chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt (who is allergic to bees) recv LYMErix & immediately react of body shakes/vibration for 30 minutes; pt carries an epinephrine kit
Developed dermatographia/chronic spontaneous urticaria approximately 2 weeks after receiving Moderna booster shot. Experienced normal reaction to booster shot in the immediate two days after injection (similar to previous doses), returned to feeing normal, then symptoms began roughly 2 weeks after date of receiving booster. Overall symptom: Rapidly (every 20-30 minutes) shifting areas of extreme itchiness all over my body, which responded to any itching or scratching with intense swelling and redness within 2 minutes. No pattern of movement, head itches, then in 20 minutes legs are itching, etc. Swelling and redness persists for 15-30 minutes. I began taking Zyrtec 10mg per day after Benadryl was ineffective. Skin still becomes bright red whenever scratched or abraded, but it no longer swells and raises as before starting Zyrtec. Overall itchiness is ~90-95% more manageable with current dose of Zyrtec. Being untreated was overwhelmingly difficult to ignore.
Initial report received from a healthcare professional on 26 June 2012. It was a cluster of 10 unidentified patients (reported by the same reporter) who each experienced similar adverse events following administration of ADACEL. A cluster of ten patients, whose age, gender, medical history and concomitant medications were not reported, had received ADACEL vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that about 10 patients out of 70 patients vaccinated had experienced swelling, itching, redness and lump at injection site. Laboratory investigations and corrective treatment was not reported. As of 26 June 2012, the outcome was unknown. Documents held by sender: none.
Pt admitted to ED c/o fever, nausea, vomiting, dehydration and fatigue. Dr ordered 3 liters of IVF and 2 injections of compazine, DR from ED with prescription (Compazine). 3/19 spoke with pt she c/o mild lightheadness.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive, notes: covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
vaccine brand other Moderna Bivalent ;Vaccine brand=Pfizer / BioNTech; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 25Jan2021 as dose 2, single (Lot number: EL8982), in right arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 15Sep2022 as dose 5 (booster), single (Lot number: AR5186C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: some shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "vaccine brand other Moderna Bivalent ;Vaccine brand=Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Positive Covid test 2days after a negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 03Jan2023 to 08Jan2023.
Following 2nd dose of COVID vaccine on 8/27, patient had low-grade fever, body aches, chills, and fatigue.  Starting 8/30 in the morning, he began having burning chest pain, described as being like he "just ran a long time in cold weather".   He came to the hospital and was noted to have elevated troponins (8/30 0931 = 0.891, 8/30 1230 = 1.123, 8/30 1531 = 1.932, 8/31 0352 = 3.363).  An echo was also completed and was unremarkable.  He was admitted to the hospital with suspected myocarditis.  Further cardiac workup was done and patient had a cardiac cath on 8/31 which showed normal coronary angiography.
Feels like "living in hell"; Shingles on stomach and Pelvic area/ Diagnosed with shingles; Red blistery rash on stomach and pelvic area; Stomach pain; Pelvic pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PELVIC PAIN (Pelvic pain), HERPES ZOSTER (Shingles on stomach and Pelvic area/ Diagnosed with shingles), RASH VESICULAR (Red blistery rash on stomach and pelvic area) and FEELING ABNORMAL (Feels like "living in hell") in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Statins), Food allergy (strawberry's), Drug allergy (Aspirin), Drug allergy (Erythromycin), Drug allergy (Codeine), Food allergy (crabs), Food allergy (lobster) and Allergy (latex). Concomitant products included QUINAPRIL HYDROCHLORIDE (ACCUPRIL), AMLODIPINE, CLONAZEPAM, LORATADINE (CLARITIN [LORATADINE]), PREDNISONE, FLUTICASONE PROPIONATE, TRAMADOL, FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and DEXTRAN (TEARS NATURAL) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and PELVIC PAIN (Pelvic pain). On 02-Apr-2021, the patient experienced HERPES ZOSTER (Shingles on stomach and Pelvic area/ Diagnosed with shingles) and RASH VESICULAR (Red blistery rash on stomach and pelvic area). On 05-Apr-2021, the patient experienced FEELING ABNORMAL (Feels like "living in hell"). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PELVIC PAIN (Pelvic pain), HERPES ZOSTER (Shingles on stomach and Pelvic area/ Diagnosed with shingles), RASH VESICULAR (Red blistery rash on stomach and pelvic area) and FEELING ABNORMAL (Feels like "living in hell") was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 16Mar2021 patient Received 1st Moderna Vaccination. Left arm(dominant) 01Apr2021 Developed stomach pain, pelvic pain 02Apr2021 Developed Shingles in areas of previous pain. Shingles are a red blistery rash. Went to MD. Diagnosed with Shingles. Treatment Valacyclovir. 03-05Apr2021 Described as feeling like living "in hell." 06Apr2021 Symptoms are resolving. Allergy's: Too long to list. Many medications: Statins, Aspirin, Erythromycin, Codeine, strawberry's, crabs, lobster, latex   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27-MAY-2021 and does not contain any new information. On 19-Jul-2021: Significant FU-AE details updated
Injection given into top of shoulder not into deltoid.   Continuing to have tenderness at injection site, with muscle spasm in surrounding area developing over past two weeks.
Around (1 year) regression, very sick, behavior change, feeding problems. (Treatment, therapies) but still was functional. Was getting more sick and more diagnose were given during vaccination time, fever, rash, vomiting, toxic diaper, no sleeping, skills lost, dysphagia. This form was completing from the Mother of 5 year old patient, as parent's we been doing everything we could to help our injure child she's been always having problems with vaccines sadly we did not have a lot of information at the time of the events, we did ask a lot of questions we never got the right answer, or what we know today what is (Informed consent) it is wrong to see your child getting more sick and disable and having told that is normal and you have to watch that ONE time healthy baby taking them to the doctor, doing the right thing and during vaccination time all of this that is in record appears => Autism, label to behavior change, hurting herself, not able to feel pain, not sleeping, lost skills and speech, lost eye contact, fever, rash, muscle twitching, sensory problems, ear infections, respiratory infection, sore throat, pink eye, toxic diaper, vomiting, gagging and choking in food into she's no longer able to process solids. 2015 Dysphagia diagnosis I was told it was feeding difficulty diagnosis a lot of lies and misinformation sad to see the CATH GONE I'm glad to have a veteran at home who still and has defended me from the bully doctor when we decide to do research and become aware of the law and exemptions has been denied. I have a 35 yr experience Medical Advocate nurse helping us also with (EE) recent diagnosis. This is me doing once again the doctor's job, not perfect but doing the right thing now I can look at her knowing she's gonna be her.
Patient reported experiencing sensation of rapid heart rate and dizziness.  Patient monitored and elevated heart rate noted.  Consistent elevated heart rate noted patient transported to local emergency room for further evaluation and care.
No adverse effect reported; patient were each administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to two unspecified patients of unknown ages and unknown genders. Information of concurrent condition, medical history and concomitant therapy were not provided.    On 24-OCT-2018, patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017635 with expiration date 20-JUN-2020 (strength, dose and route were not reported) for prophylaxis and sterile diluent (STERILE DILUENT). The varicella virus vaccine live (oka/merck)(VARIVAX) vaccines experienced temperature excursion and were stored at 6 to 14 Fahrenheit degrees (9.1 Fahrenheit degrees ) for 50 minutes (Product storage error). There was no previous temperature excursion. No adverse events were reported in any patients. A data logger was involved. The outcome of the event was not reported.  Follow-up information was received from the reporting nurse on 05-JUN-2019.  The nurse reported the patient's demographics and were updated in the case. It was also reported that on 24-OCT-2018, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, route of administration, anatomical site of injection, lot # and expiration date were not reported). There was no information regarding storage of this vaccine.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002233: US-009507513-1906USA002234:
c/o difficulty shallowing, no resp. distress noted. O2 Saturation=98%, Pulse regular and steady. Able to drink water and masticate a chewable Benadryl 25 mg.  Mom opted to leave and monitor pt. after 20 minutes in observation.
One week after the shot I began coughing up black phlegm. This is a daily event and has persisted since. At first I did not have chest pains and now I do. My breathing continues to be labored and now I feel like I am beginning to have heart problems. Strenuous activities make my heart hurt.
No adverse effects reported; improperly stored vaccine was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in July 2019 (reported as between 03-JUL-2019 and 29-JUL-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002393, expiration date 31-JAN-2021 and lot # R035225, expiration date 04-DEC-2020 (dose and route of administration were not reported) for prophylaxis and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date reported as 31-JUL-2020, but upon internal validation established as 30-JUL-2020 and lot # S008577, expiration date reported as 30-SEP-2020, but upon internal validation established as 16-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of total time in range -14 degrees Celsius to -10 degrees Celsius (-12.8 degrees Celsius) for 12 hours 3 minutes. There were no previous excursions reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA003249: US-009507513-1908USA003250: US-009507513-1908USA003251: US-009507513-1908USA003252: US-009507513-1908USA003253: US-009507513-1908USA003254: US-009507513-1908USA003255: US-009507513-1908USA003256: US-009507513-1908USA003257: US-009507513-1908USA003258: US-009507513-1908USA003259: US-009507513-1908USA003260: US-009507513-1908USA003261: US-009507513-1908USA003262: US-009507513-1908USA003263: US-009507513-1908USA003264: US-009507513-1908USA003265: US-009507513-1908USA003266: US-009507513-1908USA003267: US-009507513-1908USA003268: US-009507513-1908USA003269:
Received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   On 2nd May 2022, the patient received Havrix. On 2nd May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received an expired dose of Havrix.  The consent to follow up was given via mail. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
The patient had prostate cancer and wanted to know how long he should wait before going back to his oncologist to receive chemotherapy after being given the Yellow Fever vaccine with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had prostate cancer and wanted to know how long he should wait before going back to his oncologist to receive chemotherapy after being given the Yellow fever vaccine - [YF-Vax] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Prostate cancer.  On an unknown date patient in the past received YF-Vax (dose, strength, formulation, strength, route, site and batch lot details: unknown) for Immunization. However, the nurse discovered later on that the patient had not been honest about his health history. The patient had prostate cancer and wanted to know how long he should wait before going back to his oncologist to receive chemotherapy after being given the Yellow Fever vaccine with no reported adverse events (contraindicated product administered) (unknown latency).  The patient and his wife were going on a cruise and came to their clinic to receive the vaccine. The caller thinks that the doctors refused to administer it to him. The patient came up, got the vaccine, and then went right back for the cruise. The caller was not positive as to whether this patient was still receiving cancer treatment at the time the vaccine was given, or if the patient had treatment in the past. This is situation is reported as a medication error due to the administration of YF Vax to a patient that it may have been contraindicated to administer.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
1102: Client requesting BV Booster 1122: Client inadvertently received BV booster scheduled to early 1137: Client waited in lobby for 15 min for adverse reactions 1157: Client notified of early immunization
Approx 4 hrs p/receiving vax pt devel fever & h/a; also had chills 4 hrs later began to vomit & vomited several times thru night; Pt given APAP but fever persisted-t104.9; Seen by MD next AM dx ear infect;
Immediate dizziness, rapid heartbeat, hot flash, nausea, headache. Felt like I may faint.  Continued to be dizzy, nauseous and headache throughout the night. Pain at injection site for 5 days.  Aches & pains for 5 days. Almost a week out and still not totally recovered.
Found out on 08/13/2021 that patient had received the Pfizer COVID-19 vaccine in April or May. No reported adverse outcomes.
Info has been received from a registered nurse concerning a male pt who on 12/11/2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #637345/1449K), administered in the left arm. Subsequently, the pt developed swelling of left arm "distal to the injection site downward", pain, edema, and warmth. The reporter expressed concern with the lot. Unspecified medical attention was sought. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that 2 additional pts experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (lot #640981/1050L) (WAES #0210USA02350 and 0210USA02517). Additional info has been requested.
Pain in right shoulder, arm, neck. Tingling in right arm and hand. Felt pain in neck and arm when vaccine was injected. Will see a Dr if numbness does not resolve in 7-10 days.
Outdated VAccine given. Expiration date 08/31/2021. Vaccine given on 09/02/2021
This spontaneous report as received from a pharmacy student and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified pediatric patients received adult doses of VAQTA 25/0.5, (N016805, 04-SEP-2018) and multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (N014945, 31-AUG-2018), (Captured in MARRS 1708USA003180). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error (Product name confusion). No adverse effects were reported (No adverse event). All fields apply to all unspecified patients and all doses of VAQTA. No further information was provided. No product quality compliant (PQC) was present. Outcome of events was unknown. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003180:
patient presented for virtual visit with complaints of increased redness, swelling and severe pain of left upper arm. Concerns for cellulitis s/p vaccine administration
ER MD called apparently pt stopped breathing 1/2min, parents got nervous & brought the pt to ER exam was nl, as was pulse ox-pt sent home w/instructions for observation;
Patient felt weak after receiving the immunizations with joint pain. Had trouble getting up the stairs and possibly fell, requiring to go to the hospital
Received vaccine to Left arm at 12pm 1/1/21. At around 8 pm, Left arm developed burning pain from hand up to left neck. That night temp 102.0.  Over night developed severe skin pain, severe bone and joint pain, headache, chills, dizziness, nausea and weakness. Around 24hrs after vaccine # 2 given, 2/2/21 temp ranges from 102.0-104.4 and symptoms above continues.  Symptoms continued overnight into 2/3/21. around 10:30 am awoke with a large amount of sweating. temp 102.0 and body symptoms decreased.  Fever ranging from 99.9-101.0 continued until Thursday, 3/4/21.
After a couple of minutes of receiving my vaccine I noticed my heart rate increased, I started to feel flushed.  I alerted nurse, my pulse was 108 to 110.  They didnt take my blood pressure.  My face, chest and ears were very flushed.   After about 10 minutes, they encouraged me to take a benadryl and pepcid I had with me.  That started to help after a few minutes.  I did have mild wheezing upon expiration but I wheeze frequently so I wasn't sure if it was related.  I was not in any respiratory distress. Went home after 45 minutes.  After 4 hours, the symptoms began to return, flushing and increased heart rate (110 to 115 by my pulse oximeter) and had more wheezing.  Repeated the benadryl and called on call physician.   He advised taking 2 benadryl til symptoms subsided and ho to ER if worse.  Last dose of benadryl was around 10 pm last night, have not needed to repeat it.  Hands are a bit swollen today but not bad.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Client was at the clinic on 7/26/16 w/mother. Mother mentioned he has chickenpox due to the PROQUAD vaccine. I mentioned she would need to take him to his pediatrician to confirm. Client was w/a few blisters on side of face/arms (mom reported no fever for previous days and no itchiness).