chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported the occurrence of failing to seroconvert in an adult pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions and concurrent medications were not provided. The pt received an unspecified injection of hepatitis B vaccine recombinant (Engerix-B). After an unspecified amount of time, the pt failed to seroconvert. Comment: The reporter indicated that there were 6 adult pts who failed to seroconvert. However, they are not presently identifiable.
dose of GARDASIL 9 was administered to a pregnant patient; indication: received in error; This spontaneous prospective pregnancy report was received from a nurse and refers to a 34-year-old female patient. The patient's current condition included diabetes. Concomitant therapies included insulin aspart (NOVOLOG) and insulin glargine (BASAGLAR). No information regarding the patient's pertinent medical history, drug reactions or allergies was provided.    On 29-OCT-2019, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621934, expiration date 29-JAN-2022, intramuscularly, during pregnancy.  The last menstrual period (LMP) was calculated as 13-APR-2019, and estimated date of delivery (EDD) was calculated as 18-JAN-2020. At the time of report the patient was 28 weeks and 3 days pregnant. The pregnancy outcome was outcome pending.
Information has been received from a nurse practitioner and 65 year old female patient with hypothyroidism, Fibromyalgia, depression and Codeine and DERMOFLAST spray allergies who on 08-Oct-2008 was vaccinated with single dose of ZOSTAVAX. Concomitant therapy included CYMBALTA, LEXAPRO, ESTRACE, PRILOSEC, SYNTHROID, FLATORIL and RITALIN and "KOLAPEN". Around 10-Oct-2008, the patient experienced in the left side of her body, pain tingling and numbness over her shoulder blade, jaw, inside the mouth and on the left side of her head. The patient reported that at the beginning of the pain and tingling the bottom teeth on her left side were very sensitive as well. The patient stated that over the weekend, on approximately 11-Oct-2008 she had went to a walk in acute emergency clinic, and they had diagnosed her with post herpetic neuralgia and was prescribed NEUROTIN. The patient reported that her pain was improving since taking NEUROTIN but at times she just felt very tired because of the NEUROTIN. The patient reported that she went to see her physician's nurse practitioner on 17-Oct-2008 about the post herpetic neuralgia. The nurse practitioner was not interested in VZV analysis by PCR. At the time of reporting the patient was recovering. Additional information is expected.
Mom noticed next morning arm around injection was red and warm to the touch. Under injection site was hard. Patient complained of pain. Took TYLENOL for pain and applied ice packs. Mom states on 5-4-18 getting better.
He presented at ED with weakness, SOB, cough and fever for 2 weeks, and he was tested COVID positive. He was admitted at hospital for futher evaluation and treatment on 9/3/21. His hospital day 7.
48 year old male patient administration Fluzone High Dose, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 48 year old male patient who received a vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] at inappropriate age.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ469AB and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient describes consistent weakness & intermittent pain the arm in which injection was given. Patient says symptoms began within 24 hours of injection & has continued >4 months post-injection. Patient has not sought medical care for symptoms.
Dramatic swelling and redness shoulder to elbow-mild tenderness- no joint/movement limitation-plus small blisters around site, amber fluid.
Pt had 1 week of mild cough and runny nose prior to vaccine administration. She was otherwise fine, playful, afebrile and in good health. After receiving a PDrix vaccine on 11/7, the following day the patient developed sudden onset of generalized tonic-clonic seizures. The patient was admitted to the Pediatric ICU.
Pt breastfed during  15 minute wait period after vaccine administration. Pt reported dizziness, headache, numbness/pressure around eyes, and tingling around lips. BP 98/66 then 107/74 upon rechecking after giving pt water, crackers, and juice. Pt legs were elevated. Benadryl contraindicated due to lactation. Pt refused EMS service and signed AMA form.
he received Moderna vaccine on 03/15/2021 and on 04/13/2021.    On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911.             Per neurology consult 4/15 -  "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something.  He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words."              Tm 103.4.   On exam  4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements.   + headache.  Keppra and / or mirapex, then ativan later, seemed to help.  Symptoms had completely resolved by 4/16/21.
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON
according to mom 1130PM pt had generalized stiffening w/eye rolling lasting approx 3 mins;
Chills, fever, body aches, headache, dizziness, fatigue, rash at site of injection, large swollen red area around site.
Dizziness and rapid heartbeat five minutes after shot with lightheadedness continuing for a few days after.  Sore throat and swollen throat glands twenty minutes after shot that continued for a couple hours after.  Swollen breasts leading to back pain twenty minutes after shot continuing for a week following.  Headache, fatigue, and joint pain for 48 hours after shot.  Nausea and acid reflux for several days after shot.  Menstrual spotting occurring one week after shot (had period the week before).  I saw a doctor at an urgent care and he suspects I may have anemia that was worsened due to being on my period right before shot and that likely contributed to the dizziness and rapid heartbeat.  No explanation for other symptoms but I am healthy.
Janssen COVID-19 Vaccine EUA.  I could not possibly fill out all the questions in 15 minutes.  My usual arthritis joints were affected to an extent more painful than usual especially my  right arm.  The pain was akin to when both my rotator cuffs were torn.  Some swelling in my hands.  It lasted six weeks winding down as time went by.
Got period mid cycle (day 15), 7 days following vaccine.  This has never happened before.
At 1500hrs pt. was vaccinated with below mentioned vaccines. Pt. was in no apparent distress after and left the clinic with aunt. At 1800hrs the pt. presented at her Dr's office with c/o dizziness, nausea, fever, clammy skin. The Dr administered BENADRYL, pt. recovered and was sent home.
Patient presented to pharmacy two days after receiving FLUZONE HD vaccine. Patient had red, warm rash on upper arm surrounding vaccination site extending from shoulder to elbow. Patient reported the rash did not itch or cause pain. Rash first noticed by patient on 8-31-12 in the evening. Patient was advised to take Ibu, diphenhydramine & ice area as needed for swelling, pain & itch & report back if any worsening.
Starting having heavy irregular menstrual spotting after second vaccine.  Had not had a period in 9 years bc I have an Mirena IUD before this second vaccine. Received the booster and frequency increased. 12/13/21 I sat up and suddenly entire couch cushion was soaked in bright red blood approximately 16 x 16 inches. I went to the bathroom and found an egg sized blood clot in my underwear.  Bright red blood continued to drip down my thighs and in the floor and I became very lightheaded and dizzy.  After the continuous bleeding stopped, I had medium sized, bright red stringy clots every time I went to the bathroom and spotting smaller clots throughout the day. All bloodwork and vaginal ultrasound came back normal. 3 month trial of birth control pills used in hopes of reseting my system.  Painful period the entire 7 days first month. Never had a period like this before, when I did have them. The daily spotting stopped during the second pack. Finished third and final pack, but three days later I started passing small clots and spotting again.  Now I will have to start a 4th pack.  My doctor is not sure now if I will have to stay on these indefinitely to control the bleeding. Next follow up in two months with her.
Client passed out approximately 2 minutes after receiving J&J vaccine, client had no recollection of passing out after, rolling back of eyes and slight right arm muscle twitch upon awakening.  On site EMS called to client's side, observation  provided . Client stated he did not remember passing out but he does remember feeling dizzy prior to passing out, Pt awoke within less than a minute. Client has no history of fainting.
Swelling, 2 x 2 x .5 inches, extreme redness, itching at vaccination site beginning 3 hours after injection.  Arm soreness, which resolved after 4 days.  Swelling, etc. resolved after 6 days.  On day 8, redness and swelling 2.5 x 3 x .25 inches returned with itching.  Has not resolved.
My son had diarrhea that started the day after his initial H1N1 vaccination.  He had no fever and no other symptoms (eg, vomiting).  He was otherwise well.  The loose stools were frequent (up to 5 times daily) for four days.  He was eating and drinking well and required no medical intervention.
Dizziness, nausea, fever, chills, body aches, fatigue, weakness, lack of appetite
administration with liquid component only; administration with liquid component only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Physician reported that patient was inadvertently administered a dose of Menveo with the liquid CWY component only,, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. No other adverse event information available at this time as per health care professional. Health care professional provided consent for safety team to follow up.
Recd 2nd MMR vax 5NOV91 (1st MMR given 25SEP91); 11NOV91 2 separate maculopapular lesions, almost vesicular in appearance; hive-like lesions appeared on back 12NOV; maculopapular lesions bilateral thighs 13NOV; mildly pruritic;
Began with sluggish feeling/ tired, low grade fever 99.9 , lots of arm pain yesterday 1/27/21 -localized where shot given - hard to lay on arm -hurts to lift arm or put seatbelt on. Patient reports pain level 9/10 Denies dyspnea, no painful respirations, no loss of taste or smell Patient has tried tyelnol
Warm flushing on right side of face near the ear, then eventually on the left side of face. Nausea. Throat felt it was swollen.
Potential missed window for vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potential missed window for vaccination) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potential missed window for vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Potential missed window for vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information about concomitant medication was provided.  No information about treatment medication was provided.
This is a non-serious spontaneous case, initially received from a physician on 30-Oct-2018, concerning a male patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc (multi dose vial) MDV vaccine underwent first temperature excursion for 2 hours, reaching a minimum temperature of 34-degree Fahrenheit. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252225 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse events after the vaccination.
Left half of face went numb and weak about 2 hours after vaccine. Fever the next morning.
Feeling hot; Sleep disturbance; Sickness; Bone pain; Felt faint; Decreased appetite; Weight loss; Myalgia; all the food made me sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain) and DIZZINESS (Felt faint) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN for an unknown indication.   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain), DIZZINESS (Felt faint), DECREASED APPETITE (Decreased appetite), WEIGHT DECREASED (Weight loss), MYALGIA (Myalgia) and ILLNESS (all the food made me sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain), DIZZINESS (Felt faint), DECREASED APPETITE (Decreased appetite), WEIGHT DECREASED (Weight loss) and MYALGIA (Myalgia) outcome was unknown.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, intramuscularly, which had lot # L024999 with expiry: 06-OCT-2016. No adverse effects reported. No further information reported. Additional information is not expected, as the reporter did not wish to be contacted.
No adverse event; Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Renal transplant in 2015. Previously administered products included for COVID-19 prophylaxis: Spikevax and Spikevax. Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax. Concurrent medical conditions included Immunocompromised.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022) 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 UNDERDOSE (Caller stated that he is immunocompromised due to a renal transplant in 2015. His vaccine schedule included 2 primary dose and 3 booster dose as of September 2022).    Concomitant medications details were not reported by the reporter. Reporter stated that patient was immunocompromised due to a renal transplant in 2015. Patient's vaccine schedule included 2 primary dose and 3 booster dose as of September 2022. Treatment details was not reported by the reporter.
Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. Unspecified medical attention was sought. A product complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
body aches similar like the flu; sore throat; lungs hurt when she takes a deep breath; body aches similar like the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu). At the time of the report, INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106569 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106569:second dose
at the injection site, she has a giant lump which is growing; keeps getting bigger and itching; way lower than the deltoid, not in the muscle, but closer to her elbow, specifically a few inches above her elbox; This is a spontaneous report from a contactable consumer who reported for herself, a 57-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. At the injection site, she has a giant lump which was growing. Upon further discussion, it started this morning and kept getting bigger and itching. She said the injection was given a week ago and given "way lower than the deltoid, not in the muscle, but closer to her elbow, specifically a few inches above her elbox." Her kids who were pharmacists pointed it out to her that the injection site was "very low" on the arm. It was given at a store, not at the doctor's office. The outcome of the events was unknown.  Information on lot/batch number has been requested.
This spontaneous report as received from a female consumer refers to herself. The patient had vaccinated with dose 1 PNEUMOVAX23 in October 2009 and then got a second dose in November 2010. The patient did not report any adverse reactions to her shots. Additional information has been requested. The consumer also reported AE regarding her husband (captured in Case # 1301USA010393).
a 59 YOF admitted on 11/17/21 with a history of morbid obesity, recurrent panniculitis, OSA, HTN, DM2 who presents with a two day history of HA and pain/tenderness of her lower abdomen.
Patient states by 3:00 P site was warm and tender. By bedtime she couldn't lift her arm at all and had 10/10 pain. Took TYLENOL with min. relief. Made follow up appt but cancelled - pain lessened by mid morning. Still exp. some sharp/shooting pains once in a while.
Patient came in to pharmacy today showing a red knot that she reported is sore and warm to touch. Red knot not on deltoid where shot was given but was on the same arm. Arm had a knot and some swelling.