chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Nauseous; Vomitting; Tiredness; Bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Tiredness), MYALGIA (Bodyaches), NAUSEA (Nauseous) and VOMITING (Vomitting) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jun-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 05-Jun-2021, the patient experienced FATIGUE (Tiredness) and MYALGIA (Bodyaches). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VOMITING (Vomitting). On 05-Jun-2021, FATIGUE (Tiredness) and MYALGIA (Bodyaches) had resolved. At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VOMITING (Vomitting) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.
This case was reported by a physician and described the occurrence of bump in armpit in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included NuvaRing. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown, left arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced bump under arm pit of vaccinated arm (bump in armpit). At the time of reporting the bump in armpit was unresolved.
Information has been received from a 31 year old female pharmacist with no known drug allergies who in "1974 or 1975" was vaccinated with a dose of rubella virus vaccine live. In December 2004, the patient reported that "now her titer is negative." Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested
The patient described adverse effects beginning approximately 6 hours after administration. She described initially a tennis ball sized hard lump at the injection site that is red and warm to the touch. Shortly thereafter she began experiencing fever, severe joint swelling, cough, and malaise.
pt  called clinic  for advice regarding swelling of Right arm on 2/18/21; pt was traiged on 2/18/21 - Pt verbalized that he has  Right  arm swelling since the vaccine. RN advised pt to ice the arm at least 2-3x per day. if swelling has not gone down  in the next 2 days to please call for an in-person appt or stand- by list ; pt verbalized understanding.
Muscle aches; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date unknown) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th June 2019, 1 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional information received were as follows: The pharmacist on the line with a patient reported muscle aches since their first dose of Shingrix. The site of injection or follow-up not queried.
Transverse myelitis/idiopathic; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 22Jan2021, outcome "unknown", described as "Transverse myelitis/idiopathic". Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information provided in this case and considering a plausible drug-event temporal association, there is a reasonable possibility that the reported events are related to the suspect product BNT162b2 (COMIRNATY).  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
The second week after receiving the vaccine, I began feeling achy all over my body. I feel sore all over and I have mental fog. I have seen my doctor and they are not able to determine what is going on with me. As of today, these symptoms are still ongoing. At work, I have to really focus and be present at whatever is going on. I do not take a lot of medication, so these symptoms are really concerning.
Irritated Injected Arm the first 24 hours; Localized allergic reaction on the vaccinated arm; Redness lasted a month/Red Injected Arm; Injected Arm got bigger and bigger the first 24 hours; Had an immediate reaction on my arm/that increased over that past 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours), VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours), ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm), VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours), ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm), VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours). In October 2021, the patient experienced VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours). On 10-Oct-2021, VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours) had resolved. In October 2021, VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours) had resolved. At the time of the report, ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm) and VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: updated reporter details, patient age, vaccine start date and batch number and added new events and outcome.
Pain developed in the left deltoid muscle the shot was administered in.  That evening the pain became EXTREME.  It was a constant pain, not a throbbing pain.  It felt like someone hit me in the deltoid with a baseball bat!  Could not lift the left arm at all, not even an inch because it hurt so much!  That evening developed chills that caused shivers and teeth chattering.  Later became too hot.  Could not sleep that night because of the pain.  The next morning the pain had lessened slightly.  Called the VA clinic and was advised to take Tylenol.  Did that.  Two days later the pain was gone.  Note that I have never had a problem after any other previous immunization.  This one caused extreme pain, chills, then a hot flash.  No other symptoms.
First shot March 5th. Second shot April 1st. Diagnosed with Covid 8/23. Day 6 of experiencing severe symptoms. Full body aches (more intense then ever in my life), chills, hot flashes and sweating, pressure in chest, numbness is legs, feet and hands, fatigue, body weakness, eye pressure, head congestion, runny nose, coughing and loss of taste and smell.
Patient admitted as inpatient on 10/1 due to acute respiratory failure with hypoxia. Patient was tested for COVID-19 and was positive on 10/1.
Severe tinnitus; This is a spontaneous report received from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), in left arm on 24Feb2021 10:45 AM (at the age of 38-year-old) at single dose for COVID-19 immunisation. The patient's medical history included attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), depression. No COVID was reported prior vaccination. The patient's concomitant medications included losartan potassium, loratadine (CLARITIN), both from unspecified date. Patient had not taken any other vaccines in previous four weeks. It was reported at the time of this report patient had severe tinnitus. He had never had this symptom for prolonged periods of time without explanation. It began after the first shot on 28Feb2021 12:00 AM and got acutely worse after the second. Adverse event was reported as serious resulted in disability or permanent manage. No treatment for the event was received. The patient was not tested positive post vaccination. The outcome of the event was not resolved.
Vaccine given after the adjusted use-by date but before the official expiration date. There was no adverse event per se, health dept instructed us to file this report anyway.
Patient felt chest pain the following day (Saturday 9/4) after the second dose and called the pharmacy on Sunday to inform us of his symptom.
pt recvd vax; devel t 101.6; 7oct94 in am, lt leg swollen sl irritability;
On 7/10/22 left leg started to feel numb, as time progressed numbness ascended to right leg became unstable. On 7/15/22 was hospitalized and diagnosed with transverse myelitis with bacteria, viral infections and autoimmune disease tests  negative.
warm to the touch; itching; no fever but her temperature was a little bit elevated from her normal temperature; aches; injection site reaction - red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itching), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature), MYALGIA (aches) and INJECTION SITE ERYTHEMA (injection site reaction - red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) and FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE (GLUCOCORTICOID)) for Allergy, SIMVASTATIN for Cholesterol, HYDROCHLOROTHIAZIDE for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D deficiency.    On 26-Jan-2021 at 7:36 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature), MYALGIA (aches), INJECTION SITE ERYTHEMA (injection site reaction - red) and VACCINATION SITE SWELLING (swollen). 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (injection site reaction - red) and VACCINATION SITE SWELLING (swollen) had resolved and VACCINATION SITE PRURITUS (itching), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature) and MYALGIA (aches) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Additional information included patient details and event details. Added Dose 2 information, Concomitant medications and allergies.
Sore in arm after shot/After second shot symptoms were worse; tired/After second shot symptoms were worse; headache/After second shot symptoms were worse; inappetance/After second shot symptoms were worse; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation was Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE as for COVID-19 immunization. The Pregnancy at time of Vaccination was Unknown. The patient medical history included COVID-19 and the patient concomitant medication was not reported. On an unspecified date, the patient experienced sore in arm after the shot, next day very tired with dull headache and decreased appetite, following day more tired. After second shot symptoms were worse. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was recovered on an unspecified date.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
The doctor is thinking Lupus; ANA was elevated; My white blood count is low; This is a spontaneous report from a contactable registered nurse (patient). A female patient of an unspecified age received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), dose 2 via an unspecified route of administration in Apr2021 as a single dose for COVID-19 immunisation. The patient medical history included she didn't have an efficient immune system. Concomitant medications were not reported. The patient previously took "Hatrzam" for 4 years which mainly gave her IGG and another osteo treatment for 7 years and she and received dose 1 of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunization. The patient previously took Pneumovax and never builds immunity against Pneumovax, pneumonia or pneumococcal. The patient had her blood drawn prior to COVID-19 vaccination back in Dec or maybe Feb for an antinuclear antibody (ANA) test and it was negative.  The doctor re-did the ANA test and it came out the same. She received the first dose of the vaccine at the end of Mar2021 and the second dose at the end of Apr2021. Six weeks post vaccination, in Jun2021, ANA numbers were high The doctor believed she had lupus. She had a very high response which was not usual for her. She usually never builds immunity against Pneumovax, pneumonia or pneumococcal. She was surprised with the high response to the vaccine. The ANA test was positive with titers between 1-320 (normal range is 1-40 or 1-80 at most).  It was very elevated. The patient was wondering if the BNT162b2 vaccine could cause this. The doctor also said she had a low white count the second time around. Her ANA was normal and then after receiving the BNT162b2 Vaccine her ANA was elevated as well as she had a low white count. She reported that she also didn't have an efficient immune system. The outcome of white blood count low, ANA was elevated and lupus was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Chills; extremely tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced chills (Verbatim: Chills) and tiredness (Verbatim: extremely tired).  The outcome of the chills and tiredness were not reported.   It was unknown if the reporter considered the chills and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the chills and tiredness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingrix a day before reporting and had chills and was extremely tired so slept great that day. The follow-up could not be possible as no contact details were available.
Patient was observed in observation, and stated a headache and dizziness. Patient was evaluated by staff and EMT. Vitals  were conducted: BP 124/75, HR 91, RR 18.  Patient stated she hadn't eaten today and little anxious to receive the vaccine. Patient was cleared by medical staff and left.
He got his vaccines, he had no problems initially the day or next day.  This morning his arm was sore and when he looked at it it was red and swollen a bit.  It is not causing any discomfort and not keeping him from doing anything.  It is warm to touch, red and the skin is tight and swollen.   He has not taken anything for the symptoms, and has not contacted a physician.
Immediately felt itching and warmth to site - left deltoid, rapidly developed into swelling and redness diameter of a baseball; Per individual "I felt slightly lightheaded and my chest was a bit tight.  Later that day, I developed hives on my feet and toes which lasted several days.  I took 25mg Benadryl abuot 25 min after I got the shot and then I took more when I got home."  Hives lasted for 6 days and left arm was swollen for 72 hours.
This spontaneous report was received from a medical assistant concerning a female patient of unknown age. On 13-SEP-2013, the patient was vaccinated with first dose of PNEUMOVAX23 (lot number and expiry date were reported as H022280 and 16-JUL-2014 respectively, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in September 2013, the patient developed injection site reaction as cellulitis with redness and swelling. The patient sought medical attention (seen in office). She was treated with BENADRYL. The outcome of the events was unknown. The relatedness for the events was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
PCR Nasal Swab positive; PCR Nasal Swab positive; fever; body aches; dry cough; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 39 years old, dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EL6208) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EL6201) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient had PCR Nasal Swab positive on 16Oct2021, breakthrough symptoms of fever, body aches, dry cough on 12Oct2021. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 13Oct2021, positive on 16Oct2021. There is no treatment for all events. The outcomes of events were recovering. No covid prior vaccination.
tightness of muscle in upper right shoulder. feeling of muscle weakness throughout right arm down to fingers. occasional shaking of fingers, primarily the pointer finger
Vaccine given past expiry date of 09/30/2022 and past stability date of 10/19/2022.
Blood pressure 160/83, pounding headache, couldn't function, pain in stomach, diarrhea, flu like symptoms.
After first shot I experienced a rash in my left arm pit but did not know that it was related to the vaccine. When I got my second shot I got it in the same arm.  I first noticed a rash on my left arm and forearm on March 26th ( COVID arm).  On the evening of March 28th, the rash had spread to my chest, and torso. When I woke up on the 29th, I was covered in hives and a red rash. The hives and rash were on both legs, my back, torso, neck, abdomen and arms.  Rash was very red, itchy and uncomfortable.
Pain in arm; Tiredness; A spontaneous report was received from a consumer concerning a 65 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain in extremity and Fatigue.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20-2A) intramuscularly in the Arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, The patient experienced pain in arm and tiredness.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   On 09 JAn 2021, the outcome of the events pain in arm and tiredness were resolved.  At the time of this report, the outcome of the event(s) Pain in extremity and Fatigue were considered recovered.; Reporter's Comments: This case concerns a 65 year old female who experienced a nonserious expected events Pain in extremity and Fatigue the same day she received the first dose of mRNA-1273 on 06Jan2021. Both events were reported as recovered/resolved on 09Jan2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm pain 6pm-12am, woke up at 5:45 with bad headache, jaw pain, face rash, vomited around 12pm, fever all day
On 4/27 at 8:45am patient was vaccinated at the Health Department with Hepatitis A vaccine at 8:47am patient fainted. Nurse saw her unresponsive, with rigid muscle and during 30 seconds patient could not open her eyes. The ambulance was called when she threw up to rush her to the ER, where blood test and CAT scan were done. Nothing abnormal was found. The IV was given in the same area of the vaccine shot; patient could not move her arm due to pain. Took over the counter medicine TYLENOL and Ibuprofen.
The pt developed a severe right shoulder pain; unable to move. Took pain and muscle relaxing medications.
Arm extremely red and sore from elbow to shoulder. Pt received 2 immunizations in same arm. Adverse rxn started 1 day after injection.
My right arm became swollen, painful, and bruised on the night of my Covid booster.  The next day, there was a hot, red patch below the bruise. This seems like an extreme site reaction to a shot. Today is Sunday, 12/5, and the site is still hot, sore, and a little swollen, but it is improving daily with icing and Ibuprofen.
Case number PHEH2015US019290, is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly 23 Sep 2015. No adverse event was reported. No further information was provided.
Sudden wave of nausea and vomiting  about 5 hours after injection.  I did not have this adverse event from previous COVID vaccinations.  Injection site itchy hive.  This is a common event I've had with previous COVID vaccinations.