chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per Dad and phone report, sore the next day, by evening of 18th, red and sore, from shoulder to just above elbow. Painful to touch and to move though was able to move it and do daily functional activities. No fever. Sore and red, tender for about 5-6 days, then began to resolve, with resulting large bruise that is resolving daily.
Red, hot tender area 2 cm in diameter at site of varicella immunization. Unresolved at this point.
was put on 2 medications for a sinus infection; This is a spontaneous report received from a sponsored program Support. A contactable consumer (patient) reported that:   A male patient of an unspecified age received of first dose bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient received 1st dose of Covid vacine and then was put on 2 medications for a sinus infection. The patient wondering if he can take medication and still take 2nd dose of Covid vaccine. Therapeutic measures were taken as a result of was put on 2 medications for a sinus infection (sinusitis). Outcome of event was reported as unknown.  Information on the lot/batch number was requested.   Follow-up attempts completed. No further information expected.
Serious swelling  and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull.  upper chest and back of neck with horrible headache,   Fever of 101.4, chills but major sweating.  Ear aches in both ears from headache.   Stomach upset for 4 days and couldn't eat.  Body aches.  Sleeplessness.  Very light headed couldn't think for 4 days.
Patient reported right unilateral numbness/tingling starting at the lips, face and including arm and leg. NAD. No swelling of the lips, tongue and patient denied throat closure. Do chest tightness, SOB or dyspnea.
Pt noticed bruises and petechia on both legs from the knees down and large bruise on front torso. Pt went to urgent care and then sent to ER where she was admitted. She was transfused with platelets and given immunoglobulins. She is still currently still under MD care.
administrated with an early second dose of Bexsero. Two and half week after the first dose.; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 details was reported as follows: The date of administration of 1st dose was not provided. The patient received 2nd dose of Bexsero two and half week after receiving 1st dose, which led to shortening of vaccination schedule. No adverse event was reported. The reporter consented to follow up.
Arm pain; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced arm pain with first injection. The outcome of the event is unknown  No follow-up attempts are possible;Information about Lot/batch number cannot be obtained.
Pain at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at Injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at Injection site). At the time of the report, VACCINATION SITE PAIN (Pain at Injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Diagnosed with Behcet's Disease. Chronic arthritic joint pain, weakness, headaches, memory loss, chronic fatigue, severe headaches.
Due to mistake, child received HIB vaccine twice in the same visit, once by itself, an a second time in the combination vaccine.
began fever 18AUG95 @ 8PM T102 ax w/Advil; began crying 945PM 18AUG95 & cried cont for 5 hrs; called MD thought was related to immun Saturday noc 8PM began rash on abd;could not see MD til Thursday 2PM also poor appetite
off-label use as per local labelling due to ADACEL administration as part of a primary series with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 13 years old and unknown gender patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and it was reported as off-label use as per local labelling due to adacel administration as part of a primary series with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Feb-2022, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization.  On 22-FEB-2022 there was off-label use as per local labelling due to adacel administration as part of a primary series with no reported adverse event (inappropriate schedule of product administration) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that a 13 year old patient who received a dose of ADACEL on 22FEB2022 to have 3 more doses of the DAPTACEL for complete immunization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (off--label use as per local labelling due to ADACEL administration as part of a primary series with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Narrative:  Hospitalization, COVID positive and fully vaccinated upon admission, admitted for body aches, decreased appetite, and weakness
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2009, the patient was inoculated with ZOSTAVAX at pharmacy / drug store as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-SEP-2014, the patient was treated at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Case number PHEH2016US029287, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 26 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly following temperature excursion at 52 Fahrenheit for 01 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Swelling of the throat, change in voice. General malaise. Tx: Zyzol, Prednisone.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-JUN-2015, the patient was inadvertently vaccinated with one dose of improperly stored ZOSTAVAX (dose and route of administration were not reported; lot# L007222, expiry date 03-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Flu symptoms of body aches, nausea and retro-orbital headaches. Within 2 days after the onset of those symptoms, significant increase in hypertension with systolic readings of 150 to 175mmHg and diastolic readings 105 to 115 mmHg. at 5 days mild asthma symptoms that required oral steroid and topical inhalers for 7 days.  Flu like symptoms took 6 weeks to resolve and BP required change in medication and 3 agents at moderate dosage.  Those effects haven't abated.
Arthralgia, Fever, injection site soreness, fatigue, chills Narrative:
body was painful like getting the flu; all the arm hurt/all the arm was very sore; body aches/body was painful like getting the flu; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body was painful like getting the flu), PAIN IN EXTREMITY (all the arm hurt/all the arm was very sore), MYALGIA (body aches/body was painful like getting the flu) and VACCINATION SITE PAIN (injection site pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (remission) and Immunocompromised (immune system is very low). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), CALCIUM, COLECALCIFEROL (CALCIUM +D3), VITAMIN C [ASCORBIC ACID], MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (body was painful like getting the flu), PAIN IN EXTREMITY (all the arm hurt/all the arm was very sore) and VACCINATION SITE PAIN (injection site pain). 14-Sep-2021, the patient experienced MYALGIA (body aches/body was painful like getting the flu). At the time of the report, INFLUENZA LIKE ILLNESS (body was painful like getting the flu), PAIN IN EXTREMITY (all the arm hurt/all the arm was very sore), MYALGIA (body aches/body was painful like getting the flu) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.            Patient states if getting the third dose before 8 months have gone by from the second dose my counteract the effect of the previous one. This case pertains to patient 1.  Treatment details was not reported .    This case was linked to MOD-2021-320155.
Patient seen in emergency room with complaints of redness, warmth and swelling at injection site on left upper thigh. Pt given Benadryl, Ibuprofen and Bactrim (Bactrim for possible early cellulitis per encounter).
pt recv vax & 20 days later became pregnant;approx gestational wk 10, had a miscarriage;the products of conception were analyzed & were negative for varicella virus;no further details are expected;
Day One of vaccine, felt very fatigued Day Two after vaccine had stomach ache, lots of nausea Day Three of vaccine, was awakened at 0630 with itchy, bumpy rash on lower back.  Called her PCP and was advised to take Benadryl and call the health department to report incident.  Took 2nd dose of Allegra D and started to feel better.  Took 50mg dose of Benadryl before ending phone call.  Provided with direct line to contact on call nurse at health department to report progress over the weekend and to see her doctor on Monday if no improvement or to ER if symptoms worsen.
A report was received from a health care professional on 12/17/03 concerning an 8 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid-January. No follow up pending. All information received.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: Fm0173) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2020 as dose 1, single (Lot number: 037k20a), in right arm, on 25Jan2021 as dose 2, single (Lot number: 041l20a), in right arm, on 13Nov2021 as dose 3 (booster), single (Lot number: 004f21a), in right arm and on 29Oct2022 as dose 5 (booster), single (Lot number: 052d22a), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Jun2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (20May2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: After testing negative and no symptoms, started showing symptoms 17May2023. Tested positive 20May2023. Product: COVID 19 Treatment: Paxlovid, Treatment start date: 09May2023 to Treatment stop date: 14May2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE,COVID-19 ) and BNT162B2.
My mother went to get her Covid19 vaccine on March 27 at 3:25 pm. The following morning of the 28, she began feeling a burning sensation on her arm and onto her abdomen. She thought it was the side effect and took a Tylenol.   Today, April 1, she could not handle the pain and she went to Clinic where she was told it is a virus, the shingles.   Prior to the vaccine, she had never developed this symptoms.
Hospitalized with hypoxia to 85%,  Covid + on 4/27, and hospitalized with pneumonia probably covid related on 5/6/2022 Treatment  bebtelovimab on 4/29,  remdesivir, and dexamethasone.
SWELLING BELOW RIGHT KNEE; BLEEDING AT INJECTION SITE; WRONG INJECTION TECHNIQUE; PAIN BELOW RIGHT KNEE; TROUBLE SEEING; This spontaneous report received from a patient concerned  81 years old female . The patient's height and weight were not reported. The patient's past medical history included: double knee replacement, patient stated that she had 2 knee replacements and doctor put in a part that was too big on the right knee (doctor said the retractor couldn't get skin back far enough), and concurrent conditions included: cancer right breast, brain tumor and brain aneurism. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose, 1 total, administered on 02-Apr-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose, 1 total, start therapy date were not reported on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included influenza vaccine (flu shot in same arm about 2 weeks before booster) for prophylactic vaccination. On an unspecified date, the patient had swelling and pain just below right knee, bleeding at injection site, Patient states that the RPh (Registered Pharmacist) was too busy to give booster shot and a trainee gave injection. She felt the administration was wrong, like it hit the wrong place and caused her to bleed. She said after taking off bandage noticed blood on bandage, about 1/2 teaspoon of blood (coded as wrong injection technique). She also reported trouble seeing. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding at injection site, was recovering from pain below right knee, and swelling below right knee, and the outcome of wrong injection technique and trouble seeing was not reported. This report was non-serious.
her breathing has been so bad sick since getting the vaccine; she has been having difficulty breathing; Anxiety; breathing is bad; Diarrhea; body is hurting so bad; Chills; 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 57-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: EN6206) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Caesarean section" (unspecified if ongoing), notes: She has only had 3 caesareans. The last one was 27 years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, given in left arm.), administration date: 11Mar2021, for Covid-19 immunization.  The following information was reported: RESPIRATION ABNORMAL (non-serious) with onset 02Apr2021, outcome "not recovered", described as "breathing is bad"; DIARRHOEA (non-serious) with onset 02Apr2021, outcome "not recovered", described as "Diarrhea"; PAIN (non-serious) with onset 01Apr2021, outcome "not recovered", described as "body is hurting so bad"; CHILLS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Chills"; ILLNESS (non-serious), outcome "unknown", described as "her breathing has been so bad sick since getting the vaccine"; DYSPNOEA (non-serious), outcome "unknown", described as "she has been having difficulty breathing"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety".  Additional information: NDC number of Covid-19 vaccine was unknown, covid prevention and works with elderly people and no other products, no investigation assessment was reported. After the second dose her breathing has been bad for two weeks.  She has contacted the place where she received the shot and she was told the side effects and would go away in a week and Caller was unable to answer outcome of event for her breathing being bad and her body hurting. The pain is not bad all the time, her breathing is what she is worried about as she has no medical history and she was told to give it 2 weeks and usually it goes away. She will go to the emergency room.  No follow-up attempts are possible. No further information is expected.
20JAN91 seen in ER temp of 101, vomiting p/lunch. Non-responsive, blank look to his mother. Lab, CXR & spinal tap done. Spinal - neg; CXR revealed no definite pneumonia, increased bronchial markings.
Left side of my cheek is swelling; This is a spontaneous report from Consumer or other non-health professional via a Pfizer sponsored program, reporting for himself.   A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch no: not reported/Lot number: EL9765, Expiry date: unknown) via an unspecified route of administration, administered in left shoulder on 19Feb2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure and diabetes from an unknown date and unknown if ongoing. Concomitant medications included Carvedilol (CARVIDOL), Pravastatin, Amlodipine, Alprazolam, Losartan, Acetylsalicylic acid (ASPIRIN) and Metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR), Hydrochloride (Not further clarified) all were taken for unspecified indication and from an unknown date and unknown if ongoing. The patient reported that he had his first COVID vaccine on 19 Feb 2021 and the last 4-5 days left side of his cheek was swelling, that was going into his cheek bones. Patient was asking if that was a side effect of the vaccine. Investigation Assessment was reported as No. Treatment was included as Tylenol and it's just stated to get little uncomfortable. The outcome of the event was unknown.  Follow-up attempts are possible. No further information is expected.
Patient came in pharmacy 11-19-11. Showed her arm to pharmacist. Red, slightly swollen area warm to touch. Patient to see her physician.