chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Immunocompromised) and Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the patient was confused about what they were asking for and asked for a booster dose instead of a third dose. It was also stated that patient was asking for second booster dose. No treatment information was provided.
8 pm my blood pressure when up  201-107 89 pulse. I took 25 mg losartan.  8:40 pm blood pressure 165-98  77p.
left side swelling neuropathy; high Blood pressure; low Heart rate; severe headache; 38 weeks pregnant female received Flublok QIV; Initial information received on 24-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves female patient of an unknown age who experienced left side swelling neuropathy (neuropathy peripheral), high Blood pressure (hypertension), low Heart rate (heart rate decreased) and severe headache (headache) and was 38 weeks pregnant, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date was not reported.  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 dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in unknown administration site.  On an unknown date, the patient developed a serious left side swelling neuropathy (neuropathy peripheral), high Blood pressure (hypertension), low Heart rate (heart rate decreased) and severe headache (headache) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event.  It was also the case of Vaccine exposure during pregnancy.  (Other relevant tests included no lab data.)  Final diagnosis was severe headache, low Heart rate, high Blood pressure and left side swelling neuropathy.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for all the events.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested  Documents held by sender: none.; Sender's Comments: Patient experienced peripheral neuropathy, high blood pressure, decreased heart rate, severe headache after vaccination. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Obtained from patient. Patient is a 37-year-old female with past medical history of asthma, bipolar disorder, history of anxiety and joint pain, came to Emergency Room with above complaints.  Patient works as a  investigator and getting her first COVID-19 vaccination, Johnson and Johnson.  Patient was at work receiving her first dose.  After dose, the patient was planned to be observed.  The patient is stating that 3 minutes, the patient started getting her tongue started feeling funny.  Four minutes into vaccination, patient felt her throat was closing and the patient started drooling.  Nurse practitioner immediately gave the patient 2 shots of epinephrine with Benadryl.  911 was called and patient was admitted to the Emergency Room.  In the Emergency Room, the patient diagnosed with anaphylactic reaction to COVID-19 vaccination.  With the patient's persistent tachycardia, still having symptoms of throat itching, the patient requested to be admitted for further observation.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. On 13th March 2019, unknown after receiving SHINGRIX, the patient experienced wrong injection technique. On 14th March 2019, the patient experienced pain in arm, bruise, skin red, nausea and fever. On an unknown date, the outcome of the pain in arm, bruise, skin red, nausea and fever were recovering/resolving and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the pain in arm, bruise, skin red, nausea, fever and wrong injection technique to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After vaccination with SHINGRIX the patient experienced pain in right arm, bruise, skin red, nausea and fever. The reporter stated that, during the injection, the pharmacist hit a blood vessel which led to wrong injection technique. Did not consent to follow-up.
Initial report received from a pharmacist on 30 January 2007. A patient (age and gender not reported) received a booster dose of Imovax (lot number "Z02034", route and site of administration not reported) on 07 August 2006. Her titer was checked and was "0.35". The patient received a pre-exposure rabies series with Rabavert (lot number 334011) in June 2004. Her titer was checked in June 2006 and was "0.43". No additional information was provided. Follow-up information received on 05 March 2007. The patient completed her original rabies series on 25 June 2004. Her first booster dose of Imovax (lot number Z03016) was given in the right deltoid. Her second booster dose of Imovax was given on 13 February 2007 in the left deltoid. Her rabies titer was measured on 22 June 2006 as 0.43 IU/mL (20.5 post-vaccination) and her rabies titer was measured again on 19 January 2007 as 0.35 IU/mL. The reporter mentioned the titer was even lower after booster #1. They are awaiting the results of the repeat titer after the second booster on 13 February 2007. The results should be available in  6-8 weeks. She was taking Cymbalta and Lisinopril. She had no illness at the item of vaccination.
This treatment resulted in complete clinical remission and histologic cure without residual pain and with return of full function of the hand; Given our experience using combined systemic and intratumoral administration of the 9-valent HPV vaccine for SCCs, we offered the same to this patient;  This literature marketed report was received from the authors as stated above concerning a 87 year old male patient. The patient medical history included renal transplant. Other concurrent conditions were not reported. Concomitant medications included mycophenolic acid, tacrolimus and methylprednisolone.  On unspecified dates, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) 2 intramuscular (IM) vaccine injections at 0 and 6 weeks. Two weeks after the second IM dose, the vaccine (0.5 mL) was diluted in 2mL of sterile normal saline and 0.5 mL of 2% lidocaine and was injected intratumorally. Two months after the first intratumoral injection, a second intratumoral dose was administered. Cumulatively, the patient received 2 IM and 2 intratumoral doses. Nine months after the first IM injection of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown). The authors stated that this treatment resulted in complete clinical remission and histologic cure without residual pain and with return of full function of the hand (drug effective for unapproved indication). The observed benefit may be owing to a combination of antiviral, antitumor, and immunologic effects.  The authors considered drug effective fr unapproved indication to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Patient received flu shot and woke up about 8 hours later with diarrhea, vomiting, chills, high fever and fatigue.
Joint and muscle main, swollen lymph nodes, headache and stiffness, and fatigue
Called patient on09/16/2019 to have her come in for second dose shingrix. Patient informed that doctor does not want he to get any vaccine until her arm heals. Two months later, patient states she still has a large red swollen  area at injection site. she rates pain 7 out 10yet. States pain shoots all the way down to thumb. Patient states doctor is treating patient with prednisone and is thinking about starting gabapentin to control pain. Patient states okay to contact if more info needed.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
PATIENT PRESENTED TO PHARMACY ON 7/31/19 AFTER RECEIVING 2ND SHINGRIX DOSE ON 7/29/19 WITH RED, SWOLLEN, HOT TO TOUCH RASH THE SIZER OF A SOFTBALL ON HER LEFT ARM (RIGHT ABOVE ELBOW)
Right leg- 7cm induration, redness 10 min after injection 06/8/04 15:45. No respiratory distress. 12.5mg Benadryl PO and ice applied to area, observed x 45min. Swelling and induration decreased 6/9/04 in F/U visit.
Severe rash - all over (legs, arms, feet, hands, lots of rash -spots (red), swelling in hands & fingers, toe (joint swelled), lips swelled, wheezing, shortness of breath, vomited, fatigue, diarrhea, stomach pain legs ached, joint pain. Sweaty, dizzy, hives. Doctor gave PREDNISONE/METHYLPREDNISOLONE (several times).
MAIN COMPLAINTS ARE VISION IMPAIRMENT AND HIGH BLOOD PRESSURE SINCE VACCINATION. PATIENT STARTED EXPERIENCING DOUBLE-VISION THE EVENING OF VACCINATION. IT HAS NOT SUBSIDED AND CAUSES CLOSE UP VISION IMPAIRMENT. SHE HAS SINCE RECEIVED PRISM GLASSES TO HELP. SHE NOTES THAT HER BLOOD PRESSURE HAS BEEN ELEVATED AND HER FEET SWELL SINCE THE VACCINATION.  CURRENT READINGS  ~142/87 MMHG (NORMAL READING ~114/72 MMHG). HER PROVIDER, DR. (LAST SEEN 6/4/21), ADVISED PATIENT TO CHANGE DIET BEFORE BEGINNING MEDICATION REGIMEN.
Pt admitted to trauma after slipping on the ice and falling on his right side.  Pt tested negative for COVID on admission (1/25/2022) and positive on (2/1/2022) in preparation for admission to rehab.
Case number PHEH2014US024999, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 93 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number 145701) intramuscularly at a dose of 0.5 ml on 22 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Initially the worst (large, painful) red swelling I've ever experienced after an injection. Within two days I began to get what looked like pox all through the large red area. That lasted well over two weeks and at first was extremely painful, than so itchy that I couldn't sleep. Eventually the "pox" (large raised bumps close together) formed scabs.
That night after shot I felt strange, I was scared because I never had this reaction before. Breathing was difficult. Pain lasted longer in arm 5 days. Next day the same side I had my shot (read back) I noticed a lg, painful cyst by my collar bone. The pain subsided but the cyst didn't. I moves as I CK it. Finally I started feeling myself again after 2 days and 3 days later pain in arm went away. Scary. Cyst persistent until now.
Information has been received from a nurse concerning a 17 year old female who on 06-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot # 661766/0652X). Subsequently the patient developed rash (location unspecified by nurse). The patient had sought medical attention, saw "nurse or physician". At the time of report the patient's status was unknown. Additional information has been requested.
This spontaneous report as received from a healthcare student refers to a 13 year old female patient. On 07-OCT-2013 the patient was vaccinated with a first dose of GARDASIL injection (lot #, expiration date, dose, frequency and route not reported). On the same day, she also received a first dose of an unspecified flu shot (manufactory unknown) (lot #, expiration date, dose, frequency, route and indication not reported). There were no concomitant medication, medical history and drug reactions/allergies. On 07-OCT-2013, she developed achiness in her arm, a headache, a fever, nausea, vomiting, redness and swelling in her arm, a white blood cell count of 27.2 and a neutrophil count of 90.5%. She sought unspecified medical attention and was given treatment for adverse events, using clindamycin and BENADRYL. On 09-OCT-2013, the patient was admitted to the hospital. The outcome of events was reported as not recovered. Additional information has been requested.
p/vax pt exp fatigue, h/a & aches all over body;pt exp flu-like sx;inj site was 1 1/2inches long x 1 inch wide, raised, sore & bright pink;whole are, shoulder, & neck on the inj site side were most painful;
Pt felt nauseated and proceeded to vomit.  I stayed with client and gave client water until she felt better.
On 11/26/01, in the evening, the child was fussy and crying for over an hour. On 11/27/01 AM, his temperature was 105F and not relieved by alternating APNP and Motrin. At 21:30, the fever was down and left leg was swollen, "fire engine red" and hot to touch and had diarrhea. On 11/28/01, his left leg was still swollen "twice the normal size and child was lethargic and fussy. He had only taken 1 8oz bottle since AM and had only 2 wet diapers today. Mom is taking child to PCP.
broke out on rt side of face;lips swollen;eyes swollen;oozing/swelling to face w/blisters red & infected;
Patient came in on 9-14-2021, 7 days after receiving her flu shot complaining about local site reaction - redness, swelling, heat. No prior history of reaction with past flu shots
2nd dose received on: 04Apr2021; Reaction; Developed tinnitus (ringing in the ears); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction), TINNITUS (Developed tinnitus (ringing in the ears)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on: 04Apr2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE REACTION (Reaction) and TINNITUS (Developed tinnitus (ringing in the ears)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on: 04Apr2021). At the time of the report, VACCINATION SITE REACTION (Reaction), TINNITUS (Developed tinnitus (ringing in the ears)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on: 04Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medicines were not reported Action taken with mRNA-1273 in response to the event was unknown
pt recvd vax & devel Stevens Johnson type rxn p/flu vax;devel facial edema & mouth ulcers;@ time of report pt was recovering;pt had a hx of allergic rxn to bacillus clostridium tetani;
redness, swelling, pain, muscle weakness, tightness at injection site - started on 1/13/2021 afternoon, Plan: Claritin or Allegra during the day the next several days and also can add Benadryl at bedtime.  Elevate, apply ice pack.  Ibuprofen 600 mg three times daily with food.
has UTI; This is a spontaneous report from a Pfizer Sponsored program support. A contactable female consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The Patient medical history and concomitant medications were not reported. It was reported that, the patient has UTI and was enquiring if she could still receive her 2nd dose. The outcome for the event was unknown.
MIGRAINE HEADACHE; DIZZINESS; NAUSEA; MUSCLE ACHES; TIREDNESS/FEELING EXHAUSTED; BLIND SPOT IN LEFT EYE; AURA IN LEFT EYE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and concurrent conditions included allergy to sulpha, alcohol user, and non smoker. The patient experienced drug allergy when treated with metronidazole.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced blind spot in left eye. On MAY-2021, the subject experienced aura in left eye. On 19-MAY-2021, the subject experienced tiredness/feeling exhausted. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced migraine headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from muscle aches on 22-MAY-2021, had not recovered from nausea, migraine headache, tiredness/feeling exhausted, and dizziness, and the outcome of blind spot in left eye and aura in left eye was not reported. This report was non-serious.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
A 17 year old patient received the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient received the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient received the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Child received vaccine on 9/29/09; less than 24 hours later developed increasing redness, 8x8cm area warm to touch and itchy. Treated with Keflex for 7 days; to use po Benadryl for itch
Pt. reports an arm swollen from shoulder to elbow today (9/6/11) which is one day after immunization. Pt was advised to contact MD if it gets worse.
Developed severe tics 9 days after administration of the vaccine.  given Inderol, 10mg. to try to decrease the frequency.  Were occurring at rate initially of up to 20 per minute.  4 months later, occurring 1 every 4 minutes or so, more under stress. Was enrolling in High school of the arts for music and is now unable to attend. 60 Day Follow Up: Is still having severe tics, now being treated by Halodol. Per follow up report-Continues to have tics, usually at the rate of 1 or 2 per minute instead of many per minute. Under stress they continue at the rate of as many as 15 per minute.
This spontaneous report as received from a register nurse refers to a 4 month old female patient. Concurrent or medical conditions were not reported. On 07-DEC-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB lot #K008986, expiration date 01-APR-2016, on 10-APR-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB lot # reported as K022265, expiration date 22-OCT-2016 and on 12-JUN-2015, the patient was vaccinated with the third dose of RECOMBIVAX HB lot # reported as L007558, expiration date 10-NOV-2016 (strength, doses and route of any of the doses received were not reported). No adverse effect was reported. Additional information has been requested.