chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthritis; Swollen glands; Headache; Sore arm; 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 ARTHRITIS (Arthritis), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and MYALGIA (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and MYALGIA (Sore arm). At the time of the report, ARTHRITIS (Arthritis), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and MYALGIA (Sore arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Case number PHEH2016US031071, is an initial spontaneous report received from a nurse on 24 Nov 2016. This report refers to a 77 years old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620501, expiry date: Jun 2017) intramuscularly at a dose of 0.5 ml, twice in this flu season on 17 Nov 2016 and again on 23 Nov 2016, had an overdose accidental. No adverse event was reported following this medication error. The overdose accidental was reported as non serious.
Pt had a swollen cheek 2-3 days after taking PREVNAR 13 shot. Says he has not taken anything else different. Thinks it could be from PREVNAR 13.
The wrong dose for the first Moderna Bilavent COVID booster was administered on10/14/2022 at 0.25mL instead of the correct 0.5mL. Gave the other 0.25mL dose with the new lot number on 10/24/2022.
5DASY AFTER RECEIVING 1ST DOSE OF COVID 19 VACCINE, PATIENT DEVELOPED GENERALIZED BODYACHE, ACUTE SOB, HYPERGLYCEMIA(BG RUNS 500-600'S), AND LOWER EXTREMETIE PAINS FOUND TO HAVE STENT THROMBOSIS.
back pain; headache; A spontaneous report was received from a consumer concerning a 91 year old male patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced headache and back pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, Finasteride, Aspirin, Semi Bi Statin, OraVital.  The patient received their first of two planned doses of mRNA-1273Batch number:014L20A ) on 21-JAN-2021.  On 18-FEB-2021  the patient received their second of two planned doses of mRNA-1273 (Batch number-unknown) intramuscularly for prophylaxis of Covid 19.Since administration of the second dose of vaccine patient had experienced back pain that has been constant as well as a headache that has not subsided. No other side effects were reported for the first vaccination.  The treatment for the event include Tylenol and heating pad.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, headache and backpain were considered as not recovered/not resolved.
Severe pain throughout left arm, numbness, extreme high blood pressure, inability to sleep on account of pain. Lasting so far from Mar. 8 through today (Mar. 17).
Presented with CP, SOB Dx +Covid; COPD exacerbation; CXR increased R basilar atelectasis; TX Decadron, Remdesivir, Maxipime, Lovenox, Singulair, Yupelri neb, ; back to baseline home O2 by discharge
patient not immunocompromised given 3rd dose at full dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (patient not immunocompromised given 3rd dose at full dose) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ACCIDENTAL OVERDOSE (patient not immunocompromised given 3rd dose at full dose). At the time of the report, ACCIDENTAL OVERDOSE (patient not immunocompromised given 3rd dose at full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any comorbidities.  No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 3720 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Shingles - herpes zoster began on June 20, 2021 on forehead. Spread to scalp and eye. Treatment included famciclovir and prednisolone acetate eye drops. Treatment is ongoing.
Systemic: Dizziness / Lightheadness-Severe, Systemic: both hands tingling, crampimg-Medium, Systemic: Hyperventilation-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling of both hands, both hands cramping
RASH IN THE  LEFT ARM WHERE THE  THE VACCINE WAS ADMINISTER. THE EMPLOYEE TAKE ZYRTEC FOR TWO DAYS
Extreme flu-like symptoms, especially dizziness, weakness, blacking out, headache, body aches, nausea began approximately 12 hours after receiving vaccine and lasted 1 1/2 days, tapering off by day 3. Went to GP (CNP), who did a battery of tests: EKG, urinalysis, blood work, neuro exam, all negative.
VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE
Fevers, chills, very sore arm where administered. Diarrhea, malaise.
Diagnosed with AML; 1st dose received 2 years ago, 2nd dose not received yet; This serious case was reported by a other health professional via call center representative and described the occurrence of acute myeloid leukemia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced acute myeloid leukemia (Verbatim: Diagnosed with AML) (serious criteria GSK medically significant) and incomplete course of vaccination (Verbatim: 1st dose received 2 years ago, 2nd dose not received yet). The outcome of the acute myeloid leukemia and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the acute myeloid leukemia to be related to Shingrix.     It was unknown if the company considered the acute myeloid leukemia to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2023 The reporter reported that a patient who had one dose of Shingrix two years ago and recently was diagnosed with acute myeloid leukemia (AML).  The reporter enquired can they be given the second dose of Shingrix, or should restart the series. The reporter consented to follow up via mail. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
06/12/2022 I had early flu symptoms. I had a slight fever, felt tired and fatigued, my muscles and my joints ached. I took Tylenol thinking I was just tired and fatigued from traveling. It got better the following day. The symptoms rebounded and became much worse on 6/14/2022.  I had a fever of 102.9, my eyes felt hot, had dry and sore throat with a cough that eventually progressed with phlegm. The pain in my  muscles and joints became worse. I had loss of appetite. I had intermittent bouts of diarrhea. On 6/14/2022 in the evening, I took the COVID home antigen test, and it was positive. I had a telehealth appointment on 6/15/2022. I was prescribed Paxlovid, Medrol dose pack and recommended I use Vitamin D3, Vitamin C and Zinc. For fever control, I was instructed to alternate Ibuprofen and Tylenol.  I started Paxlovid on 6/16/2022. I took it the full five days. I was sick until about 6/21/2022.  I was still symptomatic, but I was better. I had intermittent cough, my diarrhea and fever were gone, the aches were gone. It was basically the cough and fatigue that was ongoing. On 6/21/2022 I had a COVID PCR test which was still positive.  I started feeling complete resolution by 6/29/2022. I repeated a COVID PCR on 7/1/2022 that was negative. I have completely recovered now.  I was out of the country from 6/4/2022 to 6/10/2022. My antigen test, on 6/10/2022, to leave the country was negative.
difficulty of swallowing; A spontaneous report  was received from a non heath care professional  concerning a 97 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On Date 15/02/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 with lot/batch: 006M20A/006W20A  administered intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.    On same date after receiving the vaccine, after a few hours she is having difficulty of swallowing which is non serious.   Laboratory details are not provided.    Treatment details are not provided    Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event was unknown.
I'm a school teacher and have a fever.  I can't measure the temp. because eI don't have a thermometer.  My head is heavy, hot and painful.  I'm freezing cold with goosebumps.  My joints and bones ache.  Eyes are dry hot and stinging.  I have a sore throat - not very painful but around the lower part of my ears feel like they will burst.   I'm not taking anything at the moment.  My right arm feels numb and stiff.  This is not like any other vaccines I've had when I was young.  Note:  I had Covid 19 in March 2020.
mild erythema & very minimal edema surrounding inject site lt deltoid 24 hrs p/inject that was resolving w/in 72 hrs;
No adverse event; a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient did not report any medical history or condition.     On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 04-Apr-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a patient received a monovalent vaccine on 04-Apr-2023 that was pass expiration on 01-Apr-2023.).    Previous dose information was not reported. It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine expiry date was reported as 01-Apr-2023.  Treatment information was not provided.
This spontaneous report was received from a 75 year old male patient, regarding himself. Patient's concurrent conditions included hypertension, syncope, dislocation, delusion, acute edema of feet, and gastric reflux. He reported that on an unspecified date, he was vaccinated with ZOSTAVAX eight times in a row (overdose). He explained that each of the 8 injections were consecutive and delivered on the top of his foot by an unknown physician at an unknown hospital. Concomitant therapies included PROZAC, XANAX, potassium sodium hydrogen citrate (Manufacturer unknown) and ADDERALL tablets. Patient reported that he also received a ninth dose of ZOSTAVAX on his shoulder on an unspecified date. On 01-JUL-2015 the patient blacked out on the floor for a period of 30 hours and woke up with terrible pain. He was taken to an unknown hospital for an unspecified amount of time. On an unknown date in 2015, during his hospital stay, it was determined that he was severely dehydrated and had unspecified kidney issues. Patient stated that he felt like he was poisoned and the vaccine was intentionally given to him in the manner to harm him. The patient went on to explain that he felt his mental state was messed. The patient further explained that he then went under an unspecified invasive procedure to test for any heart irregularities. On 06-SEP-2015, he dislocated his shoulder due to a second episode where he blacked out and fell. He was taken back to the same hospital facility for an unknown amount of time, where an unknown medical professional implanted a chip in his chest to monitor his heart on an unknown date in 2015. Furthermore, patient developed hypotension which later turned into hypertension (documented as reported by the patient) and was diagnosed with an autoimmune marker. Patient mentioned that he was in the process of starting a legal case with this unknown hospital. Outcome of the events were unknown. Causality assessment was not provided. Upon internal review, the patient blacked out to be medically significant and considered serious due to hospitalization. The event dislocated shoulder was considered serious due to hospitalization. Additional information is not expected, no contact details were provided.
5 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
This case was reported by a physician and described the occurrence of leg thrashing in a 2 month old female patient who received DTaP adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). The patient's medical history was notable for a premature birth at 33 weeks of gestation. On 27 MAY2004, the patient received the first dose of Pediarix in the right thigh. At an unspecified time following the administration of Pediarix, on 27MAY2004, the patient experienced leg thrashing, "excessive" crying, and screaming. The events resolved on 29MAY2004. The physician considered the events to possibly be related to vaccination with Pediarix. Report initially received via Wyeth Ref: HQWYE152702JUN04.
arm hurt but just barely; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt but just barely) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN IN EXTREMITY (arm hurt but just barely). At the time of the report, PAIN IN EXTREMITY (arm hurt but just barely) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-085331, US-MODERNATX, INC.-MOD-2021-101612 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-085331: US-MODERNATX, INC.-MOD-2021-101612:
Patient came in on 10/8/14 in the evening complaining of a sore red left arm after receiving her flu shot in that arm 2 days previously.  Her arm was red to the touch and swollen down to the elbow. Unfortunately, those were all of the details that were given.  Time of onset was not discussed.
This literature marketed report was received from the authors of the published literature article. The authors performed a retrospective chart review to assess hepatitis B titers in children with celiac disease and whether baseline titers were affected by the presence of other autoimmune diseases, gender or vitamin D levels. 67 children that had a baseline hepatitis B titer after the primary vaccine series for hepatitis B were involved. The average age of diagnosis of celiac disease was 6.74 years. The majority (60/67) were diagnosed via endoscopic biopsy while 10.4% (7/67) were diagnosed via serology based on Society of Pediatric Gastroenterology, Hepatology and Nutrition (SPGHAN) guidelines. Thirty-six (53.7%) were male and 31 (46.3%) were female. 60.6% of children (40/66) had normal vitamin D-25 levels. Of the 67 children, 25 (37.3%) had positive hepatitis B surface antibody levels and 42 (62.7%) had negative hepatitis B surface antibody levels. There was no difference in response to the initial primary hepatitis B vaccine (recombinant) (manufacturer unknown) series based on gender. Twenty-three percent of children (6/26) with vitamin D levels <30 ng/mL (considered as low) and 45% of children (18/40) with vitamin D levels greater or equal to 30 ng/mL (normal level), had positive hepatitis titers (p=0.07). Twenty-one percent of children (3/14) with an additional autoimmune disease and 42% in children (22/53) without presence of an additional autoimmune disease, demonstrated hepatitis B immunity following primary vaccination (p=0.22). This literature report refers to 22 children of unknown gender (exact age was not provided) with celiac disease. On unknown dates, the patients were vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) series (dose, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients had negative hepatitis B surface antibody levels. They were not revaccinated due to lack of pediatrician awareness for need of vaccine as child already completed primary vaccine series, parents not making an appointment to get vaccine, and recent awareness of hepatitis B titer status. The outcome of the event was not reported. The authors considered the event to be related to hepatitis B vaccine (recombinant) (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced cases: MARRS #1801USA003203). Sender's Comments: US-009507513-1801USA003203.
A report received on 2/28/02, is concerning a 73 year old male pt who experienced life-threatening tracheobronchitis, for which he was hospitalized, 3 days after receiving Fluvirin vaccine, on 10/20/1998. The pt died subsequently. It is unclear from the report what the cause of death was. The causality was stated to be possibly related. No further information was provided.
lump on the left arm pit; pain in the administration site; This is a spontaneous report from a contactable consumer or other non hcp who reported for himself.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: en6203) via an unspecified route of administration, administered in left arm on 27Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a lump on the left arm pit and vaccination site pain. Patient reported that he received the vaccine on 27Feb, yesterday he found out he has a lump on the left arm pit where he received the vaccine, the lump hurts today. Patient had received the vaccination at medical center. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
On the 18th I started having a worse cough than the normal couch I have and my daughter and husband had tested positive on the 16th and I had tested negative. But My head was killing me and I was having pain in my ear so I went back to urgent care and was positive on the 18th. I have had bad fatigue and a tightening in my throat. I was given molnupiravir due to my heart and other health issues.
Presented with headache on 5/3/18 and vision changes on 5/22/18. Hospitalized on 5/25/18 for papilledema, increased ICP and ADEM. Hospitalized 5/25/18 to 6/5/18. Treatment included IV SOLU-MEDROL and IVIG.
Something is not right with her immune system; Arthritis went off the charts; Abnormal findings( high protein); Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Something is not right with her immune system), ARTHRITIS (Arthritis went off the charts), PROTEIN TOTAL ABNORMAL (Abnormal findings( high protein)) and ARTHRALGIA (Shoulder pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Something is not right with her immune system), ARTHRITIS (Arthritis went off the charts), PROTEIN TOTAL ABNORMAL (Abnormal findings( high protein)) and ARTHRALGIA (Shoulder pain). At the time of the report, IMMUNE SYSTEM DISORDER (Something is not right with her immune system), ARTHRITIS (Arthritis went off the charts), PROTEIN TOTAL ABNORMAL (Abnormal findings( high protein)) and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test abnormal: high (High) High abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she had taken her anti inflammatory medications before receiving the 1st dose and stated that the Adverse events may be due to that.The patient stated that for the 2nd dose she took the anti inflammatory medications after receiving 2nd dose.   This case was linked to MOD-2021-100828 (Patient Link).
Pt developed area of erythema - 6 cm x 9cm distal to injection site (lower part of (R) upper arm) - warm to touch- rx'd with antibiotic (KEFLEX) and antihistamine.