chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered the un-reconstituted Menveo suspension; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via sales rep 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, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered the un-reconstituted Menveo suspension) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 The provider reported that a patient was administered the un-reconstituted Menveo suspension, due to human error, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
she has been exposed to her colleague that was tested positive; experienced the flu after the 1st dose; This is a spontaneous report from contactable consumer (patient reported) and received from Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 MRNA Vaccine, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the flu after the 1st dose, and she has been exposed to her colleague that was tested positive. Outcome of other events was unknown.  No further follow up attempts are possible. No further information is expected.
pt recv vax 23FEB96 & 29FEB96 pt exp vesicular blisters, fever 100-101, 15-20 flat, red bumps; varicella; tx acyclovir;
C/O arm stiff, unable to move, very painful, swelling, hot, red.  2nd day wife stated he had had a very uncomfortable night.  Chills, sweating, nausea, achy.  She stated his arm was swollen about that again of the other arm. However, he was able to move it and had left for coffee.
An hour after vaccine, I experienced heart palpitations. Lost taste at 8 pm. 24 hours after vaccinated, fever 99.8 degrees, chills, muscle aches, fatigue, and dry cough.
Received Moderna vaccine from Medical Group on 03/26/2021-2nd dose. Reports that about 5:30am on 03/27/2021 she began to have chills, weakness. States she eventually passed out, falling on the floor in which she does not remember, breaking her ankle. Ankle repair required surgical interventions. She is now back home wearing a cast to affected foot.
Complained of throat swelling and discomfort. Benadryl 50 mg given IM. Placed on 2L of O2. Symptoms improved with Benadryl. Patient transported via ambulance to Medical Center.
Booster shot - within 15 minutes, bad headache on forehead reported. Pain that radiated to inner left ear. Reported throat also feeling weird. Gave water, didn't help. Ear pain reported following morning.
The patient's mother called the answering service in the afternoon of 1-13-08 to report vomiting and extreme irritability. She was directed to take child to medical center and subsequently transferred to another hospital.    2/21/08 Reviewed hospital medical records which reveal patient experienced vomiting, irritability, crying w/pain & constipation x 1 day.  Seen at outlying ER & dx w/IS in RLQ. Transferred to higher level of care.  FINAL DX: ileocolic intussusception, enema reduced.  2/26/08 Reviewed ER medical records which reveal patient experienced vomiting, constipation, crying w/abdominal pain, cold, clammy, starring, unresponsive.  2nd episode of starring & unresponsiveness witnessed by EMS.  When IS dx'd, transferred to higher level of care for surgical consult. FINAL ER Dx:  Intussusception.
At 0925, pt received second Pfizer vaccine. 5 mins later, she reported to the RN that she had a mild headache, was feeling dizzy and "uneasy", reports that these symptoms started after the injection, although she was anxious prior. Denies sob or chest pain. Assisted pt to a gurney. BP 152/99, p=104, O2 sat 100% on RA. Pt reported having a hx of anxiety and paroxysmal supraventricular tachycardia. Vitals remained stable x 2, send pt to ED after 20 mins for further eval  due to pt reporting that headache worsening, nausea/dry heaves and a new numbness and tingling to L side of face.
UNABLE TO TAKE SECOND DOSE ON TIME; This spontaneous case (PVX2019-1357) was received from physician on 28-May-2019. It describes a female consumer who was "unable to take second dose on time", while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 25-May-2019 and then, forgot to take the second dose of Vivotif, which was due on 27-May-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "unable to take second dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "unable to take second dose on time" was considered as not applicable.
Information has been received from an office staff member concerning an adult male who on 10-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651400/0618F). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced edema, redness and warmth at the injection site. Additional information has been requested.
Patient recieved Tdap in LD IM and Flu vaccine in RD IM, uneventful. Four hours after the injections felt general weakness, loss of strength, no energy and felt tired. These symptoms lasted about 48hours. Symptoms improved 04/27/2011.
Atopic dermatitis flare; looser stool after receiving moderna covid vaccine; sore arm after receiving moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ATOPIC (Atopic dermatitis flare), DIARRHOEA (looser stool after receiving moderna covid vaccine) and PAIN IN EXTREMITY (sore arm after receiving moderna covid vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis. Concomitant products included FLUTICASONE PROPIONATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   In February 2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis flare), DIARRHOEA (looser stool after receiving moderna covid vaccine) and PAIN IN EXTREMITY (sore arm after receiving moderna covid vaccine). At the time of the report, DERMATITIS ATOPIC (Atopic dermatitis flare), DIARRHOEA (looser stool after receiving moderna covid vaccine) and PAIN IN EXTREMITY (sore arm after receiving moderna covid vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported. It was reported patient having missed a dupixent dose in the past and had a minor flare up of atomic dermatitis. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Received first dose of SHINGRIX at a clinic on Sunday 3/18/18. On Monday 3/20/18 she developed right shoulder pain and a vesicular rash in right axilla and right arm. Pt came into clinic today 3/23/18 for these symptoms. Pt was diagnosed with herpes zoster without complications. Pt received prescription for Valtrex and Tylenol #3 today.
myocarditis; Initial information received on 16-Dec-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp received from social media page.  This case involves a 5 years old female patient who experienced myocarditis after receiving vaccine influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (units unspecified) of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a serious event of myocarditis (unknown latency) following the administration of influenza vaccine.   It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event.  No autopsy was done. The cause of death was reported as Myocarditis.  This event was assessed as medically significant and was leading to death.; Sender's Comments: Sanofi company comment for information received on 21-Dec-2022: This case involves a 5 years old female patient who experienced myocarditis after receiving vaccine influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. The time to onset is not reported with the role of the vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations , autopsy results excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: myocarditis
The next day at injection site of KINRIX and PREVNAR - had pain and reddness and swelling (about the size of a silver dollar).
Malaise; fever; chills; upset stomach; swollen lymph nodes; rash on scalp; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number BB24A, expiry date 26th September 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th June 2019, 2 days after receiving Shingrix, the patient experienced malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash. On an unknown date, the outcome of the malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash were unknown.   It was unknown if the reporter considered the malaise, fever, chills, upset stomach, enlargement of lymph nodes and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The paient experienced malaise, fever, chills, upset stomach, three swollen lymph nodes, and rash on top of scalp.
C/o of upset stomach, arms hurt, chills, cough, fever 100.8.
Pain to right arm. Itching and redness to right deltoid starting 12/30/22. Area is still  reddened, but less that 12/30/22
Information has been received from a pharmacist concerning an approximately 66 year old female who on 14-OCT-2009 was vaccinated in the right deltoid with a dose of PNEUMOVAX 23 (injection dose unknown). The patient's concomitant medications include a flu shot (manufacturer unknown) on 14-OCT-2009 in her left deltoid. The patient's relevant medical history and past drug history were unknown. On 15-OCT-2009 the patient reported to the pharmacist that she had swelling, radiating pain, redness, warmth and black and blue around the injection site on the right deltoid. She stated that her left deltoid was fine. It was unknown if there was any relevant laboratory data. As of 15-OCT-2009 the patient continued to had swelling, radiating pain, redness, warmth and black and blue around the injection site. No further information is available.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 07-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U029319, expiration date: 19-MAR-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Extreme hives all over my body; They itch and burn; skin is hot at all times; Joint swelling; Pain in my ankles and wrists; I can't sleep because of them; Some days I can't work because of them; Excruciating pain and discomfort every day, all day; Excruciating pain and discomfort every day, all day; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:15 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none. Concomitant medication included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient received vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unknown route of administration, administered in Arm Left on 10Mar2021 02:15 PM as dose 1, single for COVID-19 immunisation. On 02Apr2021 at 07:00, Patient woke up with extreme hives all over my body. I have never had them before that day, and now I have had them every single day for 3 1/2 months. They itch and burn, my skin is hot at all times, patient had joint swelling and pain in my ankles and wrists which I also never had prior to 02Apr2021. I can't sleep because of them, some days I can't work because of them. Nothing the doctors have given me has worked and I am in excruciating pain and discomfort every day, all day. Treatment was received for the events as allergy medications, antihistamines, steroids. Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Persistent rash left face, ear, neck that started one day after shot in left shoulder, and is lasting over 3 weeks now with new areas showing up. Itchy, red, raised spots. No other likely explanation.
left eye was painfully itching put some Benadryl gel on her eye then eye became swollen, eye stopped itching but the swallen went from the the inside to the outer corner
Have a low grade fever of 99.5.  Will check again in the evening of 12/4/2021.
Patient called and said she received the Fluzone HD yesterday and woke up this morning being very dizzy no other side effects. She also claimed she had a concussion in August 2016 and she was given meclizine for dizziness. Apologized to the patient about what happened and advised the patient to go see a doctor which she made an appoitment for tomorrow. Also, advised patient to go to urgent care or ER if she needs. Also advised patient to eat and hydrate herself and she can also get meclizine OTC if she needs. The patient did not want us to check up on her and she said if she needs her son can get her some meclizine or go to the urgent care or ER.
swelling; rash; redness; tenderness; pain; This case was reported by a physician via call center representative and described the occurrence of swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th May 2021, less than a day after receiving Shingrix, the patient experienced swelling, rash, erythema, tenderness and pain. On an unknown date, the outcome of the swelling, rash, erythema, tenderness and pain were recovered/resolved.   It was unknown if the reporter considered the swelling, rash, erythema, tenderness and pain to be related to Shingrix.  Additional details were provided as follows: The patient received first Shingrix shot and experienced swelling, rash, redness, tenderness, pain of which have now resolved.   The reporter consent to follow up.
pt recvd vax; w/in hrs of vax, exp severe swelling of arm & redness, warmth, pain & soreness at inject site;
Pt recv vax on 2/9/98; on 2/10/98 pt exp erythema & hardness at vax site
01/10/2006 Mom called stating child has 10 chicken pox lesions on trunk, arms, and face.  No fever, does not appear to feel bad.  Prescribed Benadryl and call Mom later.  Had Varivax 05/30/2000.  Sibling had chickenpox 12/28/2005.
Pzfizer-BioNTech COVID-19 Vaccine EUA on 1/21/2021 (4 days after my first vaccine) at 10pm I experienced severe abdominal pains for 4 hours.  This was then followed 30 minutes later by severe vomiting for 4 hours. At that time I was able to take a Zofran 8mg tablet to suppress the nausea.  (A previous Zofran dose I had taken was immediately vomited up) Vomiting stopped. For 3 days after this I got mild stomach pains after I ate more than a few bites. I was fine after that.
This is in follow-up to report(s) previously submitted on 7/14/2007. Information has been received from a nurse practitioner concerning a 15 year old female with no pertinent medical history or drug reactions/allergies who on 07-APR-2007 approximately was vaccinated with a first dose of Gardasil (lot # 656566/1511F) in the left arm IM. There was no concomitant therapy. Almost immediately after receiving Gardasil, the patient fainted. Medical attention was sought. The nurse practitioner had made the patient sit in the waiting room until she felt better. Patient seemed to have recovered momentarily after sitting in the waiting room. Further information was not provided. Follow-up information was received. The age, date of vaccination and lot number updated. It was reported that the patient fainted during immunization. The patient was assisted to the table. A blood pressure measurement was performed and the results were 103/70. The patient was given juice and rest. On 07-APR-2007 the patient recovered and discharged home. Additional information is not expected.
Rash onset following immunizations at 8/4/14 appointment - was 8/6/14. Lesions on abdomen, legs, arms, and face. Patient had low-grade fever, but resolved. Will use calamine lotion.
patient received Fluzone Quadrivalent vaccine subcutaneously instead of intramuscular route, no AE; Initial information regarding an unsolicited valid non-serious case received from pharmacist via The Agency (Reference number- 00325597) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 57-years-old female patient who was received 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot number and expiry date not reported) via subcutaneous route at back arm for prophylactic vaccination (incorrect route of product administration).  Medical history, past medical treatment, vaccination and family history were not provided.   Patient did not received any other vaccine.  This was a case of an actual medication error case due to incorrect route of product administration (latency same day).  It was reported that pharmacist who was also a patient states that she received either a Fluzone Quadrivalent or a Flublok vaccine (she was not sure which). The patient received her dose in the back of the arm. Because of this, she believes it was a subcutaneous injection. She asks if the vaccine was just as effective if it was given subcutaneously.  The patient had not experienced any adverse event.  Reporter relationship: Self, Product used: Used, First time product used: Yes, Still using product: No and Was Device Used: Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information on the lot number for this case.
No additional AE/PQC was reported; she and her husband received a single dose of PENUMOVAX 23 approximately 6 years ago and were told they needed to receive a second dose, 5 years after receiving the first dose; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.      In approximately August 2015 (reported as 6 years ago), the patient was vaccinated with a single dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and the expiration date) for prophylaxis.         She would need to receive a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 5 years after receiving the first dose (approximately in 2020). Caller confirmed she and her husband have not received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) yet (inappropriate schedule of product administration).   This is one of two cases reporter by the same consumer. Marrs# 2109USA004716.; Sender's Comments:  US-009507513-2109USA004716:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2016 (specific date not reported), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date during 2016, the patient was treated at by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
moderate injection site pain, fatigue, headache, muscle pain, joint pain, chills, mild nausea, mild fever. All symptoms started about 18 hrs. after injection and resolved by about 30 hrs. after injection.