chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female patient who is absolutely certain that she had chickenpox as child and has never previously had shingles who exactly 3 weeks ago on 21-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 11-APR-2008 the patient was seen by the physician and appeared to have shingles in the left ophthalmic nerve distribution. Her symptoms included burning on the skin, with rash onset 5-6 hours later, low grade fever, and myalgias. It was noted that this seemed classic, as well as the rash and distribution. It was also noted that the patient had a severe injection site reaction with swelling, erythema, warmth, and bruising for 3 days. At the time of the report the patient's status concerning the shingles was unknown. Additional information has been requested. Follow up information was received from a health professional concerning the patient's reaction was not due to ZOSTAVAX (Oka/Merck), but it was dur to a dermatological treatment the patient was receiving at that time. Follow up information was received from a physician concerning the patient had facial celulitis, not zoster outbreak. The facial celulitis was not related to shingles vaccine, turned out to be coincidental timing was unfortunate.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: explained to patient that possible immune response but pediatrician wanted us to report to be safe
APNEA; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a female neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.46 kilograms, and height was 51 centimeters. No concurrent conditions were reported. The patient's parent's medical history Maternal medical history included anxiety and endometriosis. Body mass index (BMI) was 31.88. The mother had no relevant obstetrical history. The mother had history of tobacco, e-cigarette and recreational drug use, however reported no alcohol use. Maternal first day of the last menstrual period (LMP) was calculated to be 05-FEB-2021. The estimated delivery date (EDD) was reported to be 12-NOV-2021. Type of pregnancy was reported as singleton. The female fetus mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) dose was not reported, 1 total,  administered on 21-MAY-2021 for covid-19 immunization at gestational age 15 weeks. the child route of administration was reported as transplacental (Fetal exposure during pregnancy). Concomitant medications included fluoxetine hydrochloride, and prenatal vitamins. On 07-NOV-2021, at gestational age 39 weeks and two days, the mother of the neonate delivered a live, female, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was labor lasting for 15 hours. The mother was stuck' at 9cm for 6 hours due to a hematoma on her cervix. The mother spent three days in the hospital for the delivery. The neonate's birth weight was 7 pounds and 10 ounces, body length 20 inches. On NOV-2021, the neonate was admitted in the Intensive Care Unit (ICU) after the delivery due to apnea. The patient was hospitalized (days and date not specified). Laboratory data included: Cardiac function test (NR: not provided) not reported, and Hearing test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 07-NOV-2021, and the outcome of apnea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and apnea, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This parent/child case is linked to 20210801118.; Sender's Comments: V0: 20220232600 - covid-19 vaccine ad26.cov2.s -Apnea. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20220232600 - covid-19 vaccine ad26.cov2.s Fetal exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Low grade fever, 99.6. Aches, headache, lasted for about 24 hours. Called  to see if I could take Excedrin. I took 2 extra strength to relieve the symptoms. Had a little soreness around the injection site. NOTE: I didn't have any side affects after the 1st injection.
pneumonia; Initial information received on 14-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp (non-healthcare provider)  This case involves an unknown age and unknown gender patient who experienced pneumonia after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient developed a serious pneumonia (unknown latency) following the administration of influenza vaccine.   It was reported "Product name was not provided. Since this is a public post assuming the consumer is referring to the Sanofi flu vaccine."  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event pneumonia.  Seriousness criteria: Medically significant; Sender's Comments: Sanofi company comment dated 19-Dec-2022: This case involves an unknown age and unknown gender patient who experienced pneumonia after receiving  influenza vaccine. Additional information regarding condition at the time of vaccination, medical history, concomitant medication and lab tests would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Within 20 minutes of vaccination, I began wheezing and having difficulty speaking/breathing. I took a Benadryl and albuterol. Within 2 hours of taking those medications, I had hives, a severe headache and numbness in the arm I received the vaccination in.
Fatigue; Headache; Muscle pain; Joint pain; Chills; I would describe it like arthritis symptoms over my whole body because I have arthritis, but this; Every inch of my body ache, like internally.; Little of nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ARTHRITIS (I would describe it like arthritis symptoms over my whole body because I have arthritis, but this), PAIN (Every inch of my body ache, like internally.), NAUSEA (Little of nausea) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included MELOXICAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Apr-2021, the patient experienced NAUSEA (Little of nausea). On 07-Apr-2021, the patient experienced ARTHRITIS (I would describe it like arthritis symptoms over my whole body because I have arthritis, but this), PAIN (Every inch of my body ache, like internally.), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 10-Apr-2021, ARTHRITIS (I would describe it like arthritis symptoms over my whole body because I have arthritis, but this), PAIN (Every inch of my body ache, like internally.), NAUSEA (Little of nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076515 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076515:
Developed paresthesia both legs, primarily left leg. Hip down to bottom of foot spread to right leg Started 5-7 days after the 1st shot, still continues.
The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff he was experiencing some anxiety and added he gets this when he only drinks coffee and not having eaten anything.   His vital signs were done by the nurse and the PA spoke with him, too.  He was given 6 8oz water bottles, a few pkgs of graham crackers and a banana while he waited in the rear of the pod. When he mentioned "chest" breathing the PA decided he should be brought to the E.D.  The pt was going to walk but the staff requested he be wheeled down. He went to the E.D> with an RN and the Pod Mgr.  ED: 47 yo m no pmhx p/w lightheadedness after receiving his covid vaccine. AFVSS, well-appearing, nad. Feeling better after eating, no cp or sob. Do not suspect acs. No signs of allergic reaction. Possible vasovagal vs anxiety related to vaccine. Reassurance provided, Plan for dc
red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs/all over her body; red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs; feels like it was an allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0150, Expiration Date: 30Jul2021 and NDC number was unknown) via an unspecified route of administration, administered in left arm on 06Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. The patient had no medical history and did not receive any concomitant medications. On 12Apr2021 (something strange a week after receiving the vaccine, Monday), patient started a weird reaction, patient had red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs. On 15Apr2021, the red spots bursted out all over her body and patient feels like it was an allergic reaction to the vaccine. Patient wanted to know what to do with her second dose and was she going to get something in the mail saying she should not get it. The outcome of feels like it was an allergic reaction to the vaccine was unknown and recovering for rest both the events.  No follow-up attempts are needed. No further information is expected.
Pt states that a couple hours after vaccination her arm became sore.  Later that evening it started to become red.  She was seen at the ER on 10/24/2012 and was given a prescription for cephalexin 500mg qid for 10 days.  She reports on 10/25/2012 that the soreness is improving but her arm is still red.
SORE ARM,, Next morning woke up very dizzy, stood up and got nauseous, later in day had headache and fever of 100.1
1/20/2021 1st Pfizer Covid Vaccine 6pm EL3302 Left arm 18 weeks preg 2/10/2021 2nd Pfizer Covid Vaccine 1pm EL3302 Left arm 5/4 Covid POC PCR test Positive- asymptomatic 5/5 sore throat  34 weeks preg 5/15 tentative
redness, warmth, & swollen & hard from (R) elbow to (R) shoulder. (R arm only) treated with KEFLEX (from DR. visit) mother noted it started on FRI. (10/10/08) on Sun 10/12/08 the swelling and redness disappeared.
Sweats, chills, diarrheae, heart rate went down, felt horrible for about 3 days
No side effects, except itchiness, redness, sweeling, heat, mild soreness at injection site  8 days later
confluent hives & target lesions over trunk, arms, legs intermittent joint pain (knee lt) unresponsive to DPH;started pred in treatment now;
Hallucinated a little bit; Soreness in arms; Sick; no appetite; no sense of smell; No energy; Shortness of breath; Itchy on back; Very winded, like coming up a flight of stairs; Chills; High fever; A spontaneous report was received from a customer concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 03 Mar 2021, approximately 2 days prior to the event, the patient received their dose of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced sickness, high fever, chills, couldn't move, soreness in arms, felt like Covid, no appetite, no sense of smell, no energy, hallucination, shortness of breath, itching, and very winded like coming up a flight of stairs.  No other details were reported. Treatment information  was  not reported.   Action taken with the drug in response to the event is not applicable  The outcome of the events sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs were  considered to be unknown at the time of this report.; Reporter'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.
Immediately following vaccinatin, patient felt tingling at injection site.  She stated that she felt light headed and nauseous.  She felt better after lying down for around 5 minutes.  We observed patient for over 30 minutes and she left in stable condition.
no adverse effect; a second dose of Hepatitis A, VAQTA, at 5 months and 7 days after my first dose of HAVRIX instead of 6 months; This spontaneous report as received from a patient of unknown age and gender reporting on herself. No information regarding the patient's concurrent conditions and concomitant medications was reported.       On 30-SEP-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) injection (route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis. It was reported that the patient received a "second dose" of vaccine, inactivated (VAQTA), at 5 months and 7 days after the first dose of hepatitis A virus vaccine inactivated (HAVRIX) instead of 6 months. No adverse effects were reported. Product quality complaint was not involved.
Pt received 2nd dose Hep A too soon. 1st Hep A - 9/17/10 2nd given 11/5/10 CDC notified.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is fourth of four reports. A patient of unspecified age ethnicity and gender received fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not seroconvert after the fourth administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). On an unspecified date, the patient experienced after the 5th dosage, titers increased significantly. It was also reported that checking titers was necessary after a complete immune work up due to frequent illnesses. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018193889 same reporter, product and event, different patient;US-PFIZER INC-2018194075 same reporter product event, different patient.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 3:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 3:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 02 Feb 2022, the patient received booster dose.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
Headache, nausea, chills, sweating, left axillary lymph nodes inflamed.
No breast cancer in close family genes, negative genetic testing for both. Cousin was diagnosed with exact same breast cancer just a few months ago after covid vaccine. Covid vaccine Pfizer - few months after two shots and one booster I was diagnosed with breast cancer on same side as vaccine. mammograms' and PET CT scan clear month before first shots. Dr did PET scan for another disorder that came back negative for everything. Booster April 18, 2022 (1st booster) shot was painful, raised a bump looking spot, that turned into egg shaped know and arm swelled up. Lasted about two weeks. It left a permeant mark exactly where shot was given. Two days after mastectomy on left side (Oct 12, 2022) that little bump left over on arm from last vaccine, grew to crusty pencil size spot that kept growing. On Jan 4th 2023 I had it biopsied at dermatologist, that spot left by vaccine that grew was diagnosed as Squamous Cell Carcinoma. Dr convinced me that it was ok to get second booster this past week so I would not get severely ill from COVID. Step father just caught covid at his cancer apt because the medical facility and cancer center stopped wearing masks due to CDC rules. Had to get in right arm. Now my right arm is swollen, huge red area about 3-4 inches big where shot was given, another mark left, and this time right hand swelled up. Terrifed that I will be getting more cancers or the breast will spread or grow. I was early stage 1, grade 2, estogen Pret positive, HER2 negative., onco type 8, no chemo or radiation, did flat closure Contacted CDC, no response, contacted Pfizer. No response until this past week Pfizer sent me a form to fill out that also seems to have legal language in it. Need more space. Breast cancer tests and results, vaccine data and skin cancer info
Cough; Redness; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before; Rash; Mild headache; Muscle pain; Injection site pain, which went down to her wrist; Fatigue; Joint pain around the hips; Felt as if she had to breath in deeper, but had no fast heart beat; Itching on the opposite arm and face; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face) and RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain around the hips). On an unknown date, the patient experienced COUGH (Cough), ERYTHEMA (Redness), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ERYTHEMA (Redness), HYPERVENTILATION (Felt as if she had to breath in deeper, but had no fast heart beat), PRURITUS (Itching on the opposite arm and face), RHINORRHOEA (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), NASAL DISCHARGE DISCOLOURATION (Post nasal drip seeems to be thicker than before and yellowish brown, which wasn't before), RASH (Rash), HEADACHE (Mild headache), INJECTION SITE PAIN (Injection site pain, which went down to her wrist), ARTHRALGIA (Joint pain around the hips) and MYALGIA (Muscle pain) outcome was unknown and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 01-Apr-2021 to be processed with the initial report. Event were updated.
Approximately 24 hours after flu vaccination, patient developed diffuse rash to arms and trunk (anterior). C/O "mild itching to arms", relieved with hydrocortisone cream 0.01%.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age (currently 19 years old) gender not reported). The reporter stated the patient received series of GARDASIL (lot # not reported) (dose not reported, intramuscular route): the first dose was received on 12-JUL-2007, the second dose received on 11-MAR-2009 and the third dose received on 02-MAR-2011. Concomitant therapy was not reported. The reporter stated not all doses were administered in the same office, yet the doses were administered within the same practice. No adverse effects reported. Additional information has been requested.