chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected Vaccination failure; got shingles; very painful disease; My back still itch every day; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and still got shingles. The reporter stated that it was very painful disease. The reporter mentioned that his/her back still itch every day. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 15-OCT-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot# L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Starting throwing up morning after threw mouth and nose and very fussy.  It has happened one other time and I contacted the nurse in office last time and they said it was not related to vaccine although now it has happened again.
Pt. reports swelling of Right upper arm, extending around and up to shoulder and stiff neck with onset 2hr after injection.  Pt. reports nausea and vomiting for last 24 hr, unable to hold liquids. In clinic today, L and R arm both 26.5cm circumfrence at base of bicep, no observable erythema. Limited range of motion of arm to about 10 degree abduction, able to move fingers, flex and extend forearm. Pt. dehydrated, anti-nausea medications prescribed, IV attempted-unable to access vein.  Pt. recommended to ER for hydration and follow up visit at clinic Sat. early AM.
R upper arm redness & warmth 10x8 cm on 10/30/2020 No F/C/N/V
dizzness. c/o stomach pain, n/, dizziness, hot, and chills x3days. states recently started new meds (Propranolol and Sumatriptan) since last Thu. hadvaccine last Wed. CHIEF COMPLAINT & HPI:  37 yo F with intermittent epigastric pain with mild nausea.  no vomiting.  no fever/chills.  no diarrhea.  no dysuria/hematuria.  no cp/sob.
Metallic taste in her mouth; Constantly thirsty; Spike of fever 99.4; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), THIRST (Constantly thirsty) and PYREXIA (Spike of fever 99.4) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), THIRST (Constantly thirsty) and PYREXIA (Spike of fever 99.4). At the time of the report, DYSGEUSIA (Metallic taste in her mouth), THIRST (Constantly thirsty) and PYREXIA (Spike of fever 99.4) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 99.4 (High) 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Outcome of the events updated to recovering (patient stated that she was fine).
Had a dizzy reaction to the Pfizer Covid 19 Vaccine; Has had a very bad time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Had a dizzy reaction to the Pfizer Covid 19 Vaccine", "Has had a very bad time"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "Had a dizzy reaction to the Pfizer Covid 19 Vaccine", "Has had a very bad time". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Had a dizzy reaction to the Pfizer Covid 19 Vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Has had a very bad time.". Clinical course details: Two years ago, patient received three doses of the Pfizer Covid 19 Vaccine. Had a dizzy reaction to the Pfizer Covid 19 Vaccine. Ever since, has had a very bad time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018909 same reporter/patient/AE, different dose;US-PFIZER INC-202300018904 same reporter/patient/AE, different dose;
RASH AT INJECTION SITE, SOME SWELLING AND INTENSE ITCHING  Narrative:  Patient reported skin rash and some swelling around injection site  that started 9 days after injection. Patient reported intense itching of rash. All  symptoms resolved within 3 days from presentation of symptoms. Patient has no  lasting symptoms from injection.
Fatigue/Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EN6208) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue/Tiredness".  No follow-up attempts are possible. No further information is expected.
Pt's mother stated that she took the child to the ER on 01/16/2002 at around 5:30pm with a temp of 106 deg. F. The pt had rash and was excessively crying. The pt was treated with Benadryl injection and Benadryl prescription. Followed up with the doctor today and was given 2 more prescriptions and was told the pt has a viral infection, also.
This spontaneous report as received from a 60 year old female patient. The patient reported that she had no previous injection-site reactions, including when she received unspecified "flu" nad "TD" vaccines. The only reaction to prescription medications that the consumer reported was having felt "sick to [her] stomach" after taking certain painkillers including VICODIN, NORCO, and DARVOCET-N (reported as "DARVOCET"). On 30-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml/one shot, injection, strength, formulation, lot#, route and duration were unspecified). Concomitant therapies included KLONOPIN, omeprazole (manufacturer unspecified) and unspecified vitamins. Patient reported that almost exactly 24 hours later on 01-MAY-2013, she noticed an injection-site reaction including and "inch and a half circle" at the injection site which was red and swollen as a hard lump that felt hot to the touch. Another 24 hours later on 02-MAY-2013 (48 hours after receiving ZOSTAVAX), the circle at the injection site had grown "twice a big" and was still red, hot, and a hard lump. The injection-site reaction did not include any itching or rash. The consumer did not want to specify whether the physician in the "Physician Name" field could be contacted because the consumer has not yet contacted her physician about this reaction. The consumer stated that she might soon be contacting a different, unspecified doctor instead about the reaction. The patient received the ZOSTAVAX from an unspecified pharmacist. The reaction has not diminished. Patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the events. The outcome of the events were reported as not recovered. Causality were not provided. Additional information has been requested.
awake most of the night, body aches, muscle pain, joint pain, chills, nausea, HA, ok today
Pt got cellulitis around injection site on rt arm-Dr put her on Bactrim DS medication for infection.
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored vaccine of one of the following vaccines, but she was unsure which of the lots the unspecified patient received. The nurse reported that, no lot was given to a patient after the lot's expiration date. Names of the vaccine involved: PROQUAD: (K025760, expiry date 08-JUN-2016) (L005297, expiry date 17-AUG-2016)  (L030591, expiry date 10-FEB-2017) (L034931, expiry date 03-MAR-2017) (L040413, expiry date 13-APR-2017) (L046506, expiry date 17-MAY-2017) (M002053, expiry date 11-JUL-2017) (M006102, expiry date 01-AUG-2017)(M011664, expiry date 08-SEP-2017) (M037009, expiry date 21-FEB-2018) (M043306, expiry date 24-APR-2018); VARIVAX: (J013900, expiry date 30-OCT-2015) (K021484, expiry date 03-NOV-2016) (K026385, expiry date 15-DEC-2016) (L002868, expiry date 27-JAN-2017) (L012036, expiry date 07-APR-2017) (L023593, expiry date 26-JUN-2017) (L029466, expiry date 06-AUG-2017) (L035126, expiry date 14-SEP-2017) (L044419, expiry date 14-OCT-2017) (L049532, expiry date 08-DEC-2017) (M005974, expiry date 02-FEB-2018) (M009765, expiry date 23-FEB-2018) (M025864, expiry date 24-MAY-2018) (M028553, expiry date 07-JUN-2018) (M030138, expiry date 15-JUN-2018) (M034586, expiry date 27-JUL-2018) (M036272, expiry date 17-AUG-2018) (M038859, expiry date 14-SEP-2018) (M041513, expiry date 11-OCT-2018) (M045205, expiry date 11-NOV-2018); VAQTA: (L039659, expiry date 15-MAR-2017) (L023936, expiry date 15-MAR-2017) (K019560, expiry date 02-JUN-2017) (M018644, expiry date 20-SEP-2017) (M027879, expiry date 24-JAN-2018) (M022924, expiry date 24-JAN-2018) (M033611, expiry date 02-MAR-2018) (M039202, expiry date 11-MAR-2018) (N005274, expiry date 03-APR-2018); GARDASIL 9:  (L000610, expiry date 31-JAN-2017) (L044475, expiry date 12-MAY-2017) (L013429, expiry date 21-JUL-2017) (L025737, expiry date 28-JUL-2017) (L016428, expiry date 30-JUL-2017) (L019297, expiry date 18-AUG-2017) (M005714, expiry date 03-OCT-2017) (M011117, expiry date 07-DEC-2017) (M009378, expiry date 23-APR-2018) (M026306, expiry date 30-APR-2018) (M017983, expiry date 30-MAY-2018) (M031557, expiry date 07-APR-2019) (M041212, expiry date 21-JUN-2019) (M041990, expiry date 28-JUN-2019); RECOMBIVAX HB: (K020216 17-SEP-2016) (K021444 17-SEP-2016); GARDASIL: (K010574, expiry date 08-APR-2017) (K011562, expiry date 08-APR-2017). The vaccines PROQUAD and VARIVAX were exposed to a temperature range of 6 degrees F to 14 degrees F for a time frame of 72 hours. The vaccines VAQTA, GARDASIL, GARDASIL 9, RECOMBIVAX HB were exposed to a temperature of 28 degrees F for a time period of 120 hours. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. Data digital logger was involved. No adverse effects were reported. No additional information was provided.
pt recv vax & exp stiff neck w/knotted muscles; info from nurse stated that pt had pain in arm & elbow & had hand numbness; 26MAR94 pt devel pain over scapula & down arm; pt elbow was the most uncomfortable; exp severe neck & back strain
5 months after vaccine noticed left eye was sensitive to light and a little swollen. Was already scheduled for eye exam and they noticed that I had Uveitis, was prescribed Steroid drops that I used 3 times a week. Went for a follow up exam and it was mostly cleared up. Was told I could stop the drops, and was told that if I have it again I should see a Rheumatologist. Decided to go to an Ophthalmologist on my own to double check things, and was referred again to a Rheumatologist to check for any Autoimmune Diseases.
No additional AE reported; he had received a dose of PROQUAD beyond the age recommended in the PI. PROQUAD had been administered on 12/04/2019; This spontaneous report was received from a physician and refers to a 15-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, dose number, vaccination site, route of administration, lot # and expiration date were not provided) for prophylaxis beyond the age recommended in the product information (PI). The reporter wanted to know if the dose needed to be repeated. No additional adverse events were reported.
Pt awaken the next morning with headache, nausea, eczema type rash lesion located adjacent to injection site and inner thighs bilaterally, and dizziness
Pt developed wheezing, chest tightness and throat tightness 5 min post flu-shot.
I had pain radiating down the left arm that evening. It continued to worsen the next day and I was unable to use my left hand due to the pain. I had to wear a hand splint to ease the discomfort, but the pain was mostly at my wrist and top of my hand.
Vaccine was administered to the upper arm, close to the acromium process. I experienced pain greater than I have experienced to other vaccines, including COVID, flu, PPSV-23. The over the initial 24 hrs post-vaccination, the arm/shoulder area became warm, red, and extremely painful. I am now  72 hours post-vaccination, and the warmth and redness persist. The pain is less intense, but still tender. Between the initial shoulder injury for which I was in PT and the vaccine, it is difficult to sleep on my right side.
pt recvd vax & had inc t 103 w/in 1 hr, tx w/ apap & motrin; t inc  to 105 next am; seen by PMD on 10jun94, no sz of LOC;
Patient was seen in the drive thru vaccine clinic.  Patient was given a different vaccine than what was started at another location (received Dose #1 Pfizer and Dose #2 Moderna or visa versa).  Patient was contacted about the different administrations.  Patient reports no adverse effects from receiving 2 different doses.  Patient was observed on site for the required observation period and no adverse reactions reported on site.
Prior to administering vaccine. Gardasil 9 vaccine was found in the  Hep A vaccine bin in our private refrigerator after unknowingly noticing that the wrong vaccine was in the wrong bin, drawn and administered.
Information has been received from a physician concerning a 10 weeks old female patient with reactive airways disease and no allergies who on 16-SEP-2009 was vaccinated with a first oral dose of ROTATEQ (Lot No. not reported). concomitant vaccination received on the same day included PENTACEL and PREVNAR. There was no concomitant medication. On approximately 19-SEP-2009, "3-4 days later", the patient developed vomiting and bloody stools. The patient was diagnosed with intussusception. She was admitted to the hospital and underwent a bowel resection. Discharge date was not reported. It was reported that the patient "was doing well since surgery" and the patient was recovered. Additional information has been requested.  1/4/10 Received hospital medical records for 9/23-9/28/2009. FINAL DX: ileocecal intussusception Records reveal patient experienced bilious vomiting x 3 days & bloody mucousy stools x 1 day.  Seen in outlying ERs x2.  Transferred to higher level of care & peds surgery.  Enema x 2 failed to reduce IS.  Taken to OR for exp lap, ileocecectomy, appendectomy & primary reanastomosis.  Gradually improved & able to tolerate oral feeding.  1/7/10 Received vaccine records & PCP medical records: 9/16 visit w/constipation & rash dx as dermatitis on both arms;and 10/1/09 f/u visit s/p surgery.
I was coming home from out of state. I started to have a sore throat feeling and my eyes really started to itch. The next morning I woke and still had the sore throat, itchy eyes and congestion. I decided to do a rapid test and it came back positive. The same day I went to get a PCR test and the results came back the next day and they were positive. I'm down to a dry cough and congestion nose.
can not get out of bed; muscle pain; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (can not get out of bed), MYALGIA (muscle pain), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included COVID-19 on 13-Jan-2021.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BEDRIDDEN (can not get out of bed), MYALGIA (muscle pain), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm). At the time of the report, BEDRIDDEN (can not get out of bed), MYALGIA (muscle pain), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Regurgitation of medication; underdose; This case was reported by a consumer and described the occurrence of regurgitation of medication in a 8-week-old patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, less than a year after receiving Rotarix, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the mother of the patient. The patient spits out some of the rotarix vaccine. Might be half of it, which led to accidental underdose. The reporter asked was it still effective.
PATIENT CAME INTO OUR OFFICE TODAY FOR HIS DOCTORS APPOINTMENT AND THE PROVIDER ORDERED HIS BIVALENT COVID BOOSTER AND OUR BUD DATE WAS MARKED 2/27/2023 AND WE GAVE IT TO THE PATIENT
After vaccination was administered, patient developed a rash and swelling at and around the injection site. Patient came to the pharmacy 48 hours after administration and had a large area around the deltoid muscle that was red, swollen, irritated and hot to touch.
has a lot of muscle and joint pain; has a lot of muscle and joint pain; This is a spontaneous report from a contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8732) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient was calling about the Pfizer Vaccine that she recently had 3 weeks ago yesterday; she stated she had the second dose scheduled for tomorrow. She had a lot of muscle and joint pain after the first dose of the Pfizer Vaccine and just was wondering how long did the pain last and she was very reluctant to go get the second dose. She was hesitant to go get the second shot due tomorrow and it was more than three weeks from the first dose.  The outcome of the events was unknown.  No Follow-up attempts are needed. No further information expected.
A non-serious spontaneous report of a "13 week pregnant wife received vaccine" was received from a health professional concerning a 35-year-old female. Medical history has not been reported for this patient. Obstetrical history included gravida two and para two and both deliveries were C-section. Expected date of delivery was 20-Apr-2010. The patient had no problems related to pregnancy and had no illness at the time of vaccination. The patient was 13 weeks pregnant at the time of vaccination. Concomitant medications were prenatal vitamins daily one tablet oral and occasional acetaminophen. Patient received no other vaccination around the time of H1N1 vaccination. On 14-Oct-2009, the patient received H1N1, Intranasal nasally for an unknown indication. On 14-Apr-2010, the patient delivered a healthy baby boy with gestation age of 39 weeks and had no problems during delivery. There was no adverse event associated with this pregnancy. Therefore, treatment and reporter causality assessments are not applicable and the outcome of vaccine exposure during pregnancy was resolved. Additional information was received on 28-Apr-2010 and incorporated into the narrative: pregnancy outcome, neonatal information and concomitant medication. Other information received was responsible physician's details, county where vaccinated. Additional information was received on 10-May-2010 and incorporated into the narrative: Obstetrical history, gestational age of baby, EDD and concomitant medication. Other information received was Reporter's information.
9JUN95 310PM phone call to mom who states pt started w/fever of 101.5 @ 1030PM 8JUN95, then gave APAP @ that time about every 4 hr; states pt had high pitched crying & would not eat well; pt was taken to MD 11AM 9JUN95 dx poss vax rxn;
Patient reports bilateral hand and foot paresthesia starting 3 days after the vaccine. She received it on Wednesday and the symptoms started Saturday. They have persisted since then and remain