chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information ahs been received from a consumer concerning her son who on an unspecified date was vaccinated with the first 0.5 ml dose of MMR II and "a varicella vaccine (name/manufacturer unknown)" concomitantly. Subsequently the patient experienced a fever of 105 degrees. It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
This spontaneous report as received from a pharmacist refers to a 77 year old male patient. Patient's medical history included unspecified autoimmune disease. On 16-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection (lot # K010522, expiry: 25-FEB-2016), intramuscular in the right deltoid. On an unknown date in October 2014, the patient experienced red swollen band at injection site and it was further described as fluid filled sac like a saddle bag and area was painful. Sought medical attention. Patient was referred to urgent care or physician for further care beyond applying ice to site. No product quality complaint was involved. The outcome of red swollen band at injection site, area was painful and fluid filled sac like a saddle bag was reported as not recovered. The relatedness of the events with the therapy PNEUMOVAX 23 was not reported. Additional information has been requested.
Shingles rash started to become present on left leg approx 3/5/21. Using hydrocortisone and Valtrex was prescribed.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash went from just above the injection site down to the elbow and was hot to the touch. A goose egg also developed at the bend of the elbow. Benadryl helped to resolve symptoms
Numbness on the left foot and the left side of forehead; Some arm pain; This is a spontaneous case initially received from a pharmacist on 07-Jan-2019, concerning a 26-year-old adult female patient.  The patient did not have any relevant medical history. The concomitant medications of the patient included escitalopram, bupropion XL, Kariva (desogestrel, ethinylestradiol) and hydroxyzine for unknown indications.  On 07-Jan-2019, the patient was administered Flucelvax QIVc (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252685 and expiration date: not reported) for active immunization against influenza.  On the same day, after the administration of the vaccine, the patient experienced some arm pain straight away. 20-30 minutes after the administration, patient experienced numbness on the left foot and the left side of her forehead. No treatment was given till the time of reporting. It was reported that, the patient was not hospitalized.  The outcome of the events was not recovered (reported as ongoing).  The reporter assessed this case as non-serious.  Follow-up report received from reporter on 18-Feb-2019: The secondary reporter details were added in the general tab and Med info reference number (SEQ19-00784) was added in the additional information tab. The initial reporter will no longer be available for contact. The secondary reporter refused to provide any further information. Hence, this case is considered as lost to follow-up. No changes were made in the narrative.; Reporter's Comments: A 26-year-old female patient experienced pain in arm straight away after the administration and numbness 20-30 minutes after the administration of Flucelvax QIVc. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the suspect vaccine and the events.
Deep vein thrombosis in left leg. Treatment: Xarelto 20mg; been taking since 7/01/2021. Symptoms included swelling in left leg and extreme pain. Also, inability to walk on the leg before diagnosis. Diagnosis of blood clot occurred on 7/01/2021. Symptoms displayed and continued to worsen one week prior to emergency room visit on 7/01/2021.
3/28/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness, and tingling down left arm.   Assessment : Time of assessment . Alert and oriented.complains of dizziness, and tingling down left arm.   Actions taken: Water given and drinking, VS at 0840 BP- 149/82, P- 82, O2- 100%         Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 0841. Administered by RN.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/28/2021  8:25 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8733
No additional AE; HCP calling to report accidental vaccination of RECOMBIVAX in combination with VAXELIS for 6 month old male patient.; This spontaneous report has been received from a medical assistant concerning a 6-month-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 27-JUL-2023, the patient was accidentally vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) single dose (dose, anatomical location, route of administration, lot#, expiration date were not reported) for prophylaxis in combination with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) single dose (dose, anatomical location, route of administration, lot#, expiration date were not reported) (accidental overdose). No additional adverse events were reported.
(L) arm, wheal approximately 10 cm in diameter; red and warm to touch. Treatment used at home - cold compress.
Patient reported about 10 minutes after getting vaccine she was having numbness on ear and decreased vision. Patient was with family and was advised to seek care from her physician or ER , but she did not say if she was going to seek care. Patient was asked to follow back up with us with outcome.
Pt states her (L) arm began to get sore Fri pm 1/10/14 after receiving her flu shot and since then has moved up to her shoulder and chest. Additional to this soreness, there seems to be a "knot" on the anterior of (L) shoulder. No fever or other sx's. Pt recommended to seek MD care ASAP. Pt went to MD on 1/15. MD said it is just swollen lymph nodes. MD said to take ADVIL and put heat on it. MD said no follow up - I advised her to follow up if remains callus if she needs to go back or has any quest.
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   On an unknown date, the patient received Menveo and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination were not reported. The health care professional  reported that patient who were due for MENVEO and were going to receive Covid Pfizer vaccine. On the same day received the Menveo lyophilized powder portion after being reconstituted with Pfizer Covid diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter
This case was reported in a literature article and described the occurrence of renal infarction in a 50-year-old male subject who was vaccinated with DTPa ((with small D + P), manufacturer unspecified). Concurrent medical conditions included Hodgkin's lymphoma, hyperlipidemia, hypothyroidism; migraine, prostatic hypertrophy, pulmonary fibrosis, pulmonary sarcoidosis and splenectomy. Historic vaccination included Hib; manufacturer unspecified; unknown given on an unspecified date; meningitis vaccine, strain not specified; manufacturer unspecified; unknown given on an unspecified date, SYNFLORIX; manufacturer unspecified, unknown given on an unspecified date. Historic medications included Doxorubicin, Bleomycin, Vinblastine and Dacarbazine. Concurrent medications included Calcium citrate, Enteric-coated aspirin, Simvastatin, Levothyroxine and Ergocalciferol. 21 months before vaccination, a stress echocardiogram showed normal left ventricular function at rest, mild aortic-root dilatation and trivial regurgitation of the other valves. The stress echocardiogram was negative for ischemia. The subject maintained a high-fiber low-fat diet, exercised, drank alcohol in moderation and didn't smoke. His mother had had breast cancer and she and a maternal aunt had had coronary artery disease. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided). During the following 4 nights, the subject experienced mild nausea and fever (38.1 deg.C) without chills. 4 days after vaccination with DTPa (with small D + P), the subject experienced flank pain which was diagnosed as a thromboembolic renal infarction due to endocarditis. The subject was hospitalised. During hospitalisation, the subject had a methicillin-resistant Staphylococcus aureus. The subject was treated with Penicillin, ceftriaxone, vancomycin, Gentamicin, Ondansetron, Levothyroxine and simvastatin. At the time of reporting, the outcome of the events was unspecified. The authors considered that fever and nausea were almost certainly related to vaccination with DTPa (with small D + P).
Felt a warm stinging sensation as soon as it was given. My right arm was very sore after the first hour and by the night it was sore to the touch. The next day my arm had a large hard knot that was hot to the touch and very sore. I had difficulty moving my arm.  It stayed sore for several days.  I developed body aches and malaise with diarrhea  on day two. I took Tylenol for pain and chose to rest. It was back to normal after a week. This is the first time I have ever had a reaction to a flu shot. I had recovered from Covid about 12 weeks prior.
a rash forming on her chest; mild chest tightness; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female unknown pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3246, Expiration date: not reported), via intramuscular in arm left on 28Jan2021 at 14:15 (at the age of 36-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included Chiari I malformation, Ehlers-Danlos syndrome, Mast cell activation syndrome, other food allergy. Past drug event included codeine (CODEINE) and experienced known allergies: codeine (unknown reaction). The patient's concomitant medications in two weeks included alprazolam (XANAX), 3x/day, oral, gabapentin (cap/tab), oral, tizanidine, oral, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL0142, Expiration date: not reported), via intramuscular in arm left on 07Jan2021 at 14:45 (at the age of 36-year-old) as a dose 1, single for COVID-19 immunization. Other vaccine in four weeks was reported as unknown. Covid prior vaccination and covid tested post vaccination was reported as unknown. It was reported that, the patient received her vaccine, 20 minutes later reported a rash forming on her chest and mild chest tightness on 28Jan2021 at 14:15. Stated that, she has a history of Mast Cell Activation Syndrome and had pre-medicated with Zyrtec. At 14:20, the nurse administered 25mg PO Benadryl, at 14:50, she felt her symptoms decreased and went home with her spouse. Treatment medication included 25mg PO Benadryl. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient developed rigors, chills, body aches, dizziness, and headache within 30 minutes of receiving 2nd dose of Moderna vaccine. Patient was evaluated in the emergency department after development of symptoms. Temperature 97.6, heart rate 75, respiratory rate 22, blood pressure 132/66, pulse ox 99% on room air. Emergency department physician clinical impression: Anxiety reaction. Patient improved with ativan 1.5 mg.  Was discharged home.
pt recvd 1st dose of HIB/DTP/OPV 1230PM mom gave APAP & very fussy when got home, wouldn't take bottle; finally fell asleep; appeared very pale @ 630, opened eyes but groggy; felt cool, clammy, temp 99 ax;
Swollen/tingling upper Lip. Administered Benadryl + epi, and medrol.  Swelling of upper lip decreased after epinephrine. He resolved of sx with an hour.
patient was given higher than recommended dose,  Patient was vaccinated with 0.3ml (30mcg) instead of 0.2ml (10mcg) . Patient had not adverse effects, denied any problems
Information has been received from a health professional concerning a 9 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 30-MAR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Wheezing and dyspnea 10-15 minutes after receiving vaccine dose.  Administered EpiPen and transported via EMS ED.  Treatment with IV diphenhydramine, famotidine and methylprednisolone.  Released after 4 hr of observation with significant improvement in symptoms.
Pt presented to pharmacy 6 days post-vaccine administration C/O soreness of upper arm/shoulder w/swelling.
Expired Product Used; This case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a 17-month-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired drug used. On an unknown date, the outcome of the expired drug used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: The reporter was office manager. The reporter reported that, they inadvertently administered an expired Infanrix to a patient. The reporter called to inquire to know about how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The patient was inadvertently administered with an expired dose of Infanrix, which led to expired vaccine used.
Within a day, the pain developed.  It is extremely difficult to sleep on my left side as the pain is very severe and my arm becomes immobile and I need to use my right hand to move my left arm into a different position.
SORE ARM; RASH ON ARM OF THE INJECTION SITE; RASH ON CHEST; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM), VACCINATION SITE RASH (RASH ON ARM OF THE INJECTION SITE) and RASH (RASH ON CHEST) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (RASH ON ARM OF THE INJECTION SITE) and RASH (RASH ON CHEST). On an unknown date, the patient experienced PAIN IN EXTREMITY (SORE ARM). At the time of the report, PAIN IN EXTREMITY (SORE ARM), VACCINATION SITE RASH (RASH ON ARM OF THE INJECTION SITE) and RASH (RASH ON CHEST) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. No treatment information was reported.
Shingles appeared less than one week after receiving second dose of COVID series. Appeared starting on back and spread to left flank, same side of body as injection site.
excessive itching on my left arm by the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: Verbatim: Graves' disease; "hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism; VENLAFAXINE.  The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "excessive itching on my left arm by the injection site". Therapeutic measures were not taken as a result of vaccination site pruritus.  Additional information: Patient takes generic of Synthroid, the levothyroxine for hyperthyroidism. No prior vaccination (within 4 weeks). The patient would like to know if somebody going to contact her because she likes to know what to do about the itching or does, she needs to get any medical doctor. Because its so bad that she has to take a sharp object in order to feel any relief. She is embarrassed to say that she take the steak knife out of the drawer in the kitchen because it has sharp tip on it and she was using to scratch it and she has scratched her arm so bad that she left with bleeding and left mark on it and it has not gone away. And it flare up may be once or twice a day obviously not everyday, but every other day may be once or twice a day. And so, again she has to take something like fork and she has to use that because it's sharp. She need some help with what to do to get this look at.   Follow-up attempts have been completed and information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. There were no concomitant medications reported. The pharmacist reported that, on an unknown date in 2013 the patient was vaccinated with one dose of GARDASIL for prophylaxis (route, indication, lot/batch# were not reported). On 31-JUL-2017, the patient was administered one dose of GARDASIL 9 (route, indication, lot/batch# were not reported) for prophyalxis (interchange of vaccine products and inappropriate schedule of drug administration). No adverse events reported. There was no product quality complaint involved.
pt to ED with cough and increasing SOB; O2 saturation 60% on NRB; intubated in ED; found to be positive for COVID; pt developed ileus; fever; bilateral DVTs; pt's condition worsening; requiring multiple vasopressors; multisystem organ failure; transitioned to comfort care; extubated and pt expired in the hospital
Rash at site. Rash progressed all over body over the course of the next few weeks. Treated twice at the ER for allergic reaction. Nothing is helping.
This case was reported by a consumer and described the occurrence of influenza in a male subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR multi dose powder inhaler for influenza cough. On an unspecified date in September or October 2009 the subject received unspecified dose of Flu vaccine ("maybe" 1 cc, unknown). On an unspecified date in February 2010, approximately 5 to 6 months after vaccination with Flu vaccine, the subject experienced influenza and vaccination failure. On 10 March 2010 the patient started ADVAIR (inhaled at 1 puff(s) twice per day. At an unknown time after starting ADVAIR, the patient experienced lack of effect. Treatment with ADVAIR was continued. This case was assessed as medically serious  by GSK. At the time of reporting the outcome of the influenza and lack of effect was unspecified.
Itching all over the body. lasted all night.  Took some benadryl the next morning and the itching gradually went away.
sore arm; tiredness; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (sore arm) and FATIGUE (tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, OLMESARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    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 MYALGIA (sore arm) and FATIGUE (tiredness). On 04-Apr-2021, FATIGUE (tiredness) had resolved. On 05-Apr-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medications include: Diuretics 25mg and other BP medications   This case was linked to MOD-2021-163836 (Patient Link).
Information has been received from a licensed practical nurse concerning a 62 year old female with osteopenia and allergies to codeine, CELEBREX and sulfa antibiotics who on 19-APR-2007 was vaccinated with a dose of Zostavax (lot # 656609/0015U). Concomitant therapy included aspirin and calcium supplements. On 21-APR-2007 the patient developed generalized itching and redness and swelling at the injection site. Unspecified medical attention was sought. There were also lab diagnostic performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Additional information is not expected.
After feeding my kittens, upon going back to bed my heart started racing and skipping beats for a long time.  Felt like for a whole minute, but probably less.
I have some agitation in a nerve or muscle in my left armpit. The pain is very localized and not near the injection site. It feels like painful lump in my left armpit.