chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; nausea; face flushed; face flushed and is red; diarrhea; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on 05Mar2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. 06Mar2021, her face flushed and is red but she felt ok. On 06Mar2021 evening, she started to have diarrhea. 07Mar2021 she had fever, chills, nausea, and diarrhea. She wanted to know if those are normal adverse events with the Pfizer COVID-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt nauseous; Felt tired; Inappropriate schedule of vaccine administered; Bad headaches 2 hours after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headaches 2 hours after the vaccine), NAUSEA (Felt nauseous), FATIGUE (Felt tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Vaccine. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Bad headaches 2 hours after the vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NAUSEA (Felt nauseous) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Headache, at an unspecified dose and frequency. On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HEADACHE (Bad headaches 2 hours after the vaccine), NAUSEA (Felt nauseous) and FATIGUE (Felt tired) outcome was unknown.            No concomitant medications were reported.  The reporter thinks the patient received full dose for their booster dose. Patient received primary series of the Pfizer Covid-19 vaccine.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who received 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number not reported and expiry date 16-Mar-2019) via unknown route in the upper arm side unknown on 18-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Mar-2019, the patient received a Dose  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the arm NOS. It was a case of actual medication error due to expired vaccine used, inappropriate age at vaccine administration and overdose. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
was given above the deltoid muscle  at the very top of his shoulder; pain and redness in the area following the injection; pain and redness in the area following the injection; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "was given above the deltoid muscle  at the very top of his shoulder"; INJECTION SITE PAIN (non-serious), INJECTION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "pain and redness in the area following the injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Since the patient received her flu vaccine on 10/19/17 she has had a sore arm from her shoulder all the way down through her forearm area. The patient states it feels like muscle soreness/damage. The patient states she has loss of range of motion from the soreness.
He received an Afluria vaccination in the right deltoid during the AD Flu-fair, and reports that as soon as he left the building he began to have a dry cough, and by the time he arrived back to his duty area, about 1 mile away, had fullness of the right side of his nose and reports that he was not able to breathe through the right nostril, but the cough had resolved.  Additionally, he began to notice some change in sensation in the right side of his jaw which progressed to include the right side of the face up to the line b/w his ear and eye, and included area around the right ear, and right side of his tongue.  This sensation was fully developed at 2 hours post vaccination and lasted until he went to bed around midnight, but was gone when he awoke around 0530.  He did have a slight headache when he awoke the next morning, but denies any further sensory changes.  The HA dissipated toward the end of the day.  The congestion in his right nostril followed the same time course as the numbness.
Has not been feeling good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Has not been feeling good) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Has not been feeling good). At the time of the report, FEELING ABNORMAL (Has not been feeling good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
This case was reported by a nurse and described the occurrence of swollen joints in a 33 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine. On 8/20/04, the patient received the second dose of Twinrix in the right arm (lot # HAB015A8). On 8/20/04, the patient also received an injection of Yellow Fever vaccine. Approximately 14 days after the administration of the second dose of Twinrix, on 9/3/04, the patient experienced swollen joints and joint pain in his hands and feet. The patient was hospitalized. The events were ongoing at the time of initial reporting. The nurse considered the events to be possibly related to vaccination with Twinrix.
Patient reacted with hives after his 1st MMR on three occasions. 1st, reacted without cause post-shot. 2nd and 3rd, hive reactions from foods previously deemed safe and ingested on a regular basis. Noted auto-immune complications. In the week following the MMR shot, patient acquired a perforated ear drum (with no ear aches or infections prior), with excessive discharge. Antibiotics prescribed. Perforation still present after 1 month. With thick discharge. 2nd round of antibiotics started mid-March (CIPRO). Patient had two different incidents with high fever (above 102 F) after his MMR immunization, the first within 6 days following the shot, and the 2nd within 10 days of the immunization. Both fevers included malaise/lack of energy, poor appetite, neediness.
patients heart rate increased to 160bpm; patient then began complaining of swelling of the airway; patient was given 1 amp of epi. and still complaining of swelling of the throat; patients sats were 100% throughout; patient had symptoms that appeared more as if it was a panic attack vs adverse reaction; however patient was taken to the ED
Shot was given Tues morning around 7:40 am.  It was a bit sore, but nothing else that day.  Wednesday morning woke up, arm very sore still. I had no energy, very lethargic. Got a fever by mid morning. Chills, hot and cold off an on all day. Not much of an appetite. Thursday I woke up feeling fine, however arm was still pretty sore.  By late Thursday night I started seeing a red rash on my left arm (injection site) It continued to spread all over my body for the next few days. Legs are very itchy and red.  Used an anti itch cream, took a Claritin antihistamine.  No real pain, but uncomfortable with the itching.
05/07/2021 1000 - Headache, slight numbness of left side of face, body aches continuous. 05/08/2021 0800 - Lower extremity aches 48 hours duration. 05/09/2021 0600 - Red non itching red rash noted on chest, 6 hours duration. 05/25/2021 1500 - Elevated blood pressure. Diagnosed with mild hypertension with no previous history of mild hypertension.
10-3-2016 pt woke up experiencing significant redness, warmth, and discomfort adjacent to injection site (L deltoid). On 10-4-2016 she visited primary care physician who prescribed prednisone taper and diphenhydramine. Per pt on 10-5-2016 the appearance had lessened and by 10-7-2016 was completely resolved.
INCORRECT STORAGE OF VACCINE; VACCINE ADMINISTERED AFTER BEING STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 18-JAN-2022 for prophylactic vaccination. Age at time of vaccination 64 years old. No concomitant medications were reported. On 18-JAN-2022, the patient experienced vaccine administered after being stored outside of the recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after being stored outside of the recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558390, 20220558451, 20220558439, 20220558823, 20220558511, 20220558383, 20220558598, 20220558345, 20220558340, 20220558378, 20220558349 and 20220558823.
Information was received via an online newspaper article concerning a 26 year old female who alleged she was left partially paralyzed as a result of GARDASIL (see report # 1409CRI014823). The article also noted the following: "A number of other cases of partial or complete paralysis in girls and young women shortly after having receiving the vaccine have also been reported by the media since the vaccine was introduced in 2006". Upon internal review, partial or complete paralysis was considered medically significant. This is one of several reports from the same reporter. Additional information is not expected.
I brought my son in to the emergency room to walk him in for a high fever that he had for two days before. Then, when we were waiting to be seen by the doctor, he wasn't listening and he ran away from me so I spanked him and he was about to let a big cry, then he quit breathing and I ran him back to the doctors and they started working on him right away, while that was happening he had a seizure for almost 2 minutes. He was medivaced out to the medical center because he had an abnormal spinal tap. When he got to the hospital they weren't sure what sickness he had. In the end, the final result was that his spinal tap results came back normal and they said he had a virus. He never had a seizure in the past or a breath holding spell.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient came in w/ s/other to get 2nd covid shot. Gave shot to patients significant other first with patient watching. Patient got scared when they saw the needle, & we quickly moved forward with their dose. Patient walked to the observation area of the store and sat in the chair, before they felt light headed. Patient laid down on the floor on their side in fetal position, and went completely unconscious. Pharmacist shook pts arm and said name 4 times before pt regained consciousness. EMS calle
SECOND DOSE GIVEN 14 DAYS AFTER INITIAL DOSE, NOT THE RECOMMENDED 21 DAYS
Dad reports that prior to receivig his last vaccine on 12/27/18, he can say single syllable words, like hi, bye, no, yes and mama, dada. He also said that child would pay attention when he asks him to focus on his finger. He said that after the shot on 12/27/18, which was flu shot #2, child would not say any words, he just jabbers and runs around; he still makes eye contact and plays with his parents and family. H/O autism - dad said questionable vaccine - related.
rash skin on my both legs/they were just rising up and bumpy skin; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right at the age of 56 years old on 05Mar2021 12:00 (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 06Mar2021, after 27 hours of first dose vaccine, the patient experienced rash skin on her both legs, they were not itching, they were just rising up and bumpy skin. No treatment was received. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
I started experiencing stabbing pain in the top of my head then the teeth in my bottom right jaw stared to hurt after about 4 days of random headaches then it became unbearable and I thought I had a tooth infection. The whole right side of my head hurt terribly so we went to the emergency room and they suggested Trigeminal Neuralgia gave me morphine and sent me home the next morning I couldn?t take the pain in my head so we went to hospital and spent 5 days there where they also suggest that it?s Trigeminal Neuralgia I am now on gavapentin and triliptal.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure, Crohn's disease, adrenal insufficiency and decreased immune responsiveness. Concomitant products included hydrocortisone, methotrexate, triamterene, ENTYVIO, JANUVIA, metoprolol, MYRBETRIQ and PENTASA. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. In April 2018, the patient experienced fever, muscle pain, nausea, chills and fatigue. In April 2018, the outcome of the fever, muscle pain, injection site swelling, nausea, injection site erythema, chills and fatigue were recovered/resolved. The reporter considered the fever, muscle pain, injection site swelling, nausea, injection site erythema, chills and fatigue to be almost certainly related to SHINGRIX. Additional information was received as follows: At 14:00, the patient received SHINGRIX on left arm. On 13th April 2018, at 2 AM, 12 hours after receiving SHINGRIX, the patient experienced a high degree fever, severe chills, muscles aches, fatigue and nausea. On 13th April 2018, the patient's body temperature was recorded as 102 degree F. The fever lasted for about 3 days. The severe chills, muscle ache and nausea lasted for about one day. The fatigue lasted for approximately about a week. The redness and swelling on the injection site, lasted for total of three to four days. The patient gave permission to contact her healthcare physician. The physician's information was same as noted in vaccine facility information. No further details were provided.
Client reported reaction of redness/swelling for 10 days in her left thigh. Client stated that swelling and redness covered her entire thigh from vaccine injection area to about the top of her knee. Client did not report this to the health department or her PCP. She stated it resolved on it's own. Client reported adverse reaction in April during an appointment for a different vaccination.
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of influenza like illness in a 56-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza like illness, sleeplessness and feeling unwell. On an unknown date, the outcome of the influenza like illness, sleeplessness and feeling unwell were recovered/resolved. It was unknown if the reporter considered the influenza like illness, sleeplessness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at left arm. The patient felt sick enough, like he was getting the flu, that he had to go home from work. He could not sleep all night after getting SHINGRIX. This is 1 of the 5 cases, reported by the same reporter.
asymptomatic/No additional AE; inadvertently administered a dose of PROQUAD and a dose of VARIVAX at the same time; This spontaneous report was received from medical assistant and refers to a 4-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 24-OCT-2023, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) (lot #W039841, expiration date: 12-JUN-2024) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W032507, expiration date: 11-OCT-2024), (both vaccine: strength, and route of administration were not provided) at the same time for prophylaxis (accidental overdose). The patient was asymptomatic at the time of reported. No additional adverse event (AE).
Upon administering 1st dose of Pfizer vaccine for patient once the needle was in the patient's arm and I started to push on the plunger the vaccine squirted out of where the needle screws on to the syringe body.  In my opinion most of the vaccine sprayed on her arm and very little if any of the vaccine was actually administered into her arm.  I cleaned up the liquid on her arm and re-vaccinated with another syringe to ensure she received the proper 0.3ml dose of the vaccine.  I administered the vaccine in the same arm.
After first and only Modrerna shot, awful shingles fever worse than that terrible G.I. Issues. Like taboo due to folks mandated vac. Even my primary care cannot help. Skin issues and gastrointestinal issues won't go away. I am a long haul trucker and was very healthy. Through much research found rare but not alone with this. Like it is trying to get me. Modrerna cares less.
Woke up with burning gums and nose with nasal drip. Called clinic first time today and reported continued symptoms with burning gum, redness in gums with white gum above two front teeth.  Small red spot at site of injections. Slight flu like symptoms. Saw dentist today and called physcian. Was told to take Benadryl and see physician tomorrow am.
administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 5th October 2021, the patient received the 2nd dose of Shingrix. On 5th October 2021, unknown after receiving Shingrix, 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 was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219377:same reporter US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219382:same reporter
Dyspnea, coma 01/17/2022 2:40 am.
I began to have finger joint pain and inflammation. Mostly my index and middle fingers would become achy, red and warm to touch. It would switch back and forth from my right hand to my left. Only occurring on one hand at a time. It was intermittent symptoms with no symptoms at times. One evening my fingers on my right hand began to ache within several minutes the aching moved to my hand with more intensity. Then moved into my right wrist that was very painful and continued for about 2 hours then totally stopped abruptly. All these symptoms lasted over a span of 2 months. Since then I?ve had some intermittent minor finger joint aching.
inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 18-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacy operations manager called to report three patients were inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days which led to incorrect storage of drug. The manager mentioned the Boostrix was left in the stock room and three patients received it during that time. Manager unable to provide vaccine details of Lot and expiration. The reporter did not consent to follow up. This case is linked with US2023151106 and US2023151104, same reporter.; Sender's Comments:  US-GSK-US2023151106:Same reporter US-GSK-US2023151104:Same reporter