chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 5/20/07 patient noted paresthesias in hands and feet, weakness in hands and legs, decreased dexterity.  Minimal amount of shortness of breath upon exertion. Some mild skin sensations in weeks before these symptoms, unable to exactly date beginning of those symptoms.  Admitted for probable Guillain-Barre syndrome on 06/05/07 and treated with IVIG.  6/8/07 Received partial hospital medical records which reveal patient initially seen in ER on 3/31 for treatment of dog bite on left lower leg received in line of duty (police officer).  Received wound care & Td injection.  Lot # confirms VAERS report.  Patient admitted to hospital 6/4/07 after experienced paresthesias of hands & feet associated w/weakness of legs & decreased dexterity & weakness of hands.  Symptoms began abruptly 12 days prior to admission.  Neuro exam on admit revealed areflexia throughout.  LP done on admission & PICC line placed for IVIG.  No D/C summary w/records.  Call to med records to request d/c summary.  6/12/07 Received EMG/NCS report from neurologist which reveals very diminished peroneal amplitude & slowed tibial conduction velocity, prolonged motor latency & median sensory latency w/diminished amplitude. F wave latencies prolonged in median & ulnar nerves.  Unable to determine clear tibial nerve F wave.  Study felt to be c/w GBS. 1/11/2010 Continued weakness and bouts of numbness in hands and feet.
Woke up on 9/2 with headache and nauseous. Felt like my arm was being ripped off. Had a large knot at the injection site. The area under my left arm and above my left breast was very painful. The area under my left ear and chin swelled up. My joints all hurt so bad and the worse was a flutter in my chest that I thought was anxiety but was in fact my heartbeat got out of rhythm or a double beat on every fifth beat. I took Metoprolol 500 mg for several days  and it helped but I will on occasion still get the same feeling. The muscle in my left arm still feel like they?re being pulled off.
Information has been received from a registered nurse concerning a 5 year old female who on 02-OCT-2006 was vaccinated with a SC first dose of Varivax (lot # 654083/0917F). There was no illness at the time of vaccination. On 15-OCT-2006 the patient developed "break through pox and cellulitis at site". Unspecified medical attention was sought. Subsequently, the patient recovered from break through cellulitis. There was no product quality complaint involved. The patient's vaccination history included a 0.5 mL first, second, third and four dose of INANFRIX on 20-SEP-2005 (AC14A006BA), 22-NOV-2005 (AC14A06CA), 10-JAN-2006 (AC14A007AA) and 10-AUG-2006 (AC14B033AA); a 0.5 mL first, second and third dose of ENGERIX-B on 22-AUG-2001, 25-JAN-2005 (AHBVA070AA), and 27-MAY-2005; a 0.5 mL first dose of Hib conj vaccine (651250/0186R); a 0.5 mL first, second and third dose of IPOL on 13-OCT-2005 (Y0324), 08-DEC-2005 (Y0576 and 09-FEB-2006 (Y0576); a first dose of MMR (654545/0701F). Additional information is not expected.
Developed HZ despite vaccination; Information has been received from the authors of the article titled as stated below, and refers to 324 female patients of unknown age. The patients' medical history, concurrent conditions, and concomitant therapies were not provided.   On unspecified dates, the patients were vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, dose number, route and anatomical location were unspecified).   On unspecified dates between 18-JAN-2012 and 26-FEB-2015, the patients developed herpes zoster despite vaccination (vaccination failure).   The outcome of the vaccination failure was unknown.  The authors considered the vaccination failure to be related to zoster vaccine live (ZOSTAVAX).   This is one of two cases received from the same source (US-009507513-1905USA008145)  A copy of the published article is attached as further documentation of the patient's experience.   Sender's Comments:  US-009507513-1905USA008145:
sick; Initial information was received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (unknown age and gender) who became sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza vaccine as prophylactic vaccination. The patient's medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
patient tested positive for COVID on March 8, 2021 by PCR sample with positive symptoms
No adverse reaction in first 10 days. Noticed significant loss of hearing in left ear in late March of 2021.
Fever 12 days after vaccine followed by rash and oral Koplik spot 1/11 (13 days after vaccine).
Left arm injection site is red, warm to touch, painful, swollen. Area is a 11/2 inch x 2 inch area with painful nodule palpable.
Received vaccine on 9/26/16 - started with redness at injection site - redness and warmth has increased daily - measuring 8 mm tall and 11 mm across on 9/29/16
Patient complained of discomfort of left arm, nurse noted area was reddened, tender, and warm to the touch. No loss of sensation reported per the patient. No additional formation of hives surrounding the area.  Primary Care Physician prescribed Benadryl 25 mg  every six hours as needed as well as a Medrol dose pack. No further adverse events.
Patient called on 10/10/2014 and informed us she experienced adverse reaction that started approximately 20 minutes after injection. She described increased HR, difficult breathing for 2.5 hours, burning throat, achy joints, mentally "foggy" for 3 days. she was treated at ER and was released.
Information has been received from a physician via a company representative referring to a female patient of unknown age. Concurrent conditions, medical history and allergies were not reported. The patient was vaccinated with three doses of ROTATEQ, oral solution, 2 ml orally, on 20-SEP-2009 (also reported as 25-SEP-2009) (lot# reported as 03194), 30-NOV-2009 (Lot# reported as 04334) and 02-FEB-2010 (Lot# reported as 14424) respectively. Other suspect and concomitant therapies were not reported. On 10-JAN-2015 the patient came to the office after experiencing vomiting, diarrhea, weight loss, and severe dehydration after receiving ROTATEQ (events onset date was unknown). On 14-JAN-2015 the patient was admitted into the hospital (demographics and length of stay was unknown) and tested positive for rotavirus. Patient sought medical attention via office visit. Fluids and other unspecified treatments were given for the events. The outcome of the events was reported as recovered on an unknown date in 2015. Therapy with ROTATEQ was also reported to be continued. The relatedness between the event and therapy with ROTATEQ was not reported. Additional information has been requested.
Pt reported low-grade fever to 101, chills, nausea, headache, fatigue, joint pain and urinary frequency beginning the morning following the vaccination date. Resolving after 24 hours.
Given PNEUMOVAX 03/19/2014 - within 2 hours developed chills, fatigue, cough and body aches returned to office 3/20/14 - temp 101.6 injection site soreness, no erythema - WBC = 11 - CXR done.
Hives; BP getting higher; Shortness of breath; Chest pain; sugar off; Swollen lymph neck nodes; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and BLOOD GLUCOSE FLUCTUATION (sugar off) in a patient of an unknown age and gender 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), BLOOD GLUCOSE FLUCTUATION (sugar off), LYMPHADENOPATHY (Swollen lymph neck nodes) and FATIGUE (Fatigue). At the time of the report, URTICARIA (Hives) had resolved and HYPERTENSION (BP getting higher), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), BLOOD GLUCOSE FLUCTUATION (sugar off), LYMPHADENOPATHY (Swollen lymph neck nodes) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
On Day 2 I felt severe muscle aches which lasted 2 hours then went away. On days 12-16 (today) flu like symptoms, including muscle aches, headache and nausea. Resting and treating at home.
developed widespread bloodclots; This is a spontaneous report from a contactable consumer for female patient (mother).  A female patient of an unspecified age received bnt162b2 (COVID-19 vaccine), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose bnt162b2 for covid-19 immunisation on Feb2021.  The patient developed widespread bloodclots on 2021 with fatal outcome.  The patient died on 2021.  It was not reported if an autopsy was performed. The clinical course was reported as follows: patient received the COVID-19 vaccine and developed widespread blood clots. Her first dose was in February, her second dose in March and 13 days later she was gone.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Developed widespread bloodclots
Bronchospasm, angioedema; began within 5-10 min of administration. Treated with Epi-pen x 2. Transported via ambulance to ED.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (3drink /week stop date-08 Jul 2021.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Jun-2020 and the estimated date of delivery was 20-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The vaginal delivery occurred on 19-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 2980 grams (6lbs 9oz). The outcome was reported as Unknown. Female Baby Head circumference is 34cm, length was 49.53cm. The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) ongoing from 01-Jan-2021 at an unspecified dose and frequency. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Pregnancy test: positive positive. On an unknown date, Ultrasound abdomen: normal (normal) normal.         Concomitant products included one-a- day prenatal vitamin with start date of 01Jan2020 and is Ongoing. No Treatment history was provided by the reporter. Lab data during pregnancy included Glucose, ultrasounds which were normal Estimated date of conception- 27 JUN 2021, Patient is currently breastfeeding, no abnormalities on delivery and 1 month post-partum.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Pregnancy outcome form with additional information attached.
w/in 5-10min of vax pt went stiff, starring, hyporesponsive & cyanotic x30sec & then became hypotonic, pallor & dec response;petechia devel on legs & abd;
Approx one week post, started having red rash/blistering on lips. Within days it progressed around my whole mouth, lips, nose and cheeks. With swelling in the lips, mouth and cheeks.
My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is experiencing cramping all over his body but especially his legs. He has a terrible headache, feels nautious  and dizzy. Today has been the worst. This is day 3 after the  Pfizer shot.  The internet says it is normal for the lymph node in about 14% of patients. Your flyer handed out at injection day didn't mention all of this.
sore arm; felt like dying; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced sore arm (pain in extremity) and felt like dying (feeling abnormal) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore arm (pain in extremity) and felt like dying (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have taken one every year, only had a sore arm. The last time I had the flu, before taking the vaccine, I got it and I felt like I was dying, since I been taking the shot I have not had it since."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for both the events.
BLOOD PRESSURE KEEPS GOING UP; FLU LIKE SYMPTOMS/CHILLS/HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, hypokalemia, anxiety, depression, penicillin allergy, non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with lisinopril, and ibuprofen for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for prevention. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140s (unit not specified). On 09-APR-2021, the subject experienced blood pressure keeps going up. On 09-APR-2021, the subject experienced flu like symptoms/chills/headache. Laboratory data included: Blood pressure (NR: not provided) 156/78 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120s (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms/chills/headache, and had not recovered from blood pressure keeps going up. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
VACCINATION GIVEN @ 08:20.  PATIENT C/O DIZZINESS @ 08:23.  SKIN APPEARED PALE AND DIAPHORETIC.  PATIENT STATED SHE HAD NOT HAD ANY FOOD OR FLUIDS YET.  PLACED IN SUPINE POSTION WITH FEET ELEVATED.   08:30 HR 68, RR 16, BP 100/40.  PATIENT GIVEN A LOLLIPOP AND WATER.  08:40 VS HR 72, RR 16, BP 120/50.  PATIENT REPORTS FEELING LESS DIZZY.  VSS.  08:55 PATIENT SAT UP IN CHAIR.  TOLERATED WELL. SKIN PINK , WARM, AND DRY.  09:00 HR 70, RR16, BP 100/60.  VSS.  PATIENT DISCHARGED @ 9:05 SYMPTOMS RESOLVED.
Pt recvd Hep B vax & devel serum sickness w/arthralgia; MD stated that it caused "permanent disability to the pt"
Few minutes after vaccine administration, patient slumped in chair, fell to floor, and mother described twitching of arms and legs.  Nurse came to evaluate, patient was conscious, placed on exam table, given supplemental oxygen. Patient stated she was feeling better, but was visibly scared.  Emergency department team transferred patient to ED where report was full resolution after observation with no further intervention.
Arm hurt; Injection site started itching; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Injection site started itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Injection site started itching). At the time of the report, VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Injection site started itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Narrative: Pt was an 82 YO male with PHM of COPD, sleep apnea, CKD, DHF, NPH, DM, RA, HTN, and CAD. His death was reported to Hospital by Health Authority. No other details available.
No additional AE.; HCP reporting an expired dose of GARDASIL 9 (Lot: 1687291, Expiration Date: 11SEP2022) was administered to a patient today; This spontaneous report was received from registered nurse and refers to a 26-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection syringe, 0.5 milliliter, lot #1687291, expiration date: 11-SEP-2022 (expired product administered), administered intramuscularly in left deltoid for prophylaxis. The vaccine was not available for return/evaluation as it was last dose in box. The vaccine was administered inadvertently to the patient by trained healthcare professional (registered nurse). The vaccine did not need to be repeated as there was no temperature excursions prior to use. The patient was notified and she denied any concerns at the time of notification. No adverse event was reported.
BM's decreased to 1 every 5 days after receiving ROTATEQ x 5-6 weeks.
Patient began running fever within 2 hours following immunizations on 1/30/19. Initially was 101. Fever was off and on, max was 103.5. Patient also developed a rash following the immunization on 1/30/19 on the trunk and back that gradually worsened. Mom reports that following patient's 6 month vaccines (PEDIARIX, HIB, PREVNAR) they took her to the ER because the patient would not wake up. The ER was unable to find anything wrong with her per mom.
Developed incontrollable seizure that lasted 3 hours after waking from nap.  Also had episode that mom described as eye rolling back with jerking that lasted a few seconds followed by several minutes.
On 12/06/21, Patient came to pharmacy to receive Pfizer booster with 2 of her family member. Her mom who was also getting the booster was not aware that booster was only approved for 18+. We had the nurse giving the booster and she didn't catch the birthday/age that patient was still not 18. We called mom and told her about the incident. She is aware and stated that she didn't know the age limit and will watch out for any side effect. We instructed the patient's mom to report to primary doctor and to contact us if any serious reaction happens.
Client received her vaccines. A few minutes later she passed out. She regained consciousness back quickly and was helped to chair once she was ready. She put her head between her legs to help. She stated she was nauseous and was given a trash can. She began to dry heave. No vomitus noted. Client was noted pale and clammy. She was given water. Once she began to get color back, she was ready to leave. Family declined an ambulance.
Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. This lasted till about 2am. Finally fell asleep and woke up at 8am very sore but much better. Around 3:30pm I started again with the same severe chills, fever, body aches and now nausea. Woke up in the middle of the night drenched in sweat.  The following morning I woke up around 8am again with horrible mid/lower bilateral back pain.  This lasted till about 1pm. It?s not 9pm and all symptoms have subsided. I feel hopeful, thanks for all you do!
I have been somewhat achy and fatigued. Soreness in right arm. The morning after the vaccine my eyes were puffy when I woke up. The left eye is more puffy and sore. They are still puffy two days later, and the left eye is still sore. I have used warm compresses but I'm not sure they are helping.
Bright red plaques and papules at face, neck, trunk and arms. Area were confluent on face. No ulcers or pustules.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023 and were to be used within 24 hours but administered to 17 patients on unknown dates), PRODUCT TEMPERATURE EXCURSION ISSUE (Nurse manager reporting that Bivalent Vaccine underwent temperature excursion started on 21-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.
Mild fever, skin tender to touch, blurred vision, swelling of tongue, sleepy, muscle aches, couldn't lift arms, sore throat, headache, eyes burning all came on apx 4hrs after shot.
The day after my 3rd dose had a fever, chills and fatigue. That lasted for 3 days. I took Motrin. So I had a laparoscopic hysterectomy on 12/14 then I was hospitalized on 12/23 for pulmonary embolism. I was hospitalized for 24 hours. I consulted with a physician they didn't know if the PE was related to the vaccine or not. Had follow up visit 01/02/2022 with pcp. They suggested that I follow up with hematologist. I have a past medical history of PE as well.