chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had leg weakness and tingling/Neuropathy in the legs; This is a spontaneous case, initially received from physician via Med Communications (reference number: SEQ19-07658) on 31-Dec-2019, concerning a 70-year-old male patient.   The patient's medical history included hypertension, pre-diabetes, hyperlipidaemia and upper respiratory infection.   The patient's past vaccine included two Shingrix vaccines (recombinant varicella zoster virus) received on 16-May-2019 and 18-Jul-2019. The patient's concomitant medication included Aspirin (acetylsalicylic acid), losartan, Lipitor (atorvastatin calcium), vitamin D and prednisolone for an unknown indication and Bactrim (sulfamethoxazole, trimethoprim) for upper respiratory infection.   On 21-Oct-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number and expiration date: not reported] for prevention of seasonal influenza.  On an unspecified date in 2019, seven to ten days after vaccination, the patient had leg weakness and tingling. The patient visited neurologist and medical doctor (MD) reported that the patient developed neuropathy in the legs. It was reported that the patient had not been hospitalized.   At the time of this report, the outcome of the event neuropathy in the legs was not reported.  The case was assessed as serious due to the criterion of medical significance.  The reported did not provide causality assessment.  Company comment: The patient experienced neuropathy peripheral associated with Fluad (TIV). Chronology needs more clarification. The patient's medical history included hypertension, pre-diabetes, hyperlipidaemia and upper respiratory infection. Also, advanced age of the patient might have contributed in developing reported event along with reported concomitant drugs. Causality is assessed as unlikely related.; Sender's Comments: The patient experienced neuropathy peripheral associated with Fluad (TIV). Chronology needs more clarification. The patient's medical history included hypertension, pre-diabetes, hyperlipidaemia and upper respiratory infection. Also, advanced age of the patient might have contributed in developing reported event along with reported concomitant drugs. Causality is assessed as unlikely related.
3 weeks of nasal congestion and multiple joint pain and swelling (bilateral wrists, lateral hips, knees, ankles) Exam with joint tenderness but otherwise normal
Tinnitus got worse; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus got worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus and Hyperacusis.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus got worse). At the time of the report, TINNITUS (Tinnitus got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Vaccine was mixed with sterile water instead of sodium chloride. there were no know ADE.
Warm stinging lump the size of an orange at injection site. Office examining. Gave KEFLEX for treatment.
TOE PAIN; This spontaneous report received from a consumer concerned a 50 year old male. 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, batch number: Unk) 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 subject experienced toe pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of toe pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210741144.
Pt received Varicella vaccine on 8/18/04 to lateral aspect of left arm. On 8/28/04 pt developed a "quarter sized red spot" to lateral aspect of left arm where varicella was given. On 8/29-8/30 area became larger in diameter, redder, hot to touch and "itchy." Pt mother started administering Benadryl everyday to child. On 8/31 pt mother took child to doctor who diagnosed as cellulitis and prescribed Keflex 250 mg po QID for 7 days.
Patient presented to the ED on 7/14/21 for diarrhea, epigastric pain. Patient presented to the ED on 7/22/21 and was subsequently hospitalized for fever, SLE, lymphadenopathy. These visits are within 6 weeks of receiving covid vaccination.
High fever of 103.3, headaches, chills, body aches, sore throat, nausea
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (significantly worse reaction than the second/severe reaction) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (significantly worse reaction than the second/severe reaction). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not reported. This case linked to MOD-2021-317916 (patient link).
This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB injection (lot # K026666 with expiration date 22-OCT-2016, lot# L004754 with expiration date 10-NOV-2016 and lot# L016427 with expiration date 13-APR-2017; dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp varicella w/less than 50 lesions;the reporter felt the vax was not r/t vax;
On 10/22/14 PM client was brought to clinic by mom to consult regarding possible reaction to vaccine;  Nurse observed erythema area 4 cm x 5 cm on right upper arm, along with slightly warm and some swelling. Mom reported started 10/21/14 and Ct. stated accompanied by some itching. No treatment.
Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose, strength and route were unknown, lot # L016428, expiry date: 30-JUL-2017 and lot # L016429, expiry date: 09-AUG-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Information has been received regarding a case in litigation which concerns a male pt who was vaccinated with injections containing toxic mercury in the form of thimerosal in approximately 15 doses between 3 months of age and two years of age. It is alleged that the pt has been diagnosed ith neurological injuries, including "disintegrative" (or "regressive," "late onset," "degenerative") autism. A hospital discharge summery was received as follow-up information. Per the record, the pt was inoculated with diphtheria, tetanus, pertussis, polio, haemophilus influenzae type B (manufacturer and batch unknown) and hep b vaccine recombinant (manufacturer and batch unknown) on 12/27/1998. On 01/11/1999, Synagis was administered. The pt has a history of being born prematurely at 27 weeks and five days gestation. He was considered a borderline "small for gestational age" male infant and was one of a set of triplets. The pt suffered with respiratory insufficiency and needed to use mechanical ventilation from birth to day three of his life, and then again from day eight through day 15 due to persistent apnea. On days four through eight he required aid from nasal continuous positive pressure air for respiration. "Apnea of prematurity" was medically treated with aminophylline on days two through nine, and then with caffeine citrate on day 26 through day 79 (01/05/1999). His last documented episode of apnea was 12/31/1999. He also suffered with pt ductus arteriosus that resolved on its own by 11/17/1998 (documented by echocardiogram on 11/12/1998 and 11/17/1998). In addition the pt has a history of an episode of supraventricular tachycardia which lasted 30-60 seconds and resolved with suctioning, sinus tachycardia on day 23. Echocardiogram on 11/12/1998 revealed hyperdynamic contractility and poor filling, pt was treated with propanolol HCL (Inderal) from 11/17/1998 through 12/12/1998. Other history included transient hypocalcemia and hypotnatremia, both conditions responded to supplementation; hyperbilirubinemia with total bilirubin maximum level was 6.8 and was treated with phototherapy on days 2 through 5, and on days 6 through 10; anemia (requiring three units of packed red blood cells, epoetin alfa (epogen) on 11/19/1998 through 12/18/1998 and ferrous sulfate (Fer-In-Sol) on 11/19/1998; and neutropenia with an absolute neutrophil count of 948 on 01/11/1999. Upon internal review, autism was determined to be an other important medical event. No further info is available.
No adverse event. Parent lied about child's age on consent form to get the Pfizer COVID vaccine.
patient reported pain in L arm after injection and was seen by her PCP office where they did testing to assess injury including x-ray.  continues to have pain at this time
Pt given PENTACEL, Rota, and PCV 13. Had allergic reaction to what we think was the PENTACEL, hives. BENADRYL given.
Throat feeling inflamed and tingling, "my tonsils are closing on me" "throat is getting worse and so is my cough" Told through interpreter. Epi 0.3 mg (epi-pen) Mylan OFM407 expires 2/2022 given in left vastus lateralis at 515m
could not raise her arm shoulder high; looked like a cherry; I looked like a cherry - had rash on my body - also spread to my arms and neck; Muscle was so sore, could not raise arm shoulder high; That night, she started getting a pressure headache; running a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry), RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck), PYREXIA (running a low grade fever) and MYALGIA (Muscle was so sore, could not raise arm shoulder high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D10A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Cholesterol and Ear infection NOS (Dexamethasone for ear). Concomitant products included DEXAMETHASONE for Ear infection NOS, POTASSIUM and MAGNESIUM for an unknown indication.   On 01-Mar-2021 at 2:00 PM, 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 01-Mar-2021, the patient experienced PYREXIA (running a low grade fever) and HEADACHE (That night, she started getting a pressure headache). On 01-Mar-2021 at 2:00 PM, the patient experienced MYALGIA (Muscle was so sore, could not raise arm shoulder high). On 02-Mar-2021, the patient experienced HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry) and RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Mar-2021 for Headache, at a dose of 2 dosage form and MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) (topical) on 02-Mar-2021 for Myalgia, at a dose of 1 dosage form. On 03-Mar-2021, MYALGIA (Muscle was so sore, could not raise arm shoulder high) outcome was unknown. At the time of the report, HYPOKINESIA (could not raise her arm shoulder high), SWELLING FACE (looked like a cherry), PYREXIA (running a low grade fever) and HEADACHE (That night, she started getting a pressure headache) outcome was unknown and RASH (I looked like a cherry - had rash on my body - also spread to my arms and neck) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
very sick; experiencing all the symptoms of COVID; every bone in her body is aching; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021. The most recent information was received on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), COVID-19 (experiencing all the symptoms of COVID), BONE PAIN (every bone in her body is aching) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 22-Apr-2021, the patient experienced ILLNESS (very sick), COVID-19 (experiencing all the symptoms of COVID), BONE PAIN (every bone in her body is aching) and HEADACHE (headache). At the time of the report, ILLNESS (very sick), COVID-19 (experiencing all the symptoms of COVID), BONE PAIN (every bone in her body is aching) and HEADACHE (headache) had resolved.            The patient took second dose 25 days after first dose. The patient recovered but still feels tired. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was Not Applicable. Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR : AE outcome
Intense pain and loss of range of motion. No swelling or redness. Heat, ibuprofen and physical therapy.
Pt reports having a full blown case of shingles but stated she had never had chicken pox. Pt was treated by family physicians starting on 1/7/08 with Valtrex 1mg, Prednisone 20mg and Lortab.
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
Large rash close to injection site.   Arm has never hurt but still felt hard around site. That has lessened. No other side effects.
Pt states L arm red, swollen hot, et there is a 4" band at bottom of site halfway around front of arm to back - suggested she contact her personal physician.
pt recvd vax 22MAR95;2hrs later became pale, apneic, bradycardia;hospitalized & ventilated;;rx'd ampicillin & Cephalosporin;found H influneza type B in tracheal aspiration;pneumoia-haemophilus influenzae serotype B
7-10 days after injection reported body aches, followed by a red raised palpular rash.
pain at the injection site with both doses; swelling at the injection site with both doses; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip surgery. Previously administered products included Shingrix with an associated reaction of injection site pain (also experienced injection site swelling after receiving 1st dose in October 2019, refer case US2020212947). Concurrent medical conditions included degenerative joint disease.   In October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Nurse wanted to know that if the patient had the 1st dose of Shingrix in October 2019 but was not able to obtain the 2nd dose due to surgery and recuperation time do they now need to get both doses 1st and 2nd again with proper interval between them. The patient had received the 2nd dose within the last week and reported pain and swelling at the injection site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212947:Same reporter
Patient fainted after receiving flu shot. He was walking out of immunization room in front of pharmacy and fell flat on ground and hit head.  He chipped front teeth with blood from mouth and was groggy.  Dad helped him into wheelchair and ems was called.
pt recv vax 24SEP96 & exp a h/a;treated it w/1 dose of APAP;
Patient noted increase swelling, redness, warmth 12 hours after vaccination. Patient complained of stomach hurting and had oral temp of 101.1F. No respiratory s/s or hives. Mother took child to urgent care and patient started steroid dose pak. RN instructed mom to use Motrin PRN and cool compresses. Spoke with mother 9/27 and patient doing much better.
he received flu shot 5 years ago having mercury and he had a reaction to it.; Initial information received on 06-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves male patient(unknown demographics) who received flu shot 5 years ago having mercury and he had a reaction to it(hypersensitivity) of vaccine INFLUENZA VACCINE. It was also reported that then he received a mercury free flu shot and has been okay.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious allergic reaction (hypersensitivity) Unknown latency following the administration of INFLUENZA VACCINE.  No lab data was reported.  Final diagnosis hypersensitivity.  It was not reported if the patient received a corrective treatment.  On an unknown date, event outcome was reported as unknown for hypersensitivity.  Information on the batch number was requested.
Generalized hives within 12 hours. Given Benadryl and Prelone.
Patient received the pfizer booster vaccine in her left arm on 3/22/22. Today she woke up with redness and swelling around the injection site. She states it does not itch but feels warm to touch. I recommended OTC treatments but that if her swelling got worse she should seek medical care to make sure it is not getting infected
Initial report was received from a consumer on 13 November 2012. A 46-year-old female patient had received FLUZONE Intramuscular (lot number and site not reported) at the employee health center of the hospital and 4 days later experienced severe headache, neck stiffness, generalized weakness, nausea and vomiting. "A few days later" a rash developed between her scapula which looked like a bruise. Relevant diagnostic tests included an MRI which showed CSF leak. No corrective treatment was reported. The patient had a medical history of occasional headache. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: None.
Lymph node swelling; Stomach pain; Fever of 99-100 for 2-3 days; Headache; Nausea; Swelling 1 inch below the injection site/ increased to the size of a soft ball.; Tenderness 1 inch below the injection site; Redness 1 inch below the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Had chickenpox as a child). Concurrent medical conditions included arthritis. Concomitant products included adalimumab (Humira).   In September 2022, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site tenderness, injection site erythema, swollen lymph nodes, stomach pain, fever, headache and nausea. On an unknown date, the outcome of the injection site swelling, injection site tenderness, injection site erythema and fever were recovered/resolved and the outcome of the swollen lymph nodes, stomach pain, headache and nausea were unknown.   It was unknown if the reporter considered the injection site swelling, injection site tenderness, injection site erythema, swollen lymph nodes, stomach pain, fever, headache and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's comments: The reporter was the patient who had received the Shingrix one and half months ago from the time of reporting and had experienced swelling, tenderness, and redness 1 inch below the injection site, which had increased to the size of a soft ball.  This had occurred for 5 days. The fever was of 99-100 degree Fahrenheit for 2-3 days, but she usually runs a low temperature of 97.6 Fahrenheit. She did not took any Tylenol or Ibuprofen, because she did not wanted to get it impacted on her immune response. She also had experienced lymph node swelling, stomach pain, headache, and nausea.  Shingrix was administered during her off week of Humira. She did test herself of COVID since this reaction with Shingrix made her think she had COVID. Her COVID test came back negative.  She did not receive any other vaccines at the time that Shingrix was administered. The reporter had consented to follow-up.
The vaccines was given with an expired date. It was expired on March 9, 2023. FNP informed patient on March 30, 2023 of the mistake that had occured on March 27,2023. Patient understood and was not concerned. She did not have any symptoms or signs of any reactions.