chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported tingling and weakness in both arms approx 24 hours after flu shot, plus pain in right thumb. Symptoms resolved completely and spontaneously approximately 24 hours after onset. Pt states she is completely fine now.
PATIENT WAS GIVEN A MODERNA VACCINE. PREVIOUSLY HAD PFIZER. THE PATIENT SHOULD HAVE BEEN GIVEN A SECOND DOSE OF PFIZER.
pt recv vax 24JAN96 & prior to receiving a liver transplant;2FEB96 pt devel GBS & rhabdomyolysis which resulted in a prolongation of hospitalization;tx IV immunoglobulin for 5 days;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt. called Friday to say her arm was really red and swelling. she said it was about 2 inches across. I told her to put cold compresses and to take Benadryl if she had itching/rash. She said she had benadryl cream and was going to try. She came back today and it was still swollen, and warm to touch. she ended up putting hydrocortisone cream because she didn't have benadryl and bought benadryl today. The injection site was swollen ,itchy and about 2 inches still. She did not see physician .
Urticaria with macular papular rash to abdomen, edema to left upper lip and left cheek. Pruritis throughout the body. Patient was treated with Benadryl, Zantac and prednisone with resolution of urticaria, rash and almost complete resolution of edema within 3 hours. Will complete course of prednisone for 5 days.
Patient has a history of autonomic dysfunction and 1 minute post administration of Pfizer vaccine patient began to feel lightheadedness and flushing. VS: 157/92, P 88, O2 98%, Resp 18. Patient remained in Observation area for an extended period of time. Left clinic in stable condition.
LLR left deltoid, hot red, tender about 10 x 9 cm.
Pt. states that she developed nausea and vomiting for one day, no treatment, resolved on 01/06/2021
received vaccine 7/8/97 at 1 yr of age pt in 04/12/05 for rash, dx chicken pox breakthrough TX with Calamine and Benadryl.
Adv eff bact vac NEC/NOS on 2013-12-04.
arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Service Member was aministered the Anthrax ID in his right forearm and PPD IM in his right deltoid.  His right forearm began to swell and burn.  The next morning his arm became dark red, the injection site was almost white, and the redness was following the track of a vein up into his arm pit.  Service Member was treated intravenously with Clindamycin and Ibuprofen and released
TOOK ONE UNREFRIGERATED DOSE; This spontaneous case report (PVX2019-2341) was received from a pharmacist on 12-Sep-2019. It described a 46-years-old male consumer who "took one unrefrigerated dose" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 12-Sep-2019, which was unrefrigerated for one week at room temperature.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one unrefrigerated dose" was considered as not applicable.
Patient presented for COVID-19 booster and influenza vaccine. LPN checked for previous influenza vaccine status but did not review previous COVID-19 history, however patient presented COVID-19 vaccination record card with two documented Moderna vaccines on 12/22/2020 and 01/19/2021. She proceeded to administer the Moderna booster vaccine 0.25mL and influenza vaccine. When documenting the vaccines, the LPN realized she had not checked for prior COVID-19 vaccination status. There displayed were three COVID-19 doses as follows: 12/22/2020-Moderna, 01/19/2021-Moderna and 08/25/2021-Pfizer. When questioned about the third dose, she denied having a third dose. She attributed it to a documentation error, however, the following day she reported in fact she received a third dose but does not recall details due to going through a difficult time during that period and high stress levels. Patient's significant other reminded her of receiving third dose. Patient denied having any adverse reactions and reported feeling fine. However, she reported left arm soreness for approximately 3 days after vaccine administration. Patient took ibuprofen once-soreness resolved. Patient instructed she does not need any additional COVID-19 vaccines at this time. Patient verbalized understanding.
Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023; No adverse event; 42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7661B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Aug-2023, 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 27-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023) 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 (42-year-old patient received expired Bivalent booster dose of Moderna COVID-19 vaccine on 27AUG2023.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 25-JUL-2023 and vaccinated on 27-AUG-2023).    No concomitant medication was reported.  Vial size was reported as 2.5 ml. Vial did not undergo temperature excursion. It was reported that MFG lot number expiration date was extended to OCT2023. No treatment medication was reported
Within a matter of seconds around 5:45 on April 23, 2021 I got nauseous, then dizzy, then passed out while I was sitting. I came to about 5 minutes later. The rest of the day I had the usual side effects such as body aches, chills, and a fever.
9 days p/vax;fever of 103.5 w/APAP it went down 102 the next day up to 106.1;took to ER all tests were nl;has a fever for 40hrs then 98.7;
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; recvd 4th dose of Engerix-B on 16JAN92;
patient's arm swollen slightly around injection site, and warm to touch, no other symptoms, believed to be normal immune response, advised to see a dr and let her know we would report
This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 21Apr2021 around 06:00 PM, at the age of 46-years-old, as SINGLEDOSE for covid-19 immunisation.  The patient received first dose of BNT162B2 on an unspecified date.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced injection site started to itch (vaccination site pruritus) (non-serious) on an unspecified date with outcome of unknown, fever of 101f (pyrexia) (non-serious) on an unspecified date with outcome of unknown.    Follow-up actions are closed. No need of further information
Since my 2nd Dose I have had unresolved vertigo and worsening POTS symptoms.  As of My 3rd dose I have had bouts of Tachycardia/Bradycardia.   Chronic Joint Pain.  Chronic Muscle pain. Worsening Neuropathy. VERTIGO. Blood Pressure Fluctuations  trouble walking And Now I have been diagnosed with a new Cardiac Mass A Lipotamous of the atrial septum which is being investigated with more tests
Information has been received from a healthcare professional concerning a 21 year old female pt with asthma who on 1/21/99 was vaccinated with the 1st dose of Hep-B. Approximately 1 hour, post vax, the pt "felt spacey and was hallucinating." She stated that she "talked to a friend and 5 minutes later, did not remember either talking to that person or the conversation she had with that person." It was reported that her condition seemed to improve after eating lunch. She did not seek treatment. The pt's experiences completely resolved after approximately 2 hours. No further information is available.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016; dose and route not reported). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Received 6 month vaccinations on Friday. That evening onset of scattered papular rash bilateral thighs.  No fever, no other symptoms.  Rash reached peak on Sunday, starting to fade some by Monday PM (when photos were taken).  Also found bilateral otitis media on Monday, but only symptom was ear tugging.  No rash anywhere else on body.
Body aches, fatigue, nausea, vomiting and diarrhea.  Before the nausea and vomiting started ,Tylenol helped with the body aches. Pepto Bismol offered little relief for the nausea, vomiting and diarrhea.
Patient stood up to tuck shirt into dress pants and experienced red face, dizziness, sweating, and pain across back and chest. Pharmacy contacted Nurse practitioner and called EMT services at request of patient. BP reading was 140/70 per nurse practitioner. Symptoms lasted 5-10 min and resolved completely before EMT services arrived. No difficulty breathing or swelling of throat/tongue reported by patient.  Patient reported having a pacemaker and EMT checked patient with heart monitor and all readings were normal. Patient reported feeling completely well and returned home with his wife.
mom states that w/in 2hr of vax on 26OCT92 pt became flaccid, had very shallow breathing, & would not wake up;pt was taken to ER @ hosp where woke up & was released that same evening;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Toothache.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No treatment reported.
Case number PHEH2014US022012, is an initial spontaneous report received from a health care professional (material's manager) on 31 Oct 2014. This report refers to a 47 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Itching and redness to both arms-no hives, eyes also itching.  Benadryl 0.8cc (50mg) given IM in right deltoid.  Observed 1/5 hours.  Uncle contacted.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). On 15th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site pain were recovering/resolving. The reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reported injection site of FLUARIX was left deltoid. The patient experienced swelling, pain and redness at the injection site a couple hours after receiving a FLUARIX injection. The injection site was also warm to touch. The reported reactions were improving on the day before the time of reporting, but the reporter had not seen the patient on the day of reporting. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133985, US2015GSK133986, US2015GSK133988 and US2015GSK134910).
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 1172, 336, 80 and 272. The lowest recorded temperatures were of -3 and 30. The highest recorded temperatures were -3, 59 and 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a physician via a company representative and referred to a 50-year-old female patient. The patient did not have any relevant medical history, concurrent conditions, or concomitant therapies. On 28-APR-2017, the patient was vaccinated with a single dose of ZOSTAVAX 19400 "PFU", 0.65 ml, subcutaneous injection (lot number and expiration date were not reported), for the prevention of shingles. On 29-APR-2017 (reported as "one day after receiving ZOSTAVAX"), the patient felt fatigue. On 30-APR-2017 (reported as "two days after the receiving the injection"), she took an unspecified dose of TYLENOL and on 01-MAY-2017 (reported as "on the third day") she broke out in hives that started on her neck. Subsequently, the patient sought medical attention and her physician prescribed an unspecified treatment of prednisone (manufacturer unknown) for the hives. There were no laboratory diagnostic tests performed. At the time of this report, the patient had not recovered from fatigue and hives. The causality assessment between fatigue and hives with ZOSTAVAX was unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history and no drug reactions/allergies. On 28-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H014561, expiration date: 21-MAR-2013, 0.5 ml, intramuscularly). It was reported that the patient was administered an unspecified pneumococcal vaccine on an unspecified date over 5 years ago. Concomitant therapies included valacyclovir hydrochloride, Seroquel, Klonopin and estrogens, conjugated Premarin. It was reported that after the patient was administered a dose of PNEUMOVAX23, on an unspecified dated in September 2013, the patient experienced nausea, swollen lymph nodes in the arm, fever, red spots going down the arm, vomiting, a swollen and hot arm and red ring around her biceps. The outcome of red ring around her biceps, nausea, swollen lymph nodes in the arm, fever, red spots going down the arm, vomiting and a swollen and hot arm was reported as not recovered/not resolved. The patient called the pharmacist. Additional information has been requested.
Slight fever the day of the injections. The next night he Stopped breathing in the middle of the night twice. Temperature was 96 degrees Fahrenheit when arriving at the emergency room.
striped rash on opposite arm; joint pain; soreness at injection site; tredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2019, the patient received the 2nd dose of Shingrix 50 mcg/mg. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, tiredness and joint pain. On 20th June 2019, the patient experienced rash. On an unknown date, the outcome of the injection site pain, tiredness, joint pain and rash were unknown.   It was unknown if the reporter considered the injection site pain, tiredness, joint pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving Shingrix experienced soreness at injection site, tredness for 2 and half days, and joint pain. Thursday evening or Friday morning, the patient striped rash on opposite arm. The patient stated that, the daughter at the time of reporting was trying to get pregnant and could possibly be pregnant but she never had chickenpox but she had the immunization for it in 1998. The patient asked was it safe for her to be near her daughter and if not, how long should she stay away.
HEADACHE, FATIGUE COUGHING BREATHING TROUBLE SHORTNESS OF BREATH ACHES
Patient presented to the vaccine clinic. The nurse administering the dose did not accurately verify DOB. Vaccine was administered.
LAST DOSE DUE AFTER LEAVING FOR TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-686) on 20-Mar-2019. It described a 30-year-old adult female consumer whose "last dose due after leaving for travel". The consumer was receiving oral Vivotif (one dose every other day) (lot no: 300321) for typhoid prophylaxis.  It was reported that the consumer took the two doses of Vivotif on 18-Mar-2019 and 20-Mar-2019, respectively. She was planning to leave for country on 23-Mar-2019 and her last dose would be due on 24-Mar-2019.  The action taken with Vivotif with respect to the event "last dose due after leaving for travel" was not applicable.  The clinical outcome of the event "last dose due after leaving for travel" was unknown.  Company's Comment: The causality of the event "last dose due after leaving for travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "last dose due after leaving for travel" was considered as not applicable.
The patient was administered Pfizer vaccine for age 12 and older (0.3 ml) Pt did not report any reactions after vaccination. 11/24/21 Per mother patient doing well .
This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016") the patients were vaccinated with improperly stored GARDASIL injection (dosing regimen unspecified) (lot L040459, expiry 06-APR-2017; lot K014191, expiry 10-MAY-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 1C, Time frame: 25 hours, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. GARDASIL 9 and M-M-R II appear in the product list as these products were involved in the excursion, however no improperly stored doses of GARDASIL 9 or M-M-R II were administered. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
itching; rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (rash on the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (rash on the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (rash on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.No treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06 May 2021.Added second dose details and updated outcome of events.