chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:    Concurrent medical conditions included Allergy to vaccine (Flu vaccine).    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, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema) to be possibly related.    No concomitant information were reported. Patient was treated with steroids and antihistamines  This is a literature case concerning a  20 -year-old male patient with medical history of allergy to flu vaccine , who experienced the serious unexpected event of  angioedema  3 hours  after  receiving the first  dose of  mRNA-1273. Patient was treated with steroids and antihistamines. An expanded skin allergy testing (included PEG, methylprednisolone acetate, methylprednisolone sodium, triamcinolone acetonide, and polysorbate 20) was negative. The benefit-risk relationship of MRNA-1273 is not affected by this report.   This case was linked to MOD-2021-394131 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a literature case concerning a  20 -year-old male patient with medical history of allergy to flu vaccine , who experienced the serious unexpected event of  angioedema  3 hours  after  receiving the first  dose of  mRNA-1273. Patient was treated with steroids and antihistamines. An expanded skin allergy testing (included PEG, methylprednisolone acetate, methylprednisolone sodium, triamcinolone acetonide, and polysorbate 20) was negative. The benefit-risk relationship of MRNA-1273 is not affected by this report.
Temperature; Nausea; Great body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature), NAUSEA (Nausea), MYALGIA (Great body ache) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression (anti depressant use). Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Antidepressant therapy.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (Temperature), NAUSEA (Nausea), MYALGIA (Great body ache) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN for Nausea, Headache and Ache, at a dose of 1 dosage form. At the time of the report, PYREXIA (Temperature), NAUSEA (Nausea), MYALGIA (Great body ache) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.  Patient was uninsured but followed through with going to hospital twice, she was bombarded with bills. Caller was asking if Moderna provides assistance in paying for hospital bills for patients who had an AE.  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.   This case was linked to MOD-2021-187603.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received contains no new information On 01-Jul-2021: Non significant Follow-up received On 29-Jul-2021: Non significant Follow up received HCP is inquiring for funding to cover her hospital bills; 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.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included Heartburn. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Mar-2021, the patient experienced DYSPEPSIA (Heartburn). At the time of the report, DYSPEPSIA (Heartburn) outcome was unknown. Not Provided. Concomitant medications were not provided. Treatment medication included acid reducer. Action taken with mRNA-1273 in response to the event was not applicable.
red swollen face and hives on both sides of neck, monitored by facility nurse took benadryl helped to calm inflamation 30 minutes later had a rush of heat go thru my body and hives appeared 6 minutes after injection Fever and sore muscles for two days after
Information not available.  Patient died at home.  Covid 19 listed as cause of death on certificate.
Approximately 1 hour or so after vaccination, pt experienced shortness of breath and turned red all over; father reports pt may have briefly "blacked out". Consulted a physician who was a friend of the family; gave pt 2 Benadryl; pt recovered shortly after with no further complications.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
This spontaneous report as received from a certified medical assistant via field representative refers to a 13 year old male patient. The patient's pertinent medical history was not reported. Approximately in August 2013 (reported as about one year ago) the patient was vaccinated with PROQUAD (Merck) (Dose/Frequency: one shot, Therapy Route: subcutaneous injection) accidentally "in an off-label use". Concomitant medications were not reported. The reporter felt this was off-label because she stated the product information states that MMR and VARIVAX (Merck) should have been received separately by the patient rather than a dose of PROQUAD (Merck) instead. No adverse effects were reported. There was no product confusion involved, there was no product quality complaint (PQC). 04-MAR-2015: This is a corrected report. The event of 'received a dose of PROQUAD accidentally in an off-label use" was changed to '13 year old received a dose of PROQUAD' and mapped to the preferred term of drug administered to patient of inappropriate age (previous mapped to off label use). The reporter felt there was off-label use (described above). However, this is not considered off label use. Additional information is not expected.
12AUG93 pt called c/o pain & swelling in lt arm & breast; advised to come to clinic; 16AUG93 t/c from clinic pt had local reaction @ inject; heat & Advil prescribed;
Body ache; Diarrhea; Injection site pain; This spontaneous report received from a patient concerned a 70 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included myriad of digestive system issues.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, body ache, and diarrhea on 12-MAR-2021. This report was non-serious.
severe flu like symptoms, ("bad case of the flu"); swollen large area with fever in it at injection site; swollen large area with fever in it at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms, ("bad case of the flu")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A27A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.   On 30-Apr-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) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms, ("bad case of the flu")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms, ("bad case of the flu")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Patient Reports swollen large area with fever in it at injection site and also reports that this also happens when bitten by a bug due to medical diagnosis and blood disorder. Also reports severe flu like symptoms, ("bad case of the flu").    .   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received on 01JUN2021, included outcome of events flu like symptoms, pyrexia and vaccination site swelling as recovered.
Information has been received from a registered nurse concerning a female pt who on 7/26/02 was vaccinated with SC in the left forearm with her fourth dose of hep B vaccine recombinant. The pt developed "a small hard spot" at the injection site. The registered nurse also reported that on 7/26/02 the pt was supposed to be given a vaccine other than hep B vaccine recombinant, but the nurse inadvertently "grabbed the wrong vial." The registered nurse reported that the pt was seen by an MD who prescribed Allegra, BID to treat the reaction. She noted that the pt recovered after approximately three weeks and that the area is now "normal." No additional info is available at this time.
pt recv vax & exp burning sensation in arm, swelled, itched, flu like sx x 2 days;dizzy, lost balance worsening daily;
Rash/whelps (hot to touch). Fever. Nausea. Vomiting.
Patient stated some of the vaccine ran down her arm during administration. She states she doesn't know if she received all of the dose and possibly only 1/2. Pharmacy has reached out to manufacturer for data on whether the dose should be repeated. She stated she did have a very mild shingles reaction after her series.
The medicine made me extremely drowsy, as if I had taken NyQuil or even some sort of pain pill.
Dose was Pfizer Booster.  First Vaccine was Janssen.  Symptoms are ongoing:  PVCs, PACs and random bursts of Tachycardia all with sinus rhythm.  Joint Pain in hips and shoulders.
This is a spontaneous report from a non-contactable physician, case received from Merck National Service Specialist. A patient of unspecified age, ethnicity and gender started to receive PREVNAR (unknown lot# and expiration date), via an unspecified route of administration, on an unspecified date, at an dose. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced unspecified allergic reaction on an unspecified date. The patient's clinical outcome was unspecified. No follow-up attempts possible. No further information expected.
Case number PHEH2013US023496 is an initial spontaneous report received from health care professional on 07 NOV 2013. This report refers to a female patient of an unknown age and gender. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1307901) intramuscularly on 07 NOV 2013. It was reported that she had received only a partial dose of vaccine because after that the needle displaced from the syringe during administration. Reporter explained that needle was not screwed in tight enough by the administrator. No adverse event was reported following medication error.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: son called to report that pt had fallen twice after receiving vaccine; first fall was later in the evening after vaccine and second was roughly 24 hours later; patient denies any other symptoms besides dizziness; son reports no injuries were sustained from either fall; son was instructed to monitor pt closely and follow up with md as soon as possible as a precaution
1 of 4 pts exp an inject site react which began 1 wk following vax; No other clinical info available;
vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date; No Adverse event; administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 days beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 24-Oct-2022 and administered to patient on 29-Nov-2022, after the 30 day beyond use date).    No concomitant medications were reported.  The vaccine coordinator reported that, they administered expired Bivalent booster Moderna COVID-19 vaccine after the 30-day beyond use date. It was individual vial with vial size of 2.5 mL. On 24-Oct-2022, the vial was initially stored in the refrigerator and vial did not undergo any temperature excursions.   No treatment medications were reported.
Patient began to experience numbness and tingling of her mouth and lips 40 mins after administration. Denies SOB, wheezing, airway compromise or oral swelling.  Symptoms lasted 48-72 hours. She was prescribed a Medrol dose pack and antihistamines by her PCP.
Fever, lethargy, & wheezing with decreased appetite & dehydration starting the morning after receiving immunizations.  Parents also believe that patient stopped speaking at that time and has developed profound speech delay.
Initial report received on 26 July 2012 by another manufacturer (reference number 2012DX000151) who had received the original report from a consumer. The following is verbatim from the report: "This spontaneous report was reported by a consumer and concerns a 34-year-old male who experienced skin injury and a possible allergic reaction to a tetanus shot characterized by chills, shaking, redness at the tetanus shot injection site, and fever. Additional information was received on 11 July 2011 from the consumer. On an unknown date, the patient was prescribed KALBITOR 30 mg subcutaneous (SC) as needed for treatment of Hereditary Angioedema (HAE). The patient was not taking concomitant medication and did not have a significant medical history. Additionally, he has no known allergies. On 03 March 2011, the first 30 mg dose of KALBITOR was received for treatment of an acute exacerbation of HAE. On 07 July 2012, the patient was working with bales of hay and experienced a skin injury when the wire in one bale poked his right knee. He was treated in an outpatient clinic with a tetanus vaccine and placed on BACTRIM to prevent a skin infection. 24 hours after receiving the vaccine, the patient experienced chills, fever, and shaking. He also noted slight redness at the vaccine injection site. The chills, fever, and shaking resolved within 24 hours (on 09 July 2012. On July 2012, the patient began experiencing swelling in his left arm (site of the tetanus shot), left knee and left foot. He returned to the outpatient clinic on 10 July 2012 and received a 30 mg dose of KALBITOR for this exacerbation of HAE. The patient believed the events following the vaccination were due to an allergic reaction to the tetanus shot. Additionally, he attributed the current HAE exacerbation to the tetanus shot since he usually does not have HAE exacerbation from injuries such as this one. At the time of the report, all the events had resolved. The tetanus vaccine was considered co-suspect for the events. Medical history details: None. Allergies: No known. Con Meds = None, Prev meds = "UNKNOWN." Documents held by sender: None.
Pt Dx with Zoster on 8/13/04. Sx started on 8/10/04. Rx for Zovirax oint. given to be used 4-5 x's/ day.
Information has been received from a healthcare worker concerning a 44 yr old female pt with asthma and environmental allergies who on 25Oct05 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), tiotropium bromide (Spiriva), montelukast sodium, and albuterol. On 26Oct05 the pt developed redness at injection site (not specified). On 27Oct05 she was seen in the office with blisters around the injection site, with a large red swollen area around that and pain. The pt was treated with diphenhydramine hydrochloride (Benadryl) and another unspecified medication. Her symptoms persisted. No product quality complaint was involved. Follow up information has been received from a physician concerning the female administrative assistant with environmental allergies to trees, grass, dust and ragweed, who on 25Oct05 at 6:00PM was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On the same day the pt was also vaccinated with influenzae virus split virion 3v vaccine inactivated (Fluzone) in the left deltoid below the pneumococcal 23v polysaccharide vaccination. The physician reported that on the morning of 26Oct05 the pt developed lymphadenitis of the left arm extended to axilla with induration and redness. A complete blood cell count was within normal limits (wnl). The pt recovered from lymphadenitis, induration, and redness. Additional information is not expected.
Patient reported that their arm, at the site of the injection, began hurting around dinner time. The patient reported that he had trouble sleeping due to the injection site reaction.
Received HPV #3 6/2/16. Presented in our office with (L) shoulder pain, upper arm swelling, warmth at site. Started clindamycin 300mg TID.
Swelling, redness and itchiness at the site of injection. Redness lasted 5 days
This case was reported by a consumer via call center representative and described the occurrence of systemic lupus erythematosus in a adolescent female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced systemic lupus erythematosus (serious criteria GSL medically significant), ill-defined intestinal infections (serious criteria GSK medically significant), dysautonomia, female infertility, loss of teeth and general physical health deterioration. On an unknown date, the outcome of the systemic lupus erythematosus, ill-defined intestinal infections, dysautonomia, female infertility, loss of teeth and general physical health deterioration were unknown. The reporter considered the systemic lupus erythematosus, ill-defined intestinal infections, dysautonomia, female infertility and loss of teeth to be related to Hepatitis B vaccine. It was unknown if the reporter considered the general physical health deterioration to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's father. The patient was 34 years old at the time of reporting. The age at vaccination was not reported. The patient received Hepatitis B vaccine in her teenage as a requirement to attend the school. The patient was getting worse, her teeth were falling out, experienced dysautonomia, the lupus was diagnosed 6 months ago from reporting date  in 2017, severe intestinal infection and she could not get pregnant due to the drugs she was taking for these issues. The reporter stated that the Centers  for  Disease  Control  (CDC) told him that they know the dysautonomia was a side effect of the vaccine. The reporter was not able to share the brand name of the vaccine in question, but was certain it was a GSK product. The patient denied permission to contact their physician. The patient's father declined to provide any further information.
Arthralgia & Fever Narrative: Day 1 pain to injection site and gen joint pain and fever; Day 2 pain to injection site and gen joint pain; day 3 pain to injection site and fever with body aches; emp took Tylenol to help with pain; day 4 resolution of all symptoms.