chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, sleeplessness, injection site itching and injection site rash. On 1st July 2018, the patient experienced injection site warmth. On an unknown date, the patient experienced muscle pain, joint pain, influenza-like symptoms and erythema. The patient was treated with hydrocortisone, BENADRYL and Anti-Itch Cream (Antihistamine)). On an unknown date, the outcome of the pain in arm, swelling arm, injection site itching and injection site warmth were not recovered/not resolved and the outcome of the sleeplessness, injection site rash and erythema were recovered/resolved and the outcome of the muscle pain and joint pain were not reported and the outcome of the influenza-like symptoms was unknown. The reporter considered the pain in arm, swelling arm, sleeplessness, influenza-like symptoms, injection site itching, injection site rash, injection site warmth and erythema to be related to SHINGRIX. It was unknown if the reporter considered the muscle pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: The caller stated within 12 hours of receiving her first shot of SHINGRIX the patient experienced pain in her arm with swelling that was bulging. The patient stated she iced it on and off all day and went back to the drug store where she received the vaccine. A pharmacist caller her physician, who stated this, was a reaction to the vaccine and advised not to get the second dose. The patient stated she couldn't sleep because of the pain in her arm, she was having muscular and joint pain also and felt like she had flu like symptoms due to the joint and muscle pain. The patient stated 4 to 5 days later she had a severe itch over the injection area, and a rash. She was taking BENADRYL and an anti-itch cream. She went to see her doctor and he prescribed hydrocortisone on or around 6 by 25. The patient stated the rash, itching, swelling and redness finally resolved, but last night she developed itching and slight swelling again with warmth to touch on the area of the injection.
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II, (lot# M004063 and expiry date 25-JAN-2018)(lot#M010426 and expiration date 01-MAR-2018)(lot#M032153 and expiration date22-APR-2017)(lot#M017346 and expiration date06-APR-2018) and (lot#M029229 and expiration date08-JUN-2018) subcutaneously(also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 06-Jun-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) Positive.     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.   No treatment information was provided.  No concomitant medication was provided.
Mom called stating that pt started with barky cough on 10/16/2020.  Congestion/ runny nose, lots of sneezing.  Temp no higher than 99.  Mom wanted to call in as last year he rec'd flu shot as well and ended up with fever and vomiting a couple days later and thought it might be due to flu vaccine.
14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No concomitant drug information was provided.  It was reported that 14 patient had received the vaccine which was in refrigerator past 30 days.  the vaccine used by date was 26NOV2022 however vaccine was administered on 1DEC2022.   No treatment drug details were provided.  The case contains the details of one of the 14 adult patients who had received an expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-685126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685126:same reporter
PATIENT REPORTS A REDNESS AND SWELLING THAT WAS 4"X2" WITH A HARD LUMP IN THE MIDDLE THAT APPEARED SHORTLY AFTER THE VACCINATION. THIS LASTED FOR APPROXIMATELY ONE MONTH, THEN REDNESS AND SWELLING SLOWLY WENT AWAY AND THE  SKIN PEELED OFF THAT WAS OVER THE SIGHT OF THE INJECTION.
Within 1 hour after IZ, pt's right thumb, index finger and middle finger turned yellow. He was seen in ER and they sent him home because there were no other symptoms. Spoke with pt, 3 hours later, and he said that the yellowing went away.
administration of an expired Bexsero dose to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 08-SEP-2023, the patient received Bexsero. On 08-SEP-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administration of an expired Bexsero dose to a patient).The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-SEP-2023 The reporter called to report that the administration of an expired Bexsero dose to a patient, which led to expired vaccine used.  The healthcare professional asked if the patient had to receive a repeat dose of Bexsero. The reporter consented to follow up.
High fever 103 to moderate fever 100 continuously over 48 hours. Pain at injection site immediately after shot.  Underarm swelling began at 36 hours after vaccine.
15 min after shot (235pm 3/24) strong tingling in left calf and foot. Continues through today with lighter tingling however now left foot and toes are extremely  cold.
unspecified injection site side; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that the Shingrix seems to have a high side effect rate in his practice. Pharmacist did not elaborate about any patient types or specific events, only that Shingrix vaccine had a lot of side effects to it. The reporter did not consented to follow-up. This case is linked with US2020187143, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187143:same reporter
On 12/24/20  through Wed 12/30 daily while exercising; either back country skiing, resort/alpine skiing, Nordic/skate skiing or hiking uphill, I developed rapid onset, severe, debilitating, crippling 8/10 pain in my right fectus femoris thigh muscle. Duration of spasms 1-2 seconds, frequency every 10-15 minutes while exercising up to 6 hours/day. Self treatment included taking Ibuprofen 400 mg tabs po daily, OTC electrolytes po daily,  application of topical diclofenac (Voltaren) gel, increase in hydration of non caffeinated/non alcoholic beverages; without any improvement.
after vaccination pts face looked flushed and pt claimed to feel dizzy and weak. Pt was given 1 dose of liquid diphenhydramine and sat for 30 minutes. Pt attempted to leave but came back. She drank orange juice and felt better after 15 minutes. Patient was called 1 hour later and stated she felt better.
severe pain; rashes; pain in back; pain in the back and shoulder down to arm; pain in the back and shoulder down to arm; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 Vaccine on 05Mar2021 and after two hours, the patient had pain in the back and shoulder down to arm. Then in the morning of 08Mar2021, rashes showed up from the top of the shoulder down to the elbow. She also experienced severe pain on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
4 days following the injection I had chest pain similar to the reaction after Dupixent injection.
Vaccine was not reconstituted properly.  Vaccinator did not pull up the correct amount of diluent of 1.8. Error was not caught until after dose was administered to patient.   Patient did not show any adverse signs or symptoms during observation window. Potential outcome unknown.   Pfizer-BioNTech COVID-19 Vaccine .3ml dose
Patient reported severe systemic hives ~24 hours post-injection. Did not experience any flu-like symptoms or other adverse effects. Reported the reaction as "Horrible itching." Per patient, this lasted ~2.5 days until she sought reprieve at urgent care.
patient has become extremely fatigued and is experiencing bodyaches for several days. she had the same thing happen to her after the first shot, but this only lasted for 2 days and resolved. this time her symptoms are lasting for 4 days and because they are not resolving, she is in the ED.  she is also found to be clinically dehydrated
pt recvd vax 11AM & had advil prior to shot because of allergy to APAP 2Pm started crying non stop & t105 x2 days;had 6 szs that day;shook all over & eyes rolled back in head;leg was sore swollen;took to ER
Right eye lid swelled up within 24 hours of the shot and is still an issue as of this submission.  Some days the swelling has been severe some days and less severe, but the swelling has never fully gone away in the last two months. The swelling can include the eyelid, the skin between the lid and the brow, and below the eye . The eyelid and skin near brow will often turn pink/purple. Beyond the swelling pain, no major main. Some pain on outer eye bone for both eyes.  The swelling seems to get worse when I  sleep longer or lay down horizontal.  When I go to sleep propped up, the swelling is less severe. Or, if I sleep for 7 or less hours, sometimes the swelling can be less.
This spontaneous report was received from a male consumer of an unknown age referring to himself. On 27-SEP-2012, approximately (also reported as one year ago), the patient was vaccinated with ZOSTAVAX, (lot number not reported). The patient reported that he had a reaction at the injection site from the ZOSTAVAX vaccine. He had a small patch of redness at the injection site. The outcome of he had a reaction at the injections site from the ZOSTAVAX vaccine and he had a small patch of redness at the injections site was unknown. Additional information is not expected.
Fevers for 10 days, excruciating headaches and muscle aches, extremely swollen lymph nodes, fatigue
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX. No adverse symptoms were reported. Additional information has been requested.
memory loss, achy muscles and joint pain. fatigue. Symptoms reflecting M.S. and chronic fatigue syndrome. Symptoms are getting worse over time. I need help!
I have a left thyroid-megaly, no pain or symptoms. I had a fever and chills the  ight of my vaccine. The left side of my thyroid is quite enlarged and is still very present.
G3P2002 EDD 3/18/2021 Given 3/1/2021 Symptoms include diffuse whole body allergic reaction with itchy red maculopapular rash
diarrhea; swollen arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Abdominal aortic aneurysm (triple A Abdominal aorta aneurysm), Gallbladder stones and Heart attack. Concurrent medical conditions included Memory loss, High cholesterol, Stiffness and Vitamin D deficiency. Concomitant products included BACLOFEN, METOPROLOL, TERAZOSIN HCL, OXYBUTYNIN CHLORIDE, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, PAROXETINE HCL and SALINE [SODIUM CHLORIDE] for an unknown indication.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was provided by the reporter.
5/8/18 with fussiness, followed by seizure, per mom lasted about 20 minutes, with appropriate post-ictal state, ED evaluation with temp 105 down to normal after TYLENOL po, exam benign, CXR negative, rapid flu negative as of 5/26/18, mom reports no more seizures but patient still with intermittent fevers to 103, no URI sxs rash vomiting diarrhea joint swelling or other focal sxs, fevers resolve with tylenol or ibuprofen - is eating well, happy and active.
Pt received IM flu vaccine (R) arm approximately 5-10 min pt c/o itchiness (R) arm, then began w/ itch back/head, legs mild redness (R) arm 50 mg BENADRYL 1910 - pt felt less itchiness c/o tongue swollen and throat sore/tight pt observed 20 min swelling decreased - cont w/ itchiness.
Reason for Admission: Respiratory failure    Brief Summary of Hospital Stay:  Patient long time, heavy smoker  with suspected COPD (chronic obstructive pulmonary disease) (no pulmonary function testing on record) developed Acute respiratory failure with hypoxia.  The cause of the respiratory failure was was felt to be a pneumonia due to a COVID-19 infection.  For COVID she has completed a coursed of REMDESIVIR.   She had 10 days of DECADRON, For possible superimposed bacterial pneumonia she had 10 days of CEFTRIAXONE and 6 days of DOXYCYLINE.  She had been on high flow nasal cannula but now weaned down to 5-6 liters per nasal cannula though she is experiencing air hunger.  We started low dose Roxanol with good effect.   CT chest on 5/15 reporting, "New multifocal bilateral peripheral consolidation with lower lung predominance." Patient's procalcitonin remains low. Erythocyte sedimenation rate is normal.  Mild elevation of pro-BNP.  Pulmonary following and and recommended longer taper of steroids.  She was able to wean down to supplemental oxygen of 3 L/m and was discharged home on oxygen.     Active Problems: Essential hypertension she had relative hypotension for a time so her medications were held but have restarted LOSARTAN.   Dyslipidemia on SIMVASTATIN at home.   Chronic narcotic use with regular HYDROCODONE use.  Issues Requiring Follow Up: If patient is staying on steroids for a longer period would need PCP prophylaxis.
Local reaction, wide, at site of injection with erythema and induration.  Self monitored fever at home 24 hours after injection.
Throat closing sensation; Dizziness; Itchy rash injection site; Fist-sized swollen injection site; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat closing sensation), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (Itchy rash injection site), VACCINATION SITE SWELLING (Fist-sized swollen injection site) and FATIGUE (Tiredness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug (Allergy to Paracetamol) and Allergic reaction to antibiotics (Allergy to Zithromax/Azithromycin).    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced THROAT TIGHTNESS (Throat closing sensation), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (Itchy rash injection site), VACCINATION SITE SWELLING (Fist-sized swollen injection site) and FATIGUE (Tiredness). At the time of the report, THROAT TIGHTNESS (Throat closing sensation), DIZZINESS (Dizziness), VACCINATION SITE PRURITUS (Itchy rash injection site), VACCINATION SITE SWELLING (Fist-sized swollen injection site) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient has a history of negative reactions to vaccines.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On 13-JUL-2015, unknown doses of GARDASIL were improperly exposed to 32F for 63 hours. Then, on unspecified dates since 13-JUL-2015, an unspecified number of patients may have received the improperly stored GARDASIL (lot# K009482, expiration date 06-MAR-2017, dose and route were unspecified). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Starting in August of 2021, gum and tooth problems. 2 months latter osteoarthritis in knee.
Within an hour of the injection patient broke out in hives followed by numbness and tingling on the left side of the face. Mild headache with body soreness started approximately 8 hours after injection and lasted for about 12 hours. Benadryl was taken to relieve the hives, Advil and Tylenol were alternated to relieve headache and body soreness. The numbness of the face was resolved about 12 hours after onset.
This spontaneous report as received from a pharmacist refers to her son, a 17 year old male patient with acne. On 11-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (Intramuscular injection, dose 1, intramuscular, batch/lot # reported as K008621, expiration date reported as 04-MAR-2017, anatomical location not reported). Later, on 14-OCT-2014, the patient was vaccinated with the second dose of GARDASIL (Intramuscular injection, dose 2, intramuscular, batch/lot # reported as K008621, expiration date reported on 04-MAR-2017, anatomical location not reported). Concomitant therapies included clindamycin. The reporter informed that on 15-OCT-2014, the patient developed nausea and fever of 103F. It was also reported that after a throat culture performed on the same date, he was diagnosed with "strep". The patient sought medical attention, was given TYLENOL and ZOFRAN on 15-OCT-2014, and as treatment for the strep throat, he was prescribed OMNICEF. The outcome for nausea was recovering (reported as "nausea is better"). The outcome for fever was not recovered (reported as "still had fever"). The outcome for strep throat was not reported. Causality was not provided by the reporter. Additional information has been requested.