chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired vaccine adminitsred to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine adminitsred to patient) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Jun-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 (Expired vaccine adminitsred to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine adminitsred to patient) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine adminitsred to patient).    Patient have received first dose on 18-AUG-2021.  No concomitant medication was reported.  The vaccine been expired about 8 or more days. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731750 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731750:Same reporter
No adverse event occurred. The patient was given a monovalent vaccine incorrectly for a booster dose (when bivalent vaccine was indicated). The patient was called and notified. The patient was told that she may receive a repeat bivalent 2 months after the 09/07/22 dose on 11/07/22. Patient verbalized understanding.
This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients was vaccinated with ROTATEQ (route, dose was unknown) which was improperly stored. No adverse effects reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to cases MARRS #  1410USA013361, 1410USA013360, 1410USA013358, 1410USA013359 with the same reporter link. Additional information is not expected.
Patient sat down to wait 15 minutes after the vaccination. other patients observed that he appeared to fall asleep then his eyes rolled back in his head and he went rigid and his body flexed straight out. another patient prevented him from falling out of the chair. i went out immediately to check on him and he came out of it. it lasted about 30-45 seconds. his color was not good so i instucted my technician to call 911. he was taken to the store directors office and the paramedics examined him and said everything appeared normal. he suffered no more reactions.
Rash consistent with chicken pox over entire body starting 4/26/14, low grade fever.
4 hours after injection soreness at site of injection. 8 hours after tiredness/sleepiness. 12 hours after extreme tremors/shivering, fever, muscle soreness.
PATIENT RECEIVED THE PNEUMOVAX 23 ON 12/08/2017 AND STARTED TO EXPERIENCE A SLIGHT FEVER THAT NIGHT. ON SATURDAY MORNING, SHE NOTICED HER ARM WAS SWOLLEN AND ITCHY. SHE DESCRIBED HER ARM LOOKING LIKE THE CARTOON CHARACTER. I CALLED THE PATIENT ON 12/11/17 TO FOLLOW UP. SHE DID NOT HAVE A FEVER AND THE SWELLING WENT DOWN BUT A LITTLE ITCHY.
Pain in arm of injection site. Pain from injection site to armpit to middle of left breast. Swelling of armpit two days after injection for 7 days.  On 7 th day still very mildly swollen. Feels like a sore lump in armpit (lymph node). This is a booster shot. Initial first dose was given 1/7/21. Second dose was given 2/5/21. Also both Moderna vaccines. I am a health care worker is why I received the booster vaccine.
8 hours after injection felt tired 10-12 hours after injection I had extreme chills that caused me to tremble, fingers and toes felt very cold, elevated resting heart rate as high as 115 bpm, body aches all over which got worse throughout the night.  12 hours after injection I went to bed. Chills and body aches continued. I didn?t feel like I could get warm. Slept on and off throughout the night. Woke up 16 hours after injection and chills were gone and had night sweats. Still really achy all over.  Woke up 20 hours after injection and still had body aches and felt groggy.  Body aches turned into joint aches and still continue 48 hours after injection.  Minor injection site pain started approximately 36 hours after injection.
Severe redness, inflammation, pain at injection site and fever. Patient took TYLENOL for pain and fever. Also ice the area.
Pain in arm next day - dead arm for two days - sore for 5 more days - looked in mirror and saw red ball size blotch, hot to touch.  Would wake me up once at night.
Major arm pain and fever. Whole body pain and shivering. Fever over a 100 degrees Fahrenheit.
Swelling and numbness of right hand progressing to point of not being able to sleep on that side. Both hands painful and swelling now- Dropping eating utensils due to numbness. Can't squeeze fingers together. Pain wakes her from sleep.
Pain shot through arm, around my shoulder blade around inside of clavicle bone. Have lost range of motion. Very painful. Feels like it's getting cramps.
A report was received from a health care professional on 21 October 2003 concerning a female vaccinee of unknown age who inadvertently received Fluvirin subcutaneously on 21 October 2003. On 20 October 2003 the vaccinee inadvertently received Fluvirin subcutaneously. No adverse symptoms were reported in association with the event. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient developed a rash all over that evening and her eyes reddened.  She went to the hospital, and the Dr prescriber her steroids, Pepcid and OTC Benadryl.   The Dr told her it may get worse before better and to keep an eye on it.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 20-OCT-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Awfully painful swollen lymph nodes in neck and underarm on the side of my body I received the vaccine; Period become irregular; Awfully painful swollen lymph nodes in neck and underarm on the side of my body I received the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 17-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173), via an unspecified route of administration in the left arm on an unknown date in May2021 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced awfully painful swollen lymph nodes in neck and underarm on the side of her body she received the vaccine and the vaccine also caused the period to become irregular. It was reported that the patient was fairly certain that's temporary. The clinical outcome of the events awfully painful swollen lymph nodes in neck and underarm on the side of her body she received the vaccine and period become irregular were unknown at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Later that evening I begin to have brain fog which continued throughout the evening.  12/30 around 2am I got sever chills and shakes and had body aches.  I took advil and tylenol to help but felt really fatigued and tired throughout the day.  The next day I felt fine and no other symptoms since.  I also had pretty painful arm pain for about 3 days also.
fever, sore throat, and severe cough, chest congestion, phlegm in throat  Tylenol for aches and pains and fever Encourage plenty of fluids such as water hot teas soups
Patient woke up in the morning after vaccination with body aches and fever, chills, head was pounding, reports 102 fever measured by oral thermometer, fatigue that lasted throughout the day, when she got up to use restroom felt light headed and this lasted throughout the day.  The next day woke up with headache, a little worse but no fever, noted sweating all day, body aches.  Now feels congested.
Pt received COVID Pfizer vaccines on 3/27/21, 4/17/21, 10/5/21 and 6/13/22. He came for the bivalent booster dose. Due to mix up of the Pfizer monovalent and bivalent vaccine- he may have gotten either the monovalent or bivalent Pfizer vaccine. Pt does not have any effects from the vaccine
03/23/23 presents to ED for "altered mental status". PMHx of "anemia, DM 2, HTN, hypothryroidism"
BODY ACHE; CHILLS; LEG PAIN; BRUTAL HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced leg pain. On 09-APR-2021, the subject experienced brutal headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brutal headache, chills, leg pain, body ache and nausea was not reported. This report was non-serious.
HBV #1 given 5/5/03. The rest AM face and arm around vaccine site was broken out in red rash. Mom thinks pt was also febrile but did not check temp. Mom gave Tylenol and has started Benadryl. Pt had no previous reported allergies. 5/8/03 pt saw ER doctor who gave her injection for allergy.
Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and the 1st dose of Shingrix. On 14th July 2021, 6 days after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reported that, the patient received the dose of Shingrix and Boostrix on same day in same injection site and experienced return of arm pain. The reporter had limited information at that time but would call back with further details. The reporter consented to follow up. The case was linked with case US2021AMR188527 reported by the same reporter for 1st occurrence of arm pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188527:same patient, 1st occurance of arm pain
No adverse event; The patient got the 2nd dose too soon, on 09Aug2022.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.) and NO ADVERSE EVENT (No adverse event) in a 27-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     Patient's COVID positive test or diagnosis were reported as unknown.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were reported as unknown.    On 20-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient got the 2nd dose too soon, on 09Aug2022.).    No concomitant medication was reported.   No treatment information was reported.
now w/rash that looks like chickenpox;small blisters, itchy;fever on et off up to 103 ax;+ classic varicella rash all over p/having varicella vaccine;
"Terrible headaches since I got the H1N1 shot yesterday." Headaches were unrelieved by Imitrex.
Initial report received from a pharmacist on 24-Sep-2013: A 43 year old female patient had received intramuscular (IM) FLUZONE (lot # UH891AA and expiration date unknown) on left deltoid on 19-SEP-2-13. On 19-Sep-2013, the patient experienced soreness in left arm at injection site. On 20-Sep-2013 she experienced generalized body aches and difficulty raising left, on 22-Sep-2013, she experienced blurred vision, dizziness and nausea, as well as on 09/23/13 and on 09/24/13, complaining of diaphoresis and weakness. The patient was not recovered. Documents held by sender: none.
Dx 8/27/03: "vaccine - local reaction with vesicles at DTaP site". Woke up this AM with red 2" area to right deltoid - hot to touch, swollen, temp 100, cried all night in pain. Benadryl 96 degrees, ice packs. Mom to observe, will call back prn.
sporadic muscle ticks/spasms that move around my body, a new location every day, the muscle spasms last for a minute or two.
Rashes to feet, hands, legs, neck and face. Trunk was clear. Diphenhist po X 72 hours. Onset of symptoms, 24 hours, post vax of Prevnar.
COVID hospitalization 2/19/21, patient arrived at hospital. Tested positive for COVID, reported had symptoms for 3 days prior with exposure to his son also positive for COVID
GROSS SWELLING, PAIN, REDNESS, PRURITUS WITH INDURATION WITH 7CM DERMACATION LOCALLY ON LEFT DELTOID. TREATED WITH COLD COMPRESS FOR 1st 48HRS AND TYLENOL FOR PAIN.
Received Moderna booster 11/19/21, starting February 2022 progressed (present for 5 years without progress) to advanced dementia (confused, disoriented and aphasia) over 6 weeks.  Hospitalized for 10 days on April 1, 2022.  Treated with steroids and over a month returned to baseline.  Also spent 11 days in rehab.  Relapsed July 21, 2022, again confused, disoriented and aphasia.  Treated with IV steroids and IVG and returned to baseline after about 1 month. Presently on Seroquel.
Information has been received from a licensed practical nurse concerning a 66 year old white female pt with no illness at the time of vaccination who on 27OCT2003 was vaccinated IM in the Right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. The LPN reported that on 28OCT2003 the pt developed red, hard, sore right arm with swelling, and tightness on or near the injection site, almost down to the elbow. The pt was treated with ice and Advil. It was noted the pt came to the MD's office on 29OCT2003. The pt recovered. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected. The LPN also reported two other pt who had similar experiences following vaccination with pneumococcal 23v polysaccharide vaccine.
15 MIN after giving the vaccine pt reported back to the doctor of feeling shaky, sleep and over all not feeling well.
9 minutes after - lightheaded; 20 minutes after - lungs felt wheezy; 3 days later (4/11) - felt like respiratory illness was coming on and an ocular migraine began after dinner, around 8:15, zero sleep that night, dull head and crazy gibberish thoughts throughout night; truly thought I was having a stroke; flank pain; 4/12 - swelling, itching began on fingers; 4/14 - while seated at desk, pain upper left arm; pain and shooting pain and tingling in lower legs and calves; mild stomachache 4/12-4/14; 4/15 - fairly chilblains welts on fingers and toes, painful lesion under toe that appeared like a small blood blister; 4/16 - welts worsening; 4/19 - chilblains welts improving (much more rapidly than when I have had them after a Raynaud's attack)
On arrival to the ER, he was febrile to 39.1, hypertensive to 191/92, mildly tachycardic heart rate of 94, tachypneic with a respiratory rate of 24, and sats of 94% on room air.  Eventually during his stay, he became hypoxic and 2 L nasal cannula was placed.  By the time he left the ER, he was requiring 7 L and still satting 89%.  Notable labs included procalcitonin 0.31, lactate 1.5, creatinine 1.62 (baseline), glucose 135, white count 10.47, normal hemoglobin and platelets.  EKG within normal sinus rhythm.  X-ray showed no acute cardiopulmonary abnormality.  He received 650 mg of Tylenol, gentle IV fluids and 6 mg of IV dexamethasone while in the ER.   Daughter was known positive today--patient tested positive, upon admission.
End of June I started to feel off. I felt weird so called my supervisor, discussed my issue, but went to work. A month later it got worse. By end of July back of my head started burning with fire. Around 8/14/2021 I saw a string of clumps on my head. I couldn't touch the clumps. I also had a headache.
I received my 2nd dose of Pfizer COVID-19 on Monday, 8/2. When I woke up on Wednesday, 8/4, my right knee was very, very stiff - I couldn't bend it past 90 degrees. For the next week, I experienced stiffness, but by Saturday, 8/14, I felt that the knee was better.  However, I woke up on Monday, 8/16 and could barely move my leg due to the extreme stiffness - and this time, the knee was visibly swollen as well. I went to my primary care physician on 8/17 and got an X-Ray the same day. I saw an orthopedist on 8/18. There was liquid pooled above the kneecap. The orthopedist recommended compression, icing, and anti-inflammatory meds. Within a few days, the swelling and stiffness had improved, although as of today (8/28) I am still experiencing some swelling and stiffness. After the first COVID-19 vaccine (administered 7/12) I also experienced knee stiffness, although not to the same degree. I also didn't correlate it with the COVID-19 vaccine so I did not note the exact date the knee stiffness started - however, I am confident that it began after the first dose of the vaccine. I have never had knee stiffness/swelling like this before.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JUN-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J011341, expiration date: 13-DEC-2014, subcutaneous. No concomitant therapies were reported. No known adverse effects. Additional information has been requested.
Information has been received from a physician concerning a 25 week old male, with no medical history and no allergies, who was vaccinated with a first and second dose of Rotateq (human bovine) on 13 Jun 2006 and 29 Jul 2006, respectively. It was reported that there were no symptoms following the first and second dose. On 06 Oct 2006 the patient was vaccinated with a third oral dose of Rotateq (Lot # 652964/0145F). There was no concomitant medication. On 11 Oct 2006 the patient experienced foul smelling diarrhea, eight times a day. The patient did not show any signs of dehydration, no fever and has gained about 7 ounces. The patient seemed to be drinking, not eating as much. The physician also indicated that the patient has "cramping around the stool." At the time of the report the patient had been experiencing diarrhea for the past 5 days and had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Feeling fatigue and arm pain. 02/06/21 - Woke up with body shakes, chills, muscle ache and pain.  02/07/21 - Vomitting & fatigue 02/08/21 - Chest tightness
No adverse effects; Drug dose administration interval too short; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's past relevant drugs, medical history, concurrent conditions or concomitant medications was not provided.  On 01-FEB-2019, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 microgram per milliliter; on 18-MAR-2019, with the second dose; and on 03-JUN-2019, with an early third dose (inappropriate schedule of product administration). All the doses were administered intramuscularly as prophylaxis (dose, anatomical location, lot number and expiration date were not reported). No adverse events were reported for the patient and no further information was available.
This is a spontaneous report obtained from a non-contactable nurse via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medication were not reported. The patient experienced severe headache on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.