chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tuesday 10/27 patient noticed small knot + slight soreness; Wed (10/28) slightly redder + redness area about quarter size. Thurs (10/29) when patient woke up warm to touch; hard knot, redness area had double in size advised patient to call Primary care to make appt for today or go to urgent care
SWEATING REALLY BAD; WHOLE BODY HURTS; LIGHT HURTING EYES; HIGH ANXIETY; HEART RACING; FEELS LIKE SHIT; PAIN AT THE INJECTION SITE; HEAD WAS HURTING REALLY BAD; This spontaneous report received from a patient concerned a 60 year old male. 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: 205A21A, expiry: 23/JUN/2021) dose was not reported, administered on 08-APR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced head was hurting really bad. Treatment medications included: ibuprofen. On 09-APR-2021, the subject experienced sweating really bad. On 09-APR-2021, the subject experienced whole body hurts. On 09-APR-2021, the subject experienced light hurting eyes. On 09-APR-2021, the subject experienced high anxiety. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced feels like crap. On 09-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high anxiety, and heart racing, had not recovered from sweating really bad, whole body hurts, light hurting eyes, feels like crap, and pain at the injection site, and the outcome of head was hurting really bad was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # not reported) that were exposed to 47 f for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Injections: 12/22/2020 & 01/08/2021; Immediately after both vaccinations:  extreme right side headache; arm pain, right; jaw soreness (similar to TMJ), right; hip pain, right; shoulder pain, right.   alternated acetaminophen and ibuprofen with not relief for at least 12 hours.  Heating pad used at site with no relief for 12 hours. Rash on abdomen to groin & back to buttocks began less than one week of injection and lasted until May 2021.  no other changes with medications, laundry detergent, location.
Vaccine was stored for freezer temperature too long.  We have recommended to the patient to get revaccinated.
Her arm was red and inflamed, similar to allergic reactions she had in the past; It started out as a rash but it turned into a big red area; Her arm was red and inflamed, similar to allergic reactions she had in the past; a bit of a sore arm; was a bit tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (It started out as a rash but it turned into a big red area), VACCINATION SITE INFLAMMATION (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE ERYTHEMA (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE PAIN (a bit of a sore arm) and FATIGUE (was a bit tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (It started out as a rash but it turned into a big red area), VACCINATION SITE INFLAMMATION (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE ERYTHEMA (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE PAIN (a bit of a sore arm) and FATIGUE (was a bit tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Adverse event, at a dose of UNK dosage form and CORTISONE (topical) in February 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE RASH (It started out as a rash but it turned into a big red area), VACCINATION SITE INFLAMMATION (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE ERYTHEMA (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE PAIN (a bit of a sore arm) and FATIGUE (was a bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient was shocked that it took 8 days for the reaction to develop.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA HYPOTENSION 8/23/2022 &  1/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A patient received a partial dose of PENTACEL, whereby DTaP and IPV were administered, but the HIB was not, no AE; Initial information was received on 14-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who received a partial dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] whereby DTAP and IPV were administered, but the HIB was not, (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Product preparation issue). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day).  The reporter asked if the HIB could be given separately  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
SWELLING AND 6/10 PAIN IN LEFT DELTOID.  RELEASED W/O LIMITATIONS AND TO FOLLOW UP AS NEEDED.
warm feeling on her scalp; itching on her scalp; hair loss / in large quantities /falling out by the root on the top of the head / scalp can be seen on the top of her head; pain at the injection site; swelling; muscle pain; fatigue; headache; shivering; feverish; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach. On 24th September 2020, the patient experienced hair loss. On an unknown date, the patient experienced localized feeling of warmth and itchy scalp. On an unknown date, the outcome of the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever and upset stomach were recovered/resolved and the outcome of the localized feeling of warmth, itchy scalp and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, swelling, muscle pain, fatigue, headache, shivering, fever, upset stomach, localized feeling of warmth, itchy scalp and hair loss to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix vaccine on 4th August 2020. The patient reported that same evening the patient experienced pain at the injection site, swelling, muscle pain, fatigue, headache, shivering, feverish, and upset stomach.  The events lasted for 3 days and then resolved. Caller reported she left work early a couple of times due to these events. The patient reported that she had hair loss and reported hair started falling out in large quantities and was falling out by the root on the top of the head. The patient reported hair has fallen out to the point where the scalp could be seen on the top of her head. The patient reported the hair loss was still ongoing at the time of reporting. Periodically the patient had  itching on her scalp and a warm feeling on her scalp but was not sure when this started.  The patient reported she was having blood work done because of the hair loss. The reporter consented to follow up.
Swelling in his joints; Soft tissue of his breast is enlarged; Soft tissue of the breast was very tender; Wrist nodules poke out on the side of wrists; Been feeling achy ever since; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in his joints), BREAST ENLARGEMENT (Soft tissue of his breast is enlarged), BREAST PAIN (Soft tissue of the breast was very tender), WRIST DEFORMITY (Wrist nodules poke out on the side of wrists) and MYALGIA (Been feeling achy ever since) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling in his joints), BREAST ENLARGEMENT (Soft tissue of his breast is enlarged), BREAST PAIN (Soft tissue of the breast was very tender), WRIST DEFORMITY (Wrist nodules poke out on the side of wrists) and MYALGIA (Been feeling achy ever since). At the time of the report, JOINT SWELLING (Swelling in his joints), BREAST ENLARGEMENT (Soft tissue of his breast is enlarged), BREAST PAIN (Soft tissue of the breast was very tender), WRIST DEFORMITY (Wrist nodules poke out on the side of wrists) and MYALGIA (Been feeling achy ever since) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.    Reporter did not allow further contact
1.5 inch knot or bump on left arm in area that shot was given. Arm was not red but had pain in area of knot.
Information has been received from a physician concerning a female who on 11-MAR-2008 was vaccinated with Gardasil (lot# not provided).  On 11-MAR-2008 as the patient left the practice she fainted and hit her head on a curb.  The resulting injury to her head required treatment at an emergency room.  The patient had 15 sutures.  Additional information has been requested.
Swelling of right upper extremity from below shoulder and biceps muscle insertion to elbow, nml ROM without pain, nml sensation, pulses, reflexes. Very warm to touch. No fever.
DONOR HAD PAIN AT SITE AND HEADACHE 5/10 PAIN FOR TWO DAYS AFTER. HEADACHE RESOLVED WTIH NO TREATMENT.
Right deltoid-5 minutes after shot-arm red/ swollen/ hives/ itchy- ree 90x120 cm Tx: Benadryl 1.5tsp ice pack
Erythematous papules to bilat. upper thighs with 3 lesions on chest x 3 days with intermittent fever.
Soar Throat, Coughing, Post Nasal Drip, Congestion, Severe Fatigue
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms, joint pain, muscle pain and headache. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the influenza-like symptoms, joint pain, muscle pain and headache were unknown. The reporter considered the injection site pain, influenza-like symptoms, joint pain, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. A pharmacist reported that in general, the younger recipients of SHINGRIX were reporting local reactions such as pain that resolve within a day. The older age recipients were reporting flu like symptoms which include muscle and joint pain. Older patients also had reported a severe headache. The pharmacist called with an unrelated question. Whenever they had administered SHINGRIX, they had the recipient call them the next day to let them know if they are experiencing any side effects. The pharmacist wasn't sure if she should be reporting this events, as they are common and listed in the prescribing information. She had not logged the patient specific information, so unable to provide these details. This case has been linked with US2018GSK080146, reported by the same reporter.
Patient had overall aching (back, butt, arm). She did not have an appetite and was tired. She did not report a fever. Symptoms resolved after 18 hours.
pt recv vax 18FEB99 & w/in 24hr pt devel a fever of 102 & a 1 to 2cm area of redness @ the acel-immune inj site;
Information has been received from a physician concerning a 59 year old male patient who on 15-APR-2008 was prescribed and vaccinated with a first dose of VARIVAX (Merck) (lot #658405/1076U) instead of ZOSTAVAX (Merck) on his left arm for shingles prevention. It was noted that no symptoms were reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow up information was received which reported that the medical assistance indicated that doctor inadvertently wrote VARIVAX (Merck) in the prescription instead of ZOSTAVAX (Merck) and the nurse gave the patient VARIVAX (Merck). The patient do not have any adverse experience and they refused to be vaccinated with ZOSTAVAX (Merck) now. This is one of several reports received from the same source. No further information is requested.
Arm Pain; This is a spontaneous report received from a contactable reporter (Consumer).  A 54 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Mar2021 10:30 (Lot number: EP6955) at the age of 54 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Covid-19", start date: Apr2020 (unspecified if ongoing), notes: in Apr2020. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "recovered" (2021), described as "Arm Pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated the patient had Covid back in last Apr2020. Stated with the first vaccine, other than a little bit of arm pain she was fine. Patient has received both first and second doses of the Pfizer Covid Vaccine. First vaccine dose received on 17Mar2021, LOT: EP6955 and Second vaccine received on 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Patient stated the next day after his vaccine he could barely move his arm. His range of motion was limited. He couldn't reach the faucet on the sink to turn the water on. It was sore, but slowly got better maybe 2 weeks later. Now he approached me in the pharmacy to tell me he has a lump on that left shoulder and he thinks it's related to the vaccine. He can move his arm and doesn't have more pain than he usually does, but now he was a large lump on top.
Physician in ED received vaccine and within 24-36 hours developed severe arthralgia in knees, back and ankles; so much so that she could not walk or even rise from the bed; called in sick to work for 3 days due to inability to move and walk.
pt complained of red hot arm and muscle soreness. treatment was to use hot pad on arm and to take over the counter apap if there is a fever that develops.
heartbeat "went funny" / weird reaction" to the Havrix; Weird reaction; This case was reported by a pharmacist via other manufacturer and described the occurrence of heartbeats irregular in a female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced heartbeats irregular and weird feeling. On an unknown date, the outcome of the heartbeats irregular and weird feeling were unknown.   It was unknown if the reporter considered the heartbeats irregular and weird feeling to be related to Havrix and Havrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient had weird reaction and her heart beat went funny after administration of Havrix vaccine. The reporter wanted to know if patient should get Pfizer's COVID-19 vaccine or not It was unknown if the reporter consented to follow up.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 24-APR-2012. No other co-suspects were reported. NO concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062,1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006073, 1210USA006074. Additional information is not expected.
Localized red, swollen, hot area about 5-6cm in diameter around immunization sites on right thigh
This case was reported by a nurse via call center representative and described the occurrence of rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. On 9th September 2018, 13 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.  It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was in the GlaxoSmithKline Health Clinic.
but missed her second dose (day 7) that was scheduled for yesterday,; Initial information received on 12-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 43 years old female patient who was vaccinated with a first 1 mL dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] lot P1E521M, expiry date: 30-Oct-2020 via unknown route in unknown administration site on 04-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccination was given to the patient.  It is an actual medication error case due to missed dose as the patient missed her second dose (day 7) that was scheduled for 11 Sep 2019.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
While monitoring patient post COVID19 vaccine, approximately at 5:10pm patient started to have rapid eye movement. According to personal RN that accompanied patient gave prn ativan after 3 minutes of sz activity. Patient coloration or breathing did not change. Patient is globally delayed at baseline. He also has a known history of at least 1-2 seizures per day.  Mother states that he did not have this activity with his last dose fo the COVID19 vaccine. Private Duty RN states that he is tired, and has had a hard day with 4 appointments and little food. Reviewed stress triggers for epileptic patients. Mom and private duty RN stated understanding.  As a precautionary measure and concern for possible reaction to COVID19 vaccine, on call provider notified of patient condition change. Dr. visually assessed patient and reviewed care. VS 98/53 HR 65 02100% on 2LNC temperature 97.8F at 5:20pm.  5:22pm patient WNL for health condition. Last set of VS taken prior to leaving observation area post covid vaccination were: HR 65, 100% sp02 on 2LNC, BP to L Up Extremity was 103/61. Temperature 97.7 axillary, No signs of visual distress. Reviewed education for EMS and ED warning signs related to increased seizure activity and possible COVID19 reaction concern. This included facial, lip swelling, upper airway noises, increased seizure activity unresolved with seizure regimen and abnormal to patients baseline seizure activity, coloration changes, swelling or widespread rash, difficulty breathing, shallow breathing, and increased oxygen needs or other concerning signs that warrant urgent care.  Mom and private duty nurse stated understanding and left at 5:35 pm.
The next day after vaccine, I had swelling and pain in my arm at the injection site. I felt very tired and fatigued with chills. I laid in bed for 2 days. I had pain in my arm with limited range of motion. I have lymphatic swelling under both arms. I went to my doctor on 4/28/2022, when I started having chest pressure, chest pain, and confusion. I have had an EKG which was normal and blood work which is scheduled. I have started taking OTC Guaifenesin which does help.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Phantosmia (very, very strong cigarette smell), constant until day 5, then intermittent , still have symptoms every day but not constant, also had mild headache and fatigue day after, also developed "covid arm" one week after vaccine 4/3/2021. Redness, itching, swelling, discomfort at site of injection
Two days after receiving the Moderna booster shot I developed bruising and petechiae on my hands, wrists and lower extremities.  These were my symptoms when I was initially diagnosed with ITP in 2013 (which I still maintain was caused my travel vaccines - yellow fever, Typhoid and Hepatitis A)   It got worse over the next day so I went to the local ER and found that my platelets dropped to 8,000.  I was admitted to the hospital and received two 80g infusions of IVIG and a 4 day course of decadron.