chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered ActHib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598281) and transmitted to Sanofi on 12-May-2021.  This case involves a 7 months old female patient who was administered with a expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AAB and expiry date: 04-May-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 11-May-2021.   The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter wanted to know what to do.  At the time of reporting, the patient experienced no adverse 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.
neck pain; no energy; could not move arm; Knot in arm; pain in entire body; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm) and MYALGIA (pain in entire body) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SOMATROPIN (NORDITROPINE FLEXPRO) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm), MYALGIA (pain in entire body) and HEADACHE (headache). On 02-Mar-2021, NECK PAIN (neck pain), ASTHENIA (no energy), LIMB DISCOMFORT (could not move arm), NODULE (Knot in arm), MYALGIA (pain in entire body) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.
I95.9 HYPOTENSION 3/31/2023 CANCER METASTATIC TO BONE LOCALIZED KIDNEY CANCER, UNSPECIFIED SITE
17FEB99 pt recv vax 7 18FEB99 local rxn rt thigh, red, warm to touch;seen by MD. A nurse reported that an 18-month-old female received HIB-TITER, ORIMUNE and ACEL-IMUNE vaccines on 17-FEB-1999. On 18-FEB-1999, she developed an injection site reaction charterized by redness, swelling and tenderness at the HIB-TITER injection site. The infant recovered without treatment. This is 1 of 4 patients from this facility who had an adverse experience following receipt of HIB-TITER lot 361503A. "Follow-up information received from the provider supplied the patient's name and lot numbers for Acel-Imune and Orimune vaccines. This report has been submitted directly to VAERS (Ref. No. 119480)."
Information has been received from a registered nurse concerning an infant who was vaccinated PO with the third dose of ROTATEQ. Subsequently the patient experienced mouth sores. The patient sought medical attention through a phone call. The outcome was unknown. There was no product quality complaint. No further information is available.
Large area of indurated erythema at injection site covering almost the whole lateral aspect of left arm (all deltoid area and below).  Tenderness at indurated area.  Patient immunized yesterday at ~ 10:30 and erythema noted today at 09:00.
Shot sight swollen (4" area) injection sight hard red, hot (3") area. fever 103 degrees, nausea, headache dizzy, loss of appetite, "raspy" throat all symptoms lasted 24 hrs. Except shot sight stayed swollen & itched for 4 add'l days.
Patient was to get booster and was given 0.5ml instead of 0.25 ml dose. The patient did not note any side effects.
23 cm x 22 cm area of erythema, warmth at injection site. Warm but not tender. No myositis. (Subcutaneous). No limp, muscle tenderness. No fever. Will observe. No specific therapy recommended.
Existing tinnitus  got extremely worse in left ear.   Right ear pretty much the same.  Volume at least tripled.  With no diminishing  If not possibly worsening Only slight discomfort at vaccination site
Monday night, woke up in a sweat while sleeping. Tuesday morning had Severe hives all over torso, very itchy. Later in the evening it moved to my legs. Wednesday the hives all all over my body including my arms, legs, butt, torso.   It doesn?t hurt, but is very itchy.
I got heart complication. I had SOB. They are not continues but I have them through the days. I also got tinnitus that got worst and all I do is hear ringing all the time (day and night).  I went to the doctor about this. There is nothing they can do.  They did blood work, listen to my heart and checked my blood pressure.
A report was received from a consumer on 12/16/03 concerning a 2 year old female vaccinee who experienced fever between 101-102 degrees F which persisted for 3 to 4 days after vaccination and a fever of 99.6 degrees F on 12/15/03 after inadvertently receiving Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee was inadvertently administered Fluvirin. The vaccinee experienced a fever between 101-102 degrees F which lasted for 3 to 4 days following vaccine administration. On 12/15/03 the vaccinee experienced a fever of 99.6 degrees F. It was unknown at the time of the report if the fever which started on 12/15/03 still persists. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
ran the titer on her and found that the geometric mean titer is not sufficient (virtually no immunity after two years); patient received Imovax 2-dose series in 2017, no AE; Initial information received on 06-Dec-2019 and additional live follow-up information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an adult female patient who received only two doses of RABIES (HDC) VACCINE [IMOVAX RABIES] and found that geometric mean titer is not sufficient (virtually no immunity after two years) (PT: antibody test negative).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in May-2017, the patient received two doses of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) via unknown route and unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered (Inappropriate schedule of product administration). After two years titer was run and found that the geometric mean titer is not sufficient (virtually no immunity after two years) (PT: antibody test negative).   It was considered that the patient had to get a booster for the vaccine. She is requesting the booster vaccine be provided without charge to her, based on her belief that there must have been a problem with the original vaccine (vaccine was faulty).  Outcome was not applicable.  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.  Information on the batch number was requested.
I had a strong reaction to the shot of the expected reactions. However, I also had  - -  I began to have symptoms the next day that I was having an allergic reaction and hives were coming on. I have had hives before that covered my entire body and restricted breathing so I recognize the feeling. I was taking two 24 antihistamines every day and have been ever since.  Since then I have developed new allergies to products with skin rashes. I often have an itchy feeling all over like I am about the break out in hives all over. I have been applying benedryl spray to my new skin reactions. This has been ongoing the last three weeks. I am going to postpone my next vaccine scheduled for April 22. I live alone and am worried I could go into shock. I do not have an epipen at home. I don't think the current guidance for people with allergies is adequate.
Vaccine location=Left leg; Joint pain; increased pain at sites of old injuries; Increase in allergy symptoms.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 via an unspecified route of administration on 30Jul2021 10:00 (at 69-year-old) (Batch/Lot number was not reported) as unknown dose, single in leg left (inappropriate site) for COVID-19 immunisation. Medical history included asthma, high fever, ongoing old injuries pain, and known allergy: morphine. No COVID prior vaccination. Concomitant medications included rosuvastatin; and losartan. The patient experienced joint pain, increased pain at sites of old injuries, increase in allergy symptoms in Jul2021 at 10:00 AM. Emergency room visit and treatment received. The seriousness criteria of this case was reported as disability. No COVID tested post vaccination. The outcome of the events except vaccine administered at inappropriate site was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
This re-vaccinee developed scattered, non-pruritic papules and pustules on anterior and posterior shoulders on day 10 after smallpox vaccine. No other symptoms evident except mild , generalized myalgias. Had had axillary LAD on day 5-9 but was resolved at time of rash eruption. All sx resolved without treatment.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th July 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine 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: 27-Jul-2022 Reporter's comment: The office manager stated that an expired dose of Rotarix was administered to a patient. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Rotarix, which led to expired vaccine used. The case was linked with case US2022111764, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022111764:Same reporter
developed livedo reticularis on bilateral legs; This is a spontaneous report from a contactable other hcp. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EL9261), intramuscular on the right arm, at the age of 48 years, on 20Jan2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and migraine from an unknown date and unknown if ongoing and covid-19 from Nov2020 to an unknown date. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), metoprolol (METOPROLOL) and amitriptyline (AMITRIPTYLINE). It was reported that 3-4 days after vaccination (24Jan2021), the patient developed livedo reticularis on bilateral legs. No treatment was received for the event. The outcome of the events was not recovered.
Gardasil #1 = enlarged lymph node in (L) axillary area about 3 weeks after injection. Gardasil #2 = same as above, occurred 48 hours after injection (lymph node enlarged).
pt received 2nd pfizer covid vaccine accidentally early. got first vaccine 5/5/21, received 2nd dose 5/19/21
I finally tested COVID-Negative on Day 8 and am now testing Positive again; I finally tested COVID-Negative on Day 8 and am now testing Positive again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at dose 1, single and second regimen (Batch/Lot number: unknown) at dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis (immunocompromised)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "I finally tested COVID-Negative on Day 8 and am now testing Positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive.  Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical significance: Reported about covid treatment.: Received vaccine, No other medication in 2weeks. Anti-viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=12May2022, treatment stop date=17May2022, indication=Treatment of COVID-19, Covid vaccine details: vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False, Vaccine administration date=21Oct2021, vaccine lot number=EW0187, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm. Adverse event: Rebound infection on Day 10. I finally tested COVID-Negative on Day 8 and am now testing Positive again. Likewise, runny nose (only symptom) has returned. Event started on  20May2022, The event was not recovered, no treatment was received.  No follow-up attempts are possible. No further information is expected.
Patient received Adacel vaccine and had swelling to the arm. Patient's parents consulted with their family physician and was diagnosed with a local reaction.
fever 101.1; chills; mild viral conjuntivitis; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Mar2021 at 13:45 (Lot Number: EN6202) as dose 2, single for COVID-19 immunization. Medical history included sulphur based allergy on an unknown date. The patient did not have COVID prior to vaccination. Concomitant medications included calcium (manufacturer unknown); fish oil (manufacturer unknown) and latanoprost (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Feb2021 (lot number: EN6201) at 14:45 in the left arm for COVID-19 immunization. On 13Mar2021 at 23:00 the patient experienced fever 101.1, chills and mild viral conjunctivitis. The events resulted in a doctor's clinic visit. The patient nasal swab COVID test on 14Mar2021 with a negative result. The patient received an antibiotic ointment for the eye and acetaminophen as treatment for the events. The events recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
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 20-year-old male patient received bnt162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other vaccine received, No Other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 11Sep2023, Treatment stop date: 16Sep2023, Indication: Treatment of COVID-19,   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Vaccine given to a 17 year and 9 month old patient who is under age that the vaccine is approved for
One day Post vaccination patient reported fever of 102.4, debilitating headache, chills.  Non confirmed fever and headache continued 5 days post vaccination with daily decreasing intensity and frequency
PATIENT WAS ADMINISTERED MMR VACCINE IN PLACE OF MENINGOCOCCAL. PT RECEIVED WRONG VACCINE.
Body chills and shortness of breath @2100 on 10/21 Nausea and vomiting @ 2200 on 10/21 100.5 F temperature @ 2300 on 10/21 102.1 F temperature and migraine @ 1700 on 10/22
Red neck and face 10min after injection lasting 15-20min Short episode of self resolving  tachycardia
pt recv vax 25NOV96 & 25NOV96 pt exp scratchy throat, scratchy ears, & a h/a;pt took DPH to manage itchy throat & ears;
Mom suspects the reaction started the day after the shot but she saw the redness the morning of 10/10/19. No fevers, decrease in range of motion, or intense pain with direct palpation. Exam has shotty lymphadenopathy in jugulodigastric bilaterally and in left axilla but none in right axilla or supra/subclavicular.
Swollen neck; Swollen glands or lymph nodes; Discomfort swallowing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 12Mar2021 12:45 (at the age of 46-year-old), as dose 1, single, for COVID-19 immunisation.Paient was not pregnant at the time of vaccination. Medical history included acid reflux, hypothyroidism, anxiety, blood pressure high, obesity. Concomitant medications included sertraline hydrochloride (ZOLOFT); levothyroxine sodium (SYNTHROID); pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); verapamil; triamterene all for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 15Mar2021 at 07:00, the patient experienced swollen neck, swollen glands or lymph nodes, discomfort swallowing, it was not like strep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcomes of the events not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
02/13/2021 Vaccination 07/2021 Annual physical. I had blood work done and my liver enzymes were elevated. They took me off of pain killers, no alcohol and statin to reduce numbers. No reduction in liver enzymes. The Dr. then referred to hepatologist. R/O leukemia/CA; neg. The next step, was more detailed blood work (needle into liver). The hepatolgist stated I have 'autoimmune hepatitis'. No scarring on liver; 'it was recent, new condition'. Started on steroid and immunosuppressant drug. Since then, my liver enzymes have gone back to normal. I will be on immunosuppressants the rest of my life. It is a fairly rare condition.  I want people to know in case this is a side affect because unless you have a annual physical, they will end up with liver failure.
Moderna Vaccine lot #060H21A was affected due to out of temperature range. No adverse reactions from patients.  17 patient's affected.
On 02/02/21 at approximately 9:00pm I developed a rash on my face, neck and chest along with swelling of my lips. I also noted numbness/tingling in my hands and feet. About 3 hours later I began having severe nausea, vomiting, diarrhea and abdominal pain. These symptoms lasted for approximately 4 days. Starting my next menstrual cycle on 2/12/2021 I began having heavier flow with large clots which I had not experienced before during my cycles. Since then my periods have gradually become more irregular and with larger clots.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients had received improperly stored GARDASIL, PEDVAXHIB and ROTATEQ. No symptoms were reported. At time of report, the status of patient was unknown. Additional information has been requested.
Bell's palsy; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine on an unknown date and experienced Bell's palsy.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On an unspecified date, after first dose of vaccine, the patient experienced Bell's palsy. The event is  Bell's palsy was considered as medically significant.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event development of Bell's palsy was not resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Further information has been requested.
facial twitching (smile crease) on left onset the following morning after vaccine with intermittent persistence in same location thereafter
Extreme dizziness and fainting after standing up for a prolonged period of time 12 hours after the second dose of the vaccine.
Pt did not acquire high levels of immunity p/ 3 doses of hep B vax on 0,1 & 6 months schedule.
Tightness in Throat, heaviness in throat, with shortness of breath.  Bilateral Eyes- feels like "pins and needles, making them itch.  OTC Claritin given at 1600. BP 121/74, temp 98.5
At time of vax w/bioject system, I felt pain all the way down to my elbow. By early evening, my arm was so sore, that i could not move it. I woke up at 1:00am, w/numbness in entire R/arm & side of face. Pain in eye, ear & neck w/tingling.
Myalgia, Fever, SkinRash, fatigue, chills Narrative: