chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The vial was left in the refrigerator for 31 days. The dose was given on the 31st day, 1 day past expiration.
Within one hours of injection,child became irritable/fussy- not herself. She did not sleep that night. Irritability/fussiness and sleep problems lasted for 5 days and then resolved
Redness and warmth at site of injection. Noticed symptoms this morning upon waking.  Afebrile.  Started on doxycycline 100mg bid x 10 days and Benadryl 25mg qhs.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.  Treatment details included Benadryl and Singulair.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Rash is consistent with the known safety profile of the vaccine.
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001918.
Patient was inadvertantly given 0.3 ml of undiluted Pfizer vaccine. Patient was called twice immediately after this was discovered to notify her of the error. She did not answer either call. A voicemail was left with instructions to call back ASAP with the store number and my cell phone number. I will continue to call the patient until she answers. I will tell her what adverse effects to watch for and what do if she experiences them. She will be given my cell phone number to call if she has any further questions. I will plan on checking in with her later today and several times over the next few days/weeks.
Ten days after vaccination, after initial mild swelling, and pain resolved, a large red area that was in the same place as the original redness and swelling, appeared on my arm. No discomfort or itching. Lasted about a week and is fading 8 days later.
Bivalent vaccine given from vial that was opened on 10/14/22. Vaccine vial stored in refrigerator since opening and would have expired after 12 hours.
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB for prophylaxis, lot #N024572 and expiration date 02-MAY-2020 and lot #R000877 and expiration date 24-SEP-2020 (strength, dose, frequency and route of administration were not reported); with improperly stored PNEUMOVAX 23 for prophylaxis, lot #N030987 and expiration date 15-MAY-2019 (strength, dose, frequency and route of administration were not reported); with improperly stored ROTATEQ orally for prophylaxis, lot #N034401 and expiration date 09-MAY-2019 (strength, dose, frequency were not reported) and with improperly stored VAQTA for prophylaxis, lot #R002086 and expiration date 22-APR-2019 (strength, dose, frequency and route of administration were not reported). The temperature of excursion was reported as 33° degrees Fahrenheit (°F) to 35°F (32°F) during a time frame of 39 hours. No previous temperature of excursion was reported. There was a digital data logger involved. Follow up information has been received on 04-OCT-2018. A phone call was placed to medical assistant in regards to product storage issue involving LIQUID PEDVAXHIB, PNEUMOVAX 23, ROTATEQ and VAQTA. The practice manager answered the call. She explained those vaccines were "VFC-owned, vaccines for children, and they would have to able to release that information. Tons of children were vaccinated with them.
left arm swollen and 2.5 cm X 4 cm redness at injection site. Patient stated, "it started swelling yesterday, and it was warm to tough." No worsening symptoms noted. patient was given instructions about comfort measures, and was advised to seek medical interventions if symptoms worsens or failures to resolve.
tired hot fast heart rate; tired hot fast heart rate; tired hot fast heart rate; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (tired hot fast heart rate), HEART RATE INCREASED (tired hot fast heart rate) and FATIGUE (tired hot fast heart rate) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) Unknown. On an unknown date, the patient experienced FEELING HOT (tired hot fast heart rate), HEART RATE INCREASED (tired hot fast heart rate) and FATIGUE (tired hot fast heart rate). At the time of the report, FEELING HOT (tired hot fast heart rate), HEART RATE INCREASED (tired hot fast heart rate) and FATIGUE (tired hot fast heart rate) outcome was unknown.            Reporter did not allow further contact
Information has been received from a physician concerning her 9 year old daughter who on 03JUL1997 was vaccinated with a dose of varicella virus vaccine live. On 07JUN2004, the physician reported that her daughter developed a chickenpox like rash with about 80 pox and nasal congestion over the last 48 hours. No medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Additional information has been requested.
Information has been received from a LPN concerning a 75 year old Caucasian female with allergies to codeine, "Epi" and verapamil hydrochloride (Calan) who on 11/18/03 was vaccinated IM in the left deltoid with a first dose in of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N). There was no illness at the time of vaccination. On 11/19/03, the pt developed left arm pain, swelling, tenderness and was unable to use her arm. Treatment included anti-inflammatories and pain medication. Medical attention was sought. It was unknown if the pt had recovered. The reporter also mentioned (WAES # 0311USA00842 N& 0312USA00976) who experienced similar reactions after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
One week after injection, developed warm, itchy rash at site.   About size of a baseball.   Applying Cortisone  cream.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cellulitis-Medium, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: patient came into pharmacy,indicating she was getting an antibiotic for cellulitis in left arm where covid shot was given. she said alcohol pad must not have worked
09/02/22 presents to ED as transfer for "GI bleed". PMHx of "stage 4 pancreatic cancer"
an adult received "MMR administered IM not SQ."; This spontaneous report was received from a registered nurse via company representative referring to an adult patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, vaccine dosage detail, lot# and expiration date were not reported) via intramuscular (IM) not subcutaneous (SQ) for prophylaxis (incorrect route of product administration).
During morning shower noticed pain in left shoulder as I raised my arms to towel dry my hair.  Area of injection site swollen and hot and feels bruised. Significant pain in the front of the shoulder when moving the left arm.  Cannot fasten seatbelt.  Achy feeling in left arm down to elbow and also radiating into left side of neck.  Vaguely achy feeling all over.  Taking ibuprofen which helps the achiness, but the shoulder pain is still significant when trying to use the arm.  There was a lot of itching at the injection site right after the shot which the pharmacist said was normal.  My daughter got an injection the same time as I, and she had no adverse effects, just a little hive at injection site.  I have not called a doctor, but I will if it doesn't get better in a couple of days.
pt experiencing redness around injection site which has expanded significantly, and swelling like a golf ball. pt is concerned imz was administered too low
sore arm, by evening arm was swollen and she couldn't raise arm over head. Had to call off work.
2 to 3hrs p/vax pt was pre convulsive pt had glazed eyes & was trembling, jumpy, irritable, sensitive to nl sounds & bright light;pt was seen by MD on the afternoon of 26FEB;trembling cont x 24hrs;3 days later still edgy & startled easily
slight fever; 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 PYREXIA (slight fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (slight fever). At the time of the report, PYREXIA (slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
20 minutes after injection, student complained of mild itching at injection site - slight rash noted. No swelling or pain.
Had immunization on 07/02/02 at 1:30pm. Mom noticed rash at 10pm, face, heck, stomach, legs. Fussy. At HD 10am 07/03/02 now has whelts red raised on lower legs.
Next morning, she felt horribly sick/terribly ill after booster of Moderna; She had chills; She had nausea; She had fever; She had headaches.; She was vomiting.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever) and HEADACHE (She had headaches.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever), HEADACHE (She had headaches.) and VOMITING (She was vomiting.). At the time of the report, ILLNESS (Next morning, she felt horribly sick/terribly ill after booster of Moderna), CHILLS (She had chills), NAUSEA (She had nausea), PYREXIA (She had fever), HEADACHE (She had headaches.) and VOMITING (She was vomiting.) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Include significant information include consent denied by the reporter and new event terribly ill after booster dose is mentioned in events tab.
Day after vaccination - fatigue, headache, nausea, sore arm muscles that later turned into muscle spasms/knots in upper right arm, shoulder and neck (all on right side). Pharmacist mistakenly noted left arm as injection site.
Severe nausea and vomiting, general malaise, chills and sweats.  Nausea has continued now for 4 days, haven't been unable to eat much, profound anorexia.
The rash came on approx 30 min after vaccine.  It was barely visible, not raised  and was non-puritic. Limited to forearms. She had no injection site findings. She stated she felt fine. She had no cp or sob or cough.  No tongue or lip swelling.  Bp 130/80 and HR 90/min. Lung cta and heart sounds normal. Benadryl givenand resolved within 10 min
1 day p/receiving 2nd dose of vax pt arm became red, swollen, hot & sore; tx w/DPH & sx resolved p/4 days;
Felt Stiffness was coming back when over did yard work; Vaccination site reaction was larger and lasted longer; soreness at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Felt Stiffness was coming back when over did yard work), VACCINATION SITE REACTION (Vaccination site reaction was larger and lasted longer) and VACCINATION SITE PAIN (soreness at vaccine site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Felt Stiffness was coming back when over did yard work), VACCINATION SITE REACTION (Vaccination site reaction was larger and lasted longer) and VACCINATION SITE PAIN (soreness at vaccine site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Felt Stiffness was coming back when over did yard work) was resolving and VACCINATION SITE REACTION (Vaccination site reaction was larger and lasted longer) and VACCINATION SITE PAIN (soreness at vaccine site) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter  It was unknown if patient was enrolled in a trail..   This case was linked to MOD-2022-580297 (Patient Link).
COVID vaccine - booster was given too soon - last dose of primary was given 11/16/2021 - grace period would have allowed it to be given 4/12/21 and was given 4/11/2022  Tdap vaccine - patient was inadvertently given vaccine twice on 4/11/2022  Patient did not display any signs or symptoms of any adverse reaction.  He was instructed to monitor for any symptoms of medical problems and seek medical care if any come up
I went into atrial flutter on the 02/28/2021. Which lead to heart surgery.
Erythema, swelling, and itching to area around injection site which spread over entire upper arm.
A dose was administered from a vial that had been opened for more than 12 h; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered from a vial that had been opened for more than 12 h) in a 73-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-May-2022 at 1:15 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022 at 1:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered from a vial that had been opened for more than 12 h). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was administered from a vial that had been opened for more than 12 h) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Joint pain and stiffness started on 2/03/23 in neck, shoulders, elbows, wrists, hands and knees. Progressed to include jaw and hips on 2/09/23 and pain and stiffness worsened.
Breakthrough case admission after 4 vaccines Pfizer 4/8/21 Lot# En6201;  Pfizer 4/29/21 Lot# EM9810;  Pfizer 11/9/21 Lot# EW0179;  Pfizer 5/31/22 Lot# FG3527
Patient several minutes after vaccination began to develop some redness on her chest/face.  Stated she had covid in Feb-March and after recovering has been having intermittent histamine reactions/hives (particularly around menses/stress events).  She denies any current med use other than Benadryl to treat these reactions.  Patient began to visibly sweat and stated she felt high.  Her "lazy" eye began to drift as she stated it does when she's had alcohol, which was confirmed by observation her right eye was drifting left across her central plane.  I notified the other manager on duty for back up in case further help would be needed ( No tech on duty at this time)  I gave the patient an ice pack to hold against the back of her neck and observed her.  Patient stated she was feeling light headed.  I then helped her lay down on her back with legs elevated which helped.  A kind retired nurse came to my aid and helped with BP readings and keeping the patient relaxed and calm.  First BP reading at 1:30 120/80 while prone, Pulse 61.  Flushing still noticeable and consulting with patient and assisting nurse patient agreed to take 12.5 Benadryl liquid (no one to drive her home, son aged 13 was with her and was calm during this event).  1:36 pm we moved patient into a sitting position on floor BP reading 117/70 pulse 68.  1:39 pm. Patient is moved into a chair with help and bp is stable, Patient continues to deny breathing problems and dizziness has resolved. Patient was instructed to take 12.5 mg at home immediately and that pharmacy will follow up with her.  Pharmacist (me) recommended predosing 30 minutes to 1 hour prior to second vaccine to be given no later than 9/09 (42 days) due to reaction taking a larger space between shots would be preferred or at least the minimum of 28 days.
Administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Cough developed the next day after vaccination.  A 3 by 5 inches bright red spot also appeared below injection site but not itchy.  Cough and red spot lingered 6 days. Patient did not seek any medical treatment.
within approximately 5-10 minutes from receiving the injection I experienced severe itching all over and redness.  As time progressed I further experienced swelling and tingling in my face and lips.   The doctor's office provided an initial dose of Benadryl before allowing me to leave the facility.  I then took additional Benadryl to further relieve symptoms.  All symptoms had resolved within 2 1/2 hours.
It is documented that the patient received the Moderna Booster vaccine, but they are under 18 at time of getting it. Appointment was made for Moderna as well
After shots were given - immediately Pt laid head in moms lap and began to make an odd noise - I jumped up and hugged patient around trunk and she jerked her head back and started to move uncontrollably. Moved all equipment away and eased patient to the floor and placed her feet up above her head.  Mom helped to secure patients head and called for help of RN Administrator and she came and called for ambulance. Pt had incontinent episode and urinated in the floor while arms and legs and body violently moving and jerking in the floor. This went on for about 2 minutes and then patient sat straight up and was very lethargic and disoriented.  Started to come around and was asked by RN CDNS if she had had anything to eat this a.m. and patient stated "pretzels". Pt started getting very nauseated and started dry heaves with no production.  Ambulance arrived at approximately 9:08 AM patient was able to stand with assistance but was very weak and ambulance driver lifted the patient to the gurney and patient was placed on gurney and was taken to Medical Center for further evaluation.
2 inch circumference raised, red hive-like area that appeared within 24 hrs at site of injection.  Remained for over 48 hrs with no other complications.  Had annual flu vaccines throughout life with no previous reactions.  Sister vaccinated at same time had a milder, but similar reaction at same time as well.