chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQCs reported; administration of improperly stored PROQUAD.; This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 04-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA (lot number T015598 was confirmed to be valid, expiration date: 02-NOV-2021) (dose, route of administration, vaccination site were not specified) for prophylaxis. The vaccine underwent a temperature excursion between 20.5 degrees Fahrenheit (F) for 1 hour 54 minutes. There was a previous temperature excursion between 6F to 14F (12.3F) for 23 hours. Digital data logger was involved. No additional adverse effect was reported.
Symptoms from Shingles began to dissipate after the first shot.  But after this, the second shot, I began to suffer shingles outbreaks on various places on my body--where I had not had them before. Now, a year later, the symptoms are slowly going.
Arm hurts; Fever in her arm; Sore arm at the injection site; Redness; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE WARMTH (Fever in her arm), VACCINATION SITE PAIN (Sore arm at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Fever in her arm), VACCINATION SITE PAIN (Sore arm at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swollen). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm hurts), VACCINATION SITE WARMTH (Fever in her arm), VACCINATION SITE PAIN (Sore arm at the injection site), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swollen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter. The patient stated that she had no side effects with first dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information included treatment medication and outcome of events changed from unknown to recovered.
never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th December 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:31-JUL-2023 The pharmacist reported a patient never got the 2nd dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shignrix, which led to incomplete course of vaccination
Mom called - states child awoke her this am with c/o lips swollen, rash on body - no difficulty breathing per mom. Went to ER and seen by ER physician. Mom states given prednisone and benadryl at ER and has Rx for meds to take at home. Mom states pt is better now. On prednisone for 5 days per mom.
[SARS-COV2 Vaccine (mRNA), Moderna use for COVID-19 under Emergency Use Authorization (EUA)] use for COVID-19 under Emergency Use Authorization (EUA)]: Patient passed away after a long, complicated hospital course that resulted in ARDs and appeared to be precipitated by inflammatory pneumonitis that developed after receipt of the 2nd dose of Moderna vaccine. 38 yo male with select PMH of HIV on antiretroviral therapy, ALK-negative anaplastic large cell lymphoma refractory to first line therapy s/p salvage chemo/radiation in CR1 after primary refractory disease at the time of allogenic peripheral blood stem cell transplant (matched unrelated donor). Post-transplant course complicated by pharyngeal and rectal mucositis, culture negative febrile neutropenia, mild BK virus associated hemorrhagic cystitis, and mild intermittent immune neutropenia. The patient was doing well at home with a good performance status and was exercising regularly. He received his first Moderna SARS-COV2 vaccine on 2/3/21 and developed a mild rash limited to the chest. Ten days after the second Moderna SARS-COV2 vaccine (given 3/12/21), the patient developed sudden onset shortness of breath, was found to have an oxygen saturation of 94% on room air at rest, and was hospitalized for 7 days. Imaging revealed diffuse ground glass opacities. He was also found to have a new transaminitis and worsening dermatitis, still restricted to his chest in discrete patches. Patient had a complicated hospital course and ultimately passed on 5/14/21 after withdrawal of care/comfort measures only on 5/12/21.
Case previously recorded as MA2009-5092. We received the following information via the vaccine info call center from a healthcare professional on the 19 NOV 2009. An unspecified number of patients under the age of 4-years-old, were vaccinated with S-OIV FLUVIRIN (batch number 102124P1) intramuscularly on an unspecified date. No adverse events were reported. Vaccine info call center reference no. NA09-008447.
Injection site pain that woke me out of sleep multiple times the day of the injection. The site has become significantly less painful by the day. Muscle pain for about 24 hours, starting around 6:00pm the day after the injection. I noticed swelling in the lymph nodes under my left armpit on Friday morning. The swelling has not abated and has begun to be slightly painful.
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number BN-2022-003962 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: BAV22-1628) and concerns a patient of unknown demographics (seventh out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: BAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Fever 102.2; Chills; Dry mouth; Lost of appetite; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102.2), CHILLS (Chills), DRY MOUTH (Dry mouth), DECREASED APPETITE (Lost of appetite) and FATIGUE (Tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (Fever 102.2), CHILLS (Chills), DRY MOUTH (Dry mouth), DECREASED APPETITE (Lost of appetite) and FATIGUE (Tired). At the time of the report, PYREXIA (Fever 102.2), CHILLS (Chills), DRY MOUTH (Dry mouth), DECREASED APPETITE (Lost of appetite) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
This spontaneous report as received from a consumer refers to a female patient of unknown age. Medical history and concurrent conditions were not specified. In October 2013 (exact date not specified) the patient was vaccinated with a dose of ZOSTAVAX (dose number, lot number and route were not reported). Concomitant medications were not specified. On an unknown date, the patient experienced shingles in her toe. The outcome of shingles in her toe was unknown. The relatedness between the shingles in her toe and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 20 year old female who was vaccinated with her second dose of GARDASIL vaccine (yeast). Subsequently the patient experienced 2 syncope episodes immediately post vaccination. Subsequently, the patient recovered from the 2 syncope episodes. The patient sought medical attention. Additional information has been requested.
Shaking chills/fever, pruritis around back of neck, fatigue.  Started about 12 hours after injection; lasted about 4 hours.  Not sure if the fatigue is a side effect or just from lack of sleep
The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the NYS DOH and the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required by the NYS DOH given the increase in dose administered.
About 1 hour after leaving the clinic, mom called and reported that Pt was having chest pain and feeling like her heart was beating faster than normal. No other symptoms.
The patient received both Proquad and MMR on the same day. No adverse event/signs or symptoms presented in the baby. Today we are on the 6th day from the date of the vaccines.
pt recv vax; devel pain & swelling to rt axilla at 10am; at 6pm noticed lump in the axilla; site red & sore; no fever;
Patient developed bacteremia without focus and tested positive for Neisseria meningitidis from her blood.  6/24/09 Hospital records received DOS 3/27/09 to 4/3/09. Assessment: Neisseria bacteremia with early sepsis syndrome. Patient presents with maculopapular rash on wrists, palms, soles, and shoulder with fever. Headache, myalgia. Conjunctiva injected.   ICD-9 Codes: 036.9, 782.1, 054.9
ECZEMA FLARES ON BACK, ARMS (USUALLY ONLY SMALL SPOTS); 5 ENLARGED/INFLAMED LYMPH NODES IN CHEST; BAD HEADACHE FELT LIKE HORSE KICKED IN HEAD; COULD NOT SLEEP; FELT LETHARGIC; MINIMAL SORENESS IN ARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's past medical history included: testicular cancer, and radical orchiectomy, and concurrent conditions included: hyper immune system, eczema, alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 31-MAR-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for eczema. On 01-APR-2021, the patient experienced could not sleep. On 01-APR-2021, the patient experienced felt lethargic. On 01-APR-2021, the patient experienced minimal soreness in arm. On 01-APR-2021, the patient experienced bad headache felt like horse kicked in head. On 19-MAY-2021, the patient experienced 5 enlarged/inflamed lymph nodes in chest. Laboratory data included: CT scan (NR: not provided) 5 enlarged lymph gland nodes in chest. On 22-JUL-2021, Laboratory data included: PET scan (NR: not provided) lymph nodes hot, extremely active. On an unspecified date, the patient experienced eczema flares on back, arms (usually only small spots). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, felt lethargic, minimal soreness in arm, and bad headache felt like horse kicked in head on 03-APR-2021, and had not recovered from 5 enlarged/inflamed lymph nodes in chest, and eczema flares on back, arms (usually only small spots). This report was non-serious. This case, from the same reporter is linked to 20210826152.
10/21/11: 1:00AM Noticed severe Jaw pain in right jaw joint at 1:00 AM after ~2 hours sleep. 1:30AM Jaw pain increased. Mild headache. 2:00AM Fever of 101, sweating and chills. Weakness. Headache. Noticed slowness in adjusting to darkness (dilated pupils). 3:00AM Severe thirst. Weak pulse and low BP (estimated). Drank ~4 cups water, continued thirst and water for the rest of the night. 5:00AM Jaw pain decreasing slightly, better if kept still. Weak and fatigued. Temperature decreased to 99. 7:00AM Still thirsty, jaw pain same. Took ibuprofen (Advil) 200mg. 11:00AM Feeling slightly better, jaw pain same but manageable. Able to wake up, move around, eat. Still very tired and weak.  10/22/11: Jaw pain decreased and manageable with ibuprofen. Slept 11 hours prev. night. Less tired today but still about 60% of normal energy.  10/23/11: Jaw pain decreased significantly but still present. Noting higher fatigue and tiredness at all times of day.  10/25/11: Jaw pain still present, headache also frequent today. Still tired and weak at all times. Pain and soreness in right shin and thigh, reduced with ibuprofen.  10/26/11: Jaw pain more severe this morning and not dissipating. Forgoing Advil as pain is still manageable by not moving right side of jaw. Pain in legs and muscles gone. Calling doctor, 1 week since Tdap.
This spontaneous report was received from a male patient of unknown age, reporting on himself. Medical history and concurrent conditions were not reported. Approximately on 17-MAY-2014 (reported as 6 months ago), the patient was vaccinated with the first dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). The patient reported it would be a little longer before till he would financially able to receive the second dose in 2014. No adverse effects were reported. Co-suspect and concomitant therapies were not reported. Additional information is not expected due the lack of demographic information.
On April 2nd I experienced  extreme itchiness at the location of the shot, There is also a large firm bump under the skin. Started on April 2nd and it is worse on April 3rd. I feels like the itchiness mosquito bite ever!
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who experienced injection site numbness and injection site tingling, while she received vaccine TYPHIM VI. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jun-2018, the patient received 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported via intramuscular route in the left arm. The patient developed a non-serious injection site numbness and injection site tingling Unknown latency following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. Other relevant tests included No lab data. Final diagnosis was injection site tingling and injection site numbness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site numbness and for injection site tingling. List of documents held by sender: none.
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown), via an unspecified route of administration in the right arm on 27Mar2021 at 15:15 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included back pain, back hip pain and knees pain. The patient received unspecified medications within two weeks of vaccination. The patient previously received NAPROSYN and DILAUDID, both for an unspecified indications and experienced drug allergy. Prior to 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 4 weeks prior to the COVID vaccine. On 28Mar2021 at 01:00, the patient felt really tired, run down with fever, muscle aches and headaches which was coming and going and had an overall feeling that somethings not right. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event tiredness, fever, muscle aches and headaches were unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2nd pregnancy (delivered on Oct 27, 2021), birth weight of kid: 10 lb 2.3 oz I had headache for around 3 days and started having brain fog moments after 2nd shot. Brain fog (for an hour or so each day) lasted for about 6 months. I also developed gestational diabetes right after vaccination even though my HbA1c was normal during this and prior pregnancy (no gestational diabetes with first pregnancy). HbA1c was slightly elevated (higher than before) even 3.5 months after delivery even though I was still following a diabetic diet (less carbs, more protein). I am almost certain vaccine caused the poor blood sugar control and brain fog.
Pt vaccinated on Tuesday, she started having a burning sensation in chest, hoarse voice and wheezing on Wed night. She is an Asthma pt. She has not used her inhaler for a while. She has not contacted her Dr yet. She was at work today. (Friday 11/14/08).
Pt came in 4 days post injection and stated she started with redness, inflammation and pain at injection site that traveled and progessed over the 4 days to under the arm and the entire top of the arm. Went to ER on the 4th day as it wasnt getting better with ibuprofen. ER Diagnosed pt with skin infection and gave antibotics.
Began feeling pain/tightness in chest within 24 hours. Pain was generally more mild in the morning, but progressively got worse over the day. During exercise, pain was very noticeable along with shortness of breath that was not normal to the exercise being performed.  Symptoms have persisted for over two weeks.
08/28/2021 Dizziness, nausea, fatigue, sharp pain from shoulder to my elbow and in lungs. 08/29/2021 Sharp pain both legs. 09/15/2021 Migraine headache, short of breath, wheezing. 09/13/2021 Tachycardia.
Itching and rash over whole body starting the day after injection and continuing now for 5 days from head to toe.
After receiving first dose of Moderna, within minutes patient developed a sensation of tongue swelling, shortness of breath, nausea, dry heaves and throat swelling. Patient was given 50mg diphenhydramine IM and 0.3mg of epinephrine IM. Transported to ED and while en route, received an additional 0.2mg of epinephrine IV (patient reported closing of her throat).
Itchy throat, did not occur within 15 mins, Student given BENADRYL 25 mg PO, returned to class. No further reaction noted.
Information has been received from a physician concerning an 8 year old female with no known allergies who on 13-May-1999 was vaccinated SC in the right arm with a first dose of Varivax (Oka/Merck) (lot# 629613/0285J). Concomitant vaccination included a first dose of MMR II (lot# 629567/1793H) given SC in the left arm. On 07-JUL-2006 the patient experienced rash, fever of 103 and headache. The fever lasted for one day. On 11-JUN-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Sat. Mar. 20 at about 9:30 experienced back ache at center right .  The back pain got worse overnight . On Sun. Mar 21 had headache in addition to back ache and very tired.  Used BioFreeze on my back and took Tylenol throughout the night Sat. and all day Sun.  All symptoms were gone by Mon. Mar 22.
A child ages 2 year 11 months received FLUZONE QUADRIVALENT .5ml instead of the FLUZONE QUADRIVALENT .25 ml.
The Gardasil shot was giving in the right deltoid. This was her 2nd Gardasil shot. She could feel the medicine travel across her back into her left shoulder & down her side & stop right near her breast. There was pain on her left shoulder & side afterward for about an hour. It's kinda strange how it travels to the opposite side. This happened with the 1st shot also. It just scared us because it was going so close to her heart. She is due a 3rd shot September & we hope it is safe to have it again.