chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US021059, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to an 18 month old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. No adverse event was reported following this maladministration.
Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 7 months old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: UJ087AA, expiry date, dose in series and route of administration were not reported) in the left thigh on 15-Jan-2019 at 11:30. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication were given. It was a case of actual medication error due to overdose because a 7 month old patient was administered 0.5 ml dose of vaccine instead of 0.25 ml. It was reported that nurse grabbed the FLUZONE QUADRIVALENT 0.5 ml prefilled syringe in error, instead of a 0.25 ml pediatric dose, and administered it as the second dose of Flu Vaccine. It was unknown if any adverse event was occurred or not following the vaccination (Plan was to notify the parents and monitor for side effects). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
24 hour hx itching and rash, right proximal inner thigh; several small ulcerated lesions w/bacterial ? rash. Pt stated included area was chaffed from daily run. Tx: Anect, Keflex. Dx: vaccinia autoinoculation
Return 2 1/2 hours after recieving Vaccine c/o itching-slight rash to neck-chest and arms.  Denied SOB, difficulty breathing.  AXOX3 Benadryl 50 mg PO given.  Applied Caldryl lotion to areas.  Advised to call PCP from Clinic which she did.  F/U visit at 2PM.
This spontaneous case, initially received on 27-Sep-2016, was reported by a health professional and concerns a 66-year-old female patient. Weight: not provided; Height: not provided. Drug history included thiomersal (reaction: allergy). Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient has a reaction to the AFLURIA she received at her doctor's office 5 days ago. The patient experienced some swelling (outcome: not reported). Reporter's assessment: The LPN (Licensed Practical Nurse) considered the event swelling as non-serious and related (possible) to the administration of AFLURIA. The LPN does not know specifically if the patient received the PFS (prefilled syringe) or the MDV (multi-dose vial) but thinks the patient is reacting to the thiomersal in the MDV.
This spontaneous report was received from a registered nurse. It was reported that PNEUMOVAX23 had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392 1210USA000958 1210USA000959 1210USA000960 1210USA000962. Additional information has been requested.
pt vax hepta B. 3-4 hrs after 2nd dose pt developed stiffness in joints, temp 101F and nausea. Symp. remitted spontaneously w/i 48hrs
I could not lift my left elbow from the side of my body due to pain and weakness for 48 hours. I still have trouble lifting my arm to a position straight out from my body or higher, with an intense increase in pain when I try to lower my left arm without assistance from my right arm. I can no longer lay down on my left side due to pain in my arm and suffer from aching in my arm periodically for no apparent reason.  I have tried physical therapy, massage therapy and acupuncture to restore full range of motion and pain relief, with no success.
Have had ongoing spells of dizzyness. But after vaccine the dizzyness became more severe. Saw my Dr.  and had a vestibular testing and it was negative. Was given a heart monitor to wear for 2 weeks, found that I had 29 events of dizzy reactions. Wasn't any other events in the future.
Hypotonic, pale episode approx 4 hrs p/vax given; improved approx 3 hrs then recurred next AM lasting 1hr;
Extreme weakness. Body aches. Loss of appetite. 101 degrees fever. Some disorientation. Time course for event - 2 days. Treatment - after physician consult - (3) 325 mg TYLENOL.
did not verify the age of patient and she was under 18 received the moderna as her booster
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05262 and 2013-05268-05269. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case involved a 57-year-old male patient who had received Combination tetanus and reduced diphtheria vaccine (manufacturer, lot number, route, site and date of administration not reported) and 41 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Pt presented < 48 hr post-immun. w/complaint of red hive & itching about 5 inches below injection site. Directed pt to use IBU or APAP for pain & swelling & BENADRYL in case of actual allergic rxn. F/U if worsens or doesn't improve.
ZOSTAVAX given on 12/15/12. Patient reports infection and cellulitis was given antibiotics.
Raised skin under arm; Itchiness in upper torso/thigh; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 24th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced axillary lump and pruritus. On an unknown date, the outcome of the axillary lump and pruritus were unknown.   It was unknown if the reporter considered the axillary lump and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and reported that for the past few days he had experienced raised skin under his left arm and itchiness in his upper torso and thigh. The patient also reported that he received a COVID-19 booster a week before receiving the Shingrix dose. The reporter did not consent to follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Vomiting-Medium, Additional Details: Five minutes after administering the vaccine, the patient was dizzy with blurred vision. Soon thereafter, he vomited. Once he completed vomiting, patient stated that he "felt a lot better". Blood pressure was normal at 115/85. He contacted his wife to pick him up. Follow-up call: Patient stated that he had no reaction after.
Mom took patient to the ER due to vomiting and seizure like activity. He was afebrile through is admission. He was admitted to hospital service and a work up was done. He was discharged on 07/12/2017. He has been referred to neurology for further evaluation.
Information has been received on 04DEC2014 from a company representative who learned information from a physician at a conference. The physician states she prescribed ZOSTAVAX to a patient (age and gender not reported). The patient took the script to a pharmacy and received the vaccination. After receiving, the patient experienced a local reaction (severe induration) that lasted two to three weeks and then resolved itself. The physician advised the patient to return to the pharmacy for advice and does not know if any treatment was provided. No PQC was reported. No additional information was provided. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAVRIX pediatric (batch number AZ54D, expiry date unknown). Previously administered products included HAVRIX pediatric (1st dose) and HAVRIX pediatric (2nd dose). On an unknown date, the patient received the 3rd dose of HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: On unknown dates, the patient had received the 1st and 2nd doses of HAVRIX pediatric. On an unknown date, the patient inadvertently received 3rd dose of HAVRIX pediatric, which led to extra dose administration. The reason for maladministration was that the 2nd dose of HAVRIX pediatric was not documented and so the 3rd dose was administered.
Headache, tachypnea and feeling unable to breathe, shortness of breath. Acetaminophen.
High Fear, body aches, lower back pain and spina pain. Follow by chest pain. Left side where my shot was given it was extremely sore  Home care- a lot of liquid and rested for 24-48 hrs
About two weeks after I had vaccine on 11/19 woke up with nasal drip. 11/20 woke up still feeling poor, still had nasal drip, and was having fatigue. No fever but had body aches. Woke up on Monday 11/21 still feeling poor and had fever. Later in the day rechecked temperature and it was 101.4. Took at home test and it turned positive well before the 15. Called urgent care and was prescribed PAXLOVID. Began taking PAXLOVID Monday evening. On Monday I took TYLENOL twice for fever. Monday night I slept in the recliner and was able to rest. Tuesday still experiencing nasal drip and sore throat. Tuesday night woke up many times to urinate. Tired today due to several trips to restroom. Haven't checked fever recently but feel mildly feverish. Still have mild congestion, nasal drip, and sore throat.
Chest pain, heart arythmias, shortness of breath, numbness , tingling, skipped heart rate, shortness of breathe, chest tightness, weakness, shoulder pain, thoracic pain, fatigue. Pain reported as extreme 4/5 many times, sharp to dull to tight.   Symptoms began almost immediately after second vaccine and continue to this date.   Multiple trips to urgent care and Er, including 911 calls between May through November 2021.   Myocarditis and inflammation.
L upper arm red and swollen 5 cm erythema Warm to touch Began on 8/3 and lasted until 8/6/04 Rx Zrytec 10mg 1 daily for 3 days
This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2 as second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0202), via an unspecified route of administration in the left arm on 03Jul2021 (at the age of 19-year-old) as single dose for COVID-19 immunization. The patient was not pregnant. Medical history was none. The patient had no known allergies. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ) for birth control; measles vaccine, mumps vaccine, rubella vaccine (MMR) taken for an unspecified indication on 24Jun2021 in left deltoid (Lot number: S039311, company: Merck & Co. Inc). The patient previously took first dose of bnt162b2 (Lot Number: EW0177) on 12Jun2021 at the age of 19-year-old in left arm for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store.  On 04Jul2021 (within the next day or two), the patient began having a giant pain underneath her armpit on the left side where it was administered. It continued on like this and on 17Aug2021. The patient went to her primary care doctor for this pain that was constantly under her arm. The patient was still experiencing pain for this at the time of reporting. On 04Jul2021, the patient felt a lump/bump and so did her provider and it still had not gone away. These events resulted in visiting doctor or other healthcare professional office or clinic visit.  Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.
Immediately after injection, the site started swelling. In a matter of seconds the site swelled to the size of larger than a quarter and was raised. There was no rash, no itching, no trouble breathing, and the patient felt fine. I monitored the patient for about 10 minutes to make sure no further reaction occurred.
Information has been received from a Nurse Practitioner concerning a 4 year old male patient with no pertinent medical history, drug reactions or allergies who on 29-NOV-1999 was vaccinated with a dose of VARIVAX (Merck) (Lot# unknown). There was no concomitant medication. The nurse reported that "about 3 years later when the patient was 4 years old" in approximately 2002, the patient developed shingles. The patient recovered "when he was 4 years old" in approximately 2002. The patient is now 11 years old. The patient sought unspecified medical attention. Follow up information has been received from a nurse practitioner concerning the currently 11 year old male student who on 29-NOV-1999 was vaccinated with a dose of VARIVAX (Merck) at another office. There was no illness at time of vaccination. The nurse practitioner reported that the patient did not have adverse reaction to vaccine. He had a diagnosed/confirmed case of shingles at age of 4. She called to see if patient needed a second dose of VARIVAX (Merck). Additional information is not expected.
Significant axillary and anterior cervical lymphadenopathy on the right side, diffuse abdominal pain/cramping
tinnitus beginning 2 hours after the 2nd dose of COVID19 - Moderna
I started having chest pains. I went the ER and they did at EKG and it was normal. They also did a chest X-ray and it showed pneumonia. They prescribed me antibodies for 7 days. I went to get another chest X-ray and it was clear for pneumonia. 3 days later I started to get a raw sore throat, and coughing from the chest. The doctor prescribed me more medication but I am going in for another chest x-ray.
Nausea, Diarrhea, severe body aches, lethargy, chills, headache
pain in entire body; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (pain in entire body) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain in entire body). At the time of the report, PAIN (pain in entire body) had resolved.            Concomitant medication information was not reported.  The patient had pain in entire body for a few days after first, second and third doses of Moderna COVID vaccine.  Treatment information was not reported.
Right arm severely sore all day, chills  about 12 hours later, soreness of back and shoulders next morning and sniffles, cold symptoms, including fatigue, next day.
No flu like symptoms day of 2nd vax, did regular activities and regular weekly Exercise routine. Following morning 3:00am woke to severe, knife pain in heart/chest only on left side. Heart palpitations and felt faint. Never have experienced this in past
no other AE reported; Varivax administered to a patient after excursion occurred; This spontaneous report was received from a nurse and  refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 19-OCT-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml , lot # T000344, expiration date 05-JAN-2020 for prophylaxis. The vaccine was incorrectly stored for 1 hour and 23 minutes (-5.0 degrees Celsius) and for 1 hour and 6 minutes( -6.5 degrees Celsius). There was no previous excursion. Data logger was involved. No other adverse events were reported.
A non-serious spontaneous report of inadvertently administered to a one year old was received from a RN/health professional concerning an one-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Nov-2010, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
pt recv vax 30JUL96 & had abn, shrill cry for probably 8 hrs;t103 & sore, swollen leg;went to ER 230AM 31JUL96;fully recovered from all sx in 48hr;
Within first 24 hrs- Fever of 102-103, headache, fast heart rate. 2nd day- fever gone but complained of headache /back of neck pain and intense chest pain, trouble breathing. Took heart rate- was 99-107- Gave him 1/2 a Xanax of 5mg b/c he suffers from anxiety so wanted to test heart rate after he calmed down and rate went down to 82 -he was ok most of the 2nd day and evening but couldn't sleep that night and 3d day-(today) woke me up at 7 am w/ bad chest pains- he threw up twice-had slight wet cough- no fever- blood pressure 117/75 -heart rate 109 so we called the on duty nurse- she confirmed symptoms and approved another 1/2 of Xanax- it helped again- plus relaxation techniques while wearing heart monitor and was able to get heart rate down to 80-he ate noodle soup-took ibuprofen and took a nap at 3:30pm and still sleeping. will go to ER if he has more chest pains upon waking
Patient experienced nausea.  Also her irregular heartbeat kicked in.  Patient had shakes for about 15 minutes.  Eventually we decided because of heart and weakness to transfer to hospital for follow up.  Patient as of 6pm 4/13/2021 is fine.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: LOSS OF URINARY CONTROL
Narrative:  This is a 75 yo patient COVID Vaccinated (x3 Pfizer vaccine,booster 10/19) with PMH of Essential HTN,Hyperlipidemia recently Dx with COVID+ (10/17/2021) admitted after came to ED for complaint of SOB with O2 sat of 87% at RA,CTA chest : suboptimal for PE but with Extensive multifocal GGO's.Admitted 10/21 to COVID Unit Med Telemetry and upgraded to ICU (10/22/2021) due to increased O2 requirement to 60 LHFNC and 57% FIO2 and downgraded back to the medical telemetry COVID Unit 10/24/2021. Patient said he is 99% back to his baseline and is ready to go home. He could not wait. He has been afebrile. He has been having good appetite and been active. Discharged to home.
Redness, soreness, swelling, raised bruise around administration site, itchy, hot to the touch.
This spontaneous report was received from a pharmacist refers to a 61 year old female patient with iodine allergy, shellfish allergy and codeine allergy. The patient's medical history included prior case of shingles. On 14-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001009, expiry: 24-APR-2014) subcutaneously. Concomitant therapies included PRISTIQ. On 14-JUN-2013, the patient experienced hives at injection site with symptoms of redness and itching that resolved by the next day (15-JUN-2013). On 15-JUN-2013, the patient detected a knot underneath the skin at the injection site that was the size of a fifty cent piece. On 16-JUN-2013, the knot under her skin was smaller on day 3, about the size of a quarter, but the site was now red and puffy with swelling at the injection site as large as her hand. The pharmacist reported that the patient had not seen her physician yet. No treatment was received by the patient. No laboratory diagnostic tests were performed. Patient sought medical attention (unspecified). The outcome of knot underneath the skin at the injection site and the site was now red and puffy with swelling at the injection site was unknown. The outcome of hives at injection site was reported as recovered. Additional information has been requested.
ACUTE RESPIRATORY FAILURE 8/28/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 8/22/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/18/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 8/28/2021 SUBCLINICAL HYPOTHYROIDISM  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 8/22/2021 SUBCLINICAL HYPOTHYROIDISM  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/18/2021 SUBCLINICAL HYPOTHYROIDISM  ACUTE RESPIRATORY FAILURE 8/28/2021 UNSPECIFIED ANXIETY DISORDER  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 8/22/2021 UNSPECIFIED ANXIETY DISORDER  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/18/2021 UNSPECIFIED ANXIETY DISORDER