chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2011US65594 is an initial spontaneous report received from a nurse on 20 Jul 2011. This report refers to unknown number of patients. These patients were vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose more than recommended 0.5 ml of reconstituted vaccine.
Patient was a walk-in COVID-19 applicant. She filled out her form and told me she's very scared of needles and has fainted in the past from getting a vaccine. I asked whether she was comfortable receive vaccine at pharmacy setting and she said she really wanted the Janssen COVID-19 vaccine to avoid getting two shots. She appeared calm and the administration of the vaccine went smoothly without any issues. During the 15 minute observation period, patient's mother and technicians alerted me she has fallen over. I quickly instructed by technician to call 911, while the other paged CODE WHITE and I rushed to the patient. Her father helped me lie her down on their back (supine) and I elevated the patient s feet onto the chair. I took of her mask to listen to make sure she was breathing and she quickly regained consciousness and looked right at me. I had her take some deep breaths for me to make sure airways were clear and helped her sit down in a chair. I asked her to stay an additional 15 minutes to ensureshe is feeling fine. She decline emergency personnel from coming to the store. She was fine and left the store after 15 minutes. I will follow up with her to make sure she's doing well on 05/10/21.
7/2/2023 - 7/13/2023 (11 days) admitted with Covid 19 pneumonia and acute respiratory failure with  Hypoxia IV Decadron & Remdesivir  EL9263 1/23/2021 EL9267 2/15/2021 30155BA 9/30/2021
Patient received Pfizer COVID vaccine and after 15 minutes felt like she was having an "acid" trip. Felt dizzy and foggy. We took her blood pressure reading. Observed her for an additional 15 minutes and still felt the same. At that time, we called EMTs who responded to her. EMT's told us that she refused services and left.
tachycardia, elevated blood pressure, malaise, fatigue, headache, chills, warm injection site with swelling. Tachycardia and elevated BP necessitated ER visit for ECG, CBC w/diff, and chest xrays.
Shortness of breath, abnormal ECGs, lack of oxygen to the heart, numbness of legs and arms, tachycardia (130-160) for over 12 hours, difficulty breathing,  bilateral pin point pain in legs, dizzy, syncopal convusions, fainting, hyperventilation, vomiting, chills, headache, heart pain, fever, kidney pain
Severe headache; Could barely walk; Fever; Chills; Severe stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), cannabidiol (CBD) (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received loratadine (LORATAB) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 14:00, the patient experienced severe headache, could barely walk, fever, chills and severe stomach ache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, could barely walk, fever, chills and severe stomach ache was not resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
High Fever Difficult Breathing Hoarseness Weakness Dizziness Soreness All Over The Body Stomach Ache Nausea
Pt was given HPV immun. Walked to lobby then c/o numbness and tingling to (R) arm. Was brought back to clinic. BP checked 103/60. Pt was checked by NP. Could move all fingers, good grip, complete ROM. After felt pinch, states "now in top of arm and part in lower arm". Pt/mom left and was phoned later and mom said about 30 min after leaving clinic, arm was fine.
Headache  on 2nd and 3rd day - Motrin - recovered Lump in Left Armpit on day 6-7 - no medication taken - resolved on it's own  Swollen Glands in neck  with sore throat on  day 8 - not resolved yet.
Severe hives, cortisone injection, Zyrtec at bedtime, Allegra 180 during day, 8 dys Prednisone.
Clinic Staff were at School giving the teachers their 2nd Moderna Vaccine. Within 30 minutes of her getting the vaccine she made us aware that she was itching on her face, neck, and forearms and had a red splotchy rash on her forearms and checks. I gave her Benadryl 50 mg  and she went back to teach her class. The reaction started at 11:15 am and I followed up with a phone call at 1:26 and she said she was much better and if needed she will take OTC Benadryl as directed.
ELEVATED HEART RATE; HEADACHE; FEVER; CHILLS; FEELING REALLY COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced elevated heart rate. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced feeling really cold. Laboratory data included: Heart rate (NR: not provided) 144 /min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-MAR-2021, had not recovered from elevated heart rate, headache, and fever, and the outcome of feeling really cold was not reported. This report was non-serious.
Received booster moderna vaccine in R arm. Had normal pain/sore arm at injection site x2 days. Day 3 pain moved higher up on arm, more in shoulder/joint area. Progressively over the last 3 weeks pain has persisted and gotten worse. Lost full range of motion of arm. Painful, cannot put weight on it, and cannot sleep on it. Noticing I am starting to compensate on left side of body for it.
very dizzy\run out to a piece of furniture\dizziness; pain on the injection site; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy\run out to a piece of furniture\dizziness), VACCINATION SITE PAIN (pain on the injection site), HEADACHE (headache) and FATIGUE (tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site), HEADACHE (headache) and FATIGUE (tired). On an unknown date, the patient experienced DIZZINESS (very dizzy\run out to a piece of furniture\dizziness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form at bedtime. On 01-Feb-2021, VACCINATION SITE PAIN (pain on the injection site), HEADACHE (headache) and FATIGUE (tired) had resolved. At the time of the report, DIZZINESS (very dizzy\run out to a piece of furniture\dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included meds for hypertension, depression and osteopenia.
Case number PHEH2016US029710, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 158302 and expiry date: Jun 2016) at a dose of 0.5 ml, intramuscularly on 13 Oct 2016 at 09:08 AM. On the same day, the patient was vaccinated with last year vaccine it was given two staff members. It was reported that, patient given prior season vaccine. No adverse event was reported following this medication error. Follow up report received from a pharmacist on 07 Feb 2017: Added suspect drug information (vaccination time) and reporter comment.
Apneaic seizures. First noticed on 7/18/2014. Then had another 3 days later, was admitted to er and diagnosed with epilepsy on 8/26/2014.
Patient passed away on 4/1/21.  4 days after getting his second moderna vaccine. He was is good health
Information has been received from a 63 year old female consumer with high blood pressure, high cholesterol and allergies to DILANTIN and ZOFRAN, who in January 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). Concomitant therapy included LYRICA, high blood pressure medication and high cholesterol medicine. The patient reported that in February 2010, she developed shingles after getting the ZOSTAVAX (Merck). She stated she had been getting shingles twice a month. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Father in clinic with client, requesting vaccinations--father denied that child had been seriously ill or febrile in the past week that she had been in his custody---he also stated that she had NKA, was not immuno-compromised, that she was not currently taking any medications, and that she had no history of seizures--There were no contraindications to any vaccinations--Vaccines were administered at 2:23 PM--At 2:25 PM, after administration while data was being put into the computer, the child's father noted that she was scratching and had began to "break out"--This nurse noted small welts and redness bilaterally to child's lower jaw area---her temperature was 99.8, her apical pulse was 108, her respirations were 24, her lungs were clear upon auscultation and she weighed 29 lbs---She showed no signs/symptoms of acute distress---At 2:30 PM, the child was administered 6.5ml of Diphenhydramine PO---the child's father was instructed to take the child to her pediatrician or an acute care facility immediately after leaving the Health Department---the father agreed to follow the instructions---At 2:44 PM, the child left the facility ambulatory, holding her father's hand--no signs/symptoms of distress were noted upon child's exit---I called the child's father at 10:00 AM on 03/04/2011 and he stated that he had taken the child to an acute care facility and that they told him to treat the child with Benadryl---He also stated that she had another "break out" later that evening and that he gave her more Benadryl---He stated that she was doing "fine".
patient only received the liquid portion and did not receive the lyophilized portion/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number- 00368696) was received from a pharmacist and transmitted to Sanofi on 23-Nov-2020.  This case involves a 4 months old male patient who received a 0.5 ml dose of vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (lot: UJ314AA, expiry date: 23-Apr-2021), via unknown at unknown administration site. (Product preparation issue)  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included pneumococcal vaccine and rotate vaccine.  It was an actual medication error due to the incorrect product preparation (Inappropriate reconstitution technique).  At the time of reporting, the patient had no 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 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.
Pt reports waking up around midnight with a headache, shivers and fever. Received immunization around 5 hours prior. Per Dr, pt to use Tylenol for 24 hours, if not resolved he would need to be seen.
A few weeks after the vaccination, 4/07 notice rash covering elbows and thighs.  Went to dermatologist who prescribed Clarinex, Hydroxyzine and a topical steroid.  The dermatologist briefly mentioned patient may be having an allergic reaction and handed me a brochure on food allergies.  In that same month (4/07) screaming and uncontrollable tantruming began, noticed by several relatives.  Also during 4/07 1) Eye contact decreased.  2) Patient began saying the same indiscernable phrase over and over.  3) Repetitive and hyperactive behaviors.  In 6/07 at pediatrician well visit, doctor noticed developmental delays, patient not answering to his name, little eye contact.  In October 2007, Dr. noted during patient visit that "Some of his features including his repetitive actions do raise the concern that he has problems along the pervasive developmental disorder spectrum."  In December of 2007, Dr. conducted a urinary porphyrin profile on patient resulting in increased porphyrinuria 5CXP, Precopro, and Coproporphyrin metabolites suggesting a mercury toxic effect.  Chelation due to start 1/08. 1/14/08-records received-HX of mild developmental delay most notably in area of expressive language. Repetitive actions with some eye contact and some interaction. Pervasive developmental disorder spectrum. Well baby office notes included. Patient still has heavy metal toxicity, rash on elbows, language delay, immune system injury, oxidative stress, metabolic disorder, neurologic abnormalities and gastrointestinal issues.
administered a dose of PENTACEL instead of Kinrix to a 5 year old patient with no reported adverse event; Initial information received on 07-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5years old patient of unknown gender who was administered a dose of pentacel instead of kinrix to a 5 year old patient with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  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 dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (formulation, strength, dose, route, indication, administration site, batch/lot number, expiration date: unknown).  On an unknown date, the patient was administered a dose of pentacel instead of kinrix to a 5 year old patient with no reported adverse event (wrong product administered) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action Taken: not applicable  At time of reporting, the outcome was Unknown for the event (wrong product administered).  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 guidelines. 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.
Swelling, erythema 12 cm surrounding vaccine site of MMR and DTap vaccine.
Patient complained of pain where vaccine administered.  Site assessed and noted to be edematous (size of tennis ball per nurse).  Ice compress applied and Darvocet N 100 given for pain. Physician was informed and a picture of the reaction was taken
Information has been received from a registered nurse concerning a approximately 4 year old male who was vaccinated with a dose of VARIVAX. Suspect vaccination given that day included a dose of MMR II. The patient had a febrile seizure after being vaccinated. Unspecified medical attention was sought. No product quality complaint was involved. Follow up from the registered nurse indicated there was no additional information available. Upon internal review febrile seizure was determined to be an other Important Medical Event. Additional information is not expected.
When I was screwing the needle to the prefilled syringe, I heard a clicking sound, but I did not think anything of it. When I went to inject the vaccine into the patient's arm, majority of the vaccine came out the side where it had cracked. I re-gave another dose of the vaccine with the patient's permission.
Information has been received from a healthcare worker referring to a 41 year old female patient. On an unknown date the patient was vaccinated with M-M-R II (strength, dosage, frequency and route unspecified) "as a child". On an unknown date the patient had titers drawn which showed she was positive for immunity to rubella but negative for immunity to measles and mumps. As a result, the patient was administered another dose of M-M-R II on an unspecified date. The outcome of the events was unknown. Additional information has been requested.
Sat July 17 -1:30 am woke up upset stomach and headache , drank water ate something went back to sleep woke feeling better. Sunday am - 2.5" very red circle on arm at injection site , flat ,hot, managed with cold cloth, was apparent until Tuesday 20th when it began to fade. Thursday right arm from shoulder to elbow became very itchy and then swelled up very hard, red , hot, (outer surface) original red circle appeared almost purple within it.. broke out in what looked like hives that quickly turned into fluid filled blisters , inner forearm, neck ,between fingers left had and a few on foot. tongue left edge and 1/4 of top surface felt burning and likened to when nova cane is wearing off. extreme heat in arm transferred into chest and digestion and aggravated colon , cortisol suppository was prescribed by PCP. Had to ice 24/7 for 4 days  began subsiding July 21st hardness began to break up reduce, simultaneously arms and thighs began to burn as if chemical under skin - took claritin which reduced symptoms 50 % also broke out with rash on foot, this began to subside after 4 days , then left side of tongue began burning similar to right , burning went down into lungs fever of 99.5 at week 3 point lasted 48 hours , tired for several days after.- total time to recover 3.5 weeks.
This is a spontaneous report from a contactable consumer (pharmacist), reported for a consumer (patient). A patient, of unspecified age and gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, pre-filled syringe, batch/lot# unknown), via an unspecified route of administration, single dose, for COVID-19 immunization. The patient's medical history and patient's concomitant medications not reported. On an unknown date, it was reported two of his patients had a significant increase in their total cholesterol and LDL levels a few days after receiving the Comirnaty vaccine. Pharmacist also added these patients had no other change whether in their exercise routine or their dietary habits. They had not consumed food with large amounts of cholesterol. Caller would like to know if Pfizer has any reports of increased total cholesterol and LDL (low density lipoprotein) values after taking Comirnaty/Pfizer-BioNTech COVID-19 vaccine. Lab data included significant increase in total cholesterol and LDL values. The outcome of significant increase in their total cholesterol and LDL values: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Sender's comments: Linked report(s): US-PFIZER INC-202101106284 same drug/AE/reporter, different patient.
runny nose; slight cough; Lethargy; very tired; no appetite; Severe body aches; chills; fever; my lymph nodes under my injection arm became swollen and sore; my lymph nodes under my injection arm became swollen and sore; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: 0140) intramuscular in right arm on 11Jan2021 15:30 at single dose for COVID-19 immunization. She received the first dose of BNT162B2 (lot number: 0140) intramuscular in left arm on 21Dec2020 16:15 for COVID-19 immunization. Medical history included Sulfa and PCN allergy. There was no other medical history. There was no concomitant medications. There were no other medications in two weeks, no other vaccine in four weeks. The patient experienced severe body aches, chills, and fever starting approximately 8-10 hours after vaccine on 11Jan2021. These symptoms were accompanied by a runny nose and slight cough on 12Jan2021 08:00. Lethargy, very tired, no appetite also on 12Jan2021 08:00. Symptoms resolved with Tylenol, Nyquil, and one day of deep sleep. On the second day (Jan2021), her lymph nodes under her injection arm became swollen and sore. Patient is not pregnant. Events were recovered on Jan2021.
Pfizer COVID-19 vaccine administered to patient after the beyond use date. No adverse event reported by patient.
Seven days after the vaccination my arm started itching; the next morning I had a 3 inch diameter raised red warm painful weld on my arm. I went to urgent care and they prescribed cephalexin and methylpredinsolone.  Within 2 days my arm was OK.
Severe itching and hives from November 19, early morning that was recurring every 6-8 hour. Excess mucus production resulted in throat infection. Increased the dosage of allergy medications, was put on oral steroids from November 24th.
Persistent pain in right shoulder joint. Treated with over the counter non-steroidal anti-inflammatory medication. Pain still persists.
Covid monitoring documentation. PT admitted 1/5/21 documented to have positive covid. PT received Moderna 1/6/21 Lot 012L20A for dose 1. Dose 2 was Moderna given on 2/3/21 Lot 004M20A.