chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Bivalent Booster dose administered instead of primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. It was unknown if patient was diagnosed or tested positive for COVID-19. No other vaccines were given 1 month prior to Moderna COVID-19 vaccine. The patient did not have any medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination were reported.     On 11-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 11-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose).    No concomitant medications were reported.  The HCP administered 0.5ml of the new Booster Bivalent vaccine to the patient who was looking for their very first primary series dose. The patient was not experiencing any symptoms after receiving the vaccine. The patient was not on any regular medication. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Live follow-up received contains reporter details, patient demographics, suspect product dose information and  updated I narrative.
Initial report was received from a health care professional on 23 September 2011. This case is one of a cluster of three patients who experienced adverse events following administration of FLUZONE HIGH-DOSE No Preservative 2011-2012, lot number UH452AB. The events for the other two patients were captured in cases 2011-09288 and 2011-09289. A male patient (name and date of birth not reported) who was reported to be greater than or equal to 65 years of age, had received on 13 September 2011 an intramuscular injection of FLUZONE HIGH-DOSE No Preservative 2011-2012, lot number UH452AB and later that evening, experienced an acute change in mental status. The patient was transported to the ER (emergency department) and was hospitalized (dates not reported). No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Patient received notice of her vaccination appoint shortly before her AV Fistulogram, with angioplasty surgery on Tues, 2/2/21. She was nervous about getting the vaccine just days prior to her scheduled surgery.  We called her primary doctor and was told to contact the surgeon. After multiple attempts to reach the surgeon and speaking with hospital staff, assuring us it was fine to get the vaccine prior to surgery. I still wanted to confirm with the surgeon and was finally able to speak to him. He assured me and to inform patient that it was fine to get the vaccine prior to surgery.  On Sat, 1/30/21, patient received her Covid-19 Moderna vaccine. On Sun, 1/31/21, she got a covid-19 test to prepare for her surgery on Tues, 2/2/21.  Her vaccine injection site was sore and she was tired, so she rested and took naps. On Mon, 2/1/21, she went to dialysis as usual. On Tues, 2/2/21, she had her surgery in morning. On Wed, 2/3/21, her dialysis facility could not perform treatment due to swelling of her arm. On 2/4/21 she rested, her arm still bothering her but had been assured to rest. On Fri 2/5/21, she went for her usual dialysis treatment but the facility was not able to perform dialysis and shortly after starting treatment, the facility called 911 to take patient to the hospital. Patient died with the next few hours without her family at her side.
Patient developed redness and raised bump at injection site, followed by red circle around the site and pain.
Morning after receiving vaccine, I had normal redness at injection site, headache, slight chills.  A few hours later, my lower legs started burning.  Two weeks later I went to my doctor, who did blood tests and had me go to a neurologist. Nothing was found. It has now been 13 months and my legs are still burning, sometimes with stinging pain.
Patient completed primary series and was indicated to receive Bivalent booster dose.  MD ordered bivalent booster dose but monovalent formulation administered
pt became pale, limp approx 15-30mins p/vax; ambulance summoned; pt seen @ hosp ER room febrile @ discharge; sz like behavior;
numbness; tingling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling) in a patient of an unknown age and gender 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 HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling). At the time of the report, HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD21-152452 (Patient Link).
Fatigue, body aches, malaise, fevers/chills beginning at 12 hours post-vaccination and lasting until 48 hours post-vaccination.
Pain at injection site; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 11:45 (Formulation: solution for injection, Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20May2021, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 20May2021, outcome "recovering", described as "Tiredness". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional information: Vaccination site pain and Fatigue were treated with TYLENOL and rest. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  No follow-up attempts are possible. No further information is expected.
Warmth, swelling and redness at left arm below site of Td injection, size 2" x 4". Plans to visit provider who administered vaccine for follow up tomorrow 8/29/06 AM.
rxn to pneumonia vax;w/in 4hr of inj rt arm red, hot, swollen to elbow area;swollen under arm pit & down to elbow area rt hand swollen in AM;hot & throbbing;most acute sx lasted for 24hr post vax;
Following the vaccine the patient began experiencing flu-like symptoms including headache and fatigue the same day. They subsided the next day, however the injection site began to swell, turning warm and red. A large portion of patients deltoid around administration site continues to be swollen and red 3 days following administration. The patient hasn't noticed the area getting any larger and is going to continue to monitor for any worsening symptoms. Patient was advised to seek medical care if symptoms worsened.
Severe pain at injection site at time of injection. Patient returned to the office two days later with large, red, erythematous area over site of injection. Unable to move left arm due to pain. Hand tingling. Fever up to 102.
Two minutes after administration of both vaccines, pt experienced syncope for approximately 10-15 seconds. Pt felt hot, sweaty, and nauseous proceeded to vomit 20 minutes later.  EMS was dispatched and Vital Signs were WNL, pt was release ROR to MOC.  Pt was given water, juice, and cold compresses throughout recovery time. Total recovery time was approximately 25 minutes.
Temp 99.8. Itching immediately after injection; within 24 hrs arm was swollen, hot, reddened area 10cm x 7cm, with small amt clear drainage out of injection site. Called Dr and was given KEFLEX 500mg PO TID, and told to use warm compresses for pain relief.
After injection soreness followed that was normal.  At 12:00 onset of diarrhea followed by a fever in the afternoon.  Aches and flu symptoms followed for 2 days with fever between 100-103.  Day 3 fever continues to be 101.  After talking with my mother she had exactly the same response to the recent flu shot one week earlier.  She recovered after 4-5 days.  I plan on seeing a primary physician on day 5.
Daughter reported patient was not feeling well. Took blood pressure reading and results were low. Called ambulance to take to hospital. Patient currently in ICU with unknown condition
This spontaneous report as received from a nurse practitioner via a company representative, refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date in the end of 2017, the patient was vaccinated with one dose of GARDASIL 9 (strength, dose, lot number and expiration date were unknown) intramuscularly for vaccination. On an unknown date (reported as "a few months later"), the patient had a grand mal seizure. The patient sought medical attention and received unspecified treatment at an unknown facility. No intervention to prevent serious criteria was performed. At the time of reporting, the patient has also had an unknown number of other seizures since the initial one and was not recovered from the event. The causality between GARDASIL 9 and the event was not provided. Upon internal review, the event of generalised tonic-clonic seizure was considered to be medically significant. Moreover, the reporter considered the event to be serious due to significant Disability.
Patient presents today with his wife and son. He was recently hospitalized having developed a fever the day after his Covid vaccine 1 with associated confusion and some ataxia. He was admitted to the hospital overnight where an MRI scan suggested no acute change showing only moderate cerebral atrophy and some small vessel occlusive changes. He tested positive for Covid by PCR in the emergency department on 1/22. His oxygen saturation was stable. He did have a fever and describes falling off the toilet because of some generalized leg weakness and uncoordination. He has had some chronic left greater than right upper extremity sensory loss following prior cervical spine stenosis requiring urgent surgery in 3/2019. He has had some chronic left foot drop as well. He reports being somewhat deconditioned having spent some time in bed to the above episode but is now ambulating with a cane at home and has occupational and physical therapy in place. He has been mildly dyspneic on exertion above baseline but attributes this to some deconditioning. He did have an episode of lower dental pain with ambulation in the office that was more than usual though denies associated chest pain or pressure and has had no jaw or shoulder pain with exertion. Review of systems is negative for headache.
Increasing erythema of the skin in the abdominal region and arms w/ small papules on the abdomen, face slightly erythematous; Three papules on the palmar surface of the left hand; 7mg of Diphenhydramine administered x 1 with some improvement of the erythema.
Itchy mouth, difficulty swallowing, sweating, feeling that tongue was swelling, light chest tightness. Given 50mg Benadryl. Symptoms subsided.  Was required to wait additional 30minutes for observation.
infant spits out or regurgitates; infant spits out or regurgitates; This non-serious case was reported by a other health professional via sales rep and described the occurrence of regurgitation of medication in a infant patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: infant spits out or regurgitates) and accidental underdose (Verbatim: infant spits out or regurgitates). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUN-2023 The patient spitted out or regurgitated most of the Rotarix dose, a single replacement dose might be considered at the same vaccine visit. The reporter asked if this was only within the first 15 minutes. The patient spitted out or regurgitated most of the Rotarix dose, which led to accidental underdose.
Pt devel h/a following administration of Hep B vax; No further details were provided;
I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint and had rapid heart rate (pulse of 155) measured by EMT. I needed to remove the mask as I was having difficulty with the rapid heart rate and feeling of fainting. I also felt pins and needles type feeling in my legs and my face felt slightly swelled. I felt tired and that tired feeling lasted for the entire day. I stayed at the vaccination site for approximately 30 minutes at the advice of the EMT and went home. Later I had a slight headache but heart rate became more normal.
Received vaccine on 5/19. Felt feverish, unable to take temperature x 5 days. On 5/22, developed cough with bloody sputum. That evening, patient experienced chest tightness, chest pain, and felt like his "air sacs were on fire." Patient reports that symptoms resolved after walking around and improved by the morning of 5/23. Feelings of feverishness persisted through 5/23. Cough resolved on 5/25.
Fever, body aches, severe headaches for 24 hours  Exhaustion trough 48 hours
On July 23, 2012, I received the injections, on July 28, 2012, I began suffering from acute pain in my right arm, shoulder, and scapula. The acute pain lasted for two weeks. After two weeks, the acute pain turned to loss in strength and movement in my right arm, shoulder and scapula. I was diagnosed with brachial plexitis manifested by long thoracic nerve palsy.
lost the sense of smell; stopped having appetite; feels really weak in the body and doesn't want to move; feels quite pain in the arm.; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost the sense of smell), DECREASED APPETITE (stopped having appetite), ASTHENIA (feels really weak in the body and doesn't want to move) and VACCINATION SITE PAIN (feels quite pain in the arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00420A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN for Diabetes, LISINOPRIL for Hypertension.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (lost the sense of smell), DECREASED APPETITE (stopped having appetite), ASTHENIA (feels really weak in the body and doesn't want to move) and VACCINATION SITE PAIN (feels quite pain in the arm.). At the time of the report, ANOSMIA (lost the sense of smell), DECREASED APPETITE (stopped having appetite), ASTHENIA (feels really weak in the body and doesn't want to move) and VACCINATION SITE PAIN (feels quite pain in the arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Acetaminophen for pain.   Reporter did not allow further contact
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO ADVERSE REACTIONS REPORTED DURING PATIENT INTERVIEW.
SHE BEGAN HAVING TWITCHES WHERE THE RIGHT ARM WOULD STIFFEN AND KEPT MOVING TOWARDS HER FACE. AT THE SAME TIME THE LEFT LEG STIFFEN AND EYES BLINK REPEATEDLY.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 12-MAY-2015, the patient was vaccinated with 2 doses of MMR II (route, lot numbers and expiration dates were not provided). Other suspect therapies included VAQTA (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 12-MAY-2015, the patient experienced wrong technique in drug usage process and overdose as the first dose of MMR II was reconstituted properly using the supplied diluent and the second dose of MMR II, administered on the same date, was reconstituted using VAQTA instead of diluent. No adverse effects were reported. At the time of the report, the patient status was unknown. Additional information has been requested.
Depressive disorder - Suicide attempt. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Insomnia.  I take trazodone for sleep which has worked for years. Since getting the shot 2 weeks ago I havent slept more than 4-5 hours a night, waking in the early morning 2-4 am , unable to go back to sleep.  This is ongoing.
The next day after the 1st dose of the vaccine, around 12 noon I started to feel very tired and getting a mild headache.  Around 4pm, the headache became more severe.  I did take regular Tylenol.  I tried to go to sleep and around 7:30pm, I woke up feeling terrible and threw up.  I took more extra strength Tylenol.  That evening I threw up about 3 times.  I called the telehealth doctor line and was recommended to go to Urgent Care.   The follow day I went to the Urgent Care. They took my vitals, Covid test and blood work. Everything came back normal.  They said it was a reaction to the vaccine and gave me a prescription for nausea and vomiting called Zofran.  The following day, I was feeling much better.   I have fully recovered from my adverse event.
Report 200032956-1 describes the occurrence of difficulty swallowing in a 19 year old male who received hepatitis B vaccine for prophylaxis. This report was received from the patient's mother and has not been verified by a physician or other health care professional. Concurrent medical conditions included asthma. Concurrent mediations included meningococcal polysaccharide vaccine and albuterol as needed. The patient received an injection of the hepatitis-b vaccine in August, 2000. Two days post-immunization, he experienced itching of his legs. his mother treated him with diphenhydramine. Approximately 1 week post-immunization, he developed difficulty swallowing, shortness of breath and abdominal discomfort. He was not seen by a physican. His symptoms were slowly resolving as of 09 November 2000.
Mom reports swelling at site, child taken to PCP on 7/23/08 and BENADYL along with ibuprofen ordered. Please see phone message taken per RN.
elevated (fast) heartbeat / blood pressure lasting several hours.  Blood pressure medication and aspirin taken as precaution
red patch w/in 24hr, warm to touch, discomfort w/a bruise;
Infanrix and Pediarix given the same day; 1st dose of Pediarix on 6th June 2022 and 2nd dose of Pediarix on 12th Dec 2022; Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 8-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TF425, expiry date 21st October 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 6th June 2022 ).   On 12th December 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 12th December 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose, drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the overdose, drug dose administration interval too long and expired vaccine used were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received the 1st dose of Infanrix and 2nd dose of Pediarix on the same day, which led to overdose.  The patient received the 2nd dose of Pediarix as expired one later than the recommend interval, which led to expired vaccine used and lengthening of vaccine schedule.
This female pt received vax in 1996. The pt was pregnant at the time of vax and subsequently had a stillborn birth, possibly prematurely, with bilateral renal agenesis. This report is part of the pregnancy registry. Additional information is requested.