earlier - started on Decadron 2/ 13 transition from IV Solu-Medrol,Baricitinib since 2/14.  Completed Decadron total 10 days. Appreciate Infectious Disease input - Continue Nocturnal BiPAP/CPAP.Known sleep apnea- Recommended outpatient sleep study .  Patient reports intolerance to CPAP device 2 years ago. Pulmonary toileting - wean oxygen as able - DC baricitinib on discharge    Severe sepsis on admission with probable pneumonia - Blood culture Neg.  Ceftriaxone and doxycycline for total 5 days.  Completed course of antibiotics   Acute toxic metabolic encephalopathy resolved, with Agitation confusion restlessness in ICU - secondary to above improved - On  bupropion Depakote, Effexor and trazodone .Patient tolerating medication without excessive somnolence
Pt has a 3"x2" redness and swelling on (L) thigh at site of injection 9-9-11 swelling started.
Information has been received from consumer concerning  her 17 year old daughter who"2 or 3 months ago" was vaccinated with the first dose of GARDASIL and on 13-Apr-2009 received the second dose of HPV vaccine. On 13-APR-2009, soon after the second dose of HPV vaccine was given, hives appeared in her mouth and all over her body. The patient's mother reported that her daughter has bumps everywhere including her tongue, gums, roof of her mouth, anywhere there is skin she has bumps.  The bumps are itchy.  It was also reported that the patient's mother had spoken with the physician who believed it is a viral response due to the HPV vaccine.  The physician put the patient on amoxicillin but it does not seem to be helping.  The patient's mother stated that her daughter did not have an experience after the first dose of HPV vaccine was given.  In follow-up the patient's physician reported that she does not believe the HPV vaccine is responsible for the patient's hives.  At the time of reporting, the patient had not recovered.  Follow-up information was received from a physician who reported that the patient, a white 16 years old student with a history of tonsillectomy and adenoidectomy in 1996, was vaccinated in the right arm with the second dose of HPV vaccine (lot # 661531/1311x on 13-APR-2009 at 2:00 pm.  It was reported that the rash onset was on 14-APR-2009 (previously reported per mother as 13-APR-2009) and that it was not hives.  The physician stated that she did not feel this was related to vaccination.  The final outcome was not reported.  Additional information has been requested.