chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Pt had bruised area on surface of skin where shots were given. She also had a quarter sized firm knot on the left side and dime sized firm knot on the right side under the skin surface. Pt was walking fine and had full ROM.
grade 3 reaction; Hypotensive; fatigue; cough; A spontaneous report was received from a other health care professional concerning an female patient who developed grade 3 reaction, Hypotension, fatigue and cough/ Adverse reaction: hypotension: Fatigue: cough.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: Unknown) for prophylaxis of COVID-19 infection.  On, 25-Jan-2021 developed a grade 3 reaction, hypotension and was admitted to ER and 26-Jan-2021 patient developed fatigue and cough. IV fluids were given as treatment.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of grade 3 adverse reaction and hypotension and then a NS unexpected event of cough and NS expected event of fatigue.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment was not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a consumer refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with M-M-R II, subcutaneous (lot number and expiration date not reported). No further information reported. Additional information has been requested.
About 5 minutes after pharmacy personnel gave the vaccine, the pt came back to the pharmacy saying she felt dizzy. She sat in a chair with her head down and we gave her a water.
Patient developed facial swelling and a rash yesterday evening, looking back she realized that she was having facial swelling after first dose of moderna
Beginning 4-29-08, patient with fever, rash on arms, legs, irritability.  Gave Tylenol.  Over next 4 days, fever diminished, had "off & on" difficulty walking.  Rash changed appearance: on 5-3-08, rash red, scaly on arms, legs; papular rash on face.  Pronounced rash at diaper area.  Treated with antibiotic ointment.  No fever.  Intermittently fussy.
This spontaneous report was received from a other refers to patient of unknown age and gender. Patient medical history and concurrent condition was not reported. On 24-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # K010466, expiration date 23-MAR-2016) prefilled syringe (dose and frequency unknown) which were exposed to temperatures outside of the required temperature range. Concomitant medication was not reported. The reporter stated customer purchased two 10 packs of this item and did not disclose any patient information. Also reported, this product had been administered to 20 patients. The outcome of the event was unknown. Additional information is not expected as all correspondence has been received.
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 30-Dec-2013. Reporter stated that they inadvertently administered expired FLUMIST QUADRIVALENT to the patient on 30-Dec-2013. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Received telephone call from patient on 4-16-09 stating the she had slight nausea and slight swollen  lymph node in (L) clavicle area. No fever. 4-21-09 Pt presented for injection #2 of -Pre-exposure series, still c/o grape sized lymph node- swelling in left clavicle area. mild nausea, T 98 degrees. No other sx. Private MD notified; permission to continue with vaccine, may be other infection . on 4-22-09 still c/o nausea, some light headiness, fever, lymph node (L) clavicle 'larger, swelling area. MD notified.
02/27/21 Woke up with headache, fatigue, general malaise and  injection site painful to touch.
This spontaneous report as received from a Registered Nurse (R.N.) refers to a patient of unknown age. On 11-APR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L026751, Exp: 18-MAY-2017) orally and RECOMBIVAX HB (lot # L044707, Exp: 16-OCT-2018). Both vaccines were stored under 52.5 degrees Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient admitted to hospital on 6/8 with myocarditis. He had vaccine on 6/4. He began having fevers 6/5. Also discovered a tic on his feet on 6/5, treated with doxycycline.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PRURITUS (itchy hands and feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and PRURITUS (itchy hands and feet). At the time of the report, DIARRHOEA (diarrhea) had resolved and PRURITUS (itchy hands and feet) outcome was unknown. No treatment was reported. No concomitant medication was reported.
Information has been received from a 19 year old female patient, who on 30-JAN-2008, was vaccinated with the first dose of GARDASIL. On 02-APR-2008, the patient was vaccinated with the second dose of GARDASIL ((Lot # 655327/1287U). Concomitant therapy included birth control pills. The consumer reported that after received the second dose of GARDASIL and within 24 hours on 04-APR-2008 she was admitted to the ER. The consumer reported that the hospital releasing statement was that she had an allergic reaction. She complained that she couldn't walk. She was given BENADRYL in the hospital I.V. At the time of the report the patient had recovered. Not being able to walk was considered disabling. Additional information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 10-DEC-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX and Acyclovir for management of her symptoms and pain. 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.
Covid arm (rash and itching) for 1 week.  Resolved on its own.  Leg swelling and pain as well as shortness of breath.  Had Doppler scan on leg and CTs on chest. Diagnosed?DVT left leg and PE in lungs.  On blood thinner and TED hose x 6 months.  On treatment now.
Rash on his neck and his face and is raised up; This is a spontaneous report from a contactable consumer (grandparent) reported for a 15-year-old male patient (grandson). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/lot number was not reported) via an unspecified route of administration in the arm left on 16Jun2021 04:15 as unknown, single for COVID-19 immunisation. The patient medical history included allergies and sinuses. Concomitant medications included loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported and consumer stated it as a mood stabilizer; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. Consumer stated, he was taking a SSRI. (Later clarified as Lexapro) and asked, whether lot number is, is it EW01. On 16Jun2021 at around 4:15, yesterday, Wednesday, his grandson had the Pfizer COVID shot (Pfizer COVID-19 Vaccine). On 18Jun2021, a day after vaccine administration he experienced a rash on his neck and his face and is raised up and stated, this is probably a reaction not a side effect. It started to appear at around 11 AM clock right when I woke up in the morning and it remained the same still tonight. There is a difference in reaction and the reaction is worse. And asked is this normal to have a rash around the neck and face. No treatment was received. The clinical outcome of the event was not resolved.  Information regarding the lot/batch number has been requested.
The patient receiveed the first dose of VAQTA on 26-SEP-2019 and had not received the second dose yet; No addittional AE reported; This spontaneous report has been received from the patient concerning himself a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies was not provided.  On 26-SEP-2019, the patient was vaccinated with the first dose hepatitis a vaccine, inactivated (VAQTA) 1 milliliter (mL) as prophylaxis (formulation, vaccination scheme frequency, route of administration, and anatomical location of vaccination, lot number and expiration date were not reported); the patient stated he had not received the second dose yet (inappropriate schedule of product administration); no additional adverse events (AEs) reported.
Received Shingrix first injection 12/1/2020 Night of injection, slept poorly. In the morning, felt nauseated, tired, headache, and muscle aches. Next day still easily tired with slight headache, but all other symptoms were gone.
Neck swellling with in two weeks of the injection, no pain initially. April 13, 2021 diagnosed with pneumonia, Chest x-ray & treated antiobiotics & steroids at Urgent care; nearly resolved with 7 days.    April 21, 2021 appointment to scan neck ultrasound & scan lungs.  Experienced a panic attack Experienced increased breathing on May 29, 2021 admitted the hospital for 5 days.  Found lump on breast.  Wanted to insert stint in my heart which  they couldn't perform due to a mass on my left breast.  Biopsied Left breast.  Still do not know results.
Fever 102, chills for 2 days followed by local cellulitis, swelling of deltoid area around injection site.
Fever and extreme lethargy. One episode of syncope.  as of today 4/5/2021 I have a mouth sore and 4 cold sores.
pt recv vax in early fall 1994 & pt fainted & fully recovered w/o tx;
This spontaneous report was received from a medical assistant, refers to an unspecified patients. No pertinent medical history was reported. Since 12-SEP-2014, an unspecified number of patients have been administered GARDASIL (dose, frequency, route were not reported), all of which underwent supported temperature excursions. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Patient developed cellulitis on the right upper arm where the injection site was located, the symptoms developed the right after the injection was given.
Severe headache, chills, low grade fever, lethargic Lasted 48 hours. By day 3 was feeling normal.
experienced a syncopal episode; This spontaneous report was received from a healthcare professional (HCP) via a company representative referring to a 12-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date in August 2020, reported as "2 months ago", the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Then, she experienced syncopal episode. It was reported that the patient did not experience any other side effects, did not have any injury associated with the event and recovered while at the office (on an unknown date in August 2020). She she did not seek medical attention and no treatment was given for the adverse event.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
shot area bruised again; sleepy; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (shot area bruised again), SOMNOLENCE (sleepy) and FATIGUE (very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     no medical history information was reported.  Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE BRUISING (shot area bruised again), SOMNOLENCE (sleepy) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (shot area bruised again), SOMNOLENCE (sleepy) and FATIGUE (very tired) outcome was unknown.            concomitant medication included a hormone for unknown indication.   This case was linked to MOD-2021-220809 (Patient Link).
26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient never had COVID positive test or diagnosis.  No Allergies (medications, food and other products) were reported.  Concurrent medical conditions included Diabetes.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient received first booster dose on 22 Apr 2022.   This case was linked to MOD-2022-548975 (Patient Link).
slight allergic reaction; fluctuating blood pressure; lethargy; Tingling tongue; fever; bad taste in mouth; ear lobe turned bright red; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue), TASTE DISORDER (bad taste in mouth), ERYTHEMA (ear lobe turned bright red), HYPERSENSITIVITY (slight allergic reaction) and BLOOD PRESSURE FLUCTUATION (fluctuating blood pressure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Bee sting hypersensitivity, Drug allergy (Benadryl), Allergy to antibiotic (Cipro) and Allergy to antibiotic. Concomitant products included ASCORBIC ACID (VIT C), COLECALCIFEROL (VIT D [COLECALCIFEROL]) and ESTRADIOL (VAGIFEM) for an unknown indication.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced TASTE DISORDER (bad taste in mouth), ERYTHEMA (ear lobe turned bright red) and CHILLS (chills). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling tongue), HYPERSENSITIVITY (slight allergic reaction), BLOOD PRESSURE FLUCTUATION (fluctuating blood pressure), LETHARGY (lethargy) and PYREXIA (fever). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tingling tongue), TASTE DISORDER (bad taste in mouth), ERYTHEMA (ear lobe turned bright red), HYPERSENSITIVITY (slight allergic reaction), BLOOD PRESSURE FLUCTUATION (fluctuating blood pressure), LETHARGY (lethargy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, Heart rate: 140 (High) increased. On an unknown date, X-ray: normal (normal) normal.         Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Patient contact details updated. On 05-May-2021: Updated patient contact details and patient demographics, newly added relevant medical history, lab data, concomitant medications and new events
Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; severe headache; swelling painful lymphnodes on neck; swelling painful lymphnodes on neck; stumbling/Trouble walking; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Mar2021 at 13:15 (at the age of 52 years) as Dose number Unknown, Single for COVID-19 immunization.The patient's medical history included environmental pollen and some fruit, nuts and soy along with Severe allergies and asthma, Cranial nerve palsy after viral cold and Trigeminus neuralgia. Patient's Concomitant medications were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.1 hour after injection, on 02Mar2021 at 14:30, the patient experienced Tingling, numbness and paraesthesia in leg, foot, arm and hand on left side of body. Followed by fever, chills, severe headache and swelling painful lymph nodes on neck.1 week after vaccination, no improvement on numbness in leg and foot but spreading over to right side as well. Trouble walking and stumbling at times.AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received.The outcome of the events was not recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
A nurse reported the occurrence of an injection site reaction in a 4-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The medical history, concurrent conditions and concurrent medications were not provided. On 06/04/2002 the child received an injection of Infanrix. The number of previous injections of Infanrix was not reported. Sometime after the injection, he developed an injection site reaction characterized by a 4-inch area of redness that was hot and hard. The outcomes of these events were not reported. The reporter considered these events to be related to Infanrix administration.
I started to hear noise in my right ear.  noise is not loud but continues.  the noise is like something in ear moving around.  shaking and changing head positions do not change the pattern of  such noise .  my left ear behaves normal.
approx 1.5 hrs following vax pt noticed outbreak of pruritic urticaria over much of body; inspiratory & expiratory wheezing noted; vitals stable; pt given Epi & DPH;
Off label use; Drug use in unapproved population; clogged milk ducts; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 36-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 17:00 (at the age of 36 years old) as dose 1, single for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medication was not reported. The patient didn't received other medications within 2 weeks of vaccination. Patient stated I am a breast feeding mom. 5 days after receiving the vaccine I began experiencing clogged milk ducts on 06Apr2021 17:00. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427749 baby case