chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received the vaccination after a temperature excursion; had a temperature excursion in the freezer; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion in the freezer).    Concomitant drugs were not reported. It was reported that the unbroken cartons of bivalent vaccine of both 2.5ml and 5.5ml size was stored in frozen storage at the time of excursion and was returned to freezer and was still frozen. The duration of excursion and the maximum and minimum temperature reached at the time of excursion was unknown and only had manual twice a day recording. It was also reported that it was first time that patients were involved. Treatment medications were not provided.
This spontaneous report was received from a 39 year old female consumer via company representative referring to herself. The patient was not pregnant. She has a benign brain tumor, had radiation therapy a few years ago and had 3 healthy kids before the tumor was discovered. On 09-AUG-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (1 Dose once, route of administration and lot# were unknown). Concomitant therapies were not reported. On the same day, the patient experienced "serum sickness", had a fever of up to "105 degrees" and was rushed to an unspecified ER (emergency room) for medical attention after receiving an unspecified pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination. She was not admitted to the hospital. "She was feeling better today and was home". The outcome of the events were reported as recovering/resolving. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Developed lower leg petechiae vs mild purpura approximately 48 hours after the vaccination. She had no other signs illness, specifically no fever, malaise, abdominal pain or headache. There was no other bruising or bleeding noted. Seen in clinic 12/9, normal exam other than skin findings. Blood tests ordered.  Skin lesions self-resolved over the following 5 days.
This spontaneous report was received from a physician via a company representative, referring to a male patient, of an unknown age. The patient was diagnosed with "cancer" in an unspecified date. Concomitant medications were not mentioned.  In approximately December 2016 (reported as "about six months ago"), while the patient was in the hospital, he was vaccinated with a shot of PNEUMOVAX23, subcutaneously as a standard protocol from the hospital (dose number, anatomical location, lot # and expiration date were not reported). Subsequently, the patient was discharged from the hospital. The next day, he passed away (death), approximately in December 2016. It was unknown if an autopsy was performed. The cause of death was unknown. The reporting physician stated that he felt that the patient should not have been vaccinated due to his "weakened immune system" and he was not pleased about the hospital's conduct. He felt the hospital should have used individual judgment before vaccination.  No causal relationship between therapy with PNEUMOVAX23 and death was provided. Upon internal review, death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: it was not known what the cause of death was.
Metallic Taste in mouth, heart skipping a beat, chest pain, back pain, general flushing, entire arm with warm flushed feeling at injection site occuring 0-48 hours after injection. Joint pain developed in arm and should one week after the vaccine.
Received COVID vaccine on 1/19/2021 and 12/29/2020 (lot EL0142).  On 4/3/2021 developed fever, body aches, headache, cough, nasal congestion, and mild shortness of breath on exertion.   Tested positive for COVID.
Severe redness, rash, swelling, headache, nausea, muscle weakness and aches, joint pain, shakes
5 in diameter of redness inferior to site of administration. Red/swollen/painful/warm.
patient was only 17 and 7 months old. Moderna is currently authorized for 18 and up.  The system did not flag that the patient was not old enough.  It flagged when he returned for his 2nd dose.  He had no issues from the vaccine.
light redness, about 2 inches in diameter around the injection sit; pain; This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were resolved with sequelae.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient noticed light redness, about 2 inches in diameter around the injection site and also had pain in her arm for 4 to 5 days.
Today, the injection site from her second shingrix vaccine is sore; Vaccine arm is Heavy; first shingrix vaccine 10/25/2021 and then didn't get her second vaccine until 9/12/2022; This 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) (batch number 954kz, expiry date 14th September 2023) for prophylaxis.   Previously experienced adverse reactions included shingles. Previously administered products included Shingrix (on 25th Oct 2021 received 1st dose from batch number ae2j4 and expiry date 30th March 2023, refer link case US2022AMR131967).   On 12th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th September 2022, the patient experienced injection site pain and heaviness in arm. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the heaviness in arm and drug dose administration interval too long were unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the heaviness in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR131967   Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's comment: The reporter is patient self-reported that she received second dose in 12th Sep 2022 (on the day of reporting) on left arm and experienced injection site pain and heaviness in arm. The reporter did not consent to follow-up.  Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule; Sender's Comments:  US-GSK-US2022AMR131967:Same patient- FU 1
Information has been received from a nurse practitioner concerning a 63 year old female patient with sulfonamide allergy and penicillin allergy who on 05-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 664654/0823Y). On 06-NOV-2009 the patient experienced "redness and swelling" from the bicep area to the elbow after vaccination. The patient spoke to the nurse practitioner and was treated with KEFLEX. There was no fever reported. At the time of the report, the patient was improving. Additional information has been requested.
Day after the injection I ended up in bed with low grade fever that would spike, break, and spike.; headache; chills; nausea; joint pain; This is a spontaneous report from a contactable consumer (reported for self).  A 62-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 14Feb2021 at 12:30 (at the age of 62-years-old), as single dose for covid-19 immunisation. Medical history included diabetic and high blood pressure. Patient was diagnosed with covid prior to vaccination. Concomitant medications included losartan potassium, atorvastatin, bupropion HCL, multi vitamin for women and melatonin. Patient was not tested for covid post vaccination. Patient did not receive any vaccine in four weeks. The patient previously took paxil (paroxetine hydrochloride) and experienced drug hypersensitivity. On 15Feb2021 at 09:00, day after the injection patient ended up in bed with low grade fever that would spike, break, and spike, headache, chills, joint pain and nausea. Therapeutic measures were not taken due to the events. The patient recovered from the events on an unspecified date.  Follow-up attempts were completed. No further information was expected.
Sept 19, 2021 - Body aches started around 1pm Sept 19, 2021 - Fever (101), exhaustion and body aches  Sept 20, 2021 - Fever (100.7) exhaustion, body aches, diarrhea, stomach cramping Sept 21, 2021  - Fever (100.7) exhaustion, body aches, stomach cramps, chest pain and sharp pain where heart is located Sept 22, 2021 -  Exhaustion, body aches, chest pain and sharp pain where heart is located
Itching and hives on left back. Did not realise it waz so bad. 1st felt symptoms  About January 26, Went to the dermatologist on January 29 diagnosed  with shingles.  Stress  response  to vaccine?
Swollen, tense red left arm below injection site of DTaP all the way to the elbow. Onset 24 hours after vaccines. Lasted 3 days.
Pt recvd a series of 3 Engerix-B, 1st dose was given -7DEC90 & 3rd given 07MAY91; 02AUG91 Antibody titer was checked & was negative;
Patient experienced fever around 3 A.M. (around 14 to 15 hours) after getting the injection. She started with a fever but after 2 hours later she woke up and could not feel or move anything below her face. She was taken to the hospital to be treated. She was considered quadriplegia at the time of admission. She is now able to walk with a walker/cane. She is going through rehab and per doctor, she should see full recovery within 3 weeks with treatment.
Gave a 4th dose of Pfizer vaccine unknowingly with no adverse reaction onsite
pt recvd vax 8OCT92 & 22DEC92 was seen @ hosp for OM; blood & CSF cult showed no growth, however, CSF was pos for Haemophilus influenza type B;
On Monday afternoon I started feeling pressure behind my ears and in my throat and my sinuses. I woke up the next morning took a test, for COVID-19 and it was positive. My symptoms quickly deuterated. The pain from my ear, head were extreme. I started having difficulty breathing. I had an appoint via telehealth with my doctor around 11 she prescribed PAXLOVID. Around 1 PM the pain was very extreme to the point I couldn't breathe I started hyperventilating. I called the EMT, and they helped me with the breathing. My husband was able to get the prescription, so I started the medication. Within an hour the symptoms started to improve and over the next 7-10 days I started to recover. I started having something like reactive arthritis in my knees. On December 3 I started having sharp abdominal pain in the upper right quadrant whenever I had to use those muscles. It was very painful and lasted for a total of 4-5 days.
Systemic: Fainting / Unresponsive-Severe, Systemic: Patient fainted a few minutes after receiving the vaccination-Medium, Additional Details: Patient was given Pfizer COVID-19 vaccination by RPH.  A few minutes into the observation period, I heard a loud noise that sounded like a fall.  I run outside to find Patient on the floor.  She woke up within a few seconds, 911 was called.  I kept her awake and took her vitals BP prior to EMS arrival= 118/72 mmHg. Upon Fire dept arrival BP= 148/65 mmHG. Transitioned to EMS/Fire Dept.
Acute pulmonary embolism; cardiac arrest; atrial fibrillation with rvr; pulmonary infiltrate right upper lobe; hyperglycemia; This is a spontaneous report from a contactable Nurse (patient herself). A 68-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Dec2020 11:45 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation at a hospital, at 68 years old. Patient is not pregnant. Medical history included hypothyroid from an unknown date. Patient has no COVID prior vaccination and has not tested for COVID post vaccination. Patient has no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute pulmonary embolism, cardiac arrest, atrial fibrillation with rvr, pulmonary infiltrate right upper lobe, hyperglycemia on 21Feb2021 05:00 which required Emergency room/department or urgent care. The patient was hospitalized (unspecified date) due to the events for 4 days.  Therapeutic measures were taken included cardioversion twice and embolectomy. Outcome of the events was recovered with sequelae (with lasting effects) on an unspecified date. Seriousness criteria was hospitalization and life-threatening.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
This spontaneous report was received from a nurse practitioner concerning a 23 year old female patient. Her concurrent conditions included scoliosis. Other pertinent medical history was not reported. She did not have any drug reactions/allergies. Her concomitant medications included ethinyl estradiol, norgestimate(TRI LINYAH). On 11-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot # N021571, expiration date: 29-APR-2020 for Human papillomavirus (HPV) vaccination. On an unspecified date in June 2018 (reported as within 1 week after vaccination), the patient was complaining of excessive fatigue. No treatment was given for the events. A chemistry panel and a blood count were performed, however, no results were provided. She seek medical attention with the nurse practitioner. The outcome of fatigue was reported as not recovered.  The causality between fatigue and GARDASIL 9 was not reported.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at he injection site) and MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. Previously administered products included for an unreported indication: VACCINES (For whooping cough) in December 2020. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Mar-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant). On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at he injection site). On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) had resolved. On 07-Mar-2021, VACCINATION SITE PAIN (pain at he injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. The patient did not receive any treatment medications as it was reported that the pain at the injection site resolved quickly without any medications.
Resident was admitted to our center on 3-18-21.  On 3-19-21 facility received a call from Rapid Response team who offered for residents in our center to receive a vaccination. Resident was interviewed on 3-19-21 was offered vaccine which was given on 3-22-21. During Pre-vaccination checklist resident was asked by rapid response nurse if he had received a vaccination reply again was no, completed questionnaire and administration of vaccine proceeded.  When facility staff went into registry to enter resident information it was noted that resident was administered two shot series of COVID 19 vaccine sometimes in December 2020 and Jan 2021.
2nd dose of Moderna was given at 22 days instead of 28 days as it should have been during a mass vaccination health department clinic.  Patient came 1 week early during a scheduling program change and it was missed that she came on the wrong date due to being between 2 computer systems.  Patient states that only side effect after both 1st and 2nd dose was that she took a nap after receiving each one.
3/30/2021 Injection site soreness for the day of the injection .  3/31/2021 Injection site itching and redness began one day following injection and is ongoing.  3/31/2021 Chills began at roughly 3:30 am on the  day following injection and ended by 8:00 am same day.  3/31/2021 Headache, fuzzy-headedness and inability to concentrate, sleepiness, and mild diarrhea began 8:00 am day following injection  and were fully resolved by 7:00 am on 4/2/2021
47 y/o female patient, was administered fluzone high dose which is recommended for ages 65 and up instead of routine dose
Janssen COVID-19 Vaccine EUA Starting at 1am, I became very cold.  Within about 30 minutes, I was shaking uncontrollably.  This went on for about 2 hours.  Upon taking my temperature orally, it was 103.1 degrees F.  I was sweating and cold.  I then got a headache and muscle aches.  When I stood up, I was very dizzy and was only able to crawl to the bathroom as I felt nauseous (I did not vomit).   I am also breastfeeding a 1month old (delivered via c-section 1/31/22) and my milk supply dropped significantly.  I went from being able to pump 2oz out of one breast to barely 1oz.  As of 3/4/22, this  has not recovered yet.
Following a well visit that included a lab draw and three vaccinations, patient had a syncopal episode that I suspect may have been due to a vasovagal response to pain or a side effect of vaccination. The event was reported to me (ARNP) immediately by our staff and my nurse. LPN reported that the patient was sitting on the exam table for the blood draw from her left AC and then received her TDaP and flu vaccines. Then she received the HPV vaccine and was told to lie down for 15 minutes after. Just as LPN turned to set the vaccine/lab draw tray to the side, the patient let out a small sound and then fell forward from the exam table. Based on the reported mechanism of the fall and the areas in which the patient reported pain (knees and forehead), suspect she first hit her knees and then her head. LOC less than 30 seconds as the nurse reports she immediately returned to consciousness. Mother of patient was just outside of the room making a phone call regarding her own mother when the event happened. Mother of patient was immediately back in the room following the event. Patient was monitored for approximately 1 hour following the event with plans for close follow up. She reported localized knee pain bilaterally, headache, and nausea immediately following the event. Reported pain at 10/10. Patient's legs were elevated and she remained in a lying position with both mother and myself present for 15 minutes. She received a dose of ZOFRAN to help with her nausea and remained in a lying position on the floor with her head cushioned and feet elevated on a chair. 15 minutes later she was slowly brought to a position sitting on the floor and leaning against the cabinets. She received a dose of acetaminophen. Mother was present with the patient. She was rechecked by me 15 minutes later and pain was reassessed and reported to be 6/10. A neurological examination was then performed, first with the patient sitting in a chair and then slowly standing. Nonfocal neurological examination. However, I suspected she may be experiencing early signs of a concussion given the fall and her symptoms of dizziness, headache, and nausea, so I thoroughly discussed concussion protocol with patient and parent. Both verbalized understanding. After the event I had started a VAERS report, but I do not think it was completed as I can't find a confirmation in my records which is why I am reporting this now as it came to my attention that there was not a completed report. Concussion symptoms were slow to resolve. Patient was examined and had three follow up visits for the concussion, the last of which was February 7th, 2018. We had discussed having her see a concussion specialist but per phone conversations things were improving. Patient then was not seen in clinic again until 11/16/2018 with a chief complaint of difficulty focusing and headaches. She previously had a 504 plan at school following the concussion, and the parent was wondering about if she needed additional time for assignments once she starts college. I referred her to neurology and she has an appointment for evaluation 1/14/19.
large 10cm x 8 cm erythematous confluent patch around inject site w/itchy/burning; rash dec in size p/3 days;
35yo female urgent care physician in normal State of Heath when while seeing patients I got lightheaded.  Sat down, drank water, ate sugar cookie for about 10/15 minutes but symptoms persisted. Tried to keep working, but found myself just thinking about how I am going to pass out. No LOC. Evaluates by colleague. Received 2L of IVs (Cr wnl) with transient improvement in symptoms.