chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red blotchy skin just belowthe injection site; a little feverish; achy muscle; tiredness; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced tiredness, fever and muscle pain. On 17th September 2020, the patient experienced red blotches. The patient was treated with ibuprofen. On an unknown date, the outcome of the tiredness, fever and muscle pain were recovered/resolved and the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the tiredness, red blotches, fever and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 2 days later receiving the vaccine developed very red blotchy skin just below the injection site on her left arm.  She also had some tiredness, achy muscle, and was a little feverish. She is taking ibuprofen and the tiredness, achy muscle, and fever have reduced but the red blotchy area was ongoing.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187932:Same Reporter US-GLAXOSMITHKLINE-US2020187935:same reporter US-GLAXOSMITHKLINE-US2020187931:Same Reporter
Sore arm; Rash at the injection site; Nausea; Headache; red at the injection site.; itchy at the injection site; It was sore to touch/ injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (It was sore to touch/ injection site tenderness), VACCINATION SITE RASH (Rash at the injection site) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE PAIN (It was sore to touch/ injection site tenderness). On 15-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (red at the injection site.). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (itchy at the injection site), VACCINATION SITE PAIN (It was sore to touch/ injection site tenderness), VACCINATION SITE RASH (Rash at the injection site), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (red at the injection site.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Painful arm, low grade fever (99.5-100.5F) day 1 and 2 after vaccination, malaise, body aches, joint pain. Treated with acetaminophen and bed rest. Painful arm still persists 3 days after vaccination but other symptoms have resolved.
12/19/22 @ 4:00, I became extremely dizzy and nauseas. I was hot and cold, hungry nauseous all at the same time, this was constant , This got progressively bad and on 12/24/22 I went to the emergency room. Because of my age they Thought I was having a heart event, they did cat scan, ekg, blood work, chest X-ray, All negative, they wanted to admit me for an mri, however I left the hospital , and 12/28 followed up with my doctor, he thought it might be blood pressure related, prescribed 25 mg of losartin. Also complete blood work up and exam, all came back normal. I still am having the above symptoms,  however  not as severe, and not every day.
Patient said he developed a rash the size of a small pancake that comes and goes and is very itchy.
Uticaria (not at site of vaccination), beginning third day after Moderna COVID-19 vaccination and progressively worsening over 3 weeks. Initially treated with OTC Zyrtec and beginning  4/22 added  Hydroxyzine HCL 25mg and a 5-day course of Prednisone 20mg. Uticaria. Uticaria cleared on Prednisone, but began to recur 2 days later.  Obtained 2nd Moderna COVID-19 injection on 4/30/21 and uticaria returned in full force,  rapidly spreading throughout the body. Remain on Zyrtec and Hydroxyzine HCL and waiting until two weeks after 2nd vaccination (i.e., 5/14/21) to restart Prednisone so as not to interfere with vaccine efficacy.
After arriving home, patient vomited 4 times, was severely chilled, had tremendous sinus drainage for 6 hours. Then recovered without incident. Had same reaction in 1954 after flu shot.
cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Premature atrial contraction" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient's family history included: "Brother just had COVID" (unspecified if ongoing), notes: Brother just had COVID. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE, Lot Number: 006M2014), administration date: 12Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; moderna (DOSE 2, SINGLE, Lot Number: 0016219), administration date: 12Mar2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; moderna (DOSE 3 (BOOSTER), SINGLE, Lot Number: 047C2114), administration date: 22Oct2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot Number: FK9895), administration date: 30Mar2022, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; Flu shot (DOSE NUMBER UNKNOWN: MANUFACTURER UNKNOWN). The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis.  Additional information: There were no prior vaccinations within four weeks. She had gotten a cold, so she took a few Tylenol.
Approximately 18 hours after vaccinations, developed fever that led to brief generalized seizure. Evaluated at ER and admitted for observation and 48 hours antibiotics. The discharge summary received on 1/6/04 confirms the diagnosis of febrile seizure.
This spontaneous report was received from a registered nurse refers to several patients of unknown demographics. On an unknown date the patients were vaccinated with GARDASIL (dosing regimen unspecified). No concomitant medications were reported. On an unknown date, nurse reported that over the years, several patients of the office have had either several months or even years between the doses of GARDASIL. No adverse effects reported. Outcome of the medication error was unknown. Additional information has been requested.
numbness and tingling on the left side of the face, and left arm; numbness and tingling on the left side of the face, and left arm; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (numbness and tingling on the left side of the face, and left arm) and PARAESTHESIA (numbness and tingling on the left side of the face, and left arm) in a 59-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness and tingling on the left side of the face, and left arm) and PARAESTHESIA (numbness and tingling on the left side of the face, and left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Numbness and Tingling, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness and tingling on the left side of the face, and left arm) and PARAESTHESIA (numbness and tingling on the left side of the face, and left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment included fluids.
Case number PHEH2015US015961 is an initial spontaneous report received from a nurse via GSK employee (sales specialist) on 13 Aug 2015. This report refers to a 26 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) in Jul 2015. He returned the same day with urticaria all over his body. He was sent to emergency room where he received BENADRYL. He recovered and did not stay overnight. The seriousness of the event was not reported, but the event was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
DVT diagnosed; Continual pain; A red area appeared and extremely painful in brachial vein area of left arm; A red area appeared and extremely painful in brachial vein area of left arm; Stayed hot in the injection site daily; Left arm cramped; This is a spontaneous report from a contactable other health care professional.  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En5318), via an unspecified route of administration, administered in left arm on 22Jan2021 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included asthma and known allergies of Celebrex and Vioxx. Patient received any other concomitant medication within 2 weeks prior to the COVID-19 vaccine included bupropion hydrochloride (WELLBUTRIN) and ibuprofen (IBUPROFEN). Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: En0899), via an unspecified route of administration, administered in left arm on 04Jan2021 (at the age of 55-years-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Adverse event started on 22Jan2021 at 04:00 PM. The patient experienced left arm cramped and stayed hot in the injection site daily after 2nd vaccine. On 14Apr2021, a red area appeared and extremely painful in brachial vein area of left arm. On 20Apr2021, Ultrasound scan (US) performed and DVT diagnosed and continual pain since. The patient underwent lab tests and procedures which included ultrasound scan: DVT diagnosed on 20Apr2021. Patient visited to Emergency room/department or urgent care. Treatment received blood thinner Xarelto 20mg. The outcome of the events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events deep vein thrombosis,pain,pain in extremity, Erythema,cramp in hand and vaccination site warmth cannot be totally excluded 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.
Fever, chills, mild body aches and fatigue, beginning approximately 8 hours after treatment, peaking in severity roughly 14 hours after treatment, and subsiding approximately 18 hours after treatment.
1015AM pt exp itching, hives on back, face flushed, lightheaded & anxious 1045AM; seen @ clinic recv DPH & Celestine;rx given for PRed;
one the day of incident the pt cried then got pale, limp, hypotonic, hypresponsive w/almost stopped breathing-mouth to mouth resuscitation given;
On Jan 24 my injection arm started hurting and there was a red oval on my arm around what I assume was the injection site.  My arm in that area was warm for a day or two.  It?s faded but the oval is still there.  Nurse at my school had the same thing happen 10 days after her vaccination but hers was gone the next day.  My arm not really sore anymore, maybe a twinge now & again.
This spontaneous report as received from a office manager via company representative refers to a 18 month old patient. On an unknown date the patient was inadvertently administered a dose of ZOSTAVAX instead of VARIVAX (Merck). There was no adverse event reported. Additional information has been requested.
Pt was given 3rd dose Covid vaccine while symptomatic and testing positive for Covid-19
Fever 101+ degrees; Pain at injection site; Pain at injection site....large lump; Muscle pain; Joint pain; Overall achey; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN) from an unknown date for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. On 23Apr2021 at 03:15, the patient experienced fever 101+ degrees, pain at injection site, large lump, muscle pain, joint pain, overall achey and sore throat; which lasted over three days. Therapeutic measures were not taken as a result of the events. On 23Apr2021 at 03:15, the patient underwent lab test and procedure which included body temperature and result was shown as 101+ degrees. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101+ degrees, pain at injection site, large lump, muscle pain, joint pain, overall achey and sore throat were resolved on 25Apr2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 45 minutes after receiving my Covid vaccine I noticed my lower lip started to swell there was no swelling in my throat). I took Benadryl. I needed to continue taking the Benadryl every 4 - 6 hours because the swelling kept coming back. Later I noticed my lungs getting scratchy. I started using my nebulizer to stay ahead of it. I took two Benadryl before going to sleep. When I woke up I noticed my lips starting swell up again and my lungs were still scratchy. I took my peak flow and it have dropped to 345 (my normal is about 375/380). I contacted my Pulmonologist and her recommended that I go to Urgent Care and report my reaction to the CDC. I went to the Urgent Care. The doctor told me to continue with the Benadryl and nebulizer treats and she also added Pepcid and Prednisone.   It is now one week out and I am still experiencing the lip swelling and itchiness on my face  so I am still currently taking the Benadryl. From time to time my lungs my lungs feel scratchy.
Initial non-serious case received from another manufacturer on 07 October 2008 who received the report from a health care provider. A 54-year-old male patient developed fever and chills one day after receiving an injection of DTaP (trade name, manufacturer, lot number, route/site of administration not reported). His one arm was red and swollen from injection site to elbow. It was indicated that the patient developed cellulitis. No additional information was provided. Follow-up information was received 27 October 2008 from a health care professional. Upon review of new follow-up information received, it was determined this case meets seriousness criteria and has been upgraded to serious. The patient had been a 62-year-old male (previously reported as 54-years-old) and he had received a subcutaneous (incorrect route) left arm injection of ADACEL, lot number C2966AA and a subcutaneous right arm injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 12 September 2008 (previously reported as 13 August 2008). According to the reporter, the patient had not experienced any reaction at the PNEUMOVAX right arm vaccination site. The onset date for the adverse event was reported as 13 September 2008 (previously reported as 14 August 2008). The patient was evaluated by his physician on 17 September 2008 and had been prescribed Keflex. On 19 September 2008, there had been no improvement and the patient's condition worsened by spreading into the axilla and frontal chest areas. The patient had been sent to the emergency room, where they left "(eloped)" without treatment "AMA" (against medical advice). The patient was contacted by staff the following day on 20 September 2008 at which time the patient stated "it was better". Lab results included WBC 12.0, and blood cultures which showed no growth in five days. Concomitant medications included Lasix and Zocor. It was reported the patient had no pre-existing medical conditions and he had not been ill at the time of vaccination. According to the reporter, the patient recovered from the event. Documents held by sender: None.
01/04/22 presents to EC ED for "progressive dyspnea". PMHx of "squamous cell lung ca, COPD on 3 L/min home O2, asthma, CAD, HLD, diverticulitis, GERD"
This was my booster shot. I also got it with my flu shot. Within a week I was waking up at night with horribly itchy hands and feet, scratching myself raw. It processed to be itching all over my body with nothing visible to cause it. If I scratch it, then the skin raises and is red. Nothing seems to stop the itching, lotion, hot showers, creams. SOMETIMES rubbing alcohol will make it stop but by then I have scratched myself near raw. The hands and feet aren't always itchy, sometimes its a tingly feeling that makes me want to scratch. I also break out in pink or red spots or wheels or marks on my body that are raised up and red but not itchy at all, these go away once I wash them with warm water or rubbing alcohol. Sometimes something rubs my arm or stomach and causes it and other times, nothing at all but my clothes.   Other side effects, I was sick for two or three days, cold chills and couldn't get warm. Headache and exhaustion, body aches. This went away once I was allowed to rest.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 22-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot#M000592, expiry date: 12-OCT-2017 (dosing details were not reported) once, subcutaneously/intramuscularly for prevention of pneumonia. Approximately in 2016, the patient experienced redness, swelling, body aches, headache and tiredness after the vaccination. The patient did not seek any medical attention. No treatment was given for the events. The outcome of redness, swelling, body aches, headache and tiredness was reported as recovered. Causal relationship between the events and PNEUMOVAX 23 vaccinations was not reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. In addition, additional information has been received on 09-DEC-2016 from the registered pharmacist, who stated that he would find the patient identifiers and fax them in. Additional information has been requested. Sender's Comments: US-009507513-1610USA009296.
Two days after receiving second Hep B vaccine, patient reports she developed swelling to face, eyes became puffy, face red and hot, lymph nodes to neck tender and enlarged, felt groggy and tired. Patient called on 02/21/05, five days after vaccine and symptoms had improved. Patient treated self with Benadryl.
mild headache; chills; fatigue; fever of 100.4 F; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 100.4 F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (mild headache), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 100.4 F). At the time of the report, HEADACHE (mild headache), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 100.4 F) had not resolved. Not Provided          Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
near syncopal event 30 minutes after vaccination.  Improved with rest and oral hydration
Muscle aches, chills, fever and night sweats within approximately 10 hours or second dose. Lasted for ~ 48 hours. Some relief with Tylenol.
I GOT ALL COVID SYMPTOMS EXCEPT LOST OF TASTE AND SMELL. NOW MY HAIR IF FALLING OUT LIKE CRAZY!!! IF I WOULD HAVE KNOWN THIS I WOULD OF NEVER GOTTEN IT. MY HAIR IS FALLING OUT!
pt recv vax & w/in 24hr pt exp soreness @ the inj site which subsided;w/in 1 wk post vax pt exp an ache, & was sore in hip joints;sx persists;
The lymph nodes in my left underarm became very enlarged and very sore and painful for 5-6 days. I also had flu like symptoms and severe night sweats while asleep.
I have developed full-body dermatitis and peeling skin- my brain is fuzzy and it is hard to focus - I am extremely fatigued, tire easily, and run out of breath quickly - I have blurry vision and my hearing is affected - I am very shaky, my balance is off - my elbows/joints are painful and I get headaches and am severely stressed.  I do not recall noticing a huge reaction after the first shot and I am not clear exactly what minute these negative effects started - but they did become very pronounced after the second shot and are getting worse, not better. In April, I saw a dermatologist for a small amount of dermatitis, but it went away completely.