chrisvoncsefalvay/vaers-outcomes huggingface dataset:
minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician.   A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol  (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI.  The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events  due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Red, swollen, welt on left high noticed the day after flu shot was administered. Pt here with mom, LT sore and red after flu shot. Pt got a small red welt on her leg after the flu vaccine-it was on her left leg. Dad kept her home from school yesterday and took her to the fair to walk it off. Now they need a note for school. Today the welt is almost gone.
8 days after injection, injection site started itching terribly and is very painful, large round circumference  the size of the area is the size of the bottom of a large Mason Jar. Very hard. Pain goes the whole length of arm.
On 1/10/2021 my lymph node under my arm pit on my left side it was swollen, it was painful the fist day then after the next day the pain started getting better but it stayed swollen for the next 3 weeks.
Booster; typical achiness the day after the shot; weird pain in her left leg; I had a headache; you know just typical reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (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: 1), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Patient stated she had the typical flu like symptoms, fatigue and headache noting primarily after the second shot), administration date: Mar2021, for Covid-19 immunization, reaction(s): "fatigue", "headache", "typical flu like symptoms". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "typical achiness the day after the shot"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "weird pain in her left leg"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "I had a headache; you know just typical reaction". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she had the booster shot last Friday, five days ago. Patient reported the typical achiness the day after the shot and then the next day she had weird pain in her left leg that is freaking her out. Patient reported she went to the hospital two days after the shot and had her leg scanned because she was very concerned. Patient asked was this permanent. It was reported that in general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Patient stated she was very concerned about the leg pain she has after getting the booster dose.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101653985 same patient/drug, different dose/event
12/28 - got chills two hours after. Took two Tylenol  12/29 - woke up with muscle pain focused in my back and legs but it traveled. Very fatigued. Constant headache.  Loss of appetite. Felt very cold in the morning. Took two Tylenol every 6 hours and used a heating pad.  12/30 - Constant headache and reduced appetite.  Took two Tylenol every 6 hours. Nausea came in waves. That night around 9:30 pm got very nauseous, bad headache and cold sweats.  12/31 - bad headache and took migraine medicine that afternoon. It helped some but headache was still there. Very tired. Not hungry.  1/1 - Around 12:30 a.m. got very nauseous and threw up. Bad headache. Laid down with a heating pad. As the day has progressed, I still have a headache but not as bad. Still fatigued. Nausea and feeling hot comes in waves.
Giant hive like lesion  mid arm 10x10 , warm with induration and also some erythema extending dorsally and distally occurring 8 days after administration. Initially no reaction noted by patient. The lesion began 2-3 cm distal to expected area of immunization on the 14th ( a standard deltoid IM immunization). Patient awoke with the lesion which worsened somewhat through the day and presented to the urgent care here after contacting the pharmacy and her PCP
DEVELOPED ABDOMINAL PAIN RLQ 10 DAYS FOLLOWING VACCINATION.  COLONOSCOPY DONE 6/8/21 SHOWED ILEAL AND CECAL ULCERS
Pt pale, diaphoretic shortly after injection.  Reports "felt nausea then blurry vision ". Reclined in seat, cool compresses, cool air and cool drink applied. Color returned. Pt reported - "back to normal". Vital signs stable throughout. D/C'd home after 30 min additional obs.
Beginning 10/18, tenderness to touch on right side of back around waist, on 10/19 tenderness continued, red spot noted next to spine of right side, pain and burning extended from spine to front  umbilical area,  on 10/20 pinpoint spots  waist area on right side.  Pain and burning increased.  Skin very sensitive to touch.  10/ 21 area on back larger, spots on side increased in number.  sought medical attention.  Shingles confirmed and started on treatment of Valtrex, 1 g 3x day for one week, Gabapentin, 100 mg  3x day.  Pain and tenderness has continued.  No further outbreak as of today's date.
Received dose 1 of Pfizer vaccine 1/2/2021, tested positive for COVID 1/7/2021.
I?ve had severe vertigo and remained in bed several days.  Pressure in right ear.  Mild as of yesterday. Ear pressure remains.  (I?ve also had a persistent elbow rash since April with scaly patches and redness which persists though using topical cortisone  cream twice daily.)
Pt anxious exhibiting tachypnea, diaphoretic, stating that the palm of bilateral hands were tingling and radiating to her fingers. This writer de-escalated situation with deep breathing, providing reassurance, assessed vital signs, and pulse oximetry.   VSS with pulse ox within normal range. Provided pt with cold water and saltines.   EMT's already onsite assessing another pt, so they were asked to assess this pt.  She was noted to be in NAD by EMT as well with stable VS. EMT left scene with no additional treatment or recommendations for this pt.
her upper lip started to tingle; her upper lip started to swell and then her bottom lip started to swell; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling lips in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Shingrix (left arm). On 19-MAY-2023, 1 days after receiving Shingrix, the patient experienced tingling lips (Verbatim: her upper lip started to tingle) and lip swelling (Verbatim: her upper lip started to swell and then her bottom lip started to swell). The outcome of the tingling lips was not reported and the outcome of the lip swelling was not resolved.   It was unknown if the reporter considered the tingling lips and lip swelling to be related to Shingrix.     It was unknown if the company considered the tingling lips and lip swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient received the dose vaccine and on following day, Friday, her lips started to tingle and on Saturday, her upper lips started to swell and then her bottom lip started to swell. At the time of reporting she stated that, swelling was still present, but had not gotten any worse. The reporter consented to follow up with the health care professionals (HCP).
Fever, chills, dizziness, weakness, extreme fatigue, tingling extremities lasting 3 days
Skin itching all over body started at 1038. At 1040 BP 120/90 and Benadryl administered by Pharmacist. At 1100 BP 122/92. EMS arrived at 1108, left at 1109. At 1241 reported in ER she received dexamethasone and famotidine and the itching had stopped and she was tired.
Cervical lymphadenopathy, developing over 2 weeks; This is a spontaneous report from a contactable physician reported for herself. This 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on an 17Dec2020 12:45 PM on left arm at single dose (Lot # EX5730) for covid-19 immunisation. No other vaccine in four weeks. The patient experienced cervical lymphadenopathy on 23Dec2020, developing over 2 weeks. No treatments were received. Outcome of the event was recovering.
Hives within 5 minutes after flu injection, tachycardia and became short of breath and thought he was going to pass out. Sent to ER and was hospitalized for atrial fibrillation.
Case PHEH2016US024325 is an initial spontaneous report received from pharmacist on 20 Sep 2016. This case refers to female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. It was reported that, the patient felt like she did not get the full dose and felt splash during administration of FLUVIRIN on an unspecified date. No adverse event was reported following this medication error (underdose).
I had been passing huge, greater than 3 mm clots during menses since the vaccine in August 2021. Literally passing blood clots on day 1 through 6  of menses. I use to have small, 1mm clots on day 3 of my menses prior to the vaccine. Now the clots have trippled in size,  it makes loud splash noises in the toilet and are constant. I am concerned and fearful for my health. I am aware of the changes because I know my body.
A week after the first vaccine had a seizure with no history of them. Got the second dose and a week later had another seizure while driving and crashed my car into a ditch.
When I called the right Pt's name, the wrong Pt came and when I asked if her birthdate was the right Pt's, wrong patient responded yes. I gave her the immunization. Then realized it was the wrong Pt when the desk person told me the right Pt was still waiting in the lobby.  Error was reported to my immediate supervisor, spoke with Pt's physician, Health Department was called, and Pt was called. Pt reported no problems/health issues.
Patient received COVID Moderna vaccine on 2/27/21 and 4/1/21. On 8/15/21, patient admitted to our facility for COVID 19 PNA, sepsis with AKI and mild hypoxia (patient had COVID exposure from son). Patient was hospitalized from 8/17/21-8/19/21 and was discharged home.
sudden pain in right leg, leg began turn blue and toes white within 15 minutes. excruciating pain called for an ambulance and was taken to ER primary diagnosis was ischemia of right lower extremity emergency surgery for large blood clot in right leg and a small one in the left leg hospitalized for 3 days prescribed blood thinners and adjusted other meds
Patient was unknowingly given the Booster dose with expired vaccine.  Once this was discovered the patient was notified by the provider
not feeling well; headache; fever; It was supposed to be two parts but he only did 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), in 2018 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "It was supposed to be two parts but he only did 1".  Additional information: It was supposed to be two parts, but he only did 1 part. Caregiver was asking for medical information about Trumenba. Caregiver's son was supposed to be a 2-part series but he only did one part because he had side effects: fever, headache, and not feeling well. His doctor said these were common. Now fast forward 5 years, he is 21 years old and going to a dorm and needs to get vaccinated. Reporter wanted to know did he have immunity from the first shot after 5 years and did he complete it now or did he need to start series over and can it be done with Bexsero.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ( doses were given after expiration date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED ( doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED ( doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date place in refrigerator: 23-Sep-2021. The vail did not undergo any temperature excursion and patient not experienced any adverse event.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported).  There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 had five temperature excursions as follows: one for 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius), one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius), one for 64 with a lowest recorded temperature of 31 F (-0.555555556 Celsius), one for 32 hours with a highest recorded temperature of 48 F (8.888888889 Celsius) and the other one for 328 hours with a lowest recorded temperature of 29 F (-1.666666667 Celsius). The vaccine status was reported as "in excursion". The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient contacted her doctor after she developed a rash all over her body consistent with chicken pox. Itching.
The patient received a double dose of Ipol on the same day inadvertently, no AE; Initial information was received on 15-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional   This case involves a 4 year old female patient who received a double dose of IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] inadvertently on the same day (Extra dose administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE for prophylactic vaccination.  On 18-Jun-2020, the patient received a dose of suspect IPV (VERO) (lot R1D9749, Expiry 17-Jul-2021) via subcutaneous route in the left leg and a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6540AE, expiry date 25-Apr-2021) once via intramuscular route in the right deltoid for prophylactic vaccination  It was a case of an actual medication error due to extra dose administered  At the time of report, no adverse event 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.
Severe joint pain, especially where I have had injuries or surgeries.   Pain when raising my arm where injection was. Stiffening when resting, sore when moving
Information has been received from a physician concerning a 2-month-old male who in December 2006, was vaccinated PO with the first dose of Rotateq. The physician reported that, later that same night, in December 2006 the patient developed wheezing and a cough. The patient was taken to the emergency room, but was not hospitalized. The patients wheezing and cough subsequently resolved. The physician felt that the wheezing and cough were probably a reaction to Rotateq. Additional information has been requested.
body aches; headache; coughing; chills; soreness at site on left arm; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6208), dose one via unspecified route of administration on the left arm on 10Mar2021 at 15:45 (at the age of 65 years old) as a single dose for COVID-19 immunisation. Medical history included nasal congestion, bee sting allergy, high cholesterol. Concomitant medications included Atorvastatin 20 MG, vitamin and nasal spray within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 within several hours of receiving vaccination there was some soreness at site on left arm. On 14Mar2021 the patient also experienced body aches, headache, coughing and chills (within 3-4 days after shot). The patient did not receive any treatment for the events. The clinical outcome for body aches, headache, coughing and chills was recovering and for soreness at site on left arm was not reported. No follow-up attempts are needed. No further information is expected.
Took the flu shot and my neck and back became stiff and in severe pain. This is still happening to me, some 4 weeks after the shot.
Several Low blood sugar events occurring beginning approximately 10 days after receiving vaccine and continuing requiring medical intervention.
This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), BACK PAIN (backache), CONCUSSION (concussion), EYE INJURY (injured bone under eye), CONTUSION (bruised hip), PAIN (face still sore) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) Unknown. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) Unknown.         Company comment :Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with the product safety profile