chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 1st dose, not sure if received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date in 2021,  2 years before date of reporting.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comments: The pharmacist stated a patient received the first dose of Shingrix 2 years ago.  She stated that she was not sure if the patient might had received the 2nd dose elsewhere but could not find it documented in the database. She stated that she was getting this question more.  She did not report any other patients who were late with the 2nd dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023014272:same reporter
Patient was incorrectly administered monovalent Covid-19 12+ instead of receiving Bivalent booster. Patient had previously completed initial monovalent series 4/21/21, 5/12/2021 and additional booster on 11/18/2021.
08/07/2003: Swelling and redness left upper arm.  Elbow to top of arm.  Keflex 250 tid x 5 days.
pt recv vax 6NOV95&exp chronic fatigue,orthostatic syncope,progressive&gen malaise/weakness,multi-focal paresthesia w/cognitive side effects&tachycardia;MD stated that pt's malaise was so severe,was brought to ofc in wheel chair
Vaccinee (Case #4) rec'd a 1st dose (rt deltoid) of Engerix-B on 1JAN90 (third dose in series of Hepatitis B vax); Testing for titers on 1MAR90 indicated did not seroconvert;
I experienced severe pain, swelling, and heat in left arm, as well as a 3 x 5 inch rash at injection site. I had a severe headache, nausea, generalized muscular pain, exhaustion and weakness for 2 days following injection.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt says he felt "odd" after standing up from his sitting position in the observation area. He had sat for the required 15 minutes. He thought that he would be fine to walk/leave the store. He was at the front of the store when he felt dizzy and doesn't recall falling. He recalls being on the floor after the fall.  When I approached him, he was holding an towel to his chin, which was bleeding. currently in ER for stitches. Spoke to him on phone and he said he was feeling much better. Girlfrien
accidentally gave Fluzone High Dose to a 19 year old female patient/ no AE; accidentally gave Fluzone High Dose to a 19 year old female patient/ no AE; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Office Staff).  This case involves a 19 years old female patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ221AA (Expiry date 01-Apr-2020) via unknown route in the left arm, on 04-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  It was reported that accidentally gave Fluzone High Dose to a 19 year old female patient.  At the time of reporting no adverse reaction was 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.  List of documents held by sender: none.
patient was in the observation area when his family told us that the felt dizzy. i got to his side and asked if he was doing ok but did not get a response. he was sitting on a chair with eye opened but not responding. so we called 911. then a few seconds later , he said i could hear you but was not able to see. then he said he felt hot so we gave him some water. Now dispatcher on the phone told us no water and have him lay on the floor. by now he  had started to feel a lot better. then the parametic team came and took over . His vitals, blood sugar and EKG were all normal. then patient was offered to go to hospital for evaluation but he refused
POSSIBLE ADVERSE EVENT; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown and expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested .No concomitant medications were reported.  On an unspecified date, the patient experienced possible adverse event. It was reported that the patient called to call center with a question that whether it is safe to take Ibuprofen or Tylenol because of vaccine and clotting. The patient was referred to vaccine facility or HCP for medical advice. It was reported that clarification was not obtained as to what the Ibuprofen or Tylenol was for before ending the call. Call center attempted to call back but number leads to cancer institute. Additional information was received from the patient that the patient had fact sheet from Janssen website but the patient did not see anything that talks about medication for side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible adverse event was not reported. This report was non- serious; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Extremely sore arm at injection site, fatigue, nausea, body ache, fever, chills
Elevated blood pressure; Fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure) and HEART RATE INCREASED (Fast heart rate) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included LABETALOL, POTASSIUM, HYDROCHLOROTHIAZIDE, RAMIPRIL and CLONIDINE for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure) and HEART RATE INCREASED (Fast heart rate). At the time of the report, BLOOD PRESSURE INCREASED (Elevated blood pressure) and HEART RATE INCREASED (Fast heart rate) outcome was unknown.            The patient went to an urgent care clinic and had a call in to her doctor. She would be having major neck surgery in April and needed to know if the vaccine could have caused the elevated blood pressure and faster heart rate. No treatment medications were reported.
Vaginal bleeding 10 years post menopause Also Flu-like symptoms consistent with second dose
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 outcome of the events was recovering.
patient under 4 years old was administrated with Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number h9y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The manager reported that a 2-years-old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow-up.
heat was a sign of an allergic reaction; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0153) via an unspecified route of administration, administered in right upper arm towards back of arm, on 31Jul2021 at 09:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure high and Meniere's disease; cancer wherein the patient had it twice in 2014 and 2017, and COVID-19 on unspecified date in Dec and Jan. Concomitant medications included calcium taken for an unspecified indication from an unspecified start date and ongoing; multivitamins (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for high blood pressure, and Meniere's disease which is an inner ear disease and it helps with the fluid from an unspecified start date and ongoing; vitamin b complex taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication from an unspecified start date and ongoing; verapamil taken for hypertension from an unspecified start date and ongoing; and zinc taken for an unspecified indication, start and stop date were not reported. On 01Aug2021, it was reported that the patient experienced big red area size of a nickel around the injection site and each day it was getting bigger and bigger; this area was red, raised, hot, and later added itchy (medically significant). This area was concerning to her because the redness was spreading. It is now very big, halt the size of the palm of her hand. It was itchy, red, raised, hot. The patient mentioned she took allergy shots in the past and knew that heat was a sign of an allergic reaction. The patient took diphenhydramine (BENADRYL) as a treatment. The patient started to notice this redness around injection site the next day. She brushed against her arm and was rubbing her forearm and felt a knot. She looked at it and noticed it was red and then later on it started itching and hot. At end of call, the patient reiterated she was just concerned about the heat coming from her arm. It was hot and spreading. The outcome of the events was not recovered.
11FEB93 red rash, raised welts over entire body c/o feet & ankles hurting; fever 101;
Child received the adult Pfizer dose of the covid vaccine in error instead of the pediatric Pfizer dose.
INCREASED NEED TO URINATE (CONDITION AGGRAVATED); This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: increased urination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 18-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced increased need to urinate (condition aggravated). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of increased need to urinate (condition aggravated) was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2016, the patient was vaccinated with an expired and unsupported dose of ZOSTAVAX (lot # L000450, expiration date 09-MAR-2016; dose and route were not reported). No adverse reactions were reported. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
left injection site arm sore; left injection site arm red; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MECLOZINE HYDROCHLORIDE (BONINE) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (left injection site arm sore), VACCINATION SITE ERYTHEMA (left injection site arm red), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2021-296560 (Patient Link).
On Sept. 8 - received vaccine for seniors at 1:30 p:m - At 7:30-8:00 - dizzy - fainted. Next day extremely weak. treated it like flu symptoms - called Dr. - said to stay in bed - I was unwell for a couple of days. (Also short of breath).
Pt experienced high fever for 4 days post vaccine. 102 degrees, dizziness, dehydration
Developed cyst on left side of neck/It is a soft, movable lump/the mass; Developed cyst on left side of neck/It is a soft, movable lump/the mass; mild headache; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on 24Apr2021 at 11:00 (at the age of 18-year-old) as dose 2, single for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing, shellfish allergy from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration in left arm on 03Apr2021 at 11:15 (at the age of 18-year-old) as dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that 1 Tylenol 1 day after 2nd dose (25Apr2021) for a mild headache and developed cyst on left side of neck 1 week after 2nd dose (01May2021 at 09:00). It was a soft, movable lump that formed suddenly and has not changed in size since it developed (as of "today", 11Jun2021). She got an ultrasound and would need a MRI to determine what the mass is made of. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The treatment of developed cyst on left side of neck/it is a soft, movable lump/the mass was reported as unknown and TYLENOL was given for mild headache. The outcome of developed cyst on left side of neck/it is a soft, movable lump/the mass was reported as not resolved and mild headache was unknown.  Follow-up attempts are completed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning his infant son (currently "2 years old") with no pertinent medical history who in approximately 2006 "about a year and a half ago," was vaccinated PO with the first dose of ROTATEQ (no lot# given). "In approximately 2006 about 1-2 weeks post vaccination, the patient experienced diarrhea that was yellowish and had a rotavirus smell to it." Subsequently, the patient "had improved" and was noted to be recovered. There was no product quality complaint. Additional information has been requested.
The right side of my back had extreme cramping; therefore, I went to bed and took Motrin and then the next day it was still really sore. I went to the doctor the very next day (physical exam, blood work, and took x-rays but didn't find anything).
Muscle Pain Tired Nausea  Fever Shivering All resolved in about 24 hrs.
Vaccine administered at inappropriate site; Pain at injection site; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-SEP-2023, the patient received Arexvy (unknown arm). On 07-SEP-2023, an unknown time after receiving Arexvy, the patient experienced vaccine administered at inappropriate site (Verbatim: Vaccine administered at inappropriate site). In SEP-2023, the patient experienced injection site pain (Verbatim: Pain at injection site).  The outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK receipt date: 08-SEP-2023 The physician, a patient himself received Arexvy vaccine a little below the deltoid muscle of the arm yesterday (day before vaccination) and had pain at injection site The patient received vaccine below the deltoid muscle, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Pt fell out out of chair onto floor. Was pale and clammy.  4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54, P 83, O2 95% 4:31 BP 120/82 4:39 92/62 , BG 113 Vaccine site closed at 5 , Pt had no one to contact for a ride home. Transported to hospital via ambulance for further eval, discharged home from ER.
I received the vaccine Saturday 4/10/21 at 9 am. By 8 pm of the same day I had fever, chills, headache and body aches. For about 30 minutes I saw a white spot on the peripheral  view of my left eye.  By Monday, I felt dizzy and bottom right part of my chest hurt when taking deep breaths. The dizziness and chest pain lasted all week, still feel feel it today 4-18. My doctors office told me vertigo was a common side effect. On Thursday 4-15 every time I bent down and tried to get up, my right leg hurt as if I had exercised. At the moment I haven?t gone into work since Monday 4/12 since my job requires a lot of physical work.  I have mostly been home  resting  but don?t feel ready to go back to work. If someone  calls can it be a Spanish speaking person please.
within 10 mins of receiving the vaccine I had a burning sensation across my chest, arms and face, developed hypertension, tachycardia and had perfuse sweating.  Blotchiness was noted on my face. I felt like the inside of my body was on fire, only in my torso area. I was given an ice pack, vitals were monitored and the symptoms resolved after 10 mins.  Then within 5 mins, the symptoms returned.  They again last for about 10 mins and resolved enough for me to leave the vaccination observation area.  I was monitored closely for over an 1hr post injection. I did have itchiness in the roof of my mouth, so I took Benadryl 50 mg when I got home and the next morning  had major fatigue and mild soreness in the injection site.
Vaccine was administered on 12-05-2022 RN noted after administration that vaccine expired on 12-01-2022. RN contacted patient via phone call and reviewed the vaccine error and discussed possible decrease efficacy and need to repeat dose. Patient voiced understanding.
6 hours after shot extreme fever, dehydration, arm pain, chills, muscle aches  24-72 hours - extreme fever with sweating, arm pain chills, muscle aches, brain fog. Arm pain lasted a week  0-2 months - brain fog, fatigue, chest pain, hot flashes, erectile dysfunction   Still ongoing 3 months later - erectile dysfunction and complete loss in sexual interest
child awoke @ 11PM screaming & febrile, vomited twice;motrin was given by mom & child went back to sleep;955AM mom describes apparent grand mal sz lasting approx 30 seconds;child taken to ER T104 R dx pneumonia & febrile sz;