chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Acute Respiratory Syndrome (SARS).; Feeling congested; Felt sick; Weak; Sore throat; Breathing problems; Muscle weakness; Diarrhea; Gets very tired; Muscle soreness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SEVERE ACUTE RESPIRATORY SYNDROME (Severe Acute Respiratory Syndrome (SARS).) and PULMONARY CONGESTION (Feeling congested) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PULMONARY CONGESTION (Feeling congested) (seriousness criterion medically significant), ILLNESS (Felt sick), ASTHENIA (Weak), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Breathing problems), MUSCULAR WEAKNESS (Muscle weakness), DIARRHOEA (Diarrhea), FATIGUE (Gets very tired), MYALGIA (Muscle soreness) and VOMITING (Vomiting). On an unknown date, the patient experienced SEVERE ACUTE RESPIRATORY SYNDROME (Severe Acute Respiratory Syndrome (SARS).) (seriousness criterion medically significant). At the time of the report, SEVERE ACUTE RESPIRATORY SYNDROME (Severe Acute Respiratory Syndrome (SARS).), PULMONARY CONGESTION (Feeling congested), ILLNESS (Felt sick), ASTHENIA (Weak), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Breathing problems), MUSCULAR WEAKNESS (Muscle weakness), DIARRHOEA (Diarrhea), FATIGUE (Gets very tired), MYALGIA (Muscle soreness) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: found out that she had Severe Acute Respiratory Syndrome (SARS) (abnormal). On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant product use was not provided by the reporter. Treatment medication included unspecified antibiotic for congestion.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company comment: Very limited information regarding these events have been provided at this time. No further information is expected. Based on the mechanism of action of mRNA-1273 the event Severe acute respiratory syndrome is unlikely related to the vaccine.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected. Based on the mechanism of action of mRNA-1273 the event Severe acute respiratory syndrome is unlikely related to the vaccine.
Patient given improper vaccine since less than 18 years of age.  No adverse effect reports thusfar.
Patient requested to receive Johnson & Johnson covid-19* vaccine.  Patient indicated that she had never received a covid-19 vaccine and this would be his first.  Upon billing the patients insurance it was discovered that the patient had already received both doses of Moderna vaccines on 03/06/21 and 04/04/21.  No adverse event noted.
8/19/2022    Patient registered and verified medication and dose with parent.  Child received COVID-19 vaccine of 0.3mL Pfizer as 1st booster dose rather than correct dose of 0.2mL for child under 12 years of age.  Mother had proof of first vaccination given by outside pharmacy.  Mother and father advised of incorrect dose given.  Child did not have any complaints following administration and observation. 8/23/2022     Call to mother to follow up on how the child is doing.  Per mother, "she is fine", "she did not have any complaints".  Mother appreciative of follow up.  Current address verified.
Patient stated that she had redness and swelling around the injection site that radiated from close to her elbow up through her upper arm. It was painful and went all the way around her arm that was injected. Lasted for approximately 3 days then went away.
suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; suppressed WBC and neutrophils and platelets; Very loose, sticky stool; Very loose, sticky stool; gaseous episodes; This is a spontaneous report from a contactable Other-HCP (patient). A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), second dose intramuscular, administered in Arm Left on 08Jan2021 08:00 (at 65 years old, not pregnant) single dose for covid-19 immunisation. The patient had no relevant medical history. The patient had her first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 1500 for covid-19 immunisation, intramuscular on left arm. Concomitant medication(s) included colecalciferol (VIT D3); magnesium; calcium; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN; monascus purpureus (RED YEAST RICE). On 16Jan2021, patient experienced very loose, sticky stool, gaseous episodes everyday since 2nd shot in Jan2021. Patient still do not have normal solid stool today. Patient went into the hospital 23Mar2021 with suppressed WBC and neutrophils and platelets. Tested for every virus, fungus and autoimmune disease and all came back negative and then had a bone marrow biopsy with negative results. Inflammation was seen in biopsy study. Given Neupogen to increase WBC/neutrophils only once which raised levels. Released 5 days later. Blood test 4/13 showed below normal WBC/neutrophils again but not as severe. Still trying to get healthy again. Adverse event resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Five days of hopitalisation. The outcome of the events was Recovering.Patient was given treatment Bone marrow biopsy, injection of Neupogen, IV antibiotics. No Covid prior vaccination. Patient got Covid tested post vaccination, nasal swab on 21Mar2021, 21Mar2021 and 23Mar2021, all negative. No Known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events diarrhea, flatulence, abnormal feces, platelet count decreased, neutrophil count decreased and WBC count decreased and the suspect drug.  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  Committees, and Investigators, as appropriate.
Medication administration error: Pt received 0.3mL instead of 0.5mL. No known adverse reactions.
Pt had uncontrollable screaming about 12 hours straight, fever, lump where shot was given.
2 weeks after MMR given pt developed fever 101 deg F, swollen glands, achy, stiff joints. "Itchy skin" no rash visible.
The patient received a dose of Pfizer Covid  vaccine after receiving 2 doses of Moderna for her initial series
sx started w/dizziness & red rash of both palms; mom called MD @ 7PM hands (palms) cont red & had started itching, burning & painful & some tingling fingers; sx cont through noc; seen by MD 21APR94 AM; Atarax;
Pain and swelling in lymph nodes under right arm were the issue of concern. Patient did also run a fever (100-102) for 3+ days after receiving injection. Note that injection site swelled, turned red, and radiated heat in about a 5-8" circle around the injection. Patient called primary care doctor due to concern when lymph nodes' swelling and pain did not improve 36 hours after onset. PCP advised ibuprofen, application of heat (patient was already doing this), and to visit the ER if symptoms did not improve within 2 more days.   After 30 more hours (from talking to PCP), swelling and tenderness lessened (though still present). This was approx. 90 hours after injection. Patient agreed to report adverse reaction and follow-up with PCP if needed.
Information has been received from a physician concerning an approximately 2-month0old male with no medical history or allergies who on 31-OCT-2006 was vaccinated PO with the first dose of Rotateq. The physician reported that after being vaccinated the patient developed intermittent diarrhea and vomiting for a month (exact start date of symptoms unknown). Unspecified medical attention was sought. No laboratory/diagnostic test were performed. On 23-JAN-2007, the patient was vaccinated PO with the second dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of PedvaxHib and a dose of Prevnar. On 28-JAN-2007, the patient again developed vomiting and diarrhea. The patient subsequently recovered. Additional information has been requested.
After having chest pain 3/1 and then going forward with recommendation by Dr to have Angiogram and everything looked fine, then i had the J&J shot 4/10.  Since then, my EKG has been abnormal (a hernia surgery  cancelled as a result) and arrhythmia disagnosed.  Had Echocardiogram and Holter heart monitor.  Have to see a ElectroPhysiologist next week and I have been prescribed metoprolol.
I had a rash like a blotchy rash; My arm felt hot; Had mild diarrhea; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (I had a rash like a blotchy rash), FEELING HOT (My arm felt hot), DIARRHOEA (Had mild diarrhea) and FATIGUE (Felt tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Had mild diarrhea) and FATIGUE (Felt tired). On 13-Mar-2021, the patient experienced RASH MACULAR (I had a rash like a blotchy rash) and FEELING HOT (My arm felt hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Mar-2021 for Blotchy rash and Extremities hot feeling of, at a dose of 2 doses. At the time of the report, RASH MACULAR (I had a rash like a blotchy rash) had not resolved and FEELING HOT (My arm felt hot), DIARRHOEA (Had mild diarrhea) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022). No concomitant medication information was provided. The reporter administered the vaccine to the patient after the 30 day by used. Patient received half dose. The vial was initially stored in refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment drug details was reported.
In June 2021, platelet count was roughly 360,000. Was given Covid vaccine in August and second dose in September of 2021. Having spells of fatigue, lightheadedness and shortness of breath. Discovered in November of 2021 by primary care doctor that platelet count was roughly 50,000. Primary care was monitoring platelets. They were fluctuating up and down, never getting above 100,000. Primary care recommended seeing a Hematologist in late December. Late December, Hematology put me on high dose of prednisone to try to counteract platelet levels. Platelet levels were not doing anything so we began slowly tapering off the steroid. During that time, January 8, 2022, I became very lethargic, very fatigue and had severe headache. That night, my mother took me to the ER and my platelet count was critical (7,000). I received 2 bags of platelet infusions at hospital and mom transported me to another hospital. Once at hospital, platelet count was 17,000. Received 1st IVIG treatment in the ER and was admitted. 2nd dose of IVIG treatment was given once a room became available the following night. Later discharged the next day. After IVIG treatments, platelet count was over 500,000.   I was admitted again late January 2022, platelets got low not critical. I had a bone marrow biopsy later on and showed I have Chronic ITP. During this time, I was given 4 rounds of Rituximab Infusions and my platelets have been under 120,000 since.
RPh injected 0.3 ml of air instead of 0.3 ml of Pfizer.
Pt recv vax on 3/16/99; on same day pt exp swollen/red/ warm vax site
Tactile fever, red spots and few cloudy blisters, just noticed, not itching yet. Recently exposed to chickenpox per school letter. Denies all symptoms of chickenpox complications.
fingers, except her thumbs, were numb; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in fingers in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included carpal tunnel syndrome.   In JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, 1 day after receiving Shingrix, the patient experienced numbness in fingers (Verbatim: fingers, except her thumbs, were numb). The outcome of the numbness in fingers was not resolved.   It was unknown if the reporter considered the numbness in fingers to be related to Shingrix.     It was unknown if the company considered the numbness in fingers to be related to Shingrix.   Additional Information: Receipt date: 07-AUG-2023 The reporter was the patient's husband, he reported the patient received her first dose of Shingrix about 3 weeks ago.  The next day all of her fingers, except her thumbs were numb.  She saw a specialist who determined her carpal tunnel syndrome was minimal and was not causing the numbness.  The reporter did not consent to follow-up.
mom reported rash (bright red) began @ 9PM starting @ legs & advancing to stomach & back;diaper area had multiple whelps;pt warm to touch-gave APAP-rash & whelps faded;no further problem
no adverse event other than sore arm (injection site). She's only 16 years old not 18 yet.
pt was receiving 3 vaccines at well child visit. Pt was given 2 doses of MMRV (Proquad) at visit. MA gave Kinrix to Right Thigh IM, followed by Proquad to Right thigh IM accidentally instead of Havrix Hep A, patient then kicked next (3rd) syringe (Havrix) out of MA hand removing the needle and causing a waste of vaccine. MA asked LVN to draw up Proquad  and confirmed the need for Proquad, LVN then drew up and gave injection while MA held patient for injection. after leaving the room MA realized mistake and advised LVN/Clinical Supervisor that patient had been given 2 proquads by accident. mother of child was asked to return to office within 30 minutes of realization. patients provider was notified followed by Clinic manager, She contacted Health department and Merck to report incident, Poison control was contacted. and pt was observed in office by both provider and clinic supervisor. pt not having any adverse reactions at that time. mother was given ER precautions and adverse reactions to watch for. pt will return to office in the morning for follow up. pt will return to office at a later date to receive Havrix Hep A that she did not receive at this visit. Mother voiced understanding to all instructions given.
BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808020,  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:00, the subject experienced body aches. On 11-MAR-2021 21:00, the subject experienced chills. On 11-MAR-2021 21:00, the subject experienced headache. On 11-MAR-2021 21:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 12-MAR-2021, and fever on 11-MAR-2021, and had not recovered from body aches. This report was non-serious.
Lightheaded within a few hours of injection. Dizzines, lightheaded, flu symptoms, abdominal pain, nausea, vomiting, weight loss, adrenal insufficiency, memory loss, leg paralysis, difficulty walking, limb weakness.
MMRV (Proquad Vaccine) administered to patient in error.  Patient scheduled to receive MMR and Varicella.  This gave patient double dose of Varicella.
Rash; Blisters (fluid filled); This case was reported by a other health professional via call center representative and described the occurrence of rash in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 20th April 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced rash and blistery rash. On an unknown date, the outcome of the rash and blistery rash were unknown.   It was unknown if the reporter considered the rash and blistery rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacy intern called to report that the patient experienced rash within a few hours after receiving first dose of Shingrix. Within 7 days after receiving Shingrix, the patient experienced developed blisters (fluid filled). The reporter consented to follow up.
Inflammation; Chills; Sweats; Fever; Shaking; could not sleep very well and was going in and out of sleep; Dizziness; Unable to eat; Weakness; Shortness of breath; Excruciating hemorrhoid pain; Left arm was really stiff; Left arm gets locked up; This is spontaneous report received from a contactable consumer (patient). A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 03May2021 (Lot Number: EW0179) as 2nd dose, single at the age of 31-years-old for covid-19 immunization. Medical history was none. Family medical history included: High blood pressure, diabetes, high cholesterol and heart problems. The patient's concomitant medications were not reported. The patient received 1st dose of bnt162b2 on 12Apr2021 with Lot ER8729, expiration is unknown, injected intramuscularly in left arm. No additional vaccines administered on same date of the pfizer suspect. No AE following prior vaccinations. No other prior vaccinations (within 4 weeks). The patient received the 2nd dose of the bnt162b2, and the next day (04May2021 12:00) the patient had excruciating slowly pain like a hemorrhoid pain. The patient bought hemorrhoid cream. The patient experienced shortness of breath on 05May2021, when he woke up yesterday he had it as well. He could not sleep very well and was going in and out of sleep. He could not sleep because of discomfort for hemorrhoid pain. The patient also had dizziness on 06May2021 12:00, inflammation, chills, sweats, and fever. He said that his left arm (injection site) gets locked up on 03May2021 23:00. He also said that he experienced shaking, weakness and was unable to eat on 05May2021 11:00. When he woke up on 04May2021, his left arm was really stiff. Yesterday, he was not able to eat (worsened). His weight was provided as being between 180-190 lbs. There was no prescriber. NO ER or physician's office required. Outcome for hemorrhoids was provided as both persistent and worsened, of the events shortness of breath, dizziness, weakness, left arm gets locked up was not recovered, of other events was unknown.  No follow-up attempts are needed. No further information is expected.
04/09/21 @ 2:07 PM - I started itching and tingling all over by body.  Heated tingle feeling shooting down from injection site and across shoulder and neck to the right side. Rash on my back and lower back pain.  04/10/21 @ 4:30 AM - I woke up with a pounding headache, body ache to include muscles and joints, and nausea.  This was off and on  and subsided the morning of 04/13/21 04/10/21 - started have pain and cramps in my left calf and I am fatigue.  Both which still continues as of now.  04/11/21 - stomach cramps and diarrhea  I have taken Advil and Tylenol.  I called the Health Department and doctors office.  Was told to take Benedryl.
Red papular around the injection site more where HIB vaccine was given, 1 day after the vaccines were given.
Allergic reaction; she got brown spots all over her feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 26Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Sep2021, outcome "unknown", described as "Allergic reaction"; RASH MACULAR (non-serious) with onset Sep2021, outcome "unknown", described as "she got brown spots all over her feet". The events "allergic reaction" and "she got brown spots all over her feet" were evaluated at the emergency room visit.  Additional information: Reported that, 12 years old, took the shot yesterday (as reported) and she got an allergic reaction out of it. Reporter's daughter got the shot and she got brown spots all over her feet and are in the emergency room right now (at the time of report); she has several big brown spots on her feet. Reporter asking for somebody who can help them with this and wanted to know what was going on. The side effects of the Covid, reporter mean vaccine for Pfizer for children (Later reporter confirmed the suspect as Covid vaccine for Pfizer). Reporter was also advised to consult with her daughter's healthcare provider.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.