chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 15-OCT-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA009929: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
muscle discomfort; a couple joint's discomfort; my game's been off a little; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (a couple joint's discomfort) and FEELING ABNORMAL (my game's been off a little) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (a couple joint's discomfort) and FEELING ABNORMAL (my game's been off a little). On 12-Apr-2021, MUSCLE DISCOMFORT (muscle discomfort), MUSCULOSKELETAL DISCOMFORT (a couple joint's discomfort) and FEELING ABNORMAL (my game's been off a little) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Blood pressure measurement: increased (High) increased. On 12-May-2021, Oestradiol: 99 (Inconclusive) 99 pd/ml. On an unknown date, Oestradiol:.         Concomitant medication use includes a statin (specific drug and indication not further specified).  It was noted that the patient has had normal CCK and Thyroid levels (dates not provided). Following his lab appointment on 12May2021, the patient had his estradiol rechecked on 23May2021 and was found to be basically in the same range.  Also during a doctor's visit around the beginning of June, the patient had a spurt of blood pressure which he attributes to whitecoat and is a usual occurrence for him.   Treatment information was not provided.
A week after night sweats began. Persistent for 8 weeks. 6 weeks after the first symptoms of acute pancreatitis began. I don't smoke or drink and meet none of the usual indicators for pancreatitis.
18 Jan began to have strong lethargy, major muscle (ex: quads, low back, neck & shoulder) soreness which continued and began to lessen on 22nd. Generalized headache. Late 22nd began to itch at upper left arm in area of injection.  At bedtime saw 4" x 5" (approx) on arm was quite red, skin tight from swelling, had little additional bumps, hot to touch.  Morning 23rd additional area red, hot, swollen just below left collarbone. Also small red spots on low back, thighs, forearms. Former 3 areas itchy.  Visit  Immediate Care; advised to ice, take Claritin, apply triamcinalone acetoid  lotion.  Reacted to Claritin; discontinued. Still using ice, lotion.  On 19th used Tylenol which did not help.  Told it is delayed histamine reaction; still subsiding.
My left arm hurt EXTREMELY bad to move it; it even hurt to wear clothes for 4 days.  I had SEVERE redness - the color of burgundy on the upper arm, across my left chest, and going down my abdomen, I have a high fever, chills, fatigue/exhaustion, and a headache.  I had no appetite for 3 days.   I called the Pharmacist on Friday, October 25 and informed him of the reaction and questioned him.  He said that my symptoms could last 3-7 days. They lasted 7 days.
Burning lips that day and then swollen, peeling lips for more than 1 mo after
Patient was fully vaccinated for COVID-19 and then tested positive for COVID-19 on 8/9/21.  Two days prior to testing positive she developed symptoms of cough, headache, left ear pain, sore throat, and back pain.
migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Events treated with Tylenol and "migraine meds". Name and dosing information of migraine medication not provided.  No concomitant medications reported.   This case was linked to MOD-2021-034199 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: followup received  with NNI; Sender's Comments:  MOD-2021-034199:same reporter, different patient and events
Mild headache about 6 hours after then by about 12 hours after dose had profound chills, body aches, severe nausea and temperature 99.8 F. I treated the nausea with Zofran with some improvement in nausea, but other symptoms continued. My max temperature (without antipyretic affecting) was 100.7 F with continued nausea, body aches, fatigue and headache until the 24 hour after vaccine time frame. After 24 hours, nausea had improved largely to just mild, mild headache continued and fatigue/body aches. Around 28 hours, temp was 100.2 F (outside of last antipyretic dose) with same symptoms. Now around 30 hours out with recent Motrin taken, my nausea is still mild, low appetite, improved body aches and less fatigue. I have not had any site reactions other than pain starting around 6 hours after injection.  Course to come yet unknown.
Since my first vaccine, I have suffered daily from back to back genital herpes outbreaks. Nothing has helped. I have seen my doctor and two specialists about my debilitating condition, and have been prescribed high dose Valtrex. Famciclovir, Acyclovir, Gabapentin, all with no relief. What was once a random outbreak has now been relentless pain and mental anguish for almost two years.
Had both shots, now have shingles/suspected vaccination failure; Shingles, very mild case; first they itched; Light case of pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (Verbatim: Shingles, very mild case), pruritus (Verbatim: first they itched) and pain (Verbatim: Light case of pain). On an unknown date, the patient experienced vaccination failure (Verbatim: Had both shots, now have shingles/suspected vaccination failure) (serious criteria GSK medically significant). The patient was treated with lidocaine. The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus was recovered/resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 31-March-2023 The case was received from the patient via interactive digital media. The patient had both shots in 2020 and now had shingles, a very very mild case. The patient stated that at first they itched and got a tube if lidocaine, that helps the numb the area. Itching gone now and the patient had a very light case of pain. The patient was glad he or she got the vaccine. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
got sick everytime the day after; Initial information received on 15-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an patient with unknown age gender who experienced got sick everytime the day after while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, route, administration site and lot number not reported) for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick everytime the day after (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event got sick everytime the day after.
diarrhea; swollen kness; headaches; Nausea; Fatigue; chills; Muscle aches; Runny nose; Sneezing; This is a spontaneous report received from a contactable Nurse. This 59-year-old female Nurse (patient) reported in response to HCP letter sent in cross reference case that included:  A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK4176) via an unspecified route of administration, administered in arm left on 12Jan2021 (at the age of 59 years old) as dose 2, single for covid-19 immunisation. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EJ1685) via an unspecified route of administration, administered in arm left on 22Dec2020 as dose 1, single for covid-19 immunisation. The patient received seasonal flu shot in Oct2020 and the first dose of shingles vaccine in Nov2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccination Facility type Clinic/Work place clinic. No Vaccine administered at military facility. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL 12 HOUR), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME), probiotics (PROBIOTICS), ergocalciferol (VIT D), colecalciferol, ubidecarenone (COQ10+D) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced diarrhea, swollen kness, headaches, nausea, fatigue, chills, muscle aches, runny nose and sneezing. The patient was not hospitalized and not admitted to intensive care unit. The patient visit to the physician office. the patient received did not receive any other vaccines around time of Pfizer BioNTech COVID 19 vaccine. The patient underwent lab tests and procedures which included haematology test: unknown on an unspecified date. The outcome of the event sneezing was not recovered and Other all events were recovering.  No follow-up attempts are possible. No further information is expected.
shot at 10:50am, nausea at 10:58am, 11:04 am 160/90mmhg, 11:05am 162/98mmhg, 11:26am 140/80mmhg, 11:26am 98%pulse ox and 74bpm, 11:38am 25mg Benadryl given, 11:46 nausea improving
p/vax pt inj site sore, red; sx have worsened over past few weeks & described as moderate pain restricting activity; BP has been significantly elevated; condition of pt unknown
Nausea and vomiting on 03-31-2018 at 1:00 AM the evening of the vaccination. Still unable to eat due to nausea on 03-31-2018 and flu-like symptoms as of 4:30PM on 03-31-2018.
Noticed 1 bump (swollen inguinal node) in groin region got sore then the lesions began to appear on labia, L labia began to swell interfering w/ walking. Pt went to ER secondary to swelling impeding with urination and walking.
COVID vaccine breakthrough case. Moderna 030A21A 3/12/21, 018B21A 4/9/21 and boosted 042J21A 2/21/22.
This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0126, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 30Apr2021 11:00 (Age at vaccination 48-years-old) as dose 1, single for covid-19 immunization at pharmacy/drug store. The patient was not pregnant at time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient previously took penicillin b and experienced hypersensitivity on an unspecified date. The patient experienced a stable nodule in the right breast was on 04May2021. One week after first dose. Left underarm lymph node swelled to Size of baseball, Joint pain on 30Apr2021. The patient receive any other vaccines within four weeks prior to the COVID vaccine was unknown. The patient did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovering.Follow-up attempts are completed. No further information is expected.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 36 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A and expiry: 20-MAY-2022) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. Age at time of vaccination 36 years old. No concomitant medications were reported. On 24-NOV-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537532, 20220538238, 20220538292, 20220537356, 20220537507, 20220537548, 20220537688, 20220538146, 20220538210, 20220538297, 20220539045, 20220538425, 20220538428, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220538666, 20220540611, 20220538693, 20220540524, 20220540474, 20220538890, 20220540853, 20220540570, 20220538316, 20220540688, 20220540420, 20220540816, 20220540642, 20220540814 and 20220540765.
5/7/20 vaccine was given and patient s arm was sore and she was unable to sleep on that side . On 5/10/20 patient developed a bruise around injection site, on 5/13/20 patient arm was red , warm to touch, swollen and itchy. the area was 4in L by 3 in W. Advised to place cool compress on site. Spoke with PAC and he stated to have her use cool compress , take Benadryl or antihistamine. If no improvements call to be evaluated. 5/14/20 called patient and she stated  she took Benadryl and reaction was resolved.
10/2/09 14:00-FLUZONE received. 19:00-developed coughing x 3 hrs. 10/3/09 01:00 woke up with wheezing and tightness in chest and eyes crusted shut. All day stomach churning-slight diarrhea. PM felt fine.
severe swelling lt arm from deltoid to elbow w/inc heat; rx & tx: ATB, moist heat-raise (elevate) arm heart level-f/u;
aft vax pt devel unusually large red, hot, swollen, lt leg, hard lump, covered entire front, thigh area
Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023; No Adverse Event; HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023) 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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-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 02-Mar-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 (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-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 (HCP administered doses of the bivalent vaccine after BUD 01-Mar-2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-JAN-2023, BUD date was 01-MAR-2023 and dose was adminstered on 02-MAR-2023).    No concomitant medications were reported. Vial was initially stored in the refrigerator on 30-JAN-2023. Beyond used by date was 01-MAR-2023. Vial did not undergo any temperature excursions No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715478:Same reporter , Patient 1
I had reaction to my second moderna covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I had reaction to my second moderna covid vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I had reaction to my second moderna covid vaccination). At the time of the report, IMMUNISATION REACTION (I had reaction to my second moderna covid vaccination) outcome was unknown.            No concomitant medications were reported. It was reported that patient had three booster since with no reaction. No treatment medications were reported.
patient was suppose to receive the Pfizer bivalent but instead received the Pfizer pedriatic normal dose( original series). patient parents have been informed .
headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable.   Reporter did not allow further contact
Reports having severe joint pain after hep B 1 and 2 injections. Hesitated to have H3 injection.
Extreme pain, swelling,  redness, and heat around injection site started approximately 6 hours post injection. Pain and swelling moved down into armpit and below followed by extreme itching.  Swelling and pain then moved down to left elbow. Then I developed throat itching, difficulty swallowing and wheezing. I also developed joint pain in opposite shoulder. I  immediately took 600 mg Ibuprofen and 50 mg Benadryl .  Itching, redness, and wheezing, and difficulty swallowing resolved about 30 minutes after taking the medication.  Next morning (today) I still have pain and swelling around injection site. Pain in left elbow and right shoulder joints. I still have moderate pain and edema below left armpit.