chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/16/2021: Received Moderna booster shot around 10am. Started to feel nauseated around 5pm. By 10pm, was throwing up violently multiple times, stomach cramps, fever, chills, diarrhea, body aches 11/17/2021: Stayed home from work with nausea, diarrhea and body aches and fatigue. Epigastic pain (about 4 inches above belly button was severe). 11/18/2021: Went to work but epigastric pain continued, nausea, fatigue, head aches 11/19/2021: Nausea and epigastic pain continued Sun 11/21/2021: Went to ER d/t epigastric pain. Had CXR, EKG, labs and CT scan abd. Labs: D-dimer elevated to 651. CT found "mild heterogeneity of the liver with possible periportal edema. Gallbladder wall is edematous with distention. No stones.  C T impression: Abnormal liver with possible hepatitis. Gallbladder wall edema likely related to underlying liver disease. (Patient has no hx of liver issues). 11/22/2021: Went to see PCP Doc in Clinic and she ordered fasting labs and ultrasound for next day. 11/23/2021: Fasting ultrasound showed: Diffusely heterogeneous liver. Liver 17.5 cm in length (which is enlarged). Liver notes to be heterogeneous with changes suggesting underlying hepatitis. Normal gallbladder. 11/24/2021: 7 tubes of blood drawn. Labs showed Hgb dropped by 2 points to 11. Shortness of breath started and continued. 11/29/2021: Went to ER due to shortness of breath and lightheaded. CXR, EKG and labs were done. No new findings. Awaiting final send off lab results.
Child was vaccinated on tuesday, on wednesday morning, had hives on side of face. Otherwise ok. Friday evening, vomiting diarhea, fever through saturday morning 7:00. Hives began in left arm (side of shot) spread throughout left side then to right. Emergency room, Benadryl administered, hives cleared.  17:45, hives reappeared beginning again in left arm, side of immunization. Administered Benadryl again, hives gone, but still has diarrhea. Child was limp, pale and lethargic friday and saturday. Child was diagnosed as having allergic reaction but according to physician cause was indeterminable.
Second dose was Pfizer's; A spontaneous report was received from a consumer concerning a female patient, of 85-year-old, who was administered Moderna's COVID-19 vaccine and second dose was Pfizer's/wrong product administered.  The patient's medical history not reported. Products known to have been used by the patient, within two weeks prior to the event, included were acetylsalicylic acid, lisinopril, centrum vitamins, linagliptin and furosemide sodium from an unknown date for an unknown indication.  On 06 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in the right arm for prophylaxis of COVID-19 infection.   On 22 JAN 2021, the patient was given second dose of Pfizer's vaccine. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The outcome of event, second dose was Pfizer's was considered as resolved on 22 JAN 2021.; Reporter's Comments: This is a case of 85-year-old female patient who was administered mRNA-1273 vaccine and second dose was Pfizer's (wrong product administered) Lot number: unknown. There was no associated adverse event reported for the event of wrong product administered.
Patient refers after arriving home, he lost his voice. He was instructed to visit his doctor for any actions and evaluations.
Reported tightness in throat, headache, fever,body aches, and blurry vision.
fever 2 days after injection; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; patient "showed up with pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness; This spontaneous report was received from a nurse practitioner who knew about the events from a medical assistant and refers to a female patient of unknown age. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm (strength, dose, route of administration, lot # and expiration date were not reported), for prophylaxis.  On 04-JUL-2020 (reported as 2 days after injection), the patient experienced fever. Since an unknown date in 2020, the patient had been suffering from pain down her arm into her fingertips, swelling, decreased range of motion, and tenderness. She had been experiencing these symptoms for over a month. She sought medical attention. She was advised by healthcare provider (HCP) to treat the symptoms with ibuprofen and was offered with a methylprednisolone (MEDROL) pack but she refused it. The patient had no insurance and wanted to know who was going to pay for this. The outcome of the events was not reported. The causality assessment between the events and the suspect therapy was not provided.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 2:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 2:14 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. On 19-Nov-2021, the vial went from the super cold freezer to the refrigerator. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
This report is only in response to the request from the agency to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19.  No other adverse reactions to the vaccine were reported. The patient had a positive COVID19 test on 12/26/2020.
A roughly 5 to 6 inch area of redness, non-raised, non-broken, was presented by the patient on 2/3/18 around 3:00pm. She noted that this reaction started the evening of 2/1/18 when the vaccine was given. She described it as "hot to the touch", but not worsening or changing significantly in the last 36 hours or so since first noticing it. She also claims no systemic fever, although she has no thermometer at home to measure this. She also describes no other symptoms, other than injection-site pain.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-103512 (Patient Link).
SEVERE migraine that lasted for 2 days, fever, body aches, my face felt extremely hot not only on the outside but felt hot within too.  Made calls and communicated with my doctor about treatment.  Was told to take Tylenol.
Immediate pain at injection site. Not typical for vaccine administration. Pain has not gotten better. Tenderness at injection site 2 weeks after administration.
Vaccine was picked up from state department on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose six days past the vaccine usage date. Patient reported no known symptoms.
There was pain at the injection site which turned into a quarter sized swelling with redness on the morning of 02/02/202 and I was very tired and had total body aches. By 4 PM on 02/02/2021, the swelling had increased and the redness had spread to cover almost the whole shoulder area. Starting around 12:30 PM on 02/02/2021, I developed chills which lasted until approximately 8 PM. My temperature was checked at 4 PM on 02/02/2021 and it was 99.4 and at 7 AM on 02/03/2021, it was still 99.0.  At 9:30 AM on 02/03/2021, the welling is going down but the redness is still covering the entire shoulder area.
Feeling of heaviness all over then leg weakness, then pins and needles hands and feet and lastly and chronically prickling, shooting pains and weakness in arms and legs including hands and feet.
I felt no immediate side effects of the shot, but 2 hours later, while sitting calmly, my heart rate suddenly elevated and I began to feel light headed. My home blood pressure monitoring kit provided a reading of 149/99 and a resting heart rate of 108. Normally, my blood pressure is very well maintained with my meds and hovers in the 118/75 range. My resting heart rate is usually below 70. I was going to dial 911 but within 5 minutes, my heart rate began to slow down and I felt better. When I rechecked my numbers at 8 pm, BP was down to 118/80 and resting heart rate was 70.
her daughter has a heart condition; was not feeling well after her last vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 18-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HLHS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "her daughter has a heart condition"; MALAISE (non-serious), outcome "unknown", described as "was not feeling well after her last vaccine". The events "her daughter has a heart condition" and "was not feeling well after her last vaccine" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of cardiac disorder, malaise.  Additional information: she mentioned that her daughter, age 18, was not feeling well after her last vaccine. Her daughter has a heart condition.   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.
tinnitus; severe back pain; diagnosed with "neuronitis"; muscle aches; did not receive 2nd dose; This spontaneous case was reported by a physician assistant and describes the occurrence of TINNITUS (tinnitus), BACK PAIN (severe back pain), NEURITIS (diagnosed with "neuronitis"), MYALGIA (muscle aches) and PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus), BACK PAIN (severe back pain), NEURITIS (diagnosed with "neuronitis"), MYALGIA (muscle aches) and PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose). At the time of the report, TINNITUS (tinnitus), BACK PAIN (severe back pain), NEURITIS (diagnosed with "neuronitis") and MYALGIA (muscle aches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose) had resolved.        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 concomitant medications were reported. No treatment medications were reported.
Presents with painful erythremic scaling rash in linear strip with blister formation around L lateral neck, L upper chest and L scapular area.  Exam consistent with shingles herpes zoster rash. Will treat Valacyclovir as directed. Tramadol for pain due to hx of Gastric Bypass. Benadryl cream for itching.  Patient seen on 5/13 and 5/24 for follow up, lesions resolving.
Friday morning,  February 26, 2021: extremely dizzy, body aches, very tired. As morning progressed the right side of my face became numb. Mid-day, the right side of my tongue became numb.  But not so numb that I could not eat or drink. By evening I started feeling prickly sensation as one does when novacaine is wearing off. Slept throughout the night. Woke on Saturday, February 27, 2021 with less numbness and prickly sensations. Sunday, February 28, 2021, slight numbness near eye, nose and mouth.  I had Bells Palsy in June 2000.
covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022j21a, 033f4a, 036b21a and 037a21b) for COVID-19 vaccination.     The patient's past medical history included Spinal cord injury. Concurrent medical conditions included Diabetes, Hypertension and Seafood allergy. Concomitant products included METFORMIN, GLIMEPIRIDE, RAMIPRIL, METOPROLOL, ATORVASTATIN, OXYCODONE, NAPROXEN SODIUM (ALEVE), PARACETAMOL (TYLENOL) and DULAGLUTIDE (TRULICITY) for an unknown indication.   On 16-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This spontaneous case concerns a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 and tested negative at day 7 after completing Paxlovid. However, she had mild symptoms 3 days later with positive covid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI  of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 and tested negative at day 7 after completing Paxlovid. However, she had mild symptoms 3 days later with positive covid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Same day onset of b/l dorsum rash on hands 3x3cm. Felt like burns. No itch or blisters or bullae. Rash persisted for over 1mth and patient has residural dry plaques but is no longer symptomatic.
Pt felt over heated, tired and arms were achy. Pt also experienced back ache with a fever of 103.
Headache; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and HEADACHE (Headache) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Toothache. Concomitant products included AMOXICILLIN for Toothache.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 24-Jan-2021 at 12:00 PM, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, PAIN IN EXTREMITY (Arm hurt) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used a lot of medications as a Concomitant medication.
began swelling, redness, pain @ site 2OCT97;3OCT97 in to see MD 11 x 14cm area heat, redness, edema & no adenopathy, throat clear;heart regular, lungs clear;dx probable hypersensitivity rxn to pneumovax;rx Dicoloxicillin;
Information has been received from a registered nurse via a field representative referring to a female patient of unknown age. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was unknown. On unknown dates, the patient was subsequently vaccinated with 3 doses of GARDASIL (dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. The feild representative confirm that it was GARDASIL and not GARDASIL 9). On an unknown date, the patient performed papanicolaou smear (Pap) test which showed positive for cervical cancer after receiving the third dose of GARDASIL. The patient sought medical attention. The outcome of cervical cancer was unknown. The causality assessment between the event and GARDASIL was unknown. Upon internal review, cervical cancer was determined to be medically significant. Additional information has been requested.
Body aches; Sensitivity to touch; Chills; Minor headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 at 13:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methylphenidate hydrochloride (CONCERTA), citalopram hydrobromide (CELEXA), calcium (MANUFACTURER UNKNOWN) and multivitamin; all for an unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 13:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021 at 07:15, the patient experienced body aches, sensitivity to touch along with chills and minor headaches. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent lab tests and procedures, which included COVID-19 virus test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event body aches, sensitivity to touch along with chills and minor headaches were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 30-year-old, adult male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235 and expiry date: 30-Jun-2019]. At the time of this report, no adverse event was reported. This case 201804667 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The event was corrected from 'extra dose administered' to 'overdose'. The narrative and case comment were amended accordingly.