chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves a 5 years old patient (gender not reported) who was vaccinated with vaccine FLUBLOK QUADRIVALENT on an unknown date (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history included egg allergy. The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the administration of the vaccination. 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. Documents held by sender: none.
pt recv vax 6APR99 in lt deltoid;the day following vax pt noticed some redness & swelling @ the shot site;apparently also had intramuscular bleeding;IM bleeding drained into inner aspect of upper forearm;ecchymosis
pt recv vax 17JAN96 & 18hr later pt could not stand on lt leg;no swelling, redness or induration;22JN95 pt was able to crawl but still would not stand;dx arthralgia;further diagnostic studies revealed fracture of distal tibia & fibula on lt
Patient claims he came in and received his vaccine and his arm still hurts . He went ahead and received his 2nd vaccine on 7-30 and claims his arm is still hurting him on 8-30-21.  Informed patient to contact physician to be seen and we would report to manufacturer.
EXCRUCIATING PAIN IN ALL JOINTS, WRISTS, ELBOWS AND KNEES AND THIS INTENSE PAIN WOKE UP THE CONSUMER FROM SLEEP, PAIN IN NECK AND DUE TO THIS PATIENT HAD A LOT OF DIFFICULTY GETTING OUT OF BED; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included erosive osteoarthritis, antibiotic allergy, egg allergy, mold allergy, chemicals (silver) allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the pain has subsided from its severity right after getting the vaccine, but still lingers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced excruciating pain in all joints, wrists, elbows and knees and this intense pain woke up the consumer from sleep, pain in neck and due to this subject had a lot of difficulty getting out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating pain in all joints, wrists, elbows and knees and this intense pain woke up the consumer from sleep, pain in neck and due to this patient had a lot of difficulty getting out of bed. This report was non-serious.
injection site red; injection site sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine and 4 days after Shingles vaccination the patient experienced injection site red and sore. Additional supportive information: Follow-up would not possible as no contact details were available
The PROQUAD also suffered from a non supported temerature excursion; No Additional AE/PQC reported; the patient was given PROQUAD instead of MMR II; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered), subcutaneous injection, lot #W029552, expiration date: 14-MAR-2024 (dose, dose number, route of administration and indication were not provided).   On an unknow date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had been improperly stored in the temperature of 8 C for 936 hours (product storage error). No additional adverse event (no adverse event) and product quality complaint (PQC) was reported.
Patient arm was red and warm in about a 2 inch spot on the left upper deltoid. Doctor gave patient advice said to get BENADRYL. Patient came to pharmacy to get BENADRYL.
child moved around quite a bit and the needle came out of her skin during administration and it was unknown how much of the vaccine was received/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 09-Oct-2020 from a Health Care Professional via The Agency (Reference number- 00309435) and transmitted to Sanofi on 09-Oct-2020.  This case involves a 17 month-old female patient was vaccinated with (less than 0.5 mL, once) dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) (batch number UT7065LA and expiry date 30-Jun-2021) via an intramuscular route at the left arm on 06-Oct-2020 for prophylactic vaccination (under dose).  Patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.    It was a case of actual medication error due to vaccine under dose (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Case number PHEH2014US018202, in an initial spontaneous report from a pharmacist received on 09 SEP 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145205) intramuscularly at a dose of 0.5 ml on 05 SEP 2014. It was reported that the FLUVIRIN received by her was stored at 49 F for two  hours. No adverse event was reported following the medication error (incorrect storage of drug).
I had scalp pain on the left side of my head, felt like shingles, urgent care doctor did not know what it was, possible un-erupted shingles without rash.  Put me on high doses of valtrex in case.  Then 5 days after my 2nd shot I got a severe pain on the R side of my face,  the docs thought it was possibly cheek muscle spasms or trigeminal neuralgia.  Other theories are possible bells palsy without paralysis.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX on 30-JUN-2012 (expiration date 01-MAY-2012; lot number, dose and route not reported). Additional information has been requested.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), IRON and FOLIC ACID for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.   This case was linked to MOD-2021-103190 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information was received on 4 Jun 2021: updated the outcome of the event from unknown to Recovering/Resolving.
She received her pneumococcal vaccine upon hospital discharge on 2/24/05 at 1030am.  Pt went home and developed flu-like symptoms with nausea/vomiting/diarrhea during the next 24-48 hours.  After experiencing "blackness" in her vision - she reported to a ER.  She was found to have a SCr of 6.9.
Please see hospital notes - skin rash.  Patient has developed a rash over the last 2 hours on her arms and left knees.  She is now complaining of throat pain.  She got her first GARDASIL shot and her meningitis vaccine about 7 days ago and her mom says when patient was five she had a reaction to a tetanus shot 6 days after she got the vaccine.  Mom is concerned.
Patient with flu-like illness including headache which has been chronic but went away after the first Pfizer vaccination, returned after her second; having orthostatic symptoms despite being hydrated; no menses since first vaccine
Shot administered at 12:18. I felt fine for the rest of the day, went home and went to bed. Woke up at 3am in cold sweats, with a temp of 103.4. Fever, chills, body aches, loss of appetite, difficult focusing and extreme fatigue lasted for 4 days.
Began to break out in hives 6-10 hours after shot, along with fatigue and muscle aches. Within 24 hours, hives had spread to cover my body and I experienced swelling in my lips, hands, and injection site. I went to Urgent Care at 12:15 pm on 10/29, and then the ER at 7:00 pm on 10/29.   After the first sign of hives (10/28, the morning following the shot), I took 2 Benadryl. That evening, I took 2 more Benadryl. The following morning (10/29, ~36 hours after injection), the hives had spread over my entire body. The Urgent Care prescribed Prednisone 20 mg. I took 3 of those around 3:00 pm. By 6:30 pm, the hives had spread to my face (around my eyes and mouth) and back. I went to  the emergency room around 7:00 pm, and was discharged around 9:30 pm when the hives had begun to subside. I have continued to take the Prednisone as directed and Benadryl. As of 10/30, the hives have subsided but are not completely gone.
12/25/21 presents to EC ED for "cough and sob". PMHx of "esophageal cancer - currently on chemo"
Initial and follow-up information has been received from a physician concerning a female who on approximately 07-JUN-2007 received her first dose of GARDASIL, 0.5 ml. The patient experienced an "acute immediate reaction" after receiving the vaccination. She was rushed to the hospital. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Follow-up information has been received from a physician who states that, "It was not my patient who had the adverse event with GARDASIL vaccine. Additional information is not expected.
Pain began in lower spine mimicking spinal meningitis of 2004. Over a period of 2weeks pain moved up to neck left shoulder and eventually mimicked w less severity wn meningitis head pains w pressure dizziness and pain.  10 days following vaccination developed extreme muscle weakness in legs which continued for 4 days and still exists to some degree 1 week later. Also nausea and lack of appetite for 9 days following vaccination and improved after accupuncture.
DEVELOPED TENDER ERUPTIONS ON ARM AREA OF VACCINATION, SINCE 1/20/2021. NO EDEMA, HAS MILD ERUPTIONS DIFFUSE ON BACK AND CHEST. NO FEVER.
FEVER; SORE ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore arm. Laboratory data included: Body temperature (NR: not provided) 98.7 F, 100.8 F. On 08-APR-2021 19:00, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and sore arm. This report was non-serious.
Client attended the flu shot clinic.  She received a 0.5cc flu shot, Sanofi, Lot# UH734AC, Expiration date 6/30/13,  in the left deltoid muscle at 1655 hours.  Student nurse administered the dose with her instructor supervising.  After receiving the injection the client reported she felt like she was going to faint.  She was assisted to the floor to lie on her back with her feet elevated by RN.  RN applied a covered cold pack to the client's forehead.  Student nurse assessed vitals at 1705 hours: Blood pressure 80 systolic, pulse 44, and respirations 16.  This nurse was called to assist and reassessed at 1708 hours: Blood pressure 90/62, pulse 64, respirations 16.  Client rested in a lying position for another 7 minutes, states she felt better, so was allowed to sit up and had juice at 1715 hours.  Student nurse reassessed blood pressure at 100/66.  Client was then allowed to stand, which she did without problems.  Client was released with her mom and dad at 1725 hours.  This nurse called the client's parents today at 0815 hours to follow up, but had to leave a message.  This nurse then called the client's physician's office to report the incident to Dr., but left a message with Dr's nurse.
Patient stated he was "nervous" before injection. Five minutes post injection, patient became diaphoretic and nauseated. Vital signs assessed; patient provided water and a banana, tolerated without incident. Patient left after 10 minutes. EMS not activated, no medications provided.
Patient had a syncopal episode post vaccination. Prior to episode patient felt hot. EMS arrived. Patient refused BP to be taken and refused transport to hospital. Observed for 30 mins. Did not eat prior vaccination. Symptoms resolved and patient was discharged home.   Pulse 67
pt recv vax 7JAN99 1015AM & devel sl fever, felt warm until 7:30, would not eat giving APAP;730PM went to ER 8PM T100 or 101;MD stated had ROM recv ATB;cried all noc would stop breathing cried until midnight;
Swelling; Chills; Shaking; Redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included TETANUS TOXOID (TETANUS).   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, chills, tremor and injection site erythema. On 25th April 2019, the outcome of the chills and tremor were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, chills, tremor and injection site erythema to be related to Shingrix.  Additional details were provided as follows: On 16th April 2019, the patient received Tetanus intramuscularly on left arm. The patient received Shingrix on right arm. The patient experienced chills and shaking, along with redness and swelling at the injection site. The chills and shaking lasted for about 2 days. The redness and swelling has continued to spread to 5 inches up and down the injection site, and it was spreading to the side of her arm. No further details were provided. The reporter did not consent to follow-up.
10AM Pt  had Pfizer vaccine  in clinic had observation after vaccine 15 minutes, pt went home . but in 10:20am, mom carry Pt, rush back to clinic , and report to me Pt c/o black out/ weak/ dizzy. , VS T 97.6T HR 84/55 Pain scale 0, Oxygen sat 99, PT A/O x3 but pale , and state she don't feel well.no SOB, place Pt in Bed with f oot elevated,. and Pt  was monitor x1:30 hour. give vital sign check, fluid to drink, Pt was discharge At 12:15 AM, with no sx of illness, vital sign WNL, instructed call if sx recurrent or  ER, f/u 3 week  ,with PMD,
I had convulsions for over an hour last night and I've run a very high fever since with a headache. I ache all over and I also have this painful nerve feeling in my skin all over my body.
FEELING HOT; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 130 pounds and height was 64 centimeters. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) (dose number in series 1), 01 in total was administered on APR-2021, dose was not reported for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: Unknown) dose was not reported, (dose number in series 2), 01 in total was administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JAN-2022, following administration of covid-19 vaccine ad26.cov2.s, he said that felt hot and thought that his fever could be probably due to sudden weather change. On the same day, the patient self-medicated with two Motrin and 1 Motrin the next day.  On 06-JAN-2022, he tested his body temperature which was 100.1 degree celsius (C), and has tested twice for (COVID-19) corona virus disease via self test and the result was negative for both tests.  On 07-JAN-2022, he again tested his body temperature which was in range of 98-99 degree celsius (C). He used oral thermometer and had been measuring his temperature regularly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and fever on 06-JAN-2022 (Dose number in series 2). This report was non-serious. This case was a duplicate of 20220112244.
Red hot rash and pain in joints down left side. Lasted 3-4 days and resolved on its own.
Patient reports that she experienced back pain, nausea, vomiting, chills, low grade fever within 24 hours of receiving the vaccine.  Those symptoms did subside.  Patient's husband called to report that after 5 days of having no symptoms on 03/11/2021 she has the same symptoms again of nausea, vomiting, back pain, fatigue, and weakness.  I advised her husband to contact her primary care office to schedule an appointment.
patient fainted 10 min after shot. paramedics were called. bp was low at 80. father stated patient has been in fasting state since last nite. systolic went up to 110 and patient refused transport to hospital
BLEEDING OF THE STOMACH; CLOT IN LEFT LEG AND RIGHT KNEE; STOMACH CRAMPS; STRESS; ANEMIA; LOOSE STOOL/BOWELS; This spontaneous report received from a patient via other manufacturer concerned a 6 decade old adult female of an unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) dose was not reported, first dose, 1 total administered on 22-JUL-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 56 years old. No concomitant medications were reported. The patient also received non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported and expiry: Unknown) dose, frequency and therapy dates were not reported for moderate to severe ulcerative colitis.  On an unspecified date, the patient experienced bleeding of the stomach, clot in left leg and right knee, stomach cramps, stress, anemia and loose stool/bowels (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from clot in left leg and right knee, and stomach cramps, had not recovered from bleeding of the stomach, stress, and anemia, and the outcome of loose stool/bowels was not reported. The patient also additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) dose was not reported, second dose, 1 total administered on 29-OCT-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220859758-covid-19 vaccine ad26.cov2.s-bleeding of stomach. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220859758-covid-19 vaccine ad26.cov2.s- Clot in left leg and right knee. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.