chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; getting more and more sick, it is getting worse as the day goes; stomach problems; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), ILLNESS (getting more and more sick, it is getting worse as the day goes) and ABDOMINAL DISCOMFORT (stomach problems) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C2HA) for COVID-19 vaccination.     The patient's past medical history included Back surgery (2 back surgeries) since an unknown date. Concurrent medical conditions included Hypertension, Epilepsy, Spinal cord disorder (Spinal problem) and Seizures.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), ILLNESS (getting more and more sick, it is getting worse as the day goes) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (stomach problems) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), ILLNESS (getting more and more sick, it is getting worse as the day goes) and ABDOMINAL DISCOMFORT (stomach problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified seizure medication, blood pressure patch and pain medicine.  No treatment products were reported.  Patient had her first dose on 20 May 2021 in her right dominant arm. On 21 May 2021, patient experienced nausea, getting more sick and worse as the day goes stomach problems. Patient called her family doctor but doctor was left for the day. Patient wanted to knowwhat to do about her side effects. Patient provided her doctor's contact information and permission to contact her doctor. The patient had her first dose in her doctor's office. No treatment medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt received the Pfizer Bivalent 5-11yr old vaccine as dose #3. Pt received a 12+ bivalent vaccine at an outside facility in 12/2021. Did not receive 2 age appropriate monovalent doses.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose,route, anatomical location, lot# and expiration date were not reported).  On an unknown date (reported also as "at later time"), the patient received another dose of ZOSTAVAX 19400 PFU (dose, route, anatomical location, lot# and expiration date were not reported). Both vaccines were reconstituted with sterile diluent (MRK). No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient; it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured). On 17-Jun-2021, EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 Contains No significant information
Developed a rash under both breasts - sl itchy - no pain -started 2 days after High Dose Flu shot.
COVID 19; COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: AMIODARONE. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "recovering", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "recovering", described as "COVID 19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Treatment start date was 28May2022 and treatment stop date was 01Jun2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N001007, 1 DF, intramuscular for prophylaxis. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.; Sender's Comments: US-009507513-1708USA013507:
10 days after booster I broke out with hives and itching on the back of my scalp.  I showered and then my arms and legs and chest starting itching and breaking out with hives.  that evening (12/28/21) I took over the counter benadryl and Aveeno topical itch cream.  Monday morning (12/29/21) I was seen by an Physician at Urgent Care who stated that it appeared to be dermatitis and said I could treat it with OTC medicine (benadryl and hydrocortisone cream).  Early Tuesday morning  I was in pain all over my body which felt like I was sunburned and itching from the bottom of my feet to the top of my head.  I awoke and my left eye was swollen and one of my hands was swollen and I had hives rash blotches on different parts of my body.  On Tuesday morning (12/30/21)  I was seen by a different practitioner at Urgent Care who gave me a steroid shot in the read and prescribed me daily Presidone, Famotdine and instructed me to start taking Clartian daily and Benadryl in the evenings and to use Hydrocortisone cream as a topical treatment.  I then saw my PCP Dr. on Friday (12/3/21)  who instructed me to continue on the prescriptions that were prescribed but that I could take Claritan 2x a day if needed.  I stopped taking Presidone after 5 days, stopped taking Famotdine after 5 days and continued taking Claritan 2x a day and Hydrocortisone cream.  I saw an allergist on 12/21/21 who said I should stop taking Claritan and start taking Zyrtec daily, which I am continuing to do up to this point.
Terrible headache started morning after shot, continues now second day after. Tiredness and lack of appetite. Pain reliever doesn't help.
Patient was given moderna booster dose out of vial which was punctured 28 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given moderna booster dose out of vial which was punctured 28 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given moderna booster dose out of vial which was punctured 28 times). On 20-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given moderna booster dose out of vial which was punctured 28 times) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
I recovered from Covid-19 in Aug 2020 and took the two Pfizer vaccines, where the last one was on May 12 2021. I wanted to report that since the second vaccine I have been having muscle issues for three months now (muscle weakness for a month and a half, then stretched muscles for more than a month and I almost couldn't exercise for 3 months). Unfortunately, it was not written that the vaccine can have such long term side effects. In addition, a few days ago I received the Covid-19 antibody test result and I have 120 times more antibodies than required (18086.1 AU/mL). In my opinion, people that recovered from Covid-19 should receive one vaccine as they do in other countries.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) reported that the patient received a dose of SHINGRIX and then the patient experienced active Shingles. No additional information was provided.
Tues 1/5/21 heart flutter feeling shortly after vaccine administered (within 10 min.- went away Dizziness approx. 30 min later-went away 4pm- headache, dizziness, pain at injection site, lower back pain, scapulae pain 10pm-5am- chills, no fever  Wed 1/6/21 shaking chills in/out of shower despite hot water; chattering teeth Chills and freezing all day at work- wore scarf all day and had personal heater directly on me as well as hospital heat- still freezing Felt feverish at times, though did not check temp, no sweating headache all day, severe achiness at injection site, scapulae area, lower back, hips, joints- Took Tylenol throughout day/eve Eve took 2 hr nap then bedtime around 10:30pm Shaking shills all night long/ more like rigors; husband woke me up to ask if OK as I was shaking entire bed. Freezing feeling continued No fever, did not feel hot; short time later completely soaked- nightshirt, blankets, hair as if I had been in shower  Took Tylenol  Thursday 1/7 Headache, achiness severe Continued feeling freezing cold ( I am NEVER cold)- could not get warm despite covered with blankets Took nap then went to bed  Friday 1/8  woke with headache still- Tylenol though does not take away headache- have had continually since vaccine blisters on upper lips; blisters under both nostrils; swelling, pain of mucous membranes in nose L arm injection site red, very warm Entire upper arm hard and swollen  Still with symptoms as of 8pm this eve
Numbness along entire right arm Extreme fatigue (10 days) High fever (5 days) Extreme dizziness (9 days) Nausea (9 days) Inability to. Maintain balance while standing (9 days)
Cold sweats, dizzyness, nausea, almost fainted (hearing got muffled, vision was fuzzy)   All in the first 5 min then about 15 min later another bout of cold sweats and nausea.
On August 21, 2007, patient recieved Gardasil vaccination in left upper arm, while seated on eximaning table.  Immediately felt arm pain, then almost immediately after that, within approximately 2-4 seconds, felt extreme dizziness, had profound headache, and stated that vision "went black" momentarily, and that her hearing also faded out.  Felt as though she would lose consciousness.  Became very nauseated, and had extreme pallor, and profuse sweating.  Was helped to lie down, on her right side, on the examining table on which she was seated.  Hearing returned to normal quickly after this, but dizziness, nausea, headache, and sweating continued for about 15 minutes. Patient then felt able to sit up, but still felt unwell, although no longer felt as though she would lose consciousness.  Drank some sips of water.  Was able to stand and walk within about 15 more minutes, and left doctors office ambulatory and unassisted at approximately 11:00am.  Headache, however, and a minor nausea and extreme fatigue, lasted throughout the rest of the day.  Had patient not already been in a doctor's office, she would have been taken to one for these very serious syptoms, hence the answer to question #8.
Pt recv vax on 6/4/97; on 1/10/99 pt exp viral infection of flu-like sx, rash on left shoulder to wrist, LA pain; dx=shingles
pt ran fever & became listless; all extremities look mottled upon report to nurse; advised visit to MD for eval of sx;
unstable blood pressure; bruised left finger/ bruised right arm; pink eye; hyperventilated; rosacea; hives; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives), CONTUSION (bruised left finger/ bruised right arm), ROSACEA (rosacea), EYE COLOUR CHANGE (pink eye) and HYPERVENTILATION (hyperventilated) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Drug allergy (Severe allergic reactions to Cefaclor 10 years ago causing near death). Concurrent medical conditions included Blood pressure high, COPD, Arthritis (RA, psoriatic), Osteoporosis (Osteoporosis of hip) and Spinal pain (chronic spinal pain).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VOMITING (vomiting). On 10-Apr-2021, the patient experienced URTICARIA (hives). On 13-Apr-2021, the patient experienced ROSACEA (rosacea). On 16-Apr-2021, the patient experienced EYE COLOUR CHANGE (pink eye) and HYPERVENTILATION (hyperventilated). On 06-May-2021, the patient experienced CONTUSION (bruised left finger/ bruised right arm). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (unstable blood pressure). At the time of the report, URTICARIA (hives), CONTUSION (bruised left finger/ bruised right arm), ROSACEA (rosacea), EYE COLOUR CHANGE (pink eye), HYPERVENTILATION (hyperventilated), BLOOD PRESSURE ABNORMAL (unstable blood pressure) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information included administration of Decadron injection on 13-Apr-2021 and 16-Apr-2021 for severe allergic reactions.
She was diagnosed with metastatic pancreatic cancer at the end of January 2023 and opted for no treatment in follow-up with oncology.  3/7 she saw a pain specialist in the plan clinic and is scheduled for a celiac plexus block 3/27 for pain control.  3/13 she had an ERCP with a covered metal stent placed in the CBD.  3/23 - 3/21 she was admitted to the hospitalist service for pain control.  She was started on a fentanyl patch in addition to Norco.  CT at that time showed rapidly progressive malignancy.  She declined both hospice and home health at that time and opted to discharge home.  3/23 she returns to the emergency room with audio and visual hallucinations, paranoia, weakness, fatigue, severe right abdominal pain, constipation.  She discharged 3/27 on hospice.
Minor constant pain in my left arm muscle.  Pain worsen significantly stretching my arm and lifting.  Pain severity restricts motion like bending my left arm to put on a coat.  Pain bothers me while sleeping if I lay on the arm.  I lived with this a while thinking it would go away over time.  I do moderate exercise to use the arm muscle.  The pain is now seeming to get worst and wider into my lower shoulder so I filed this report.
Employee presents to EHS complaining of swelling, redness, itching at injection site. States she had some discomfort within 24-48 hours and by Friday, 6/1/07, she had pronounced swelling and more discomfort at injection site. Began itching yesterday. States she also had swelling in her left underarm. Pain extends to elbow. Marked edema, 60 mm x 70 mm erythema, increased skin temperature and fine raised maculopapular rash noted left deltoid area.
Patient called the pharmacy today 11-10-18 stating that her flu shot caused a damage to her arm's muscles because the injection site was too high.
Inflammatory polyarticular arthritis with rash and elevated sed rate. Resolved in a few weeks with NSAIDs and time. No prescription medication.
Pt. Deceased  1st Dose 7/1/2021 - Moderna 08c21a 2nd Dose 7/28/2021 - Moderna 021b21a
This spontaneous report was received from a pharmacist referring to a 19 year old patient, gender unknown. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On 02-AUG-2018, the patient was vaccinated in error with a dose of ZOSTAVAX (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Pt. describes discomfort across the shoulders at base of neck that radiates down both arms.  Describes pain down the arms as equal in intensity.  Pt. took an aspirin and stated the pain improved.  Encouraged pt. to seek medical attention if the pain returned was more intense than previous.
RECEIVED PEDIARIX VACCINE (DTAP-IPV-HEP B)APPROX 10:30 AM ON 07/30/2003. APPROX 4HRS LATER WAS FEEDING AND VOMITED LARGE AMOUNT, THEN IMMEDIATELY BECAME LIMP AND UNRESPONSIVE FOR 5-10 MINUTES. BROUGHT IMMEDIATELY TO LOCAL ER, WHERE SHE WAS FULLY RECOVERED ON ARRIVAL. CURRENTLY ASYMPTOMATIC.
She is getting problems, it is like a rushing noise but it is not necessary ringing;; Head has been fuzzy; Dizzy; Ear trouble; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Heart issues" (unspecified if ongoing), notes: Verbatim: Heart issues. The patient took concomitant medications. Vaccination history included: Bnt162b2, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "She is getting problems, it is like a rushing noise but it is not necessary ringing;"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Head has been fuzzy"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; EAR DISORDER (non-serious), outcome "not recovered", described as "Ear trouble". Therapeutic measures were not taken as a result of tinnitus, feeling abnormal, dizziness, ear disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Violent, explosive diarrhea! Holy cow! Not fun at all.  Started mildly about 5 hours after injection. The next day - OMG - horrible! First regular poop on 03/22/21.
Acute cellulitis of L thigh vaccine 10/16/02. Admitted on 10/19/02 IV antibiotic and supportive care-d/c home next day doing well.
patient had redness, and itchiness at injection site at 3 days after administration. patient already rec'd prevnar-13 four years ago, but was advised by her md to restart the series (prevnar and pneumovax 1 year apart) due to her missing the pneumovax-23 after her initial prevnar administration.  redness did not appear too pronounced, covering about a 4 inch span around the injection area with mild to moderate swelling. patient did not report any change to urine color to indicate rhabdomyolosis, nor did the area cause the patient any pain or weakness
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM; LARISSIA; ALEVE-D SINUS & COLD. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medications within 2 weeks of vaccination. The patient received treatment with Paxlovid (lot number: 1917995A) from 28Jul2022 to 29Jul2022 for Covid-19. No known allergy reported. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a sting in the left side of my throat. This lasted less than 30 minutes and started immediately after receiving the shot. I had numbness in my lower face. This lasted less than 30 minutes and started immediately after receiving the shot. I had mild dizziness on and off for 4 hours. This started immediately after receiving the shot. I had nausea on and off for 5 hours. This started immediately after receiving the shot.  I was given water and told to stay longer to ensure nothing escalated. After the throat sting and numbness disappeared, I was free to go.