chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Achiness worsened; Muscles are fatigue; Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness; Headache worsened; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness worsened), MUSCLE FATIGUE (Muscles are fatigue), MYALGIA (Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness) and HEADACHE (Headache worsened) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-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 (Achiness worsened), MUSCLE FATIGUE (Muscles are fatigue), MYALGIA (Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness) and HEADACHE (Headache worsened). At the time of the report, PAIN (Achiness worsened), MUSCLE FATIGUE (Muscles are fatigue) and MYALGIA (Soreness in her whole body,body was achy,muscles are in pain,muscles are with soreness) had not resolved and HEADACHE (Headache worsened) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-370173 (Patient Link).
Diffuse skin rash distant from AVA site after #1 and #2 shots. Also with throat "tightness" after each shot. Symptoms started about 48 hours after shots. Lasted 3-4 days.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING (Swelling). At the time of the report, SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
6 hours after receiving vaccine became very achy with pain in left upper arm radiating to back and up to neck.
C-reactive protein of 183; gastritis; severe epigastric pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: EL8982) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; XYZAL; OSTEO BI-FLEX EASE; MAGNESIUM; ASPIRIN (E.C.). Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Multaq, reaction(s): "Known allergies: Multaq"; Triamcinalone, reaction(s): "Known allergies: Triamcinalone". Vaccination history included: Bnt162b2 (Lot number:  EL3246, on 01:00 PM via Intramuscular, administered on Left arm as dose 1), administration date: 08Jan2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: C-REACTIVE PROTEIN INCREASED (non-serious) with onset 12Feb2021 20:00, outcome "recovered", described as "C-reactive protein of 183"; GASTRITIS (non-serious) with onset 12Feb2021 20:00, outcome "recovered", described as "gastritis"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Feb2021 20:00, outcome "recovered", described as "severe epigastric pain". The events "c-reactive protein of 183", "gastritis" and "severe epigastric pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of c-reactive protein increased, gastritis, abdominal pain upper. Additional information: Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination. The treatment received for the events was reported as Endoscopy and prilosec therapy.  No follow-up attempts are possible. No further information is expected.
Patient was extremely nervous prior to receiving vaccinations. After receiving the vaccinations, the patient stated she was feeling lightheaded and dizzy. The nurse laid her down and put her feet/legs up on the chair. Dr. was called to assess. Moved patient to the faint cot and raised her legs up for circulation. After a few minutes, the patient was feeling better. BP monitored throughout event and stable. Patient was released home with her brother and mother with ER precautions explained.
Within an hour of getting booster, all the rashes and pain/itchiness went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "horrible flare-up with eczema" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Within an hour of getting booster, all the rashes and pain/itchiness went away". Additional information: the patient wonder if it was a positive result from 2nd booster shot. The patient had been struggling with a horrible flare-up with eczema for more than a month. Within an hour of getting the booster, all the rashes and pain/itchiness went away. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax; 24 hrs later, devel cellulitis at site of inject;
Dizzy,nauseated Brought via wheelchair to medical screening for evaluation by medics. No interventions Left in stable condition at 13:03 p.m. Recorded by RN
She had a reaction to all 4 Moderna COVID-19 vaccines that she received.; The fever went very high 104F with the 4th shot (Bivalent Booster); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had a reaction to all 4 Moderna COVID-19 vaccines that she received.) and PYREXIA (The fever went very high 104F with the 4th shot (Bivalent Booster)) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     There was no parental vaccine exposure.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had a reaction to all 4 Moderna COVID-19 vaccines that she received.) and PYREXIA (The fever went very high 104F with the 4th shot (Bivalent Booster)). At the time of the report, IMMUNISATION REACTION (She had a reaction to all 4 Moderna COVID-19 vaccines that she received.) outcome was unknown and PYREXIA (The fever went very high 104F with the 4th shot (Bivalent Booster)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104F.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   On 20-Dec-2022, at 10:11 AM, the patient reported that she had a reaction to all 4 Moderna COVID-19 vaccines that she received. The fever went very high 104F with the 4th shot (Bivalent Booster) and she ended up in Emergency Room. She stated, she will never get another shot.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-690228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-690228:Husband's case
Tachycardia (fast heart rate); Lightheaded; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Tachycardia (fast heart rate)) and DIZZINESS (Lightheaded) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced TACHYCARDIA (Tachycardia (fast heart rate)) and DIZZINESS (Lightheaded). On 28-Dec-2020, TACHYCARDIA (Tachycardia (fast heart rate)) and DIZZINESS (Lightheaded) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Heart rate: 140 140 heart beats per minute.     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.; Reporter's Comments: This case concerns a 49-year-old male patient, who experienced non-serious unexpected events of Tachycardia an Dizziness. The events occurred 3 to 5 minutes after first dose of mRNA-1273, lot # 011J20A. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Child began sneezing, coughing, nasal congestion, red eyes, c/o throat hurting upon ausculation: wheezing heard, one red bump on abdomen,  red, swollen left arm injection site MMR.
PATIENT RECEIVED SHINGRIX SHOT ON 10/5/19 ALONG WITH FLUZONE QUAD IN LEFT ARM. THE FLUZONE WAS GIVEN AT TOP AND SHINGRIX WAS GIVEN BELOW FLUZONE. SHE SAID THAT THE SPOT WHERE SHE GOT SHINGRIX IS THE SPOT WHERE REACTION WAS LOCATED. PATIENT SAID THAT ARM BECAME ITCHY, RED, SWOLLEN AND WARM TO THE TOUCH ON 10/6/19. SHE TRIED ICE PACK AND BENADRYL. IT DID NOT GET BETTER SO SHE WENT TO DR ON 10/9/19 AND WAS DIAGNOSED WITH CELLULITIS.
Chronic debilitating tinnitus. Primarily in right ear but found to be persistent in both.
Woke up with severe pain at sight of injection. No noticable adverse reaction at sight of injection.
Vaccine dose 3, booster was given 7 days early. At that time it was due to be given 6 months after the 2nd dose, it was given 7 days early.  The patient has been in for regular prescription refills and has noted no concerns.
Postural vertigo - unable to lie down flat on back or rise to sitting position without experiencing vertigo and some nausea which continues 1-20 through 1-26 (has not ceased).
Rash/probable disseminated vaccinia.  Multiple papular lesions on an erythematous base located primarily on patient's back.  Lesions manifested on day 11 post vaccination.  No documented fever.
Information has been received from a physician concerning a 55 yr old white retired female with no allergies who in approx Oct 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). Concomitant suspect therapy included a dose of influenza virus vaccine (unspecified) administered at the same time into the same arm. On 26Oct05 the pt developed redness from the shoulder to elbow, swollen tender, axilla glands, and throbbing pain. It was reported that the pt stated that she received the pneumococcal 23v polysaccharide vaccine yearly for 10 yrs except last year. The pt outcome was not reported. Additional information has been requested.
Patient reported swollen lymph nodes in jaw area and fatigue. As of 04/07/2010, these signs/symptoms continued. No fever reported.
patient developed cough and new loss of taste or smell on 7/25/2021.  Tested positive for COVID on 7/29/2021.
Bowel movement had blood and pus; Bowel movement had blood and pus; Loose bowel movements; Joint pain; She had terrible stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bowel movement had blood and pus) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Blood pressure abnormal.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (She had terrible stomach cramps) and ARTHRALGIA (Joint pain). On 19-Jun-2021, the patient experienced HAEMATOCHEZIA (Bowel movement had blood and pus) (seriousness criterion medically significant), PUS IN STOOL (Bowel movement had blood and pus) and DIARRHOEA (Loose bowel movements). On 21-Jun-2021, HAEMATOCHEZIA (Bowel movement had blood and pus) and PUS IN STOOL (Bowel movement had blood and pus) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (She had terrible stomach cramps), DIARRHOEA (Loose bowel movements) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medications included blood pressure and antipsychotic medications. The patient was on multiple concomitant medications however the reporter did not have specific names and details for the medications.  Treatment information was not provided by the reporter.  This case concerns a 48-year-old female with a serious unexpected event of haematochezia, and nonserious abdominal pain upper, pus in stool, diarrhoea and arthralgia. Event latency 3 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-230296 (Patient Link).; Sender's Comments: This case concerns a 48-year-old female with a serious unexpected event of haematochezia, and nonserious abdominal pain upper, pus in stool, diarrhoea and arthralgia. Event latency 3 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
LEG WEAKNESS, leg numbness, went to a hospital and had lots of test done emg test showed he had neuropathy  hasnt been able to walk since april
tongue , lips, face swelling. rash on upper legs and upper both arms, one blister on left upper arm
Still down for a day; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Still down for a day) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEPRESSED MOOD (Still down for a day). At the time of the report, DEPRESSED MOOD (Still down for a day) had resolved.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-307765 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 18:30 as dose 1, single (Lot number: EN6201), in left arm, on 02Mar2021 at 18:30 as dose 2, single (Lot number: EN6198), in left arm, on 08Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 04Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHELATED MAGNESIUM [MAGNESIUM CHELATE]; CALCIUM; VITAMIN D3. The patient received other medication in 2weeks.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Negative, notes: Tested negative on 08May and 10May; (10May2022) Negative, notes: Tested negative on 08May and 10May; (13May2022) Positive, notes: I tested positive again 13May. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 02May2022, Treatment stop date: 07May2022 and Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme abdominal gas, very gassy; Extreme abdominal bloating, very bloated; This non-serious case was reported by a consumer via call center representative and described the occurrence of gas in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 12-APR-2023, 8 days after receiving Shingrix, the patient experienced gas (Verbatim: Extreme abdominal gas, very gassy) and abdominal bloating (Verbatim: Extreme abdominal bloating, very bloated). The outcome of the gas and abdominal bloating were not resolved.   It was unknown if the reporter considered the gas and abdominal bloating to be related to Shingrix.     It was unknown if the company considered the gas and abdominal bloating to be related to Shingrix.   Additional Information: GSK receipt date: 13-Apr-2023 The patient wanted to know if abdominal gas and bloating are side effects of Shingrix vaccine.  The patient spoke, gave medical disclaimer, referred to healthcare professional.  The reporter was offered medical information telephone number to give to her healthcare professional but she declined.  The reporter did not consent to follow up.
tested positive for covid after having nasal congestion. Pt lives in a group home, which wont take him back until he tests negative. admitted to hospital pending group home placement
Patient called and reported reaction on 2/5/18. Patient reported swelling to the size of a silver dollar and itching at the injection site. Patient did not notice the reaction until she started experiencing itching on 2/4/18. Patient took a Zyrtec D this morning as she normally does but was advised to take liquid benadryl to counteract the reaction. Patient has contacted the Dr to report the reaction since he recommended that she receive the vaccination. I also called to report the incident to the Dr but had to leave a message for nurse to return call.
felt itching, redness and had a fever; felt itching, redness and had a fever; felt itching, redness and had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (felt itching, redness and had a fever), ERYTHEMA (felt itching, redness and had a fever) and PYREXIA (felt itching, redness and had a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PRURITUS (felt itching, redness and had a fever), ERYTHEMA (felt itching, redness and had a fever) and PYREXIA (felt itching, redness and had a fever). On 07-Jan-2021, PRURITUS (felt itching, redness and had a fever) and PYREXIA (felt itching, redness and had a fever) had resolved. On 10-Jan-2021, ERYTHEMA (felt itching, redness and had a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Headache, SkinRash, Diarrhea, FATIGUE Narrative:
Developed bilateral pulmonary embolisms and moderate to severe right ventrical heart dysfunction. Misdiagnosed originally as "walking pneumonia", and blood being coughed up as bronchial inflammation from bad cough. Began having trouble breathing about one week after GARDASIL injection.  4/17/09 Received hospital medical records of 2/26-3/1/2009. FINAL DX: bilateral pulmonary emboli; SOB Records reveal patient experienced worsening dyspnea & chest pain x 2 days.  Fatigue had increased since 11/08 & around 12/25 began to have bouts of coughing which had continued & now w/dyspnea & hemoptysis.  Seen by PCP multiple times & had been on several courses of antibiotics for pneumonia.  Had developed dull pain in both LEs & chest pressure when lying down.  Now difficult to walk even across a room.  Seen at outlying ER, tx w/anticoagulant & transferred to higher level of care for heme admit when CT scan revealed bilateral PE.  Cardio consult done.  Hypercoaguability w/u done.  OCPs d/c.  D/C to home on continued anticoagulant therapy, heme/coag clinic & referred to pulm HTN clinic on d/c.
Tinnitus began a few days after booster vaccination. I had very minimal low-grade tinnitus prior, but after booster the ringing became very loud and remains so five months later.