chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Skin:  Left central/medial upper thigh with 6 cm round, erythematous, warm and indurated area with central injection; right central upper thigh with faint erythema noted around injection site
Patient presented to ED on 11/27/21 for stomach pain. Patient fully vaccinated with Moderna on 3/11/21, 4/8/21, and boosted on 11/23/21. Patient diagnosed with acute gallstone pancreatitis. Transferred and admitted to acute care surgery on 11/26/21. Following surgery, patient was discharged 12/1/21.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 8:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 8:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 08am and 09am, temperature was 35 and total 39 doses were administered for that day. Vaccine was not frozen prior to administration. Vaccine moved to fridge on 03-May-2021 and moved to clinic on 24-May-2021. 01 vial was sent to the clinic. BUD date was 02-Jun-2021. Vials only punctured right before administration.  Vial was stored on cooler 1, on 24-May-2021, Excursion temperature at 08 AM and 09 AM was 35 and at 04 PM: 32.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # L046900 for prophylaxis. On 17-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.
Legs tender to the touch, can barely touch very painful. Thigh is very painful at the top of leg and bottom is sore and painful at the shin to ankle
8 days p/vax pt broke out in rash, t103 R & cough these persisted for 3 days then complete recovery;
Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored M-M-R II (which had a lot number of L027591 and an expiration date of 23-JUL-2017; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received 2nd dose of COVID-19 vaccination, Pfizer instead of Moderna.  1st dose of COVID-19 vaccine was Moderna @ a Publix .  Patient complained of body ache and body soreness the next day.  patient  stated "he woke up to body ache and body soreness the next day."
fast heartbeat; pains in her upper chest; seriously ill; dizziness; weakness; pain in her legs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness), ASTHENIA (weakness) and PAIN IN EXTREMITY (pain in her legs). At the time of the report, PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness), ASTHENIA (weakness) and PAIN IN EXTREMITY (pain in her legs) outcome was unknown.            No relevant concomitant medications were reported. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received: Second dose and hospitalization reported via email to be reported with Dose 2
This spontaneous report was received from a nurse referring to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapy, medical history and past drugs were not reported. On 22-JAN-2018, the patient was vaccinated with fourth dose of RECOMBIVAX HB lot # L048236, expiry date: 31-MAR-2018, intramuscularly (dose volume, strength, and frequency were not reported) for prophylaxis. No adverse effects was reported. No product quality complaint was reported.
Information has been received from a healthcare worker concerning a 20 year old female patient with a history of anxiety and no drug reactions/allergies who on 07-MAY-2012, was vaccinated IM with a 0.5 ml dose of GARDASIL (lot# 672233/1561AA, exp date: 26-AUG-2014, site not reported). Concomitant therapy included FEMCON FE. It was reported that the patient developed an injection site reaction after receiving a dose of GARDASIL in May 2012. The reaction area was about 3 inches and it was red, swollen, and little painful. The patient had not lab diagnostics studies performed. At the time of the report, the patient had not recovered. The patient saw the physician. Follow-up information has been received from a reporter from the physician's facility via B-form, concerning a 20 year old female student with no drug reactions/allergies, no illness at the time of vaccination and no adverse events following prior vaccination, who on 07-MAY-2012, was vaccinated with the first dose of GARDASIL at her left arm. The reporter stated that the patient had rash, redness and tenderness at injection site, and was advised to be seen in office. On 14-MAY-2012 the patient pronounced wheal subcutaneous at injection site. No new streaks, denied fever and chills. Additional information is not expected.
P/T stated she need to throw up. ( symptom: nausea).  9:29 bag 3 cold packs to neck area. No vomiting, 02 Sat 99%  BP 110/80 R20  T 96.6.  9:36  pt without nausea ,vomit or dizziness, no headache.  02 Sat 99% pulse 81 BP 100/80 R20 9::45 BP 110/78 P 86, R 86, R20, 02 Sat 100% Pt left with no symptoms at 10:16 a.m.
Arm where tetanus given, swelled, ached and 3" welt formed. Ache crawled up into neck, down back and gradually to rest of body. Glands swelled in neck and stomach nausea started. Pin prickles on arms, scalp and back of neck when startled. Still on anti-nausea meds after 4 weeks. Also low grade fever. Still sick with nausea. Now know not cancer, not giardia, not virus.
Soreness at injection site; Nasal and chest congestion/coughing; Nasal and chest congestion/coughing; coughing; Chills and shivering without associated fever; This is a spontaneous report from a contactable consumer.  A 50-year-old patient of an unspecified gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 03Nov2020 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced soreness at injection site, nasal and chest congestion/coughing, chills and shivering without associated fever. Soreness at injection site developed 6 hours after administration and was ongoing. Nasal and chest congestion/coughing developed 7 hours after administration and resolved 2 hours after onset. Chills and shivering without associated fever developed 7 hours after administration and resolved 12 hours after onset. The events were non-serious.  The information on the batch/lot number has been requested.
Dtap-IPV was given RT, itchy, pink, splotchy warm to touch no fever BENADRYL/IBU.
Patient experienced heaviness in Left wrist area, on/off. BP 108/73, HR 80, RR22. Patient released in stable condition
3 total seizures beginning at 9pm until 2am the following morning, needed oxygen to get through seizures as well as seizure stopping medication. She is now on anti seizure medications for the time being.
Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient received bivalent booster on 11/3/2022.
18jan90 pt vax hepta B. following day pt devel. generalized non-pruritic, non-urticarial macopapular rash over arms and trunk. pt under treatment w/ Medrol Dosepak. rash seemed to be spreading.
Patient experienced nausea, dizziness, and headache for 10 days after getting his vaccine. His first 2 doses were Moderna on 3/10/2021 and 4/7/2021. He switched to Pfizer for his booster. He said at times the dizziness and headache were so bad he was afraid to drive.
pt given 1st DTP/OPV/HIB 2nd Hep B on 14APR & was a little fussy that noc; pt put down for nap the following afternoon, found dead;
My sister experienced 18 days later a stroke after receiving her J&J vaccine.  She was at the hospital for two weeks and was then discharged on 06-13-2021 to go home.  At the hospital they performed extensive lab work and medical imaging and nuclear medicine study as well. Then on 06-13-2021 she went back to the hospital due to thrombosis in her right leg. My sister is at home now and is receiving physical therapy at this time. My sister can not walk at this time and is taking medications. The doctors at the hospital stated she is doing very well from the stroke and the hemorrhage has stopped and is almost 100% and at this time her right leg is still in pain due to the thrombosis and is bed ridden.
sore arm, headache, chills, loss of appetite, fatigue for the whole day, April 9, 2021.
had covid and was hospitalized; had covid and was hospitalized; The initial case was missing the following minimum criteria: Medical Information. Upon receipt of follow-up information on 08Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)  A male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6202), on 21Mar2021 as dose 2, single (Lot number: EN6202), on 11Oct2021 as dose 3 (booster), single (Lot number: 30145BA) and on 19Apr2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history included: "Had some heart problems before he got covid.", start date: 2007 (unspecified if ongoing), notes: Had some heart problems before he got covid since 2007. The patient's concomitant medications were not reported.    Conclusion of Previously Completed Investigation  The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot EN6202 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   Follow-up (08Nov2022 & 09Nov2022): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported for her husband in response to Non-HCP follow-up letter sent via telephonic follow-up activity in cross reference case that included: Updated information included: Primary reporter information; Other medical history start date added; hospitalization details;  investigation results (Batch and lot tested and found within specifications).
arm blew up where shot was; arm Bright red; arm hot; arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site swelling (received 1st dose of shingles vaccine on an unknown date and presented with injection site erythema, injection site warmth and pain in arm. For tolerance to 1st dose, refer case US2022AMR014088).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling, injection site erythema, injection site warmth and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and pain in arm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR014088  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after receiving 2nd dose of Shingles vaccine, his/her arm blew up where the shot was given, it was bright red and hot and the arm hurt for 3 weeks. The patient experienced same reactions with the 1st dose but he second time they were not as bad. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014088:Different dose
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-OCT-2011, the patient was vaccinated at a  pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but caused the patient to contact a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, he developed severe pain and stiffness throughout his body. The patient presented to his primary care physician and was diagnosed as suffering from polymyalgia rheumatic. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Polymyalgia rheumatic, persistent strain of herpes zoster and vaccine did not prevent shingles was considered disabling. Upon internal review, polymyalgia rheumatic was determined to be medically significant. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. A 25-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 16Apr2021(at the age of 25-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced arthralgia and muscle soreness. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arthralgia and muscle soreness was not recovered at the time of this report.    No follow-up attempts are needed; information about lot number cannot be obtained.
In the days following the vaccination, I felt a lot of pain in my right arm. I chalked it up to having the vaccination. Two days after I had the vaccine, I was in an excruciating amount of pain, my arm was hot to the touch, red, swollen, and started to have a fever. I went to an urgent care clinic, and the doctor diagnosed me with cellulitis, and put me on a dosage of Clindamycin - 300mg, three times a day. On February 11th, I was still in excruciating pain, and returned to the urgent care clinic. They sent me to radiology to have a sonogram done on my arm, to rule out any pockets of fluid in my arm. There was no fluid or pockets of concern, but the sonogram did confirm the cellulitis diagnosis. I had blood work done a couple of weeks after finishing the medication, and my white blood cell count was shown to still be elevated. I came very close to having to be admitted to the hospital to receive intravenous antibiotics.
I was given the preservative free flu vaccine via injection (I don't know which one but am trying to find out) during the afternoon of Oct 19. Within a couple of hours, my torso was covered in hives. I waited until Oct 23 before going to my doctor who prescribed prednisone for 6 days. Two days after finishing the prednisone, the hives were back and were also beginning to appear on my arms and legs in addition to the torso. Nov 3 I was prescribed 12 days of prednisone and after completing the prescription, the hives are gone. I have been getting the flu shot for years and have received both the preservative free and the non preservative free version without any side effects. I do not have egg allergies.
At time presented (11/15/17) approx. 3 1/2" red, raised rash; hard and hot to the touch; very sore. Still increasing in size but slowing down. Rash covers both injection sites.
Dizziness,  high fever, chills, headache, muscle weakness,   Started and I?m no better
NOTICED INCREASED SOB APPROXIMATELY 3-4 WEEKS POST VACCINATION.  INITIALLY ATTRIBUTED TO RECENT WEIGHT GAIN.  PROGRESSIVE SOB CONTINUED THEN ACCOMPANIED WITH CHEST PAIN.  MET WITH PCP ON 6/7 WHICH RESULTED IN CARDIAC WORKUP  INCLUDING A HEART CATH ON 7/9 WHICH RESULTED IN NO CORONARY OCCLUSIONS.  FOLLOWED UP WITH PCP WHO RECOMMENDED FOCUS ON WEIGHT LOSS.  SOB CONITNUED AND ON 8/6 I MET WITH PCP AGAIN TO COMPLAIN THAT SOB NOT GETTING ANY BETTER.  HE ORDERED V-Q SCAN WHICH INDICATED PULMONARY BLOCKAGE CONSISTENT WITH PE.  I WAS HOSPITALIZED SAME DAY (8/6) AND PUT ON A COURSE OF IV HEPARIN FOR DURATION OF STAY.  NO DVTS WERE FOUND ON ULTRASOUND.  DISCHARGED ON 8/9 WITH PO ELIQUIS PENDING RESULTS OF HYPERCOAGULABILITY STUDY.
Severe headaches; Severe neck pain; Severe diarrhea; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6200), via an unspecified route, administered in Left Arm on 18Feb2021 at 12:00 PM (72-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history included Rheumatoid arthritis. The patient was not on any concomitant medications. The patient's past medication included known allergies Codeine. The patient was not on any other vaccine in four weeks prior to Covid vaccine. The patient was not on any other medications in with in two weeks after Covid-19 vaccination. The patient had no covid infection prior to vaccination. Vaccination facility type was reported as other. On 19Feb2021 at 03:45 AM, the patient experienced severe headaches, severe neck pain, severe diarrhea, abdominal pain. These adverse events resulted in doctor or other health care professional office/clinical visit. The patient received Tylenol and Advil as treatment medications for the resulted events. The patient was not tested for Covid-19 post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible; No further information was expected.
As patient was leaving Observation area he complained of chest pains. He took nitro which he had from home and as instructed by his provider. BP 151/102 EMS arrived and patient still complaining  of chest pains BP 82/58 patient transported to hospital by EMS