chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme body aches, swelling at injection site, extreme chills. Fever of 102.1, nausea, vomiting, diarrhea, migraine, exhaustion
the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022; dose of the Moderna COVID-19 vaccine was administered after the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022 at 8:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 vaccine was administered after the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored on 31-Jan-2022 and the vaccine was administered on 03-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Thaw expiration date was 02-Mar-2022. It was reported that the HCP did not know that the vial should not be used past 30 days from thawing the vial. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-583132 (Patient Link).
2"X2" red area L thigh, crying inconsolably, HR 160, RR 40, T99.3R, vomited X 1 at 04:20 PM
Was changing clothes for bed and noticed under my left breast it was real red and some rash. At first, I thought it was because I had sweated that day, but it was just my left side. The next day, I noticed when I brushed my arm against my left side, it was really sore. That evening, I changed clothes early, around 8:00 PM, and there was more rash around my nipple and a red streak that went up. It was so sore that it hurt to go and sleep without a bra. I planned on calling my doctor the next morning, but by then it had started to fade and was light pink in color. I had just been to her the morning before we got the shot. Today, it is still sore, fading in color and now itching. I get periods that I just don't feel right, some lightheadness, but do not run a fever.
Dizziness, fatigue, neck and back pain, pain shooting into legs, low grade fever, and chills. Neck pain and stiffness continued through the week.
This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a 70-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date unknown) for prophylaxis. Concomitant products included SHINGRIX. On 17th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 17th July 2018, immediately after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), dizziness, sweating, injection site pain, pallor facial and arm discomfort. On 17th July 2018, the outcome of the loss of consciousness was recovered/resolved. On an unknown date, the outcome of the dizziness and sweating were recovered/resolved and the outcome of the injection site pain and arm discomfort were not recovered/not resolved and the outcome of the pallor facial was unknown. It was unknown if the reporter considered the loss of consciousness, dizziness, sweating, injection site pain, pallor facial and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient had a similar reaction to a vaccine when he was 4 or 5 years old. The patient did not know which vaccine. The patient had no history of seizures or anything similar. On 27th April 2018, the patient received 1st dose of SHINGRIX and did not experience adverse events. The patient received SHINGRIX on the left arm. The patient became dizzy and pale in the face immediately after getting the injection. The patient was also sweating all over his body. The pharmacist had to lie down him and he lost consciousness for 5 to 10 seconds. Emergency medical service (EMS) was called and arrived within minutes. The patient did not remember anything. He had not eaten anything that day. The EMS checked heart, glucose and blood pressure and readings were normal. The patient refused emergency room (ER) transport. Less than a day after vaccination, the patient also complained of pain in his left arm and that it was uncomfortable. The patient stayed in pharmacy for an additional 30 minutes after EMS departed and then left on his own. The pharmacist noted that a script for CELEBREX was called in on the answering machine from the ER when she arrived the next morning. It was unknown when he went to the ER. The pharmacist last spoke to the patient on 19th July 2018 and his arm was still uncomfortable but the patient was still planning to leave on a trip on 23rd July 2018.
2/18/2019 Injection in arm by pharmacist; 2/19/2019 Soreness in arm; 2/20/2019 Extreme fatigue - flu like; 2/21/2019 Beginning pain and tenderness in the base joint in large toe; 2/22/2019  Excruciating pain, tenderness, and red spot in base joint of the large toe; 2/252019 Appointment with primary care physician Dr resulting in a diagnosis of gout. No prior history.
This was an administration error, patient received Fluzone HD for 65+, but patient is currently 64 years of age
Received shot at 1750 on 3/4/22. Woke up at 0700 3/5/22 with pounding migraine and nauseous. Went to an appointment at 0815 where my heart rate was over 100 (normal is 60-70s for me). Came home, taking Tylenol and ibuprofen alternating. Took a nap, watch woke me up 5-6 times in about an hour informing my heart rate was over 120 for 10 minutes while sleeping. Heart pounding fast, migraine still hurting.
Approximately 1 week following vaccine felt sensation of walking on glass and tingling in fingers. After 2nd MMR on 4/8/14 developed excess salivation and vertigo. Seen in ED on 4/17/14 and referred to neurologist. MRI of brain on 5/15/14 reveled new demylinating lesion. Treated with IV Solumedrol on 5/27/14 for 3 days and is taking Neurontin and Cymbalta.
On day 2 following the vaccination, patient stated that she had a local reaction at the injection site of  left arm with redness, swelling, and hot to touch. On day 3, symptoms increased including diarrhea, headache, nausea, and abdominal cramping. On Day 4, she had dizziness and was unable to get out of bed. On day 6, she dizziness increased and she lost her balance and fell. As of 8/1/17, patient continues to have dizziness and balance instability.
Pt recv vax on 11/4/98; on 11/5/98 pt exp raised, warm, red &blue hemangioma lesion at vax site (10x6 cm)
Dizziness, extreme nausea, headache, weakness about 10 minutes following vaccine.  Still having severe headaches, dizziness, memory loss, blurred vision, fatigue, restlessness.
5 minutes after receiving VZV vaccine stated didn't feel well, skin warm and damp B/P 148/82 Pulse 82 Resp 20. 20 minutes later stated felt better. Escorted client to exit client stated felt dizzy, lower to floor. Client lethargic responded to verbal stimuli Ammonia to nose x2 B/P 148/78 Pulse 83 Resp 16 02 100% room air. EMS called to transport to ER>
She has pain; A 4" raised red area around the injection site which began on 8-13-2023; She had a headache the first day; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 12-AUG-2023, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: She had a headache the first day). On 13-AUG-2023, the patient experienced injection site pain (Verbatim: She has pain) and injection site erythema (Verbatim: A 4" raised red area around the injection site which began on 8-13-2023). On 13-AUG-2023, the outcome of the headache was resolved (duration 1 day). The outcome of the injection site pain and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2023 The patient reported that she received her first Shingrix vaccine and had a headache the first day that resolved the next day. The patient had pain and a 4" raised red area around the injection site which has not resolved.  The patient reported that the raised red area did appear to be lessening today. The reporter did not consent to follow-up.
one of our  Ambulance staff inadvertently used the same syringe to vaccinate eight people ? he did change the needles in between each patient.
she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation.  The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported.  On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were.  The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
Left knee joint pain; This is a spontaneous report from a contactable consumer reported for herself. This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3247), via an unspecified route of administration at single dose in the left arm on 27Jan2021 09:00 for Covid-19 immunisation. Medical history none. Concomitant medications were not reported. The patient experienced left knee joint pain on 28Jan2021 18:30 with outcome of not recovered. No treatment required. The vaccine was administered at clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination.
Face swelled up, red blotches all over body and itching intensely all over body.
18 mo old infant vaccinated on 1MAR90, developed a temp of 102 to 104, became bery irritable and fussy, not sleeping and not eating, some stiffness of neck, office visit on 3MAR90 & seen in ER.
Patient / received a dose / expired during March 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 30th April 2021, the patient received Menveo. On 30th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired vaccine of Menveo. The reporter asked if dose was valid or not. The reporter was concerned regarding how to proceed in case when Menveo was administered after expiration date. The reporter consented to follow up.
Ten days later, a large lump formed at the injection site that is very itchy on the skin, red and inflamed, and sore to the touch.
Case number PHEH2015US027173, is an initial spontaneous report received from a medical assistant on 24 Dec 2015. This report refers to a 59 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) at a dose of 0.5ml, intramuscularly on an unknown date which was stored out of recommended temperature range (temperature excursion of 55.6 degree Fahrenheit/at 7:50 am the temperature was 38 degrees and at 3:50pm the temperature was 38.3 degrees). No adverse event reported following this medication errors (incorrect storage of drug).
dizziness, flushing in face, and heart pounding  (felt like she just got done running)  pulse 100
Information has been received from a physician concerning a 7 year old patient who on 09/07/1995 was vaccinated with a dose of varicella virus vaccine live.  On 05/18/2000 the patient experienced a case of breakthrough varicella.  There were 20 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  This is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 86-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication reported.
Two days after booster, I had a terrible earache and sore throat with difficulty swallowing.  This was all on my left side. Three days later my eyes became  red and irritated. I had terrible pressure in my eye along with blurred vision. I am now sixteen days post vaccine booster and my eye is still red and irritated  with blurred vision. My earache comes and goes, but last night, I couldn?t sleep due to pain in left ear. I am concerned about my eyesight and long term effects. Also, I don?t know what to do about future boosters.
Large red and swollen welt at injection site lasting 1 week. Rash on shoulder and injection site lasting 3 days approx 5days after injection. Itchy and redness at injection site for approx. 1 week beginning 5 days after injection.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in an unspecified number of patients who received PEDIARIX for prophylaxis.  On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. No lot number, expiry date and patient details were available. The licensed practical nurse reported that the patient had experienced a red, raised, swollen area at the injection site following administration of PEDIARIX. The area felt hard to the touch. The reporter did not consent to follow up. The call was disconnected before any healthcare professional details could be obtained. The reporter indicated that more than one patient experienced these symptoms, but did not have an estimated number of patients affected.
Change in taste/smell- metal taste x2 weeks after 1st shot and ever since 2nd shot headaches x2 weeks after 1st shot and ever since 2nd shot now progressing to almost daily severe debilitating migraines (nausea, vomiting, sensitivity to light/sound, etc) not responding  to medication,  requiring ER visits.
Severe redness, pain, swelling (L) arm from mid-deltoid to elbow. Began approx 24 hrs after administration. Unable to move arm. No fever, respiratory problems. Treated with NSAIDS, ice.
The effectiveness of seroquel greatly decreased. I have been taking seroquel for over a year to help with sleep. Since the first vaccine, I have not been able to sleep through out the night. I wake up in the middle of the night for hours. Prior to the vaccine, I would sleep for a minimum of 7-9 hours every night without waking up at all. I am still unable to sleep throughout the night even after increasing my dosage, as per my psychiatrist's suggestion, to 100mg.
Extremely early menstrual cycle. My period ended 2/23 one week before I was vaccinated and started again 2 days after vaccination. My periods are regular (between 27-29 days) so this is very irregular and concerning. No other changes has occurred in my life to cause such a drastic cycle change. I am only on day 2 of my period but so far it looks like any other day two so I'm assuming it will run the full 5 day course.
experiencing tiredness, muscle pain, headache, chills, joint pain, and nausea for 2 days, feeling better now
Pt also states he had 2 or 3 anthrax vaccinations during this time reports he developed multiple symptoms including rashes in the groin area. He states he sought medical evaluation and was told it was chafing and was benign. He also gradually developed muscle and joint pain in the hands, feet and knees, and low back. Additionally he experienced chronic fatigue, night sweats, difficulty concentrating, short term memory loss, alternate constipation/diarrhea, and anxiety. Groin rashes were later diagnosed as psoriasis and joint pain developed into psoriatic arthritis. Disturbance, sleep NOS.
72 hours later I still have a terrible headache; Chills; muscle ache fir 48 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Jan2022 11:30 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]; B12 [CYANOCOBALAMIN]. The following information was reported: HEADACHE (non-serious) with onset 22Jan2022 21:00, outcome "not recovered", described as "72 hours later I still have a terrible headache"; CHILLS (non-serious) with onset 22Jan2022 21:00, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 22Jan2022 21:00, outcome "not recovered", described as "muscle ache fir 48 hours.". Therapeutic measures were not taken as a result of headache, chills, myalgia.  Additional information: Patient had no other vaccine in four weeks. Patient was not tested COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 13-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient with erythema and swelling of (L) arm/forearm consistent with cellulitis started on KEFLEX 500mg PO QID x 10 days pt instructed to follow up in 10 days.