chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; Sore arm at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 06-Jul-2020 to an unknown date for Pregnancy.    On 27-Jan-2021 at 8:00 AM, 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 07-Jun-2020 and the estimated date of delivery was 14-Mar-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Sore arm at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Pregnancy test: positive (Positive) Positive. On 08-Jul-2020, Blood glucose: normal normal. On 30-Oct-2020, Ultrasound abdomen: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Estimated date of conception reported as 16JUN2020. No Treatment medications was provided by the reporter.; Sender's Comments: This is the case of product exposure during pregnancy with an associated adverse event for this 32-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
VARIVAX and Flu vaccine given (R) thigh 3/9/17. Mom noticed firm lump Rt. thigh 3/18 and 3/19/17. Redness developed 3/21/17. No fevers. Acting well.
pain in upper back; pain in chest area; legs began to heavy; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in upper back), CHEST PAIN (pain in chest area) and LIMB DISCOMFORT (legs began to heavy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in upper back), CHEST PAIN (pain in chest area) and LIMB DISCOMFORT (legs began to heavy). At the time of the report, BACK PAIN (pain in upper back), CHEST PAIN (pain in chest area) and LIMB DISCOMFORT (legs began to heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DAY AFTER ADMINISTRATION, PATIENT HAD A FEVER OF 101.5 F AND LEFT ARM RED, HOT, SLIGHTLY SWOLLEN AT INJECTION SITE. WITHIN 24 HOURS, FEVER RESOLVED AND REDNESS/SWELLING BEGAN TO RESOLVE.
Upper lip swelling. Treatment in ER: Prednisone 20mg Tab BENADRYL Allergy 25mg capsule. Recovered.
Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache and begin to cough.  I took another dose of cough meds but it didnt work.  That next morning I visited my PCP and my temp was 98.7 when I arrived but the temp elevated to 99.9 while there and another temp was taken shortly after and was 100.8 so I was advised to go back home.  Once home I was so tired and weak I could barely make it to the couch.  My temp  then was 101 so I laid down.  The couch was so bad it caused my throat to begin to hurt.  I lost my taste and sense smell, my body ached so bad it was unbareable and I developed various bruises all over my body still while continue to cough presistantly.  I was off work for about 3 days and those 3 days were the worse days of my life, I was so unconfortable and scared it was almost unbareable I thought I was going to die. And on Thursday the symptoms begin to diminish and by that night it was if nothing had ever happened.
After receiving the vaccine, began to have several canker sores in mouth and upset stomach after eating. After 8 weeks, I was diagnosed with ulcerative colitis (inflammatory bowel disease) which I believe was caused by an immune response to the vaccine since I had no signs or symptoms of this IBD or change in daily habits prior to receiving the vaccine.
12/08/17 at 4 pm: Approximately 5 minutes after receiving vaccine patient was sitting in chair, then complaint of feeling dizziness, nausea, stomach pain. She was assisted to lie flat on exam table. Patient became lethargic, hypotensive, and complained of chest tightness. EMS called and evaluated patient. Patient sent to emergency room with EMS.
Patient received the wrong vaccine due to miscommunication between technician and patient. Patient was the questioned by the pharmacist and another technician prior to vaccination, but patient was not paying attention on which shot he was about to receive.
New right knee pain, ongoing 10 days after vaccination. Patient also reports redness + swelling x3 days after vaccination Other Relevant Hx: & knee pain + injection site reaction
Initial information regarding an unsolicited valid serious case was received from a physician via consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00512481) and transmitted to Sanofi on 10-Mar-2021. This case involves a 60-year-old male patient who had a Guillain Barre syndrome, paralyzed, unable to move his left side at all (hemiplegia), feeling weak (asthenia), unable to hold up the weight of his body, fell (fall), broke C3, loss of sensation on right side, numbness on right side (hypoesthesia) and stroke while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On 19-Feb-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ493AAA, expiry date: 30-Jun-2021) via unknown route in the left arm for vaccination. In Feb-2021, the patient got out of bed and was feeling weak, unable to hold up the weight of his body and because of this, he fell and broke his C3 and was unable to move his left side at all, approximately 12 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On 20-Feb-2021, the ambulance came and took him to the Hospital. They ruled out a stroke and Guillain Barre syndrome (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. On an unknown date in 2021, the patient was experiencing numbness and loss of sensation on right side (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Initially he could not move left side, but now he could move. On 02-Mar-2021, the patient was transferred to hospital out of state due to help gain mobility. The events were assessed as medically significant, and patient was hospitalized for the events. The Caller stated that her stepfather took the flu vaccine and within 24 hours he was paralyzed and is still hospitalized. He is unable to work. The Caller and wife of patient were requesting compensation from the adverse events (AE's) that they feel is a result of the Sanofi flu vaccine. No laboratory data was provided. It was not reported if the patient received a corrective treatment. On an unknown date in 2021, the hemiplegia recovered while outcome of other events was unknown. Sender's Comments: This case concerns 60-year-old male patient who had Guillain-Barre syndrome, hemiplegia, asthenia, weight bearing difficulty, fall, cervical vertebral fracture, sensory loss, hypoesthesia and cerebrovascular accident after vaccination with FLUZONE. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Only adjuvant administered; Only adjuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 5M39B, expiry date 28th May 2024) for prophylaxis.   On 8th February 2023, the patient received the 1st dose of Shingrix. On 8th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The  vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was supposed to received the first dose of Shingrix  but was administered only the adjuvant component of such vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Case number PHEH2015US026990, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Redness,; Arm sore, warm and it has quite red around it; Her upper arm is red in a circle and tender to touch and a little bit swollen; Redness, sorenss and pain in her arm and it may be getting little bit worse; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller received her second dose of Pfizer's COVID vaccine on Sunday. She still has redness, soreness, and pain in her arm, and it may be getting a little bit worse. Caller stated it's been 5 days. Her upper arm is red in a circle and tender to the touch and a little bit swollen. The outcome of the events was unknown on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patient was discovered deceased in her apartment  at 3pm on March 12, 2021.
As a result of the 2nd Moderna booster on June 24,2022, I developed tinnitus the day after injection, including ringing in both ears. The sound is an electronic high-pitched buzzing sound at a medium volume level. Worse at night. Can hear it all the time.
Swelling, redness and muscle pain lasted two weeks and still redness and slight swelling and some muscle pain after 4 weeks.
Information has been received from a physician concerning a 10 month old male who on 2/4/99 and 3/19/99 was vaccinated with the 1st and 2nd dose of Hep-B. In 5/99, at 3 1/2 months of age, the pt developed a left upper lid/orbital lesion. The reporting physician noted "exam is consistent with either a dermoid cyst or perhaps a prolapsed palpebral lobe of the lacrimal gland." On 7/20/99, the pt was vaccinated with the 3rd dose of Hep-B and on 8/18/99, the pt was re-evaluated. The reporting physician noted "today's exam shows lesion to be similar in size to his exam in May. It is much smoother and whiter in appearance, making it more likely that this is a conjunctival or orbital dermoid or epidermoid cyst. Dermolipoma is also a possibility. It is possible that this will continue to grow, but very slowly. Simple observation is all that is required at this point." Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 included PF-07321332, RITONAVIR (PAXLOVID) from 29Mar2023 to 03Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Nausea - lasted about an hour (11:00 am - 12:00 pm) Light headedness - lasted about 15 minutes (10:45 am - 11:00am) Soreness in left shoulder - ongoing (has been sore since 11:00am on 3/16) it woke me up a few times during the night while sleeping.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 27-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ).    Concomitant medications were not reported.   Patient had dose 1 Moderna (Monovalent ) 25 mcg on 19 Apr 2023 (Lot number - AS1903B).  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
pt states the next morning when he woke up his left arm was sore and he had fatigue.  He started having a humming noise like a ringing in both ears.  He had his 2nd dose on 4/12/21 where he had the common symptoms but continued to have the ringing in the ears.  Today on 5/10/21 a month later he is still having trouble with his left ear.  He says it is completely plugged and  feels like there is water in it.  He will contact his PCP for medical advice.
Patient recieved her monthly immune globulin infusion 1/4/12 at the physician's office.  While there she recieved the flu vaccine.  The next day the pt reported a low grade fever.  On Monday 1/9/12 the pt experienced lower extremity weakness.  By Saturday 1/14/12 the pt fell secondary to leg numbness.  Wednesday 1/18/2012 the pt was admitted to Hospital and was worked up for suspected Guillain Barre.
Patient passed out in lobby of clinic.  Front desk staff called RN to lobby.  Patient's face and lips pale.  Patient was able to stand and was assisted to a chair to sit.  Pulse weak upon palpation. Vitals obtained.  Patient brought back to patient room to lay down with feet elevated, Provider notified and evaluated patient.  Patient laying down for approximately 5 minutes, then assisted to sitting.  Patient was provided and drank 8oz water while sitting.  After approximately 10 minutes of sitting patient's vitals were obtained a second time. Patient assisted to stand and was observed for approximately 2 more minutes.  Patient reported feeling ok, no lightheadedness, weakness, dizziness, tingling in extremities, etc.  Patient allowed to leave clinic.
Received influenza immunizations on 11/10/06 (Lot #U2255 AA given by LPN) and 12/21/06 (administered by RN).  She had very mild cold symptoms (slight rhinorrhea) early in January 2007.  On 1/13 she developed ataxia, fatigue and leg pain.  She had then progressive weakness and pain (legs/arms/back) and then frank refusal to bear weight.  She was hospitalized on 1/16/07. She had an LP and nerve conduction velocities done on 1/17.  LP with elevated protein and no pleocytosis and EMG revealed prologed nerve conduction velocities.  She was diagnosed with Guillain-Barre Syndrome and received 5 days of IVIG.  She was discharged on 1/24/07 still with weakness and refusal to bear weight, but her truncal ataxia was improved as was her pain.  She was discharged home on Neurontin and with physical therapy. 2/2/07 Received medical records from hospital which reveal patient experienced inability to walk, leg pain, hip pain, back pain, arm pain, malaise & constipation.  Patient had significant left hip pain w/touch or movement. Parents reported a couple of weeks prior to onset of s/s patient had mild URI in addition to having flu shot 1 mo prior.  Admitted 1/16-1/24/07 for probable toxic synovitis; constipation; & low grad emp.  Ortho consult done to r/u septic hip which was ruled out.  Neuro exam revealed areflexia by 1/17.  Tx w/5 course IVIG w/significant motor improvement.  D/C to home w/PT & to f/u w/PCP & neuro. FINAL DX: Guillain Barre Syndrome. No CSF labs or report of NCS included.  T/C to medical records.  Unable to locate.  Request refaxed. Per information received from annual follow up, she has recovered complete motor control. Still does not have reflexes in lower extremities bilaterally. She is still recovering. She is in physical therapy and has residual weakness in her legs.
vaccines have surfer multiple temperature excursions; No adverse event; vaccines have surfer multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions).    No concomitant medications were reported. It was reported as unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine No treatment medications were reported.
A nurse reported that a 6 year old received the first dose of Acel-Immune, as well as Orimune and MMR vaccines on 04/26/00 and subsequently, developed a rash on the upper right arm, site of Acel-Immune administration. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Acel-Immune lot 467-674.
This spontaneous report was received from a medical assistant regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported.  On 22-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter.  Additional information has been requested.
Within 24hours tenderness & sensitivity to left side of stomach area. Next day rash developed & continued to develop for next several days around middle to back (left side). Diagnosed with shingles on Nov 1.