chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I usually get a genital herpes active outbreak once, maybe twice a year for the last 25 years.  I have had an active outbreak continuously since late January.
hard time going to the restroom; hard time passing a bowel; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (hard time going to the restroom) and BOWEL MOVEMENT IRREGULARITY (hard time passing a bowel) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (hard time going to the restroom) and BOWEL MOVEMENT IRREGULARITY (hard time passing a bowel). At the time of the report, FEELING ABNORMAL (hard time going to the restroom) and BOWEL MOVEMENT IRREGULARITY (hard time passing a bowel) outcome was unknown.            Concomitant product use was not provided by reporter. No treatment information was provided.
woke uo on the 23rd with extreme problem hearing and ringing in right ear. went to see my dr on 28th. she referred me to EAr specialist. he saw me in April said hearing is gone and cant help with ringing.
12/04/21- None noticed  12/05/21 - fatigue, armpit tender 12/06/21 fatigue; armpit/lymph nodes  tender and swollen 12/07/21 armpit/ lymph nodes more swollen-phoned doctor's office and had an appointment;  12/08/21 armpit/ lymph nodes less swollen
Patient reported fever, dizziness and lightheadedness, as well as low blood pressure to this nurse by phone.  This nurse requested patient to be seen by provider as soon as possible.  Patient agreed and came to clinic soon after phone call.  Dr notified this nurse that patient was advised to be seen by provider in ER for possible IV fluids and lab work due to symptoms.  Pt refused and went home.
Arm rash developed around the injection site 8 days after receiving the first dose of Moderna. Rash was large, itchy, hot to the touch, raised, and bumpy. I put an ice pack on arm and that help relieve some itching. This is day 2 of rash still present but redness and itch have subsided.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient received vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) and product storage error (stored Moderna vaccine in the refrigerator and administered vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Jan 28, 2022, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 28, 2022, patient administered expired product (patient received vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021). On an unknown date, patient experienced product storage error (stored Moderna vaccine in the refrigerator and administered vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021). At the time of the report, administered expired product (patient received vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) and product storage error (stored Moderna vaccine in the refrigerator and administered vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Expiration date of the vaccine: Mar 19, 2022.
approx 930PM mom heard pt gagging; when got to pt had stop breathing; mom called ambulance @ hosp MD x-ray showed small amount of formula in airway; t101;
Herpetic lesions on both sides of torso; This non-serious case was reported by a physician and described the occurrence of herpetiform lesion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced herpetiform lesion (Verbatim: Herpetic lesions on both sides of torso).  The outcome of the herpetiform lesion was not resolved.   The reporter considered the herpetiform lesion to be related to Shingrix.     The company considered the herpetiform lesion to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-AUG-2023 The reporter consented to follow up.
This spontaneous report was received from a registered nurse refers to a currently 1 year old patient. The patient had already received 3 doses of RECOMBIVAX HB sometime in the past (unspecified dates). On an unknown date in 2014 (also reported as recently administered) the patient inadvertently received a fourth dose of RECOMBIVAX HB 5 mcg/0.5 ml. The patient was supposed to received an unspecified hepatitis A (manufacturer unknown) but instead received RECOMBIVAX HB. No symptoms reported Additional information has been requested.
arm pain and numbness in the arm she felt she was given the immunization; arm pain and numbness in the arm she felt she was given the immunization; left arm mass; This spontaneous report was received from a physician and refers to a female patient of unknown age (reported as between 11 and 13 years old).   Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was unknown by reporter.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On 17-AUG-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On 31-AUG-2020, the patient experienced arm  pain and numbness (hypoaesthesia ) in the arm she felt she was given the immunization, which the patient reported as her left arm.  On the same date, patient went to physician office and the physician noticed a left arm mass and sent the patient for an ultrasound which showed a small focal convexity in the region of clinical concern involving the superior lateral aspect of the left upper arm. However, the medical record showed that the patient received the vaccine in her right upper arm, and the patient is having these issues in her left upper arm. It was reported that the patient  did not have any issues previously when received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  The outcome of pain in extremity, limb mass and hypoaesthesia was reported as recovered on an unknown date.  The causality between the events  and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was unknown.
Low grade fever for 5 days chills migranes cloudy vision muscle spasms joint pain
This spontaneous report was received from a pharmacist regarding an unknown female (Gender was also reported as unknown) patient (age not reported) who on an unknown date received a second dose of ZOSTAVAX 0.65 ml subcutaneously (site not specified) (Lot number and expiration date not reported). On an unknown date, the patient had "bumps which she thought was a rash" and she sought medical attention reporting "she went to the emergency room where she was told she had shingles". It was reported she was given treatment (not further specified) for the adverse event. No further information was provided. No information was provided regarding when the patient received the firs dose of ZOSTAVAX. The treatment and outcome of the adverse event of shingles was not reported. Additional information has been requested.
Patient began sweating profusely approximately 5 minutes after vaccination. Also complained of lightheartedness. As per pt account he has fainted previously following vaccination. Patient was staying hydrated with water, and provided cookies to help in case blood sugar was low.
Post flu shot patient reported throat tightness. No breathing difficulty. 911 called - Transferred to E.R. Hospital unknown.
The day of vaccination, I went home and I was feeling fine. I started to get nauseated. I had Diarrhea. The nausea lasted for more than a week. I tried to hydrate as much as possible but the Diarrhea wouldn't stop. On March 24 I couldn't do anything because the Diarrhea began to become severe. I went to the ER and they said I had colitis and I was dehydrated. They told me to follow up with my PCP the next day. I was told to get Imodium. I was also told to start a brat diet.  Colitis is inflammation that causes bleeding in the large intestine. They doctor said it could of been inflammation in large intestine due to the vaccine. As of now everything has gone back to normal.
Pt received his first dose of Pfizer Covid vaccine today and after sitting for approximately 15 min. He was observed getting up from his chair and appeared to sway.  Immediately went to pt to assess and asked how he was feeling.  Pt states "feel a little dizzy".  When asked if experiencing any other symptoms describes "my left arm is tingling".  Pt denies any difficulty breathing or other symptoms.  Pt did not want to try anything to drink.   1557:  BP= 158/80 and Apical HR=80-82/min and regular. Resp. Rate 16/min.   Pt began feeling dizzy while sitting so had another nurse assist to try to get to the floor and pt unable to stand or scoot.  Had medical emergency team called.  Able to get pt down to the floor with further assistance of two nurses.  Pt alert and oriented the entire time.  Pt able to move all extremities including the left arm which continues to feel tingling sensation.  Pt is feels clammy while on the floor.  BP: 140/100, HR 82/min.   Med team arrived and decision made to transport to the ED.  Pt lifted to gurney by team and transported.  Accompanied pt. and contacted his wife to notify of pt. situation.  She was at doctor appointment and will arrive in approximately 30 minutes.  Report given during transport and on arrival to ED.  Pt remained alert and oriented throughout episode.   Pt was given IV Benadryl in the ED along with a liter of normal saline.  Pt discharged after approximately 2 hours.
Allergic reaction; Received his booster, third shot; Feels like he is "sick with the flu"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like he is "sick with the flu"), HYPERSENSITIVITY (Allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his booster, third shot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like he is "sick with the flu"). 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his booster, third shot). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like he is "sick with the flu"), HYPERSENSITIVITY (Allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his booster, third shot) outcome was unknown.            No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.
Sore arm at 12 pm. Unresolved. Nap until 3:30pm. Woke up with fever of 101.4, took Tylenol 1000mg total. Rested, took temperature again at 7:00pm, which was 101.3. Took Tylenol again at bedtime, 9:00pm, same dosage of 1000mg. Slept most of the night. Took temperature upon waking up at 6:00am (4/25/21) and it was 98.7.
Swollen lymph node IOP in  the right eye went way up to 42, which also affected the vision  A small patch of poison  oak reoccurrence
Nausea onset 3 hours following vaccine on 1/22/21. Vomit onset 12 hours following vaccine lasting 1 hour.
Initially (L) deltoid soreness progressing over 3d to intense (L) axillary pain/swelling and pain at base of neck. Exam: No cellulitis. Tender 4-10 mm lymph nodes at (L) base of neck, supraclavicular chain and (L) axilla.
has history of HTN; post vaccination BP was 204/126; recheck was 185/119; at 8:23 BP was 192/98; at 8:31 BP was 181/97; we escorted her to ED for evaluation.
Child was lightheaded, body aches, chills, tired easily and local reaction of swelling and redness, tingling down leg, onset day after TRUMENBA.
3 syncopal episodes within 24 hours of receiving vaccine in patient with no known history on syncope in her life.
a moderate amount of the vaccine "squirted out" onto the patient's arm.; 2nd dose given 25 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (a moderate amount of the vaccine "squirted out" onto the patient's arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25 days after the 1st dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 UNDERDOSE (a moderate amount of the vaccine "squirted out" onto the patient's arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25 days after the 1st dose). On 21-Apr-2021, UNDERDOSE (a moderate amount of the vaccine "squirted out" onto the patient's arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 25 days after the 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: pt passed out for about 30 seconds while still in sittling position with family. was dizzy and tired and had HA for about 20 minuts then felt better and left with family.
This case was reported by a healthcare professional and described the occurrence of maladministration in a 4-month-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On 14 May 2012 the subject received 2nd dose of KINRIX (unknown) and experienced maladministration. The nurse reported two 4-month old subjects were administered KINRIX on 14 May 2012. KINRIX is not indicated for this age (too young). The nurse reported the subjects were taken to the emergency room by the mother because "the mother was very concerned that something might happen". The nurse reported "that from her knowledge the subjects were fine, and they were not admitted". At the time of the report no other information was available. This is the second case of two, for the first case see A0977550A.
mom reports pt devel rash 24hr p/vax;little rash on face, heavy rash from neck on down rash-pinpoint, red, raised, dry;itching;skin bright red,no hives, no breathing diff;mom gave DPH;saw MD 27AUG;no tx plan to get next HEP B @ MD office;
Swelling and redness with pain to both hands also rash to body; symptoms started at 7:00pm - 9/27/07. Treatment: Benadryl 25mg tab 1 PO q hour.
Flu vaccine administered four days prior to age of 6 months. Attending physician aware. No side effects experienced. Plan to revaccinate at next visit.
pt recvd vax;3 mo p/ dose 3, exp herpes zoster & an inadequate titer;
Fatigue 1-2 days post injection Muscle ache 1-2 post injection Extremely Sore neck started around 2pm 2nd day post injection.
Pt was inadvertently administered a Bivalent Covid vaccine for their 2nd dose. No adverse reaction was noted. 3rd dose has not been administered.
24 hours after the injection- arm soreness; Fatigue; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the arm (unspecified) on 15Mar2021 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 16Mar2021, 24 hours after the injection, the patient experienced arm soreness. A week after the injection, on an unspecified date in Mar2021, the patient experienced fatigue and diarrhea. The patient believed that the diarrhea and fatigue occurred prior to the vaccine but it was unsure. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, diarrhea and fatigue was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Over the month after getting first vaccine, he developed shortness of breath, fatigue, and lymph node swelling in the left axilla
Swollen lymph nodes, dizziness, headache, fatigue, unable to lift arm more than a few inches
Severe wheezing. Started slightly wheezing about 2 hours (0930) post vaccine. Took 4puffs of Xopenex HFA MDI with spacer. Slept until 4pm and awoke with severe wheezing episode. Took Nebulized xopenex twice.... wheezing is still audible oxygen saturation is currently at 95%
Lymphoid under left day swollen and bruised. 2 inches under vaccine site was swollen, red and hot to touch. Now bruising down the arm to her elbow. Last Lymphoid behind her left knee was swollen and enlarged.
Extreme pain and tightness on right side, back of head, back of neck, and right shoulder. Could not turn head to the right nor look up. Lasted 9 days.
chills with fever, body aches, headache, nausea. very uncomfortable. took Tylenol, used heating pad. went away about 36-48 hours after
tingling in tongue, behind ears started immediately.  then headache in forehead.  Shaking in legs. never progressed to anything further.  no respiratory symptoms.  needed her inhaler the next day, but usually uses it twice a week so that isn't unusual.  Had really bad chills that night without fever.  Has had a headache everyday for 1 week after the vaccine.
Client in to receive vaccine for college. Gardasil/ Varicella given to Right upper extremity. Writer immediately noticed clients eyes waddled to the side as he passed out. Writer shook client to establish consciousness and his eyes immediately opened. Color pale. Supervisor notified at this time. Incontinent bladder episode noted. Code Blue called per intercom system. Skin diaphoretic. O2 per non-rebreather applied. V/S 79/45 52 Sat 100%. Close monitoring per nursing staff. EMS notified @ 11:52 AM. Vitals monitored Q2H until EMS arrived. Per EMS evaluation and patient declined transport to ED for further treatment.
On the next day of a booster shot, she developed swelling and local pain in left upper arm where she received the shot. Significant swelling in left upper arm spread to the upper chest (especially in the area around left clavicle). She also developed swelling and pain in axillary lymph node.
swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): US-PFIZER INC-202101313990 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization; Bnt162b2 (Dose number: 2), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional information: Patient didn't have any side effects after the first two dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10AM Initial reaction of mild swelling in neck and throat area at work. Coughing due to throat irritation, then low wheezing. ED Provider Notes MD at 7/9/2021 11:02 AM HPI: Patient presents for evaluation of allergic reaction.  Initial history limited due to her significant respiratory distress.  She is stridorous and moving poor air.  She can speak only a few words at a time.  History initially provided by her significant other. He states she called him from her work this morning stating she was having trouble breathing.  He went to her place of employment to pick her up and bring her here.  While in route in his car, her breathing became more difficult.  This prompted her to administer her EpiPen in her right thigh.  He notes there is quite minimal appearance of improvement in her condition.  She still seemed labored in her breathing and her breathing was quite loud.  Upon arrival here she was immediately brought to an ED room where I assessed her.   11:05 AM After receiving 0.3 mg 1-1000 IM epi here in the ED, she improved within minutes.  Stridor resolved.  Work of breathing normalized.  Lungs clear.  Able to speak to me with ease now in full sentences. She tells me that she felt some throat tightness this morning actually before work, prompting her to take p.o. Benadryl. Total patient critical care time required for stabilization and resuscitation of anaphylaxis was 35 minutes and includes direct patient care at bedside, medical decision making, lab/x-ray interpretation, historical review, coordination of care and discussion with consultants and family.  This is separate from other procedures listed and performed. She has received 2 doses of epi thus far for quite significant stridor/ respiratory distress.  We discussed the option of admission to the ED observation unit.  She is amenable to this. Discussed with ED observation unit provider Dr., who will evaluate the patient for admission.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter indicated that the receptionist at her dermatology office experienced bad reactions (unspecified) after receiving the SHINGRIX vaccine. The reporter wanted to end the call, so was unable to obtain additional information. This case was one of the 5 cases reported by the same reporter.