chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The dose was administered to the patient after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Dose 1 - Very restless sleep, very itchy around head, injection site, and neck and shoulders. I had headaches, slight fever and nausea--which lasted about 5 days. I used ginger to treat it.  Dose 2 - I had the restlessness again. Thirteen hours later, I had a fever of 102, diarrhea, soreness around injection site, fatigue and headache. The fever lasted about two days and went down to around 99, but the fatigue lasted for about 2 weeks. I only took aspirin.
PATIENT CAME IN AND SAID ARM WAS SPLOTCHY WITH BRUISES AND UPPER ARM FELT KNOTTED UP ABOUT A WEEK AFTER GETTING A PFIZER COVID SHOT.  PATIENT DOESN'T RECALL HITTING HIS ARM ANYWHERE. UPON QUESTIONING, PT IS ON BLOOD THINNERS.  ARM IS NOT RED, RAISED, AND DOES NOT HAVE A RASH.
Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Rash. Prednisone 40 mg every day, hydrocortisone 1 units BID.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 24-OCT-2014, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) at a pharmacy for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-JUN-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
fatigue over the last few days; loss of sense of taste; Headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of sense of taste), HEADACHE (Headaches) and FATIGUE (fatigue over the last few days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Seasonal allergy and Hyperlipidaemia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Seasonal allergy.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (Headaches). On 14-Jan-2021, the patient experienced AGEUSIA (loss of sense of taste). On an unknown date, the patient experienced FATIGUE (fatigue over the last few days). At the time of the report, AGEUSIA (loss of sense of taste), HEADACHE (Headaches) and FATIGUE (fatigue over the last few days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact; 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.
1hr p/vax pt devel transient flushing of skin & wheals on face;
After 24 I had all the symptoms on your checklist.  Arm pain, arm swelling, Fever of 100.7, chills, tiredness, headache.  Also had body aches and diarrhea.  I took two Pepto Bismol and two Tylenol.  I went to bed.  The next day my arm was very sore and red but my sickness was gone.  Three days from the shot I had lots of itching and swelling in the area that my shot was from.  Today is 2/8/21 and my arm is still very sore, swollen and super itchy.  I am not sick.  I took Motrin and allergy pill.
Patient developed shingles 9/20/06 (4 months after receiving Varicella vaccine).  Shingles were in a dermatomal pattern involving T9 dermatome.  Also had concommitent ear infection as same time.  Was evaluated in ER and by PMD.  No treatment was given.  One week later, lesions are starting to resolve.  Did have mild pruritis from lesions, but does not seem to have neuralgia.
Pt admitted to Hospital with COVID symptoms. She was placed on the medical covid floor requiring supplemental oxygen. She did receive IV steroids. Remdesivir contraindicated d/t poor renal function. Pt did continue to decline with increasing oxygen requirements. She was eventually transferred to ICU for close monitoring, precedex infusion and BIPAP. Pt did began to tire and did require incubation, Pt continue to Decline. She required vaspressor support and throughout the night required maximum doses of three different medications. Family arrived to discuss goal of care. They did decide to transition to comfort measures. Pt passed with family at bedside TOD 1427 on 10/17/2021
left arm pain, soreness flu like symptoms cold achy stomach pains nausea loose stools
Headache Narrative: C/o headaches almost every day x 3 1/2 weeks, relieves with motrin 800 mg every 4-6 hours. Not sure if related to 1st vaccine. Has increased water consumption. Denies having ha prior to vaccines. Has appoint with pcp on 2/22/21
1. Initial reaction was site injection pain for several days.  2. After a week, the pain was gone, but the injection area emanated heat. 3. On the 14th day after injection, a red rash broke out from the shoulder down to almost the elbow.  Doctor advised taking Benadryl.  By the 15th day (today), further spread of the rash has ceased, but area is somewhat itchy. Will continue Benadryl.
Achy Joints; Felt Feverish; Flu-like Symptoms; first Shingrix vaccine approximately one year ago; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced joint pain, feeling hot, influenza-like symptoms and incomplete course of vaccination. On an unknown date, the outcome of the joint pain, feeling hot and influenza-like symptoms were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the joint pain, feeling hot and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported for the 1st dose. The age at the vaccination was not applicable for the 2nd dose. The patient received Shingrix vaccine approximately one year ago and had flu-like symptoms, felt feverish and had achy joints. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Event occurred 4 months after 2nd vaccine shot. First symptom diarrhea only lasted 1 to 2 days. Ran a low grade fever for next 5 weeks along with medium nausea and medium to heavy fatigue. No congestion, coughing, or shortness of breath. Televisit with PA. Doctor ran tests: Covid was negative, antibodies was positive. He prescribed antibiotics for 6 days. The fever and symptoms subsided over the next week.
Acute COVID-19 infection.  Not hypoxic.  Not short of breath.  Has mild cough.  Received 3 days of remdesivir.  Continue contact and isolation precautions. As needed Tessalon Perles for cough. Seen by ID service. ID recommends continue isolation through 10/15/2022.
Client received TD, Twinrix on 10/25/2005 9:30am. Client reports feeling irritation at 3pm same day in back of throat, felt weak that evening with flu symptoms, fever 102 F, headache. Next day vomited in am. Today noticed rash, red all over chest and back, no SOB today. No coughing per report.
Difficulty of breathing; Anxiety; Problem in sleeping pattern/can't sleep at night time; Chest pain; Feels sick; Numbness; Produces a lot of saliva; Extremely weak; Bulging arm veins; Weird lower back pain (Kidney pain); Experiencing weird dreams; Itchy little bug bites; Itchy little bug bites; Dizziness; On and off extreme fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Difficulty of breathing), ANXIETY (Anxiety), INSOMNIA (Problem in sleeping pattern/can't sleep at night time), CHEST PAIN (Chest pain) and MALAISE (Feels sick) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MAGNESIUM for Stress, PROBIOTICS NOS and ASCORBIC ACID (VIT C) for Supplementation therapy. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced DYSPNOEA (Difficulty of breathing), ANXIETY (Anxiety), INSOMNIA (Problem in sleeping pattern/can't sleep at night time), CHEST PAIN (Chest pain), MALAISE (Feels sick), HYPOAESTHESIA (Numbness), SALIVARY HYPERSECRETION (Produces a lot of saliva), ASTHENIA (Extremely weak), VASODILATATION (Bulging arm veins), RENAL PAIN (Weird lower back pain (Kidney pain)), ABNORMAL DREAMS (Experiencing weird dreams), ARTHROPOD BITE (Itchy little bug bites), PRURITUS (Itchy little bug bites), DIZZINESS (Dizziness) and FATIGUE (On and off extreme fatigue). The patient was treated with PREDNISOLONE ongoing since an unknown date for Adverse event, at a dose of Took for a month. At the time of the report, DYSPNOEA (Difficulty of breathing), ANXIETY (Anxiety), INSOMNIA (Problem in sleeping pattern/can't sleep at night time), CHEST PAIN (Chest pain), MALAISE (Feels sick), HYPOAESTHESIA (Numbness), SALIVARY HYPERSECRETION (Produces a lot of saliva), ASTHENIA (Extremely weak), VASODILATATION (Bulging arm veins), RENAL PAIN (Weird lower back pain (Kidney pain)), ABNORMAL DREAMS (Experiencing weird dreams), ARTHROPOD BITE (Itchy little bug bites), PRURITUS (Itchy little bug bites), DIZZINESS (Dizziness) and FATIGUE (On and off extreme fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) BP Normal. On an unknown date, Blood test: normal (normal) Blood works normal. On an unknown date, Electrocardiogram: normal (normal) ECG Normal. and normal (normal) EKG Normal. 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. The patient visited ER three times in a span of 2 months. 1st ER visit was related to difficulty of breathing which was diagnosed as anxiety. he was not getting enough oxygen. At the 2nd ER visit ruled out pulmonary embolism (blood clot in the lungs) and some blood works was done. At the 3rd ER visit ruled out myocarditis.
Some itchiness on her torso/ More itchiness in her abdomen area and it expanded in night; Hives; A spontaneous report was received from a physician's assistant and the patient on 25OCT2022.   A 41-years-old female patient who had "hives" (PT: Urticaria) and "some itchiness on her torso/ more itchiness in her abdomen area and it expanded in night" (PT: Pruritus) following administration of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation.   On 22OCT2022, the patient received the first dose of Vivotif, followed by the second dose on 24OCT2022 at 7 AM. It was reported that the patient had hives within four hours of the second dose of Vivotif. Reportedly, following the second dose; on the same day, at about 1 in the afternoon, the patient noticed some itchiness on her torso, and later at about 8 PM, she noticed more itchiness in her mid abdomen and leg area which expanded at night. Additionally, it was reported that the patient was given Zyrtec (anti histamine) and hydrocortisone cream to counter the effect of the events.  The patient had not recovered from the reported events, at the time of this report.  Action taken with Vivotif with respect to the reported events was unknown.  The patient had allergic reactions to Keflex and Cephalexin (rashes, itchiness) and had a seasonal allergy to grass and trees mostly in spring (June-July). The patient had undergone laparoscopic surgery of the uterus and caesarean section (C-section). Reportedly, the patient had three babies, she retained her placenta, and had to have it surgically removed.  Concomitant medications included iodine and progesterone.  No additional information was reported.  Company comment: It was reported that a patient took second dose of Vivotif and developed hives (urticaria) and some itchiness on her torso/ more itchiness in her abdomen area and it expanded in night (pruritus). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out, and the causality of urticaria and pruritus is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took second dose of Vivotif and developed hives (urticaria) and some itchiness on her torso/ more itchiness in her abdomen area and it expanded in night (pruritus). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out, and the causality of urticaria and pruritus is assessed as possible. The case is considered non serious as per medical assessment.
Extremely painful/sensitive skin in left axillary area, several inches away from site of the shingles vaccine.
A report was received from a health care professional on 01Oct03 concerning a male vaccinee of unk age who developed arthritis and joint pain on his ankle an unspecified length of time after receiving Fluvirin vaccine on an unk date. On an unk date the vaccinee received a dose of Fluvirin vaccine and developed arthritis and joint pain on his ankle. The vaccinees symptoms had been resolving gradually at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up information received from a health care professional indicated that the vaccinee experienced inflammation of the right ankle joint on 30Sep03 following vaccination the previous day. Uric acid crystals were seen in the fluid but serum uric acid was 5.4. The vaccinees symptoms resolved in a week following treatment with NSAIDS. The reporter has assessed the relationship of the vaccine to the event as possible. All information received, no follow up pending.
This spontaneous report as received from an unspecified health professional (manufacturer number: 61009) refers to group of 30 patients of unknown age and gender. Patients' medical histories were not reported. On 24-NOV-2041, doses of PNEUMOVAX 23 (prefilled syringe) (lot # K010466, expiration date: 23-MAR-2016) have been exposed to temperatures outside of the required temperature range (exact temperatures and duration of exposure were not provided by the reporter). On unspecified dates, 30 patients were vaccinated with incorrectly stored doses of PNEUMOVAX 23 (prefilled syringe) (lot # K010466, expiration date: 23-MAR-2016) (doses, frequencies, routes of administration and indications were not specified). Concomitant medication were not reported. The reporter stated that to her knowledge no adverse reactions were reported to the office. Additional information has been requested.
Feverish, chills, body soreness and aches, fatigue, feeling faint/could pass out, lethargic, headache
About 1 1/2 weeks after 2nd dose of covid vaccine, patient began exhibiting symptoms of Parosmia, namely: consistently complaining of rancid smells when around certain foods (eggs, chicken, onions, garlic).  There is no available treatment in her local area.  Symptoms are ongoing.
severe migraine (sometimes causing rainbows in my peripherals), fatigue, chills, occasional fever, sun sensitivity (bad sunburn in only minimal sun exposure that isn?t healing), my skin keeps turning splotchy with burning and itching sensations and blistering (my face, hands and feet mostly), high blood pressure, bruising easily, dizziness, memory loss, swelling, body aches, muscle cramps in places i didn?t know I could have them, vaginal bleeding for 2 weeks after, nausea, vomiting, stomach cramps. I?m sure I?m forgetting some stuff. They keep just saying it?s a multi system immune response. I had my second shot on 3/5 and haven?t had relief since.
general lethargy the day after or so, as was expected.  However, several weeks later and now 4 weeks later, I have had consistent, daily lower digestive issues including irregular and incomplete bowel movements, and low level cramps throughout the day.   I had NONE of this prior to getting the vaccine.   I would consider it to be specific to me, but my wife had reported similar symptons when she received the Pfizer vaccine several months earlier (she's a nurse so was able to get the vaccine sooner) and they last 10 weeks and she went to the doctor.   She was told by the doctor she is "not the first person" he's heard this complaint from.
FLUID RETENTION; INJECTION SITE REDNESS; BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced generalized aching. On 10-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced fluid retention. On 12-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, fatigue, and injection site redness on 12-APR-2021, and had not recovered from fluid retention. This report was non-serious.
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 14-year-old male. Neither medical history not concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 08-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Extreme Fatigue; Fever; deep intense muscle pain all over her body; Headache; Slept for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7) for prophylaxis.   On 22-AUG-2023, the patient received Boostrix (intramuscular, left deltoid). On 22-AUG-2023, an unknown time after receiving Boostrix, the patient experienced headache (Verbatim: Headache). On 23-AUG-2023, the patient experienced fatigue (Verbatim: Extreme Fatigue), fever (Verbatim: Fever), muscle pain (Verbatim: deep intense muscle pain all over her body) and sleepiness (Verbatim: Slept for 2 days).  On 23-AUG-2023, the outcome of the fever and headache were resolved.  On 27-AUG-2023, the outcome of the fatigue and muscle pain were resolved (duration 4 days). The outcome of the sleepiness was resolved (duration 2 days).   It was unknown if the reporter considered the fatigue, fever, headache, muscle pain and sleepiness to be related to Boostrix.     It was unknown if the company considered the fatigue, fever, headache, muscle pain and sleepiness to be related to Boostrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 The patient was self-reported this case. The reporter reported that she received Boostrix Vaccine. On the evening of the 23rd August 2023 patient experienced headache that lasted through the night and also had a fever as high as 100 degrees Fahrenheit, event was resolved.  On 23rd August 2023 patient started with deep intense muscle pain all over her body and also she experienced extreme fatigue and slept for 2 days.  The reporter stated that all events resolved.
This spontaneous report as received from a pharmacist via a company representative refers to two patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (vial 19400 PFU) (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patients experienced allergic dermatitis on their arms after receiving ZOSTAVAX. The outcome of allergic dermatitis on their arms was not reported. This is one of two reports from the same source. Additional information has been requested.
Temp 104 degrees & some delirium the day after vaccination small red area Rt deltoid at injection site, tender painful - Pain is mild moderate.  Constant, aching non radiating.
Admit for COVID pna and septic shock, also with bacterial pna. Treated with HFO2, steroids, rocephin, doxy, cefepime, vit-c, singulair, zinc. Eventually improved and was weaned to RA. Discharged home.