chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm but the next day pain in underarm axilla - the pain continues - this is the 2nd day of it
The client notified RN  that she received a dose of Janssen COVID vaccine on 06/17/21. The client reported that about three hours after receiving the vaccine she developed dizziness, weakness, and a headache. The client stated the symptoms lasted about one hour and then she went to sleep. The client denied any persistent symptoms when she woke up the next morning. The client took Tylenol which helped her symptoms. The client denies any chronic conditions or medications. The client has no known allergies.
8/19/2023 - 9/10/2023 (22 days) Date of Admission: 8/19/2023  Discharge Date: 09/10/23 Discharge Disposition: Skilled Nursing Facility (SNF) with Medicare Certification in Anticipation of Skilled Care past medical history  -presyncope and  loop recorder in place -prior fall with intracranial hemorrhage in 2021  4/12/2021  046B21A 3/10/2021 044A21A 10/26/2022 AS716
There has been no symptoms or sign . Call patient and informed them. Patient is to return within 4-6 weeks to give adol/adult dose
delayed for their second dose of shingrix/ First dose / Nov 2049; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2019).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if patient can continue with 2nd dose or should restart the series. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021080779:same reporter - same patient
I do not have the whole story. Patient spoke with me 4 days after getting vaccine and said she had been suffering from swelling in arm, fever over 103 degrees Fº, inability to move arm for a few days, and feeling very fatigued. She said I must have given her the vaccine too low on her arm (in her bicep) but I think she is saying that because of where the swelling is (I cannot recall the event in detail but generally take steps to avoid administering vaccine too low on arm). She was encouraged to see a doctor because of the severity of the situation that she was describing. According to her, she was diagnosed with cellulitis and given antibiotics. I believe she went to the Urgent Care but do not have the details.
diluent portion of Pentacel administered without using it to reconstitute the powder portion with no reported adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who administered diluent portion of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without using it to reconstitute the powder portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5v (rotateq) and pneumococcal vaccine conj 13v (crm197) (prevnar 13) both for Prophylactic vaccination.  On 03-Jun-2022, the patient received a  dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) (lot U7197BA; expiry date: 28-Jan-2023) (strength, dose, formulation, route: unknown) in unknown administration site for prophylactic vaccination.  On 03-JUN-2022 the patient developed a non-serious diluent portion of pentacel administered without using it to reconstitute the powder portion with no reported adverse event (Product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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.
incredibly sick for 2 days.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: incredibly sick for 2 days.).  In SEP-2023, the outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 26-SEP-2023 This case was reported the patient via interactive digital media. The patient had the vaccine last weekend and was so incredibly sick for 2 days.  The patient reported that they should warn people of the side effects. Follow-up not possible as no contact details provided.
145PM MMR given inj site became mottled et red, ice applied;DPH given; BP 136/90;pt flat, monitored pt, no resp distress;2:05 BP 142/92, P 70 reg c/o severe h/a, face flushed;c/o nausea called MD, pt to clinic; pt vomited
Meningo-encephalitis  Pt started having fever, chills, altered mental status, drowsiness, confusion.
This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. On an unspecified date in August 2014 (also reported as during this past week) two unspecified patients were administered a re-filled syringe dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not provided). On an unspecified date in August 2014, both patients experienced a moderate local reaction at the injection site of administration described as swelling and erythema. The outcome of the event was unknown. The relatedness between the event and the vaccination with PNEUMOVAX23 was unknown. Additional information has been requested.
Case number PHEH2014US025346, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 54 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 21 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Arm hurt; This is a non-serious spontaneous case, initially received from other non-health professional on 22-Jan-2019, concerning a 14-year-old, adolescent male patient.  On 05-Jan-2019, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication.  On an unspecified date in Jan-2019, after vaccination, the patient experienced pain in his arm.  The outcome of the event was not reported.  The reporter did not provide consent to follow up, hence the case is lost to follow up.; Reporter's Comments: A 14-year-old, male patient experienced pain in arm, unspecified date after the administration of INN Flu Vaccine Seasonal. The company assessed the causality of the event as related due to plausible temporal relationship between the event and the suspect vaccine.
Significant nausea and diarrhea.; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 27Mar2021 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient did not have allergies to medications, food, or other products. Concomitant medications included unspecified statin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) both for an unknown indication and started from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 00:00, the patient experienced significant nausea and diarrhea. The events had not resulted in the visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events nausea and diarrhea. The clinical outcomes of the events nausea and diarrhea were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Immunizer administered vaccine too low. Patient reported administration site in tricep instead of deltoid as usual for IM immunizations.
This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an unspecified route on 19Jan2021 at 11:15 (at the age of 83-years) as 1st dose, single dose in the right arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. 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 been tested for COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing and went to Emergency room and diagnosed has pleurisy. The patient received treatment for events with steroids, pain meds and muscle relaxers. The patient underwent lab tests and procedures which included nasal swab, COVID test was negative on 19Feb2021. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
2 1/2wk p/vax devel sl larger than quarter size red area w/some vesicles w/itching feeling;
74 year old vaccinated male was admitted for pneumonia from Covid-19 with associated respiratory failure. He has been treated with Remdesivir and continues to be on high dose steroids. He has become dependent on HFNC at 60%. He will be transferred to specialty hospital today for further care.
Mild tingling in head (not severe enough to feel like a headache), lasting 10 minutes. Did not undergo any treatment other than avoiding usage of left arm.  Mild, dull pain in left forearm, felt like in a single point (rather than across the entire forearm), lasting 10 minutes. Did not undergo any treatment other than avoiding usage of left arm.
Patient says that she experience swelling under her armpits after receiving her first dose of the moderna vaccine.
Heavy menstrual cycle started today, roughly 36 hours after vaccination, and is eight days early. My cycle is never more than a day off.
got covid (tested positive); got covid (tested positive); GI issues; weak; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient's daughter) that an 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 (at the age of 84 years) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was daughter, her mom (patient) got 1st dose on 04Feb2021, then patient got covid (tested positive) on 23Feb2021, patient had GI (gastrointestinal) issues and weak in Ferb2021. Patient took antiviral treatment and had to be in hospital in 2021. Patient was currently out of hospital, recovered, and in rehab place. Caller was asking for information about 2nd dose past 21 days. Caller was asking if her mother should restart the series. The case was reported as non-serious. Outcome of events was recovered in 2021.   Information about batch/lot number has been requested.
Shingles - c2 Dermatone; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 19Apr2021 12:30 (at the age of 41-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive other medications in two weeks of vaccination. Patient received vaccine Facility in other. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unknown route of administration, administered in Arm left on 22Mar2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. The patient experienced shingles - c2 dermatone on 05May2021 06. Treatment was received for the events as bacterial ointment. Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the event was reported as recovering.
All over body aches and soreness, headache, heaviness in lungs with shortness of breaths,  cough, and hypersensitivity on skin. Took tylenol and rested.  Lasted about 4 days.
Mild sore throat (June 27 - current); post-nasal drip (June 28 - July 5); mild cough (June 28 - July 1); zero appetite/food intake (June 29 only); mild fever never exceeding 99.8f (June 30 - July 3)
A day and half later I started to itch in multiple places. My hand was covered in red dots, a rash and it was all over, my back, chest, legs. I figured it was typical due to the antibiotic medication I was on. I contacted my doctor's office and was told to take antihistamine, which I took for 3 days. It's been getting better than when it first occurred.
Client's mom calls into clinic.  Reports client received a PPD (TB skin test) and Varicella vaccine on 06/22/2021 here. States she later received a flu shot on 06/25/2021.  Mom says about four hours after receiving the flu shot her daughter started experiencing; headache, eye irritation, neck pain, back pain, sinus irritation, cough, tiredness, and injection site arm pain. Voice she has been sleeping a lot. Denies any rash or changes in skin.  Voices her daughter is still not back to normal, but, almost there. Mom adds in she usually experiences the same symptoms after getting a flu shot.
Patient reports having a fast heart rate, overnight after receiving her Covid bivalent vaccine in the afternoon. Patient reports heart rate resolved on its own and she will continue to monitor symptoms.
This spontaneous report was received from the patient's daughter referring to her 85 year old mother. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient developed shingles after vaccination with ZOSTAVAX. No product quality complaint was involved. At the time of the report, the outcome of herpes zoster was not reported. The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.
An 84 year old male with a past history of diabetes but no other medical problems, no lipid abnormalities and no prior cardiac history. He had a documented allergy to Iodine. This pt had received flu shots in my office every year since 1997. He received his Fluvirin dose this year on 1/18/03. He was found dead at home of a presumed sudden cardiac death on 11/20/03. The death certificate received on 12/3/03 states sudden cardiac death.
14 days after 3rd Moderna COVID immunization, developed raised irritated skin & rash broadly over body.  Primarily occurring on back of neck, forearms, hips, stomach and groin.  Typically raised and red skin, itchy and sometimes burning.  Hives like in appearance.  Recurring daily and spontaneously.  Seems to respond well to Zytek, Benedryl and short prednisone course.
Initial misuse report received from a healthcare professional on 12 November 2013. A 10-year-old patient (gender was not reported) received a dose of DAPTACEL. No adverse event was reported. Documents held by sender: none.
Regarding Covid booster#2. I experienced very high BP for 3 days; now very low BP; weakness; a loss of some hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "have had cardiac bypass" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 3, First Booster), for Covid-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "Regarding Covid booster#2. I experienced very high BP for 3 days"; HYPOTENSION (non-serious), outcome "unknown", described as "now very low BP"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; HYPOACUSIS (non-serious), outcome "unknown", described as "a loss of some hearing".  Additional information: This never happened upon receiving 1st 3 Covid shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
described it as a light bleed, similar to a menstruation. She mentioned she has not had a period in years; bleeding from her vagina; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200102251 (Pfizer).  A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Jan2022 (Lot number: FJ1611) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "described it as a light bleed, similar to a menstruation. She mentioned she has not had a period in years"; VAGINAL HAEMORRHAGE (non-serious) with onset 18Jan2022, outcome "recovering", described as "bleeding from her vagina". Clinical Course: The patient received first dose of the COMIRNATY vaccine on 17Jan2022 and stated 2 days after the shot she was bleeding from her vagina. The patient doesn't see this on the paper of side effects. She never bled down there before so she was calling to see if this could be a side effect. It was light bleeding, similar to a menstruation but doesn't know if its from the shot because she wasn't bleeding before. At first it started spirting but now its not coming out really heavy but like a period or menstruation. The caller hasn't had a period in years. The caller has been in the hospital but this was way before she received the vaccine.   No follow-up attempts are needed. No further information is expected.
Oct 6th received shot - from the 8th thru the 11th so painful - Iced & took TYLENOL - went away- then on Oct 18th it returned so painful from top of arm thru lower arm - couldn't drive had to have someone take me to Medical Group for X-rays & needed cortisone shot to stop rush pain.
08/29/22 presents to ED for "shortness of breath and bilateral lower extremity edema". PMHx of "atrial fibrillation, hypertension, congestive heart failure"
Initial and follow up information has been received from a foreign legal firm concerning a case in litigation in which a female child was vaccinated on 9/12/95, at the age of 1 year, with a dose of MMR (second generation) (batch HW63900: lot 611486/0285A). Subsequently, the patient developed epilepsy, ileal lymphoid hyperplasia with lymphocytic colitis, and autism. Upon internal review, ileal lymphoid hyperplasia, lymphocytic colitis, epilepsy, and autism were determined to be other important medical events (OMIC). No further information is available.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU, (route: subcutaneous) for prevention of reoccurrence of shingles. On an unknown date in December-2016, (reported as a couple of days ago), the patient had another case of shingles. The outcome and causality of the event were unknown. Additional information has been requested.
loss of vision; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently 81 or 82-year-old patient (pt.) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 11-MAR-2015, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles (herpes zoster). On an unspecified date, the pt. was subsequently treated by healthcare providers (HCP) for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX) herpes zoster and loss of vision (blindness). The pt. claimed damages as a result of injury to itself and economic losses. The outcome of the events was not reported. The reporter considered the events to be related to vaccination with zoster vaccine live (ZOSTAVAX).  Upon internal review, the event blindness was considered to be medically significant.