chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills - severe, vomiting, dirr, abdom. swelling, weakness, runny nose, muscle aches.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # L010598, expiry date: 06-AUG-2016 (route of administration was not reported). No concomitant therapy was reported. The patient did not experience any adverse effect. Additional information has been requested.
Patient passed out and had a brief (5-10 seconds) loss of consciousness twice within 10 minutes of receiving vaccination. Pt was evaluated by EMTs and cleared to go home after 20 minutes sitting in waiting area. Pt encouraged to contact the pharmacy and his primary care doctor if any further issues or loss of consciousness.
A few minutes after the vaccine was administered, the patient stated that the left side of her face felt numb and was tingly. We let her rest for 15 minutes and the feeling did not subside. I contacted her primary health provider and I gave her 50mg benadryl IM, and she had total relief of her symptoms within five minutes. She left for home with her mother in stable condition, with instructions to call us if she had any other problems.
This spontaneous report was received from a registered nurse and refers to 20 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L048237, expiry date 08-MAY-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was injected after needle went into RPh finger first. No adverse events patient requested Hep B shot.
1/26/2021 broke out in sweat about passed out 9:15 am. 9:45 am  broke out in sweat about passed out again arm red & sore  1/28/2021 about passed out in the shower 2x5 arm red  and sore.
She is sick; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She is sick), FATIGUE (Fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). On an unknown date, the patient experienced ILLNESS (She is sick). At the time of the report, ILLNESS (She is sick), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient 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 10Aug2021 at 17:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease. The patient had no known allergies to medications, food, or other products. The patient had received concomitant medication (unspecified) within two weeks of vaccination on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 17:45, the patient experienced insomnia. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event insomnia was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
I began having pain on October 5 in my lower back and left side. I went to the ER on October 7 and was diagnosed with diverticulitis. I do not believe it was related to the vaccine.
Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolved in 1 day)
Broke out in hives and rash all over: chest, arms, back, neck, ears, face, parts of thighs. Had doctor's visit on October 4, 2021 to discuss and in turn the doctor prescribed Prednisone and Triamcinolone.
3/4/10 approx 8 pm client c/o everything spinning, sweating, started vomiting had terrible headache felt like she was going to pass out. Client went to bed next day still dizzy had to hang onto things to get around - has been fine since occurred over weekend. This was reported on 3/8/10 to providers office.
Patient received his first dose of Pfizer vaccine and stood up to wait in short line for observation. While standing in line, patient lost consciousness and fell backward, with his fall broken by his father who was standing next to him. It is unclear if patient hit his head. After the 15 minute observation period, patient was transported via wheelchair to  the minor injury clinic for evaluation. Patient did not complain of head pain or show any signs of head trauma.
nausea, vomiting, and tonic-clonic seizure lasting approximately 1 to 2 minutes. The patient had a postictal period following her seizure.  Mom reports that the patient has been ill over the last few days with runny nose, congestion, cough, wheezing. Temp 103.6. Bronchiolitis.
Exactly two weeks after innoculation, a severe shingles infection which after treatment left nerve (1) from solar plexis around rib-cage to the spinal column dead. Doctors suspects distinct pathology (neurological reaction).
He was given flu vaccine Friday 11/21/2003. He awakened on 11/22/2003 with hives on legs which then moved up progressively trunk-arms.  Cetestone soluspan 2 ce.  Deep Benadryl 25mg each 6 hours with 50mg HS.  Follow up 11/26/2003 if hasn't cleared.
Pt recvd vax & had tinnitus; pt seen by MD who was unable to determine the etiology of sx & recvd no treatment;
NAUSEA; HEADACHE; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and herniated disc, and concurrent conditions included copd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced general body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, headache, and general body aches on 04-APR-2021. This report was non-serious.
approx 3PM (4hr p/vax) pt face rt side from chin/jaw area to above rt eyelid & to midline of face swelled-eye is shut, lip bottom & top rt side swollen-no other c/o by child;ER visit approx 8PM given ATB;
Pt received the COVID-19 Pfizer  BioNTech vaccine instead of Pfizer BioNTech Bivalent vaccine .  No adverse reaction reported.
Call received from patient and spouse reporting an adverse reaction from the shingrix. patient reports after receiving the first dose of shingrix on 3/14/19 a small rash appeared in the middle of his back 2 weeks after administration but did not correlate it to be from the shingrix.  Then, on 5/14/19, pt. received his second dose of shingrix and 6/3/19 started having the rash reappear. patient reports it being itchy but denies pain. Patient reports the last rash went away after 3 weeks with no scaring.
minor throat swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (minor throat swelling) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PHARYNGEAL SWELLING (minor throat swelling). On 20-Mar-2021, PHARYNGEAL SWELLING (minor throat swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
8 days after the injection, my left arm developed an oval shaped rash around the injection site. It was approximately 3"-4" long and 2" wide. It got larger over a 24 hour period and grew itchy. I applied a cortizone cream to the rash twice a day for 2 days. Over 4 days the rash disappeared.
Received fluzone vaccine in AM and had 4 hour episode of internal chills and feeling incapacitated.  Denies diaphoresis during episode.  Felt "chilled to my core."
After the booster it seemed right away I started feeling a swelling or fullness in my underarm area. I then got more pain and started losing my range of motion and noticed a lump underneath my arm, and that's when I called my healthcare provider. They felt around and felt something also and sent me to get an ultrasound and found a solid 2.3 cm mass underneath my left arm that is still there to this day. I still have problems with my arm and my information will be sent to the hospital for general surgery. It hasn't been scheduled yet and they've done a couple of other tests but it's mainly in the lymph node in my arm. Reaching back with my arm, I can't do that motion, and when I try picking something up I cannot hold the weight of that arm. My arm seemed to bother me more and more than the original shot and it seemed even in the muscle in my arm and up into my shoulder hurt more, and that's when I noticed the fullness under arm and started feeling the lump after awhile.
Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours Chills, blanket, intermittent over 24+ hours
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with MMR II with lot # J014876 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Emesis of all feeds, unable to hold down any breast milk, abdominal distension, decreased bowel sounds & ? pain with palpation, slight mottling of skin. ? intussusception - referred to ER for U/S and possible more imaging, blood work.
local rxn to vax consisting of arm edema, induration, warmth, erythema & pain;
(R) local deltoid swelling with erythema onset yesterday 1/19/11 vax given 1/18/11.
AFTER THE SECOND INJ i HAD A VERY BAD HEADACHE FOR ABOUT 5 DAYS. IN APRIL I NOTICED I WAS SOB, IT CONTINUED TO WORSEN AND APR. 28 I LEFT WORK TRYING TO CATCH MY BREATH.  I WENT HOME AND LAID DOWN AND IT LESSENED.  STILL HAVING SOB ON EXERTION, I SAW DR.  I WAS FOLLOWED BY  CARDIOLOGIST.  I WAS PLACED ON LOPRESSOR, STILL HAVING ISSUES, GOT 2ND OPINION BY CARDIOLOGIST. HE DC'D LOPRESSOR AND PUT ON CARDIZEM. RETURNED TO WORK FOR FOUR DAYS, NOW HAVING EDEMA AND HIGH BP.  DR. ADDED LISINOPRIL.  I HAVE TRIED TO RETURN TO WORK TWICE UNSUCCESSFULLY.  STILL HAVING ISSUES, AND THE DRS CANNOT FIGURE OUT WHY.
Complained of right arm soreness, redness and inflammation noted to site, ibuprofen PRN, heat x 2 days.
W/in 24 hours, baby was "out of it", not active, quiet no fever. No seizure activity.
pt recv vax; fever of 105 x 36 hrs; irritable for 24 hrs;
Had the shingles vaccine and still got them/Suspected vaccination failure; Lymphoma; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), lymphoma (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, lymphoma and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, lymphoma and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporters comment: The case was reported via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles when he was first diagnosed with the lymphoma and he had a bad case at the time of passing. The patient stated that, stress could bring them on even though you have had the vaccine. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Severe L arm pain continuing 2 weeks post injection, causing decrease in mobility and causing shoulder pain when trying to raise L arm above head.
has been really sick; had flu like symptoms; diarrhea; Fever; muscle aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 010M20A and 012120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever), MYALGIA (muscle aches) and CHILLS (Chills). At the time of the report, ILLNESS (has been really sick), INFLUENZA LIKE ILLNESS (had flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (Fever), MYALGIA (muscle aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Mother stated small raised area about 4 cm with small bump around area on the Rt thigh.
had the vaccine 4 years ago and just got shingles/ suspected vaccination failure; had the vaccine 4 years ago and just got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had the vaccine 4 years ago and just got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine 4 years ago and just got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2023 The patient self-reported the case. The patient asked why was the vaccine not effective in some peoples. The patient had the vaccine 4 years ago and just got shingles. It was the worst case patient's physician had seen with someone being vaccinated. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt describes itchy hive-like rash on his left arm around area of injections beginning on same day of injection. Itchy hive like rash spread to left side of his trunk over next few days. Pt denies SOB or any difficulty breathing at any time.
Menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks; Initial information was received on 08-MAR-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves an adult unknown gender patient who experienced menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.     On an unknown date, the patient received one dosage of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested.   On an unknown date the patient developed a non-serious menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks (inappropriate schedule of product administration) following the administration of  Meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives from scalp to bottom of feet, eyes itched nonstop for hours.  Took (2) antihistamine tablets,   Eyes still itched the next day until noon.
Developed temp 102 deg 2/27/07 evening; talked to on-call physician, mom instructed to give child Tylenol which child responded to. After Tylenol wore off temperature back up, ran temp until 2/28/07, no fever after 9:00 am.
Huge rash which is red; raised bumps near injection site; Huge rash which is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Huge rash which is red), VACCINATION SITE SWELLING (raised bumps near injection site) and RASH PRURITIC (Huge rash which is itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Huge rash which is red), VACCINATION SITE SWELLING (raised bumps near injection site) and RASH PRURITIC (Huge rash which is itchy). At the time of the report, RASH ERYTHEMATOUS (Huge rash which is red), VACCINATION SITE SWELLING (raised bumps near injection site) and RASH PRURITIC (Huge rash which is itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was allergic to opioid medications. Patient has been using cortisone creams to alleviate adverse events. No concomitant medications were reported.  No treatment medications were reported.
3 day Hx of multiple erythemic papulo - pustular lesions - majority ?? and trunk (ant / post). Findings consistent with with folliculitis. spreading legs / buttocks.
This spontaneous report was received from a nurse, referring to an adult patient of unknown age and gender. There was no information about the patient's medical history, concomitant medication, concurrent conditions and drug reactions/allergies. On an unspecified date, the patient was inadvertently administered a dose of PROQUAD, lot number R008207 and expiration date 16-SEP-2019 (strength and route not provided), instead of the intended dose of M-M-R II lot number N023150 and expiration date 24-AUG-2019, (strength and route not provided). Additionally, the patient received a dose of VARIVAX lot number R009411 and expiration date 29-MAR-2020 (strength and route not provided). Both, PROQUAD and of VARIVAX were reconstituted with sterile diluent (MERCK) lot number M041688 and expiration date 12-JUN-2019. It was reported that the error occurred because the provider that administered the vaccines did not realize the clinic had PROQUAD in stock, therefore she mistakenly thought the dose of PROQUAD was actually a dose of M-M-R II. No adverse effect reported.
Patient describes gastro problems, body aches  and headache, lymph nodes are swollen and slight nausea
headache; This is a spontaneous report received from a contactable consumer reported for himself. A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# EW0162) on 09Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a headache last night (09Apr2021) and he still had it today, and inquired if it was safe to take extra strength tylenol or ibuprofen. The outcome of event was not recovered at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. states that after receiving the 1st dose of Moderna 03/2021, started experiencing symptoms a rash developing throughout the body (shingles-like). Primary visit 03/2021 with no recommendations. Follow-Up with 6 Dermatologist visits (Unknown) Symptoms subsided after 3 weeks.