chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & p/pt devel shingles on lt cheek; Information has been received from a physician concerning a 44 month old male who on 18-AUG-1999 was vaccinated with one dose of VARIVAX vaccine. Other vaccinations included one dose of MMR II. Subsequently, after receiving the vaccine, the patient developed shingles on his left cheek. On 14-MAR-1999 the patient's brother was vaccinated with VARIVAX vaccine. On 17-MAR-1999 the patient developed shingles for the 2nd time on his left cheek. No further information is available. This is in follow-up to report (s) previously submitted on 05/14/1999. Information has been received from a physician concerning a 13 month old male who on 18-AUG-1995 was vaccinated with one dose of VARIVAX vaccine. Concomitant vaccination included a first dose of MMR II.
This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (late second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (late second dose). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (late second dose) outcome was unknown. Not applicable      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.
Red swollen eye lids - Rash on forhead - got worse after 10 days. leasion from hairline to eyelid right side. face swollen - went to urgent care 9/2/19 NP prescribed ValacycloviR said I had shingles. This was my 2Nd shingles shot. I had shingles vaccine 2001 and I goet the shingles 2018 on my head and right side of my face over my forhead and right eye. 5/3/19 got 1st shot and 8/15/19 got 2ND shot, a few days later my eyelid swelled and was red, that cleared over a 10 - 11 day period I got a rash on my forhead and it got gradually worse with water blisters under the skin. On 9/2/19 I went to urgent care got the RX Valacyclovir for shingles. I started taking the pills - my face got swollen but after 2 - 3 days started to get better. after a week I was pretty much healed. Thank you for mailing the forms.
Patient lied on vaccine consent form and in person about previously receiving a dose of a COVID-19 vaccine. The patient had previously been vaccinated with Janssen and received the first dose of Pfizer.
I have fibromyalgia that first appeared in April of 2020 and was diagnosed shortly after my vaccine. I take a supplement called Guiafenesin and  follow a protocol that has reversed my fibro symptoms. In the last month a new wave of new (different) symptoms has risen up and I am experiencing significant joint pain in my hands/wrists, very sensitive and "raw" sensation in my legs, as well as burning in my legs, arms, and shoulders. There are also times where the temperature of my body raises and I feel markedly warmer. It can get to the point that it causes mild adrenal panic/rush.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (few patients more than 12 hours post vial puncture, specifically 4 days later.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H213) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (few patients more than 12 hours post vial puncture, specifically 4 days later.). On 12-Mar-2021, EXPIRED PRODUCT ADMINISTERED (few patients more than 12 hours post vial puncture, specifically 4 days later.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-435267, MOD-2021-435296, MOD-2021-435283, MOD-2021-435303, MOD-2021-435276, MOD-2021-435306, MOD-2021-435309, MOD-2021-435297, MOD-2021-435299, MOD-2021-435363, MOD-2021-435358, MOD-2021-435356, MOD-2021-435369, MOD-2021-435334, MOD-2021-435362, MOD-2021-435418, MOD-2021-435424, MOD-2021-435409 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up received on 20-Dec-2021 contains reporter's address and contact details has been updated. On 31-Dec-2021: Followup received added reporter details, added patient demographics, added suspect product details.
allergic reaction to Shingrix; red blotchy rash over her legs, arms chest torso and neck; red blotchy rash over her legs, arms chest torso and neck; fever; felt lethargic all day; headache; didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Allergy shot. Concurrent medical conditions included allergic to dogs and allergy to plants.   On 2nd January 2020, the patient received the 1st dose of Shingrix. On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced fever, lethargy, headache and feeling unwell. On 4th January 2020, the patient experienced allergic reaction, blotchy rash and red rash. The patient was treated with prednisone. On 4th January 2020, the outcome of the fever, lethargy, headache and feeling unwell were recovered/resolved. On an unknown date, the outcome of the allergic reaction was recovering/resolving and the outcome of the blotchy rash and red rash were unknown.   The reporter considered the allergic reaction to be related to Shingrix. It was unknown if the reporter considered the fever, lethargy, headache, feeling unwell, blotchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: The patient got her first dose of Shingrix last Thursday.  The patient had allergies to dogs and trees, she takes allergy shots for that. On friday morning the patient had a fever, felt lethargic all day, headache and didn't feel well. On saturday she felt fine, those issues had resolved but late in the day she noticed red blotchy rash over her legs and then on her arms, that she had noticed earlier. On sunday the rash was all over her chest, torso and neck. The patient was seen at Clinic and the physician diagnosed her with Stephen's Johnson Syndrome. The patient was sent to the Emergency Room, who changed the diagnosis to an allergic reaction to the Shingrix.  She was started on prednisone. The patient went to her primary physician office, who confirmed the reaction to Shingrix diagnosis. The patient noted things are looking better, but her legs are the worst and remain with the rash. The patient had referred to a Dermatologist for the continued rash on her legs. She noted no allergy to any ingredients in Shingrix. The reported consented to follow up.
PERIPHERAL SWELLING; JOINT SWELLING; LABORATORY TEST; PAIN IN EXTREMITY; RASH; RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (reference number 1437585) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient experienced drug allergy when treated with levothyroxine, and lisinopril.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (aspirin low dose), atorvastatin, estradiol, gemfibrozil, insulin glargine (Lantus Solo star Pen), levothyroxine sodium(Synthroid), metformin, and omeprazole. On 18-MAY-2021, the patient experienced Left arm sore (pain in extremity) for about 9days and the patient's right finger had started to swell at the joint (joint swelling), On the same day the patient experienced rash, undergone laboratory test and was diagnosed with rheumatoid arthritis.  By 21-MAY-2021, the patient's finger pain went through hand and had painful bumps on elbows and fingers. On 28-MAY-2021, the patient both hands and left foot were swollen (peripheral swelling). It was reported that the patient had follow up appointment with doctor on 29-JUN-2021 and by then both the feet, hands and left knee were swollen. The patient's laboratory data included: Laboratory test (NR: not provided) Lupus, autoimmune negative and the patient was diagnosed with Rheumatoid arthritis based on symptoms. The patient visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis, pain in extremity, peripheral swelling, rash, joint swelling, and laboratory test. This report was serious (Other Medically Important Condition).  version created to amend previously reported information on 09-JUL-2021. Upon review, the following information was amended: onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021, narrative updated.; Sender's Comments: V1 - This version created to amend previously reported information on 09-JUL-2021 regarding : onset date of rheumatoid arthritis, pain in extremity, laboratory test captured as 18-MAY-2021. This does not change causality of previously reported events. 20210722011-covid-19 vaccine ad26.cov2.s-Rheumatoid Arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date.  There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
This spontaneous report as received from a physician refers to a 60 years old female patient. The patient was vaccinated with ZOSTAVAX (1 vial dose, injection, lot# was unknown) on 27-AUG-2012. Other suspect therapies included PNEUMOVAX 23 (lot# was unknown) on 27-AUG-2012. On 28-AUG-2012 the patient experienced swelling and inflammation, about 10x5cm in size, of the injection site, from after receiving ZOSTAVAX and PNEUMOVAX 23 in the same deltoid area. The patient sought unspecified medical attention, an anti-inflammatory was given for the adverse events. Additional information has been requested.
mild shortness of breath,; flu-like symptoms; cough; Fever; 2 episodes of vomiting; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (mild shortness of breath,), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), PYREXIA (Fever) and VOMITING (2 episodes of vomiting) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNEA (mild shortness of breath,), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), PYREXIA (Fever), VOMITING (2 episodes of vomiting), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). On 16-Apr-2021, DYSPNEA (mild shortness of breath,) and COUGH (cough) outcome was unknown and INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever), VOMITING (2 episodes of vomiting), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) had resolved.
Chills, fever, coughing, throwing up, dry heaving, very sick. Lasted 3 weeks
Client called and reported a blotchy, flat, itchy rash on his chest.  He denied chest tightness or difficulty breathing.  He reported that his symptoms were not getting better or worse.  Client was referred to see his doctor.  The next day the client reported that his symptoms abated by the time he went home around 5:30 PM, so he decided not to go to the doctor.  Client was encouraged to advise his doctor of the adverse event.
Inadvertently reconstituted with sterile water; Inadvertently reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 4th May 2022, the patient received Menveo. On 4th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-MAY-2022 Reporters comment: Pharmacist reported that, Menveo powder was inadvertently reconstituted with sterile water and administered to the patient.  The reporter consented to follow up. Additional supportive information: Menveo powder was inadvertently reconstituted with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JUN-2008, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2011, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 13-OCT-2014, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous (lot#, expiration date and strength not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
pericarditis diagnosed on 9/13/21 - treated with ibuprofen, famotidine, and colchicine with resolution of pain and normalization of labs, resolution of pain in 24 hours
Zero apetite; fatigue; body ache; low grade fever; dull headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Zero apetite), FATIGUE (fatigue), MYALGIA (body ache), PYREXIA (low grade fever) and HEADACHE (dull headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure in 2019. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (percocet), Bladder cancer NOS since 2018, Familial hypocalciuric hypercalcaemia, COPD since 2000, Kidney absent since 1975 and High cholesterol. Concomitant products included METOPROLOL for Blood pressure management, FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DECREASED APPETITE (Zero apetite), FATIGUE (fatigue), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (dull headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, DECREASED APPETITE (Zero apetite), HEADACHE (dull headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue), MYALGIA (body ache) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101 (Inconclusive) fever 101 degree F.         No treatment was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient stated she spent 3 days in bed , symptoms completely gone on day8.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Added patient demographics, medical history and concomitant medications. AE(s) added, outcome of event(s) updated from unknown to recovered.
pt recvd vax;devel fever of 101 & rt leg erythema; swelling involving entire leg & severe pain;also became very irritable, screaming, difficult to console;improved p/2-3 hrs w/ apap & cool packs to rt leg;
Patient fainted, hit her head was experience seizure like activity for about 10-15 seconds. She was taken to the ER for follow up and treatment
CRAMPING IN ARM WHERE INJECTION WAS ADMINISTERED; PAIN IN ARM WHERE THE INJECTION WAS ADMINISTERED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cramping in arm where injection was administered, and pain in arm where the injection was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm where the injection was administered and cramping in arm where injection was administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210842894.
diarrhoea; vomiting; Nausea; headache; muscle pain(pins and needle feeling); This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhoea), MYALGIA (muscle pain(pins and needle feeling)), VOMITING (vomiting), NAUSEA (Nausea) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included GABAPENTIN and METFORMIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (muscle pain(pins and needle feeling)), NAUSEA (Nausea) and HEADACHE (headache). On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhoea) and VOMITING (vomiting). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhoea), MYALGIA (muscle pain(pins and needle feeling)), VOMITING (vomiting), NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient also took flu night pills as treatment for the events which gave her temporary relief from the symptoms.
Soreness at injection site; left arm was Sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows:  After receiving 1st dose of Shingrix, the patient experienced soreness at injection site and left arm was sore to the touch. All information was not available. The reporter did not consent to follow up.