chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left foot cramping; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Left foot cramping) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Cramps calf in February 2021.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE SPASMS (Left foot cramping). At the time of the report, MUSCLE SPASMS (Left foot cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
No adverse effect; Improperly stored dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy details were not reported.     On 12-SEP-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S005874 expiry date 31-OCT-2020 (strength, route of administration were not reported) for prophylaxis (Product storage error). No adverse event was reported. The vaccines was exposed to a lowest temperature of below2 degree Celsius (1.2 Celsius) for a time frame of 24 hours and 36 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No product quality complaint (PQC) was associated with this report.
Ocassional pain in joints; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Ocassional pain in joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK. In 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (Ocassional pain in joints). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, ARTHRALGIA (Ocassional pain in joints) had not resolved.            No concomitant product was reported. No treatment information was reported. The reporter's causality for the event Arthralgia was reasonable possibility and for event Fatigue was no reasonable possibility with Humira. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Day 2 in the evening, noticed pain under left arm and my lymph node was swollen to about an inch high and 3 inches in diameter.  It is painful to the touch.
The patient presents on 8/10/21 for a new patient visit; she was recently seen by the hematology service and given suspicion for HLH, r/o lymphoma.  The patient is a 64 yo woman with history of Guillain-Barre syndrome/AIDP (2015), SLE (no longer on any meds), OSA (no CPAP use for past 2 yrs), TDM2, HTN, chronic lower back pain, b/l knee osteoarthritis s/p b/l TKR, LLE DVT (2000, no longer on AC), asthma, anxiety, depression, neuroendocrine tumor of pancreas s/p resection (8/31/20) who presents initially to LIJ on 7/18/21with generalized weakness, poor PO intake, weight loss, and recurrent fevers after Pfizer vaccine 1 month prior to presentation. Initial concern was for resistant bacterial PNA vs cryptogenic organizing PNA given recent admission for PNA, but hospital course c/b persistent fevers despite long course with antibiotics and fluctuating neutropenia of unknown origin so workup for malignancy started. Patient had bronchoscopy with hilar LN biopsy on 7/27/21, and BM biopsy on 7/30/21 as well as PET scan on 8/2/21 to r/o lymphoma.  Patient was seen by ID, rheumatology, and hematology services.CT A/P showed postsurgical change at site of prior neuroendocrine tumor vs neoplasm, re-demonstrated patchy pneumonia and lymphadenopathy especially in axillary and left supraclavicular nodes. Of note, patient was found to have elevated COVID-19 nucleocapsid antibodies, indicated that patient may have had prior COVID infection, which may have been the cause of her peripheral opacities on CTA, in addition to diffuse weakness. Rheum consulted due to patient's history of SLE (not on meds) and +SSA/SSB Ab and they evaluated for possible vasculitis, sarcoidosis, or autoimmune flare and results were nonspecific. 8/2 PET scan with FDG-avid cervical, axillary and hilar adenopathy. Differential includes inflammatory and neoplastic etiologies, including lymphoma. FDG-avid lymph nodes in neck and thorax, predominantly unchanged as compared to recent diagnostic CT scans, also are nonspecific. Mild, diffuse bone marrow hypermetabolism was noted but nonspecific. Peripheral blood flow cytometry (7/29) showed small population of monotypic B-cells in a polytypic background, and bone marrow biopsy (7/30) revealed moderate B-cell lymphocytosis with no clonal B-cell population on BM flow cytometry; further work up was pending to r/o underlying hematological malignancy, which the patient preferred to have performed as an inpatient. The patient was discharged from LIJ on 8/4/2/1 to follow up with hematology today to follow up on final bone marrow biopsy results as well as to arrange for an axillary lymph node biopsy to r/o suspected lymphoma.  Infectious work up, including blood, urine, bronchial and tissue cultures, including acid fast and fungal cultures, have demonstrated no growth of pathological organisms as of 8/4/21. She had no further fevers for >48 hours prior to Discharge.
Rash and itchiness on arm where vaccine administered. Rash increased in size on arm.
This spontaneous report as received from a registered nurse refers to a unspecified number of patients (gender and age unknown). The nurse reported that the patients may have received improperly stored doses of RECOMBIVAX HB (lot number, route and dose were not reported) over the past three months. No symptoms were reported. No other details were provided. This case is related to case MARRS # 1212USA004546 and case MARRS # 1212USA005494 (same reporter link). Additional information has been requested.
I started feeling ill on Monday, 1/31.  Mostly a little tired and sore throat.  It got worse on Tuesday and included a headache and congestion.  I took a COVID test on Wednesday and started coughing; I got a positive COVID result the next day.  I did not see a doctor, but I talked to a Telemed doctor who prescribed some cough medicine.  I felt better by Saturday.  I realize this might not be an adverse reaction to the COVID vaccine, but when I researched whether getting the COVID vax along with the flu could cause flu-like symptoms with a positive COVID test and it said there was no significant data to suggest any issues with taking both vaccines at same time.  So I felt it was important for me to report my case so that it can be considered among the rest of the data.
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home.  No relief with med.  lower feet noted trace of swelling,  jaw pain and epigastric discomfort.  Leg pain subside after 3 days but with muscular pain esp the upper arms.  Extreme fatigue and mild tenderness on the back of head.  It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
red, raised rash on the left side of her neck which spread to her right side of her necK; red, raised rash on the left side of her neck which spread to her right side of her necK; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red, raised rash on the left side of her neck which spread to her right side of her necK) and RASH PAPULAR (red, raised rash on the left side of her neck which spread to her right side of her necK) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red, raised rash on the left side of her neck which spread to her right side of her necK) and RASH PAPULAR (red, raised rash on the left side of her neck which spread to her right side of her necK). At the time of the report, RASH ERYTHEMATOUS (red, raised rash on the left side of her neck which spread to her right side of her necK) and RASH PAPULAR (red, raised rash on the left side of her neck which spread to her right side of her necK) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Hive like rash with central induration tenderness. Treated with antihistamines and KEFLEX.
potentially refrozen vaccine administered to approximately 9 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (potentially refrozen vaccine administered to approximately 9 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.  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 PRODUCT STORAGE ERROR (potentially refrozen vaccine administered to approximately 9 patients). At the time of the report, PRODUCT STORAGE ERROR (potentially refrozen vaccine administered to approximately 9 patients) had resolved.        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.   No concomitant medications were provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up document contains no new information. On 09-Nov-2021: Non-Significant follow up appended
Two weeks later rash all over body that was extremely itchy. Almost like welts, would not go away with Benadryl or cortisone cream.  Went to doctor and received a steroid that helped and Zyrtec. Rashes show up and disappear all over, and is incredibly itchy.
5 year old female patient received a dose of Daptacel on an unspecified date.  The route and site of administration were not reported.  An unspecified amount of time later, the patient developed Cellulitis at the site of injection.  As per the reporter, it is unknown if the patient recovered from this event.   The reporter stated that this patient was one of a total of 3 patient who experienced an adverse event following the receipt of this lot number.  No information was provided for the other two patients.
Severe headache, weak, fatigue , cold sweats, fever of over 101 for over 48 hours.  Adopted where multiple vaccines taken at once after birth and have never had good reactions or success with future vaccines. Only took this vaccine 1 day after 18th birthday to comply with university requirement and took more natural J&J vaccine. Should not have taken it based on history and adverse events. Any future vaccines of any type would appear to be quite risky from a medical perspective and certainly do not want to mix any vaccine or booster from conflicting manufacturers or MRNA vs. non-MRNA, which is not advisable due to conflicting medical opinions.
10 days post injection itchy, non-raised rash. Just below the injection site about the size of a tennis ball.
pt recv 2nd dose of vax & devel erratic urticarial eruptions all over torso, upper & lower extremities w/in a wk of vax & persist;pt saw family MD who confirmed rxn;
After receiving an influenza vaccination, patient's significant other reported that patient had anaphylaxis reaction hours after the administration. Patient has a history of receiving influenza vaccinations with no reported problems prior to this occasion.
A pounding or fluttering heartbeat; Heart inflammation; Chest pain; A feeling of breathlessness; A pounding or fluttering heartbeat; This is a spontaneous report from a Pfizer sponsored program  reported via consumer (patient's wife). A male patient (reporter's husband) received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 29Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On 02Jul2021, two days after receiving second dose of vaccination, patient experienced heart inflammation, which include chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat. Patient went to seek an emergency, but they did not find anything causing these. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
The patient presented stating her arm hurts and she has pain when she tries to lift her arm. She is trying to work out the pain using ibuprofen and range of motion exercises.
Flu Vaccine: Immediately had horrible pain when administered. Within 30 minutes, experienced stiff neck accompanied with extreme neck, shoulder and arm pain; could not reach or extend arm without pain. Continued to move arm in rotating and upward movements to ward off the pain and move the muscles. Didn't help. One day late, still experiencing same, but with less pain but tightness in shoulder and neck persist. Have NEVER experienced this before (usually just a low grade fever and soreness)
Patient got a welt distal to the vaccine sites and subsequently developed swelling and redness in her upper extremity to level of elbow. Still had symptoms 10/31/18.
A patient received a dose from a vial of Ipol which was the 11th dose from a vial which contained 10 doses. The 11th dose was a full 0.5 mL with no adverse event; Initial information regarding this unsolicited valid non-serious was received from other health care professional and transmitted to Sanofi on 26-Feb-2021.  This case involves a 03-months old female patient received a dose from a vial of IPV (VERO) [IPOL] which was the 11th dose from a vial which contained 10 doses. the 11th dose was a full 0.5 ml (incorrect dose administered) (batch number: R1B251M and expiration date: unknown) via unknown route and unknown site for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL), LABETALOL HYDROCHLORIDE (IPOLAB) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was an actual medication error due to the inappropriate dose of drug administered (latency: unknown).  At the time of reporting, the patient had no adverse event.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medication was provided.  The BUD of the vaccine was provided was 12May2022.   Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow up received contains non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
This case was reported by a consumer (subject's mother) and described the occurrence of myoclonic seizure nos in a 2-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medications included Anesthesia for the MRI (magnetic resonance imaging) test on 7 March 2013. On 16 January 2013 at 14:30 the subject received a dose of Hepatitis A vaccine (unknown route and volume, unknown thigh). The reporter stated that the vaccine was administered on 16 January 2013 or 23 January 2013. It was unclear at the time of reporting why the dates were unclear. On 19 January 2013 (or 26 January 2013 dependant on the date of vaccine administration), 3 days after vaccination with Hepatitis A vaccine, the subject experienced jerking of head ("jerking his head backwards in a strange manner"), grimacing ("grimacing his face further clarified as scrunching up eye and nose area") and repetitive eye blinking ("blink his eyes non-stop"). The reporter stated that these events "started off slowly but by the following weekend, it had worsened." The mother reported that the subject was having "50 episodes of these a day but later slowed to about 30 times a day." The subject was hospitalised; however, the dates of hospitalisation were not reported. Relevant test results included an outpatient MRI on 7 March 2013, specific results not reported, and EEG (electroencephalogram) on 8 March 2013, specific results not reported. Based on the results of the MRI and EEG, the subject was "formally diagnosed as having myoclonic seizures" on 8 March 2013. The subject was treated with DEPAKOTE which began on 8 March 2013. Per the reporter, the events had improved "but the dosage might need to be further adjusted." At the time of reporting the events were improved. The mother stated that the subject's "physician reported these events to VAERS but did not think the seizures were related to the hepatitis A vaccine." It was unknown if the immunization series was discontinued or delayed at the time of reporting. The mother also reported another case. See case A 1017132A for details on the other case.
slight rash on the right side of her chest, on the side where she received the shot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 74; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced slight rash on the right side of her chest, on the side where she received the shot. She states the rash was subsiding. The Outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from an other health professional refers to a female patient of unknown age. The health care worker reported that the patient was vaccinated with the first dose, 0.5 ml GARDASIL on 01-AUG-2011 and received the second dose 0.5 ml GARDASIL on 21-AUG-2012. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Tested positive for covid after first dose of the vaccine./ The caller's friend tested positive 2 weeks after getting the vaccine.; Tested positive for covid after first dose of the vaccine./ The caller's friend tested positive 2 weeks after getting the vaccine.; This is a spontaneous report received from a contactable consumer. Report 2 of 2.This consumer reported for a 59-year-old female patient (friend) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number, expiration date: unknown) via an unspecified route of administration on 15Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. On 29Mar2021, the patient tested positive two weeks after getting first dose of the vaccine. The patient received the vaccine on the same day as the caller on 15Mar2021. State filed in. The Product Complaint as the patient tested positive 2 weeks after getting the vaccine. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Headache starting 24 hours post vaccination for 48 hours+; intense rigors starting at 60 hours; after rigors decreased, felt very hot and temperature was 104 degrees; monitored temperature and it slowly decreased one degree at a time (so did not seek medical attention); three hours after rigors started, cycled between cold/hot and unable to sleep extended periods of time for an additional 3-4 hours (fell into deep sleep around 5-6am); extreme lethargy for two days following this ordeal; ok on day five post vaccine