chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over her torso, calves, armpits, and the back of her hands; Two red dots appear on the skin around her ribcage; Chills; Fever; Body aches; This spontaneous case  was received on 30-Nov-2020 via Med Communications (reference number: SEQW20-05480), received by other non-health professional (consumer) and concerned a 58-year-old, female patient.  The patient's historical vaccine included vaccination with Fluvirin on 6-Oct-2015 and 27-Nov-2016 and Afluria QIV on 25-Nov-2019 and the patient experienced no issues after receiving those vaccines. The patient's relevant medical history and concomitant medications were not reported.  On 25-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid, and route of administration: not reported) for protection against seasonal influenza. The batch number was not reported.  On the same day, shortly after receiving Flucelvax QIV, the patient saw two red dots appear on the skin around her ribcage.  On an unspecified day in Nov-2020, reported as overnight after receiving Flucelvax QIV, the patient developed body aches, chills, and fever. These issues worsened through the night and by the time the patient woke up for breakfast the next day, these issues still persisted.  On 28-Nov-2020, three days after receiving Flucelvax QIV, the patient developed hives all over her torso, calves, armpits, and the back of her hands.   On 29-Nov-2020, the patient went to an urgent care center and received a steroid shot, but it did not seem to work. The patient subsequently received a dexamethasone shot and it seems to have worked a little, but the symptoms were coming back.  At the time of initial reporting on 30-Nov-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reported assessed the events as non-serious.  Company comment: A 58-year-old, female patient developed general body pain, skin disorder (reported as two red dots appear on the skin around her ribcage), chills, pyrexia and urticaria after vaccination with the suspect product, Flucelvax QIV. Information regarding the underlying medical history and concomitant drugs have not been provided. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).; Sender's Comments: A 58-year-old, female patient developed general body pain, skin disorder (reported as two red dots appear on the skin around her ribcage), chills, pyrexia and urticaria after vaccination with the suspect product, Flucelvax QIV. Information regarding the underlying medical history and concomitant drugs have not been provided. With information presented, causality cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes).
Patient presented in office with approximately 20 lesions.  Rash started 2/27, patient presented on 2/29.
Patient came in for 2nd dose of Pfizer vaccine on 4/29/2021. Prior to second vaccine, DOB was confirmed and patient was only 15 years of age. Pt. had already received dose by RN on 4/7/2021 with parent present and permission received, according to documentation. Mother of patient was told by Lead to reschedule 2nd dose for vaccine after 16th birthday, and he explained the situation.
Achy, nausea, swelling in hands, joints ached, faint, headache hot then cold. Started feeling sick on Friday, by Monday really sick missed work. Down all weekend. Still have achy joints and headache. Reported this to employee health.
Swelling, erythema, cellulitis around injection site 10 cm >48 hrs later. TX with Keflex.
This spontaneous report as received from a pharmacist refers to a 4 unspecified patients of unknown age and gender. In September 2013 (thin the last 2 weeks), the patients were vaccinated with the dose of PNEUMOVAX23 (dose, lot number and route of administration were not reported). In September 2013 (within the week after receiving the vaccine) the patients developed cellulitis. The patient sought medical attention (unspecified). The outcome of cellulitis was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Extreme pain at injection site. Swelling and red rash from shoulder to elbow.  Chills/headache and flushing first evening.  Unable to move arm to undress or move in bed.  Pain/rash and fever in arm persisted thru 6/09/2007.  Advised to take Benedryl after second call to physician's office. Symptons subsiding today but arm still sore and red.
Initially has localized hives at Inj site of left leg only below TRUMENBA site. No other Sx. Told to give MENACTRA. By the 2nd day post injection area was large and had diffuse rash. C/O lower extremities and some on arms. Pt. was given steroids, BENADRYL and ZYRTEC.
reported on June 1st 2021 today / patient received a 2nd dose /first dose was received on April 25th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 1st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix on 25th April 2021 and on the day of reporting received a 2nd dose of Shingrix earlier than then recommended schedule, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
This spontaneous report as received from a nurse practitioner via field representative refers to a 22 year old female patient. The patient's medical history, drug allergies/reactions and concurrent conditions were not reported. The patient was not pregnant. Approximately in October 2015 (reported as 1 month ago), the patient was vaccinated with one shot of GARDASIL in the left deltoid region. No information on concomitant medications was provided. Approximately in October 2015 (reported as 1 month ago), the patient experienced soreness around the injection site after receiving the shot. The patient received medical attention at the nurse practitioner's office and the patient continues to have soreness (3cm) and hematoma (or spot) was identified. No treatment was given for the events. The patient stated that it was very painful when she rolled on it and she gets a pain in her left arm. The patient had full range of motion. The outcome of the events was reported as not recovered/not resolved. The relatedness of the events with GARDASIL was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Feburary 2006 Gastrointestinal, diarrhea/loose stool treatment in June Dicyclomine 20mg 3x a day. March 2006 Rash on top of both hands, treatment steroid cream. 14 May 2006 Insomnia, treatment June 2006 Ambien 10mg. May 2006 Tingling in hands and feet. May-July 2006 20lb weight loss/Acute adjustment disorder.
A 27 year old female pt reported that she received a dose of Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date. Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (IN).  Concomitant therapy included Protonix.  Lab test results: influenza test positive was done on an unspecified date.  On an unspecified date in Dec 03, a 27 year old female pt developed influenza after receiving a dose of Flumist.  Treatment consisted of Tylenol and Levall.  The reporter indicated that she "found out she was pregnant" soon after the administration of the Flumist vaccine.  No additional information was available at the time of this report. As of 14-Jan-2004, she has recovered from influenza.
dosing error (temperature excursion); product storage error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dosing error (temperature excursion)) and PRODUCT STORAGE ERROR (product storage error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dosing error (temperature excursion)) and PRODUCT STORAGE ERROR (product storage error). On 09-Apr-2021, PRODUCT STORAGE ERROR (product storage error) outcome was unknown. At the time of the report, EXPIRED PRODUCT ADMINISTERED (dosing error (temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were not provided.
all of its sequelae; shingles; Information was received from a lawyer regarding a case in litigation concerning a 88-year-old female patient (Conflicting information: Also reported that the patient was 79-years-old when she received the zoster vaccine live (ZOSTAVAX) vaccine).  No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In January 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), administered at a Family Clinic (indication, strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). In February 2016, result of her receipt of zoster vaccine live (ZOSTAVA), the patient suffer shingles, including any and all of its sequelae (Ill-defined disorder). As a result of her receipt of vaccine live (ZOSTAVA), the patient, has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of events was not provided. Causality was related.
pain at injection site; pain traveled under her arm pit; pain traveled under her arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "pain at injection site"; PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "pain traveled under her arm pit".  Additional information: It was reported that it was very painful and wondering if this was a side effect and how long will the events might take to go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Varicella vaccine 1/6/97. Onset of varicella 1/10/02 > 50 pox. Positive exposure.
Second dose presented fever, major abdominal cramping, swollen lymph nodes, lower back pain for 24 hours after the vaccination. Four months after my 2nd dose, I haven't received had any sort of menstrual cycle.
Congestive Heart Failure decline, AFib w/RVR, hospitalization, Respiratory decline, Cardiac decline, possible UTI, Hospice Care, continued decline, expired.
Patient states that he developed headaches, low grade fever of 99 degrees and general malaise.
She c/o HA evening of 08/01 -> resolved 08/02/14. She c/o onset severe fatigue 08/02/14, resolved by 08/05. She c/o onset of multiple oral ulcers on 08/02/14 which resolved by 08/06/14.
The day after vaccine I was very tired so I slept, but I didn't sleep as long as I did after the 2nd dose. I only slept about twelve hours and I normally go to bed around 8 or 9 and wake up at 4, but I didn't wake up at 4 which is unusual. After I did wake up I felt pretty good.
This case was reported by a healthcare professional and described the occurrence of diarrhea in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, prior to 22 July 2014, the subject received 2nd dose of ROTARIX (oral, batch number not provided). At an unspecified time after vaccination with ROTARIX, the subject experienced severe diarrhea. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was related to vaccination with ROTARIX.
Give me insomnia for four nights in a row I have bipolar it would have been nice to know this was a possible side effect; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: En6199), via an unspecified route of administration on 04Mar2021 at 03:45 as SINGLE DOSE for covid-19 immunization. Medical history included bipolar. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL and lamotrigine. On 04Mar2021 22:00, the patient experienced insomnia for four nights in a row. The patient wanted to know if this was a possible side effect. Since the vaccination, the patient was not tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was recovering.  Information about lot/batch number was provided. Additional information has been requested.
pt states inj site became red & painful & swollen;devel itching over upper half of body;also reports h/a;one hive present lt arm near inj site;
Information has been received from a registered nurse concerning a 12 year old female who on 17-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot # 65822/0927U). Concomitant vaccination included Menactra. On approximately 19-AUG-2007 "two days after vaccination" the patient developed a rash. The patient presented with little crusty lesions on her knees and buttocks. The rash was localized to the lower area of the body. The patient went back to the doctor's office a few weeks ago and she still had some lesions. The patient's status was reported as recovering. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008. Follow up information obtained on 11-DEC-2007. The physician reported that the 12 year old female patient with asthma and a chronic allergic rhinitis weighed 131 pounds and height of 64 inches. It was reported that there were no asthma symptoms at the time of vaccination and that the allergic rhinitis is better with immunotherapy. It was reported that on 17-AUG-2007, the patient was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot # 558222/0927U), intramuscularly in the left deltoid with the first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot # C2657AA) and the subcutaneously in the left deltoid with the second dose of varicella virus vaccine (lot # 658058/0837U). On 19-AUG-2007, the patient developed molluscum contagious/multiple lesions in different sites. The patient's dermatologist was consulted and gave "unspecified" topical treatment. It was reported that the patient status improved after treatment. Additional information has been requested.
Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 021B21A) for COVID-19 vaccination.     No medical history was provided.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHAPPED LIPS (Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.). The patient was treated with XIPAMIDE (AQUAPHOR [XIPAMIDE]) for Chapped lips, at a dose of 1 UNK. At the time of the report, CHAPPED LIPS (Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product used included blood pressure medicine.  Treatment medication included Aquaphor, Lip balm, stayed hydrated.  On 01-Mar-2021 the patient's lips were chapped and were scaly after first dose on 27-Feb-2021.  And it still continues after 2nd dose which was on 27-Mar-2021.
Extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Extreme pain). At the time of the report, PAIN (Extreme pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
left arm about 10 cm round erythematous lesion, tender to pressure. Pt c/o headaches.
pt recv vax 2DEC97 & several hr later that day pt exp pin head like bumps red tinged on both thighs;rxn not eval by MD;
Left eye started twitching within 30 minutes of the 2nd dose of the Pfizer Covid Vaccine.  It is not constant but happens through out the day, every day.  It has been 2 1/2 weeks since the shot and it is still going on.
On Friday I was dianogosed with Bell's Palsy.; On Thursday night i started showing signs of a full-blown stroke; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; June 22nd I started having issues with my eye. It would look like it was cloudly and I couldn't blink.; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 34-years-old male patient received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, tch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Right on 11Jun2021 12:00 (at the of 34-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with covid. The patient had no allergies. Since the vaccination, the patient had not been tested for covid 19. The patient previously took BNT162B2(Pfizer covid vaccine, formulation: solution for injection, lot number=EW0168) via unspecified route of administration, administered in Arm right on 19May2021 12:00 as DOSE1, SINGLE for covid 19 immunisation. On 22Jun2021 at 19:00, the patient experienced  having issues with his eye. It would look like it was cloudly and he could not blink and eye disorder. On 23Jun2021 , Wednesday, the patient experienced issue with his eye and got worse. On 24Jun2021 Thursday night, the patient started showing signs of a full-blown stroke. On 25Jun2021 Friday, patient was diagnosed with bell's palsy and on Wednesday the issue with eye got worse. The outcome of the events was not recovered.  Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse concerning an 83 year old female with a sulfonamide (sulfur) allergy, hyperlipidemia and hypothyroidism. The patient's social history includes tobacco and alcohol use. In 1999 the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 21-NOV-2007, the patient was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (Lot #655501/1035F). Concomitant therapy included BONIVA, ACIPHEX and an unspecified thyroid medication. On 21-NOV-2007, later that night the patient developed a fever. On 22-NOV-2007, the next day, the patient developed a red and swollen arm extending from the upper arm to the elbow. The patient was diagnosed with cellulitis. On 22-NOV-2007, she was examined in the emergency room, but was not admitted. In the ER she was administered ROCEPHIN intravenously and released with a prescription for KEFLEX. A complete metabolic panel was performed, results not reported. On 23-NOV-2007, she was administered a second dose of ROCEPHIN at the ER but was not admitted. On 25-NOV-2007, the patient had completely recovered. On 26-NOV-2007, she was examined by the physician. The nurse considered cellulitis with fever and red and swollen arm to be disabling events and other important medical events. Follow-up information was received from the nurse with Medical Records. The physician commented that "I would normally suspect this is a simple reaction to the vaccination but the size of this and the exquisite tenderness points to a potential cellulitis." The final impression was cellulitis in the left arm. Additional information is not expected.
Triple bypass heart surgery following catherization after tiredness and chest pain.    One week hospitalization. Home care, cardio rehabilitation.
pt revd vax & exp shaking appeared alert, felt had trouble breathing when shaking, t103 put cool wash cloths, 4oz juice taken; sleeping 30 mins shook-now t103;
Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no fever, no headache, no smell or taste alteration. On Dec 31 developed aching pain right shoulder scapular area, on Jan 5 developed weakness in the right arm and hand with intrinsic hand muscles weak and wrist flexion extension weak. Transient numb feelings in the right little finger. Diagnosed by myself as a Neurologist as an immune mediated motor brachial plexopathy affecting C6,7,8 and T1 myotomes. Prednisone 60 mg/ day for 5 days followed by a tapering dose completed. Complete recovery in 8 weeks.