chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a re refrozen dose of the vaccine; Patient received a re refrozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re refrozen dose of the vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23C21A) for COVID-19 vaccination.  No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re refrozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re refrozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender,  with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender,  with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
No more than 5 minutes after receiving the vaccination, the patient felt a little disoriented and started to lose her balance. She said her chest felt weird and she had trouble hearing. Her grandmother said she was feeling very hot and the patient started to sweat. About 20 minutes later the patient started to feel better and said she couldn't remember what her grandmother was saying to her.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: "silty taste in mouth"-Mild
Very sweet pleasant lady brought in from her independent living after a fall. She was seen by trauma- no acute injuries. Today, she is ambulating without pain with full room of shoulders elbow/ wrists/ hips/ knees/ ankles. Head ct and c spine ct without acute change She did test incidentally covid positive. Inflammatory markers are minimal> CXR negeative- she has NO cough, sore throat, congestion etc. She may return to her assisted / independent living with ongoing care.
102 fever which spiked at 103.8 and resulted in a febrile seizure lasting 5+ minutes.
pt recvd vax; 1dec94 high fever & loss of appetite; 8dec t 105, swollen eye lids; 15dec & 16dec high fever, convuls, passed out, listless;
Been diagnosed at hospital Er with  Bells Palsy. treatment was  prednisone and valacyclovir pills.
DTaP given instead of Tdap. No adverse effects - per step-mother 11/06/07.
Breakthrough case admission after 2 vaccines Moderna 7/21/21 Lot# 078C21A;  Moderna 8/18/21 Lot# 002F21A
Information has been received from a physician concerning a male who was vaccinated with a "single dose" of Zostavax. Subsequently the patient experienced a "shingles reaction" on his shoulder. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 29-MAY-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
The patient stated she had rashes on both arms and torso. It spread to full body and caused hand swelling and temporary throat swelling
Severe lower back pain, still persistent a week later. Breathing feels short. Tiredness even after 1 week after the shot
arm was sore; tired/very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) and FATIGUE (tired/very tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lyme's disease, Fibromyalgia and Blood pressure high. Concomitant products included CLONAZEPAM, LISINOPRIL and PAROXETINE for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and FATIGUE (tired/very tired). In May 2021, VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, FATIGUE (tired/very tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-251831 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information include  action taken reassessed from unknown to no change and outcome of pain in arm updated from unknown  to resolved  which was missed to be captured in initial version and narrative updated
Patient received monovalent covid booster dose when monovalent booster is no longer recommended by the CDC as of this date. New bivalent booster is recommended instead.  No adverse symptoms.
Within  minutes my face flushed beet red and hot to the touch, which lasted from about 11:26 to almost 8 pm. Within minutes in addition to the face flush  my arthritis pain spiked in my left wrist, and is still worse than the pain was prior to the MRNA. I am having some  runny nose which started later in day of vaccine as well. On that day at one point when I ran up the stairs my breathing felt heavier than normal.
Pt had chills in the evening, very dizzy and heart beating fast/racing. The pt was still very dizzy and blood pressure was high the next day when he came in. I told the patient to take some acetaminophen and rest and give it another day and to call md if symptoms got worse or did not improve in another day.
pt recv vax;webbing over lt eye,floaters;pressure on eye & HAs;deteriorating acuity;macular degeneration;
Left thigh: 8x9cm erythema with central injection mark; tender to touch; 101.3 temp
Patient should have received the pediatric dose for 5-11 years old but patient was given the dose for 12+ years old.
Approximately one week ago, I had what I thought was a bug bite on my stomach.  Very itchy and looked like a large red bite.  However, over the next few days the 'bites' spread over my stomach area and down into my inner thigh and pubic area.  I commented to my husband that it looked like I had the measles.  Having had shingles years ago, and even though the 'bites' presented like shingles, I ruled that out since it was on my stomach (an atypical shingles site).  I considered going to my dermatologist, however it seems to have subsided over this week.  I just read a report that there have been cases of exactly what I have - except they seemed to occur sooner after the vaccine than mine did.   Just think it may be a useful piece of datum as you track side effects and reactions.
Swollen lymph nodes in right arm pit; Painful lymph nodes in right arm pit; Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old-non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 02May2021 at 16:30(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00,the patient experienced swollen and painful lymph nodes in right arm pit and also experienced body aches and chills. The clinical outcome of the events swollen and painful lymph nodes in right arm pit, body aches and chills were recovering.  No follow-up attempts are needed. No further information is expected.
A physician reported that a 40 year old female received an injection of TD Toxoids Adsorbed, Purogenated in 10/00. Subsequently, the pt experienced a "loss of strength in her right arm due to possible intratendinous or nerve injection".
Redness, swelling at injection site - radiating around arm, seen in ER. Dx cellulitis per mom. Ct. received 4 shots (2 in each arm). Arm dx with cellulitis was (L) arm - received PEDIARIX and MMR.
Patient reports tingling in both arms and legs and tingling in the tongue. Her physician prescribed prednisone 10mg.
pt recvd vax & c/o tremors in Lt arm & tingling in Lt hand; also c/o SOB, & tiredness(weakness) & chest tightness;
Presents with redness warmth and tenderness to the touch including pain and swelling in the left upper extremity at injection site,
Mild Fever, Feeling tired and dizzy; mostly after 8 pm for two days in a row
Pt phones provider's office reporting redness to left arm. Pt states redness is "a couple inches diameter around injection site and a spot below it", a bump on injection site and a line under his arm. He reports temp of 99.2 F starting last night, "went down since then", stiff fingers and cramping in the arm. Pt denies adverse reaction/allergy to vaccine in the past. Per Dr., pt having an immune response to the vaccine as it has been within 24-48 hours from when the vaccine has been received, have pt ice area, draw a line around the reddened area and monitor it for increasing redness outside the marked line, pt can take ibuprofen as well. RN phones pt with Dr. further direction, pt verbalizes understanding and is agreeable to plan. RN advises pt to call provider if redness increases outside of line drawn, temperature increases, arm becomes warm to the touch, symptoms do not improve. Pt verbalizes agreement to do so if needed. Pt denies further questions/concerns/needs at this time.
Hives were found all over my entire stomach, buttocks, and thighs.  The hives on my thighs caused swelling over the rashy areas.
Woke up the following morning after receiving the vaccine with golf sized lump at injection site, pain, redness, warmth and developed a fever of 100.2-100.4 for 2 days (4/19/12-4/20/12).
no fever;mom said seizures for next 24hr-approx 30x; describes sudden sitting up, waking w/a jerk;stops breathing; in hosp x 24hr; no tests done;
Employee was found unresponsive in floor at her home. EMS arrived and person had expired.
aches; fever; We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Jun-2023, the patient experienced PAIN (aches) and PYREXIA (fever). 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023). At the time of the report, PAIN (aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Dose was moved from the freezer to the refrigerator on 16-MAY-2023. It was unknown that patient took any medications or treatments to try and help with those symptoms.
Pt has had significant generalzied weakness and a bloody nose that persisted for over 10 minutes.
Pt received varicella vaccine on 8/1/05. Returned on 8/3/05 for PPD reading and CXR and INH initiated on 8/10/05. Returned 8/13/05 for scheduled physical with diagnoses of well child. Returned to clinic 8/22/05 covered in blisters- diagnosis varicella. Plan-use Benadryl, Quarantine until last one scabbed, clean nads, reported to CD.
Patient notified staff that she had received Pfizer covid 19 booster on 10/11/22. Patient stating she is interested in receiving Pfizer Bivalent booster vaccine. Pfizer Bivalent booster administered o 12/16/22. Data states vaccine received on 10/11/22 was Pfizer bivalent booster.  Phone call to patient to notify of vaccine administration error. Informed patient that data records show she received Pfizer Bivalent booster on 10/11/22. Per patient information must have been entered wrong due to her being told that she was receiving a covid vaccine booster and not bivalent booster. Patient states when she received her vaccine in October, she asked if the vaccine administered was the new covid vaccine. Patient states she was told it wasn't. Per patient, she was told that it was the covid vaccine booster and that they didn't have the bivalent booster. Patient went on to say that she was disappointed because she was hoping to receive bivalent booster that day. Patient disclosed, that is the reason why on 12/16/22 when she approached us at the event, she made sure to ask that the vaccine we were administering was in fact the bivalent vaccine, and not a booster vaccine. Patient denies any rash, sob, difficulty breathing. Patient denies any other symptoms such as: head ache, body aches, fever, pain, redness or swelling to injection site. ER precautions given. Patient verbalized understanding and denies any questions at this time.
Approximately 25 minutes after receiving the dose she felt nauseous and mildly dizzy.  Settled her to a guerney.  BP was 72/44, HR in the 60's, O2 sat 98%.  She did not develop other symptoms or distress, with those noted resolving to very mild dissiness at the time we brought her to ED at approximately 0840.  Her vitals resolved to BP 101-66, HR 84, RR 16, 100% O2 sat on Room air
11-19-09 had DTAP and H1N1 vaccine 11-21-09 developed hives on face, trunk, extremities, no edema noted 11-21-09 evaluated at clinic @ 1pm given PREDNISONE rx 11-24-09 pediatrician ordered BENADRYL rx was on AMOXICILLIN for otitis media R ear. To follow up @ pediatrician on 12-2-09
3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm broke out in full body hives, very red and became flushed and hot
No additional AE; The interval between the first and second dose was outside the recommended time range; This spontaneous report was received from a physician concerning a 16-year-old patient of unknown gender. Informaiton on concurrent conditions, medical history or concomitant medications was not reported.   On 20-OCT-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mL for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). The patient received the second dose outside the recommended time range on 20-FEB-2017 (Inappropriate schedule of product administration). The interval between the second and third dose was under the recommended time range, as it was administered on 20-APR-2017. No adverse event was reported.
runny stool - started one day after injection - has continued for two days --  pain in bowels prior to bowel movement.; runny stool - started one day after injection - has continued for two days --  pain in bowels prior to bowel movement.; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 06Feb2021 as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced runny stool-started one day after injection has continued for two days, pain in bowels prior to bowel movement on 08Feb2021. The patient received any treatment for the events. The patient did not received prior vaccination and Covid tested post vaccination. The patient known allergies as no. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Breastfeeding; Felt Sleepy; Sore arms; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding), SOMNOLENCE (Felt Sleepy), PAIN IN EXTREMITY (Sore arms) and FATIGUE (Tiredness) in a female 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding), SOMNOLENCE (Felt Sleepy), PAIN IN EXTREMITY (Sore arms) and FATIGUE (Tiredness). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding), SOMNOLENCE (Felt Sleepy), PAIN IN EXTREMITY (Sore arms) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported   This case was linked to MOD-2021-225149 (Parent-Child Link).   See case ,MOD-2021-225149 for details regarding the child case.
Pt also reported that she received Pfizer vaccine to R upper extremity on 8/7/2021. On 8/9/2021, she noted several non-painful "yellowish bruises on her R side only. -1 pinky size yellowish bruise on R shoulder -1 dime size yellowish bruise above R elbow -1 dime size yellowish bruise in R thigh - 1 dime size yellowish bruise above R knee - 1 dime size yellowish bruise below R knee, -1 dime size yellowish bruise at R shin and - 1 dime size above ankle.  Pt with no significant PMH. Denied headache, or any. Stated this was first noticed on 8/9 but as of 8/12 had started to fade - patient was referred to PCP and hematology for further f/u. Patient
After second dose of comirnaty patient developed life threatening adverse reactions which ended up being terminal; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "After second dose of comirnaty patient developed life threatening adverse reactions which ended up being terminal". Event took place after use of product. The patient date of death was unknown. The reported cause of death was "patient developed life threatening adverse reactions which ended up being terminal". It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient developed life threatening adverse reactions which ended up being terminal
Information has been received from a physician concerning an approximately 44 year old female with hypothyroidism, Addison's disease, and allergies to iodine, novocain, PABA and penicillin who in 1985 was vaccinated with a second dose of Pneumovax 23. Subsequently, in 1985, the patient developed cellulitis at the injection site. The patient was "probably taking" a steroid and thyroid medication at the time of the vaccine. The patient also received Pneumovax 23 in 1984 but did have any adverse experiences. Subsequently, the patient recovered from cellulitis at injection site. Additional information has been requested.