chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; pain to her back; red spots on left breast; pain left breast; itching on left breast/itching on back; left arm sore; Headache; can barely move; This is a spontaneous report from a contactable consumer (the patient). A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0150, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 11Apr2021 12:15 (at the age of 46-years-old) as single dose for covid-19 immunization. The patient's medical history was not reported. concomitant medications was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021-13Apr2021, the patient had a headache at 14:00 and a left sore arm at 16:00. On 14Apr2021 she noticed red spots on her left breast at 12:00 which she thought was the seam of her bra and pain left breast at 12:00 for which she visited physician clinic. On 15Apr2021-16Apr2021 she had itching at 15:00 /pain at 02:00 on her back; for pain back she visited physician clinic and thought it was poison ivy. On 20Apr2021, she went to the doctor for shingles 14:30 at. Stated that the pain is unbearable sometimes and can barely move. Stated that she was told to report it because it may be related to Covid vaccine. Stated that her second shot is 03May and wanted to know if she should get it and she will be fine or should not get the second shot. The patient received treatment with Ibuprofen for headache and pain left breast. Stated that she was given Valcyclovir. At the time of report, it was reported, headache recovered completely from 3-4 days later. Stated that the pain from the shingles comes and goes. Outcome of the event: headache- unknown; left arm sore recovering, red spots on left breast- recovering; itching on left breast/itching on back, can barely move- not recovered and pain left breast, shingles, pain to her back- reported as not recovered (worsened).  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker refers to a 12 month old patient of unknown gender. No pertinent medical history was reported. On 23-DEC-2014, the patient was inadvertently administered improperly stored PROQUAD (Merck) injection (strength, dose, route, lot# were not reported) when patient was supposed to receive MMR II instead. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Client received the COVID vaccine (Janssen, Lot# 1808980) complained of feeling dizzy at 1424, EMT  and RN responded. The client was sitting in a chair with her head in her hands, stated that she felt dizzy and was having a "hot flash." The client stated that she is anxious around needles and has a history of syncope after blood draws. She also complained of experiencing tunnel vision and hearing. The client's vital signs were a temperature of 96.7, blood pressure of 122/82, heart rate of 92, and O2 of 99%. The client stated she did eat that morning, and refused a set of repeat vitals, but agreed to wait 30 minutes for observation after her symptom onset. Per the client, she has no allergies or medical conditions, and takes no medications. At 1435, the client accepted some water to drink. At 1440, the client stated that she no longer felt dizzy. The client's color had returned and she was no longer dizzy. She agreed to have repeat vital signs at this time: blood pressure of 118/82, heart rate of 90, respiratory rate of 16, and O2 99%. The client refused benadryl at this time. At 1454, the client's vital signs were as follows: blood pressure of 116/82, heart rate of 90, respiratory rate of 12, and O2 of 99%. The client stated that she felt "back to normal" and called her sister to drive her home. She was escorted to her car by the EMT, she ambulated with a steady gait. Education provided regarding emergency response, V-safe, and the importance of following up with a primary care provider.
fatigued; hot; fell asleep; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued), FEELING HOT (hot) and SOMNOLENCE (fell asleep) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (fatigued), FEELING HOT (hot) and SOMNOLENCE (fell asleep). At the time of the report, FATIGUE (fatigued), FEELING HOT (hot) and SOMNOLENCE (fell asleep) 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.   No treatment information was provided.
lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered.   Information on the lot/batch number has been requested.
Peripheral neuropathy (for about 2 months post vaccine, which slowly faded and is now gone), skin was painful the first 2 days, mild vertigo (first few weeks), itchy skin (6-8 days post vaccine), blurry vision (About 3 weeks later), numbness in hands, feet, legs where neuropathy had been (seems to be slowly repairing/fading), skin rashes/hives periodically (about 7-8 rashes/hives events) since the vaccine (none prior to the vaccine)
I received my second Moderna shot in late January and started have hives in mid February; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I received my second Moderna shot in late January and started have hives in mid February) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (I received my second Moderna shot in late January and started have hives in mid February). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (I received my second Moderna shot in late January and started have hives in mid February) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient took second Moderna shot in late January and started to have hives in mid February.
Pt received a vaccine that was past the 30 day use date. No adverse affects noted at time of administration or following administration. No treatment was necessary after administration of vaccine.  Moderna was contacted, case #CEA-2944. Lot analysis completed and they determined that the vaccine maintained the activity necessary to protect againt the SARS-Cov-2 virus.
Patient vaccinated for smallpox on 4-8-03.  Experienced severe headache x 3 days post vaccination and fever (greatest temp = 101 degrees F) x 2 days post vaccination, but did not report these symptoms.  Two weeks post vaccination patient experienced chest pain with exertion x2 while on nursing duty.  Patient sent to ER where EKG showed superventricular MI.  Patient admitted to hospital x 2 days. Cardiac cath done - no pathology seen.  Discharged 04-24-03.  Patient recovered.
sore arm; SWEATY; weak; Fatigue; thirsty; Left shoulder is weak; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue) and THIRST (thirsty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-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) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-026636 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue) and THIRST (thirsty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-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) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (SWEATY), ASTHENIA (weak), FATIGUE (Fatigue), THIRST (thirsty) and MUSCULAR WEAKNESS (Left shoulder is weak) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Initial unsolicited report received from physician on 09-Jan-2017. This case linked to 2017SA004554, 2017SA004557, 2017SA004559, 2017SA004560, 2016SA186099 (master case), and 2017SA004563 (same reporter). This involves 33-year-old female patient who was vaccinated with dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UI640AB, expiry date: 30 Jun 2017 and route of administration was not reported) in arm, on 18-Oct-2016. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defect, medical conditions was reported as no known drug allergy. Any other vaccination within 4 weeks prior to suspect vaccination was reported as no and other medication was unknown. On 18 Oct 2016, immediately following the vaccination, the patient had severe itching with redness at injection site, bulge at site. Lab data and corrective treatment was not reported. On an unknown date, the patient recovered from the severe itching with redness at injection site (duration 48 hour) and bulge at site (duration 7 days). List of documents held by sender: none.
Initially arm pain at injection site. Later that night, chilliness, fatigue, low grade fever. In morning, only arm pain persisted, without other constitutional symptoms
Chest pains , tightness , shortness of breath, breathing discomfort . 3 days straight and on going
MODERNA COVID VACCINE #3 GIVEN 8/18/2022, LOT # 055A22A.  pt resides in LTCF; positive COVID test 12/1/22; given Zinc and Vit C; developed vomiting and diarrhea; followed by Hospice Care; passed away on 01/09/2023 in Post Acute and Rehab Center
Immunizations (Hep B, Td, MMR) administered on 4-28-04.  On 4-30-04 patient seen in clinic by RN. Patient complaining of right arm red/swollen.  RN noted right deltoid swollen, hot to touch and immunization site red.  Referrral given to patient to see MD or visit ER.  Patient returned 7-30-04 with follow-up report from MD - MD saw patient on 04-30-04.  Reported right arm warm over deltoid area with erythema about 4mm diameter at injection site.  Gave Zirtec 10 mg po q am
Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure
Initial symptoms were dizzy, light headed, flushed and shaking, about 1 hr post vaccine then progressed to confused by 2 hr 25 min post vaccine, decreased blood pressure and difficulty breathing at 3 hr 45 min post vaccine, paresthesias under the skin of the face approx 3 hrs 45 min post vaccine.  Treatment required Clortrimaton 12 mg pill, 2 doses of 0.3 mg epinephrine IM, 25 mg IV, NS 1300 cc, 25 mg Benadryl IV, Methylprednisone acetate 120 mg IV, O2 via nasal cannula.
High fever, chills, dizziness, nausea, headache, one syncopal incident.
1 day after DTaP/ Comvax/ IPV/ Prevnar pt developed bumps on Left and right thighs bilaterally. Temp = 101 degrees Fahrenheit, resolved in the next day. No fussiness, Normal Behavior.
little pain (on day three); Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a female patient who experienced little pain (on day three) (Pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Fibromyalgia.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious little pain (on day three) (pain) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was little pain (on day three).  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for little pain (on day three).
2 days after vaccination (Sunday May 2) I began to feel slightly chest pain when I would breath on the upper left chest shooting downward to the bottom breast rib area. Every time I would take a deep breath I would feel the pain.  Called loyola hotline to discuss and state worries I had. Pain continued the next day. Went to the loyola urgent care center Monday at about noon. Took EKG test there and everything seemed fine however they did mention my birth control and possible side effects. So they sent me to thenhospotal for more test. Sent me to the ER. From the ER took several test and blood work. Another eck as well as D-dimer test, lots of blood work and a CT scan. Later that night I was told I had a pulmanary embolism (blood clot in my lung) and I needed to stay overnight. They continued to take addt. Exams the next day and.more blood for test. Took a heart echo since pains were happening on my left side. As well as ultrasound on my leg to check for DVT and if more blood clots exist.. Addt. Test done that Tuesday, then was discharged Tuesday at about 5pm.
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcoholic (24 ounce cans of beer 2 per week), and non-smoker, and other pre-existing medical conditions included the patient had no known history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 102.2 F. On 16-MAR-2021, the subject experienced body aches. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 17-MAR-2021. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pt recv vax on 9/23/96; on 10/13/98 pt exp chicken pox
5 year old receiving an ADACEL vaccine on 11Nov2022 instead of DAPTACEL with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 years old male patient who had an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine on 11nov2022 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 11-NOV-2022 the patient developed a non-serious event of 5 year old receiving an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine (batch number: U7624AA and expiry date: unknown, route, administration site, formulation was unknown for Immunization) on 11nov2022 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]with no reported adverse event (wrong product administered) (latency: same day).   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  Outcome: Unknown   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.
Initial information received on 30-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 47 years old patient who received 0.5 ml expired dose of vaccine TYPHIM VI (lot M1287-1, expiry date- 01-Jun-2018 via unknown route) in unknown administration site on 29-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if patient experienced any adverse event or not. 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 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. Document held by sender: None.
Narrative:  Patient previously tested Covid positive on 12/9/20 and was admitted through 12/31/20. He did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 and had to be readmitted on 1/10/21 after a fall and feeling weak. PMH included CAD, dementia, AAA, prostate cancer, and thrombocytopenia.
PT C/O REDNESS AND SWELLING TO LEFT ARM. LEFT TRICEPT AREA RED, WARM TO TOUCH, 70 W X SSL. PT DENIES ANY PAIN TO AREA. PT DID NOT APPLY ICE TO AREA OR TAKE ANTI-INFLAMATORY AT ONSET OF REACTION. INSTRUCTED PT: TO APPLY ICE TO AREA 20 MINS ON/20 MINS OFF AT LEAST 3X A DAY X 3 DAYS, TAKE 200-400 MG (1-2 TABLETS) OF ADVIL OR ALEVE 2X'S A DAY X 3 DAYS. IF REDNESS SWELLING OR PAIN INCREASES SEEK MED CARE IMMEDIATELY.