chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dr.  placed order for Pentacel for the patient. Only one vial of the Pentacel vaccine obtained by LPN. Vaccine second checked by RN. LPN administered vaccine. Patient only given the liquid form of the pentacel and not the powder. RN called and notified father that a partial dose was given. Patients father was agreeable and scheduled for have vaccine on Friday (06/30/2023).
Error in administration of the patient's father reports that the date of birth is 2008 when the real date is 2011 a second dose of vaccine was administered to patient over 12 years of age 10 years and 9 months.
Urticaria started 48-72 hours after Hep A # 2 and no obvious trigger. CLARITIN 5mg/5ml qd prn.
She got her vaccine, the next morning she woke up around 5:30 and noticed a star shaped rash of about 4-5 cm out from the injection site.  Her arm was not sore as she had exercised it and worked through it.  She had a headache and took some Tylenol, drinking a lot of water due to the heat in the area.  She has been having a lot of pain, which she notices it first thing in the morning, stiff all over.  She has a hospital bed and sleeps with her head elevated and her head down.  She has a very high tolerance for pain, but she notices the pain.  She did not have the pain or stiffness prior to the vaccine.  She has an APT to see her doctor on 8/21/22 and her PCP on 9/27/22.
bone pain; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of bone pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 15th September 2022, the patient received Shingles vaccine and TETANUS VACCINE. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced bone pain and fever. On an unknown date, the outcome of the bone pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the bone pain and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:16-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Reporter stated that patient's bones hurts so bad and had fever. Yesterday patient had the shingles vaccine and the tetanus vaccine at the same time. Additional supportive information: The follow up would not possible as no contact details were available. It was unknown if the reporter considered the bone pain and fever to be related to TETANUS VACCINE.
Left upper arm swelling 4 x 4 cm. Reaction to Menveo vaccine
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 2nd of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There were 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.
Weak; Short of breath; Dizzy; Feels lousy; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-May-2021 included no new information.
pt recv vax & w/in 1/2 hr devel hypersensitivity rxn w/a swollen throat,a feeling of something stuck in throat,pain in the rt side of neck & a choking feeling;pt recovered later that day;
Patient came in 34 weeks pregnant looking for the RSV vaccine. Instead of the approved Abrysvo RSV vaccine, Arexvy RSV was given. No major side effects have been reported.
12MAY92 PM had t103, weak, ill, took 2 naps, vomiting x 4; mom states was ill Wed AM, then agian in evening; currently has t105 & diarrhea started Wed PM; current t100 w/diarrhea; mom states unable to get family MD;
Patient complained of body aches, fever 100.0, chills, fatigue. Tylenol administered.
severe cramps, lst in the calve of my right leg every night for a week, then 2 days later severe cramps in the bottom of my feet for a week, then 2 days later cramps in my big toes for a week,  this last week had severe cramps in my abdoman area and back that lasted for 3 days. went to chiropracter  for adjustment thinking it was my back (did not help)  Called and made an appointment to see a Dr.  for Monday June21, 2021 to check out severe abdominal pain and back pain.
A physician's assistant reported that a 32 year old female inadvertently received an intradermal injection of Pnu-Imune 23 on 8/14/00. Within 24 hours, she developed an injection site reaction characterized by a 12" X 4" area of redness, tenderness and swelling. She also had "severe" muscle pain in and around the area of erythema.
Chills, body aches 6 hours after vaccine. Treated with ibuprofen regularly that day/night.   The following day, continued with ibuprofen all day. No chills or body aches, just tiredness and foggy head.   Second day post vaccine, I felt fine.
It started with a cold. She had a lingering runny nose, but her dad tested positive the week later. We tested her for COVID and she tested positive. Her running nose got worse from the 18th to the 20th. On the 20th of January she started a cough. We did over the counter cold medication and she was doing well. On the 24th, she went into the doctor for care and they gave her Decadron because she had developed coop on top of the COVID.  About a week later she was feeling better and she is fully recovered now and back in daycare.
my arm is very sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Shingles vaccine. On 12th January 2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JAN-2023 Reporter's comment: This case was reported by the patient via  interactive digital media. The reporter stated that the he/she had received his/her first shingles vaccine on the same day as reporting day.  The reported had stated that he /she would be going back in March for the second dose.  He/she was glad that he/she had got it.  The only negative on this was his/her arm was very sore, but it was well worth it. Additional supportive information: Follow-up would not possible, as no contact, details were available.  This case was linked with US2023AMR004672 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR004672:Same reporter
Patient is a 16 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate  of observation: Patient received vaccine at 4:21pm and proceeded to recovery area where she verbalized to her mother that "I don't feel good." 4:23pm Patient had a witnessed syncopal episode and fell to the ground where she was attended to. Patient was treated/managed as follows:  4:25pm VS BP 118/88, HR 57, RR 18, O2 sat 98% on room air. Patient alert and verbal. 4:35pm: VS BP 144/80, HR 85, RR 18, O2 sat 97% on room air. Patient alert and oriented. Denies shortness of breath, difficulty breathing, or pain. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 4:37pm Paramedics arrived and care assumed by paramedics at this time. Patient mother present.
rashes- one on her neck, right groin, and thigh.; Low grade fever; Rash was reported as worsened; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiration date: unknown) via an unspecified route of administration on 01May2021 (at the age of 26 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in arm right on 02APR2021 (at the age of 26 years old) as dose 1, single for covid-19 immunization and experienced arm soreness and fatigue. On 01May2021 patient experienced fatigue and on 02May2021 rashes- one on her neck, right groin, and thigh; low grade fever and rashes in a few areas of her body, that seem to be progressed. The caller also had a low-grade fever, fatigue but it was fine. Today the caller woke up with 4 different rashes and still had a fever. The caller read that if you're allergic you may have a rash on the arm where she had the shot. The caller wants to know have her symptoms been reported and if everything was okay. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
I woke about 1.5 hours into sleep first night after the shot to a pounding headache.  My entire head and most of my body was in pain.  I took Acetaminophen 1000 mg every 6 hours from that point until the end of the event which was bed time the following day.  It was tolerable about 3 of those 6 hours that I could sleep.  I was wiped out and rested the second day after.
Injection pain; General malaise; Case reference number US-BN-2023-000767 is a spontaneous case report initially received on 27-Apr-2023 from a consumer via Manufacturer (reference number: NUS2023US062725) and concerns a female patient of unknown age.  The patients' relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient received unknown number of rabies vaccines (brand name: unknown, batch number not reported) at an unknown dose, route or site of administration, for an unknown indication.  On unspecified dates, an unknown amount of time after rabies vaccination, as reported, patient always experienced injection pain and general malaise.  At the time of initial report, the outcome for the events 'malaise' and 'injection site pain' was unknown.  The reporter did not provide seriousness and causality assessment.  Additional information received from Bavarian Nordic on 01-May-2023 included local case ID.  Additional information received from Manufacturer on 02-May-2023 included confirmation of country of occurrence.; Reporter's Comments: A female patient of unknown age experienced injection site pain and general malaise, unknown time she received  unknown number of rabies vaccines, at an unknown dose, route or site of administration, for an unknown indication. Injection site pain and malaise are both listed and expected according to database and insert. The outcome was unknown. The patients' relevant medical history and concomitant medication details were not provided. Injection site pain and malaise are both assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A female patient of unknown age experienced injection site pain and general malaise, unknown time she received  unknown number of rabies vaccines, at an unknown dose, route or site of administration, for an unknown indication. Injection site pain and malaise are both listed and expected according to database and insert. The outcome was unknown. The patients' relevant medical history and concomitant medication details were not provided. Injection site pain and malaise are both assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.
9JUL93 230A fever 104 only down to 102 p/APAP & returned to 103-104; inc fussiness; dec eating; no local reaction; MD dx ? rx-dx w/sl otitis-on Ceclor;
Received the incorrect dosage of vaccine, numbness in feet and calves, pain in ankles, unable to sleep, has trouble walking - gets tired quickly, symptoms has been going on for 1 year. Prescribed Gabapentin by nurse practitioner.
Erythema, swelling, pain, rash that is localized. Treated with cool pack/ice, TYLENOL. Cont to monitor closely with follow up in 1 week.
Abscess of intestine; Crohn's; Cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4189072-00 (AbbVie).  A 56 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABSCESS INTESTINAL (medically significant), outcome "not recovered", described as "Abscess of intestine"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's"; NASOPHARYNGITIS (medically significant) with onset Apr2021, outcome "recovered" (May2021), described as "Cold". The action taken for adalimumab was unknown.  Clinical information: Causality for HUMIRA (ADALIMUMAB). The reporter's causality for the event(s) of abscess in intestines, active crohn's, second dose of covid vaccine had fever and first covid vaccine felt like had mild cold was not provided. As per reporter Causality (Drug/Vaccine) for events Abscess of intestine, Crohn's disease was not reported and for cold was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events - Abscess intestinal, Crohn's disease, Nasopharyngitis and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER_INC-202101780644 same reporter/patient/drug, different event and dose
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 10-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
31 yo F presented with dizziness and blurred vision. EMS eval. Pt's insulin pump was noted as running. BP 122/81, BS 466, HR 100, Temp 96.7. Pt care transferred to responding EMS unit, Pt transported to local hospital emergency room for further treatment.
This spontaneous report was received via a company representative from a female patient of unknown age who was reporting on herself. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified adverse reaction. The outcome of the adverse event was unknown. The reporter considered adverse reaction to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
The patient developed a rash and the vaccination site was swollen and hard. She was diagnosed w/ cellulitis at the ER and  got a prescription for Cephalexin and as of 9/22/21 should have started on the antibiotics. We are still waiting to see if there is any improvements.
I am a long term diabetic. This booster and the one before spiked my blood sugar. The next day my blood sugar was 400. Since then, mu blood sugar has been high and hard for me to get under control. I have been working with my Endocrinologist and she has prescribed some medications but we have not found a solution. It has been a constant struggle to get my blood sugar down. My doctor has seen this  before.
Patient received PPSV23 on 10/4/17 in the AM, by the same afternoon patient noted arm to be swollen, painful, warm, and red area covering his whole shoulder area. Had improved by 10/5/17 but still red rash present.
Increased phlegm, cold like symptoms that gradually worsened, Bronchitis diagnosed today (03/02/2016), x-ray to r/o pneumonia.  Patient requested it be reported today.
Information has been received from a medical assistant via company representative who reported an anonymous female patient (unspecified age) experienced unspecified adverse reactions on an unspecified date after receiving all three shots of GARDASIL (start dates of administration were not reported). It was unspecified if the patient received treatment, sought medical treatment and/or had any laboratory diagnostic tests performed for the adverse reactions to GARDASIL. The outcome of the adverse reactions to GARDASIL and action taken were not provided. No further information was provided. Additional information has been requested.
he has the Pfizer covid19 vaccine for his first, second, and booster doses. He mentioned that he recently tested positive for Covid; he has the Pfizer covid19 vaccine for his first, second, and booster doses. He mentioned that he recently tested positive for Covid; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ALFUZOSIN (ongoing). Patient stated that he has the Pfizer covid-19 vaccine for his first, second, and booster doses. He recently tested positive for Covid and was prescribed with nirmatrelvir; ritonavir (PAXLOVID) tablets. Outcome of the events was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient's medical history was not reported. There were not known drug reactions or allergies. On 11-JUL-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous, (strength, dosage, frequency, lot# and expiration date were not reported). There were not concomitant therapies. On 11-JUL-2016, the patient experienced headache, dizziness, large welts around the arm injection site, and stated that her arm felt hot, itchy and achy. The pharmacist also stated that the patient used topical hydrocortisone cream and BENADRYL to treat the symptoms, which did not resolve the symptoms. Therefore, she sought medical attention from her primary care physician, who prescribed prednisone oral tablets. There were not laboratories diagnostics performed. The outcome of dizziness, pruritus, pain in extremity, feeling hot, injection site urticaria and headache was unknown at the time of this report. Additional information has been requested.
I developed hyperthyroidism, and then diagnosed with Graves Disease shortly after 2nd dose of Covid Vaccine.
Many many blood clots in my right leg.  So many I had zero blood flow to my foot and now have probable permanent neuropathy and numbness in it.  I was hospitalized and treated multiple times for blood clots in July/Aug,  then again had to be hospitalized and treated for blood clots in my right leg in September. I was in ICU for many days and hospitalized a total nearly 6 weeks.  Also I have missed months of work because of it.  Symptoms was a grey cold right foot and extreme intense pain.  The pain continued due to the necessary treatments and still today I have horrible pain that I have been told may last a lifetime.