chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 25 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 3 year old, male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3306AA on 17 August 2009, lot number C3432AB on both 19 October 2009 and 02 December 2009; and 1 dose of TRIHIBIT (lot number U3009BA) on 02 June 2010 (site and route of administration not reported). Approximately two years after the TRIHIBIT dose, on 05 September 2012, he developed a paroxysmal cough. He also experienced sleep disturbance (onset date not reported). Laboratory testing included positive PCR on 07 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 07 September 2012. The subject was not hospitalized. At the time of final contact on 21 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
MISSED THE LAST DOSE; This spontaneous case report (PVX2019-1885) was received from a pharmacist on 22-Jul-2019. It describes a male consumer who "missed the last dose" (PT: Product dose omission), while being on therapy of Vivotif for an unknown indication.  Case report: The consumer took Vivotif doses on 14-Jul-2019, 16-Jul-2019, and 18-Jul-2019, respectively. He did not take the last dose.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.
dizziness; swelling at injection site; redness at injection site; lymphadenopathy swelling of lymph nodes; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 21; unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he previously received the first dose and experienced a few adverse reactions and wanted to know if it was ok to get the second dose. He reported dizziness within 10 minutes of receiving it, a very hard case of it, swelling at injection site accompanied by redness at injection site, lymphadenopathy swelling of lymph nodes (one of them). He was going to get his second dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Ct was to receive PPD for TB skin test on 8/16/04, instead Ct. was administered Adult Td 05.cc ID in left forearm. Ct. not visually assessed by staff- unknown if local reactions.
tested positive for covid; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number: Expiry date: Unknown), dose 1 via an unspecified route of administration on 24Mar2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid (drug ineffective) (medically significant), tested positive for covid (covid-19) (medically significant) on 31Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. The outcome of the event was unknown.  information on about lot/batch number has been requested.
Vaccinated at 12:50 PM and went home.  Felt pulling at top of right foot.  At approximately 1:40 PM foot started to hurt - took off her shoes and pain (cramplike) started.  Couldn't stand on foot and kneecap triggered pain when trying to standed.  Patient feels achy and foot is  hot to touch.  Patient took Advil at 4:45 PM.  Right arm does not hurt.
"Pea size bumps" arose in occipital region bilaterally along "glands" in back of head, approx 30 mins after receiving vaccine. Lasting 2 1/2 hrs. Bumps subsided without a sequences. No other s/s accompanied two episode. Episode not reported until the date the this report.
painful rash, and drug induced hypersensitivity syndrome.; painful rash, and drug induced hypersensitivity syndrome.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 57 or 58-year-old patient of unknown gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-MAY-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as subsequently), the patient was treated by health care providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) used: painful rash and drug induced hypersensitivity syndrome (drug reaction with eosinophilia and systemic symptoms). The outcome of drug reaction with eosinophilia and systemic symptoms and rash was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Upon internal review, drug reaction with eosinophilia and systemic symptoms was considered a medically significant event.
Within 12 hours of my second shot I experienced the typical symptom cluster, headache, fever, aches, and fatigue. I then experience stomach cramps and a brief bout of diarrhea. All of the above symptoms resolved within three days, however the stomach discomfort and cramping persisted for more than a week. Upon going to my local ER I was subsequently diagnosed with appendicitis. I am suspicious that this was triggered by the vaccine, as there is growing evidence that the appendix plays a role in the immune system, the response of which was exploded by the second shot. I have never had stomach issues in the past, confirmed my medical exams and preventative colonoscopies. I am extremely healthy, eat well and my bowel habits are quite regular and reliable.
flu-like symptoms; rising temperature during that time from 99.8 to 101; This is a spontaneous report from a contactable consumer. The 70-Year old male consumer reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided) via an unspecified route of administration in left arm on 27Jan2021 11:00 (at the age of 70-year-old) at single dose for COVID-19 immunisation. Relevant medical history included prostate cancer from 2019 (treated) and COVID-19. Concomitant medications included rosuvastatine 5mg and sildenafil citrate 20mg. The patient experienced flu-like symptoms beginning approximately 18 hours after vaccination, and lasting approximately 30 hours, with rising temperature during that time from 99.8 to 101. Onset date for both events was 28Jan2021 05:00. The patient had not tested for COVID post vaccination. The events were non-serious and resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
More than 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (More than 12 hours after puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021 at 11:14 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021 at 11:14 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (More than 12 hours after puncture). On 07-Dec-2021 at 11:14 AM, EXPIRED PRODUCT ADMINISTERED (More than 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial had been initially punctured at 14:48 on 06-DEC-2021.  Concomitant medications were not provided.  Treatment information was not provided.
drug dosage duration too long; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix  (received 1st dose on 11th January 2023).   On 21-JUN-2023, the patient received the 2nd dose of Twinrix. On 21-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: drug dosage duration too long). The outcome of the drug dose administration interval too long 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: 21-Jun-2023 No reaction was reported. The reporter consented to follow-up via postal. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
After 4mo vaccines pt presented 6/8/15 with diarrhea and fever. Admitted to hospital for dehydration/sepsis. Vaccine administered 5/29/15.
headache, weakness in arms and legs, double vision. patient was contacted via phone for a phone appointment and directed to go immediately to the ER for further evaluation.
(L) thigh developed 3x4 bluish lump after administration of 2nd shots. blue, non indurated discoloration like a birth mar, persists at 9 mths.
her left arm feels fleshy compared to the right; swelling underneath/below/involving the left arm pit/swelling under her left arm; left arm pit, feels like something is in the way and noted that it is fleshy compared to the right; a little bit of swelling of the lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Oct2021 13:00 (Lot number: FF2590) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Tonsillectomy and Adenoids", stop date: 1958, notes: Tonsillectomy 1958 (approx); "Diseased gallbladder", start date: Jun1976, stop date: Dec1981, notes: Cholecystectomy Dec1981; "Cholecystectomy", start date: Dec1981 (unspecified if ongoing), notes: Cholecystectomy Dec1981; "Elevated liver enzymes" (unspecified if ongoing), notes: Liver biopsy; "Barrett's Esophagus", start date: Sep2020 (ongoing), notes: Endoscopy Sep2020; "Hepatitis-C", start date: 2004, stop date: 2014, notes: Regentron Inj. Concomitant medication(s) included: OMEPRAZOLE taken for barrett's oesophagus (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Date: 05Feb2021, Time: 3 pm, Site and Route of injection:, Anatomical site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9264), administration date: 05Feb2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd, Date: 28Feb2021, Time: 10 am, Site and Route of injection:, Anatomical site of Injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: EN6198), administration date: 28Feb2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: AXILLARY MASS (non-serious) with onset Oct2021, outcome "unknown", described as "swelling underneath/below/involving the left arm pit/swelling under her left arm"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "left arm pit, feels like something is in the way and noted that it is fleshy compared to the right"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "a little bit of swelling of the lymph node"; PERIPHERAL SWELLING (non-serious) with onset 13Oct2021, outcome "unknown", described as "her left arm feels fleshy compared to the right". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The family Medical History Relevant to AE(S): Maternal grandfather- Cancer of tongue, Maternal grandmother- Cancer of liver, Father- Stroke, Mother- Colorectal cancer, Brother- Pancreatic Cancer, Paternal grandfather- Stroke, Paternal grandmother- Stomach cancer.  No follow-up attempts are possible. No further information is expected.
Caller reporting that their patient received a partial dose of MMRII due to their leg moving during administration. No PQC. No additional information.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 07-JUL-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live A (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 ml, lot #W002786 confirmed to be valid with expiration date 25-JAN-2024 (route of administration and anatomical location were not reported), for prophylaxis. The patient received partial dose due to their leg moving during administration (accidental underdose).
Right ureteral stone - treated and discharged in 13 hours. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
ended up scratching the baby; a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 6-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 17Apr2023 at 15:00 as dose 3, single (Lot number: GD1168) at the age of 6 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumococcal vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Immunization; Pneumococcal vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Immunization. The following information was reported: DEVICE ISSUE (non-serious) with onset 17Apr2023 at 15:00, outcome "unknown", described as "a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination"; SCRATCH (non-serious) with onset 17Apr2023 at 15:00, outcome "unknown", described as "ended up scratching the baby".  Additional information: It is PREVNAR 13 vaccination and a part of the needle or a part of the, what you call the vaccination two things fell apart while giving the vaccination to a baby. It happened on 17Apr2023 at 15:00, this was the third dose of the baby. The blue portion of the syringe of the vaccine shot came off while injecting. The nurse pulled it out quickly. However, it scratched the child, and she ended up pricking herself with the needle. When probed if the needle got injected to nurse accidentally, no. The blue part on the syringe or the needle broke off while giving the vaccine to the baby. So, when she pulled it out knowing that it is already broken, ended up scratching the baby and poking herself at the same time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300164496 Same reporter/ drug, different patients;
Tennis ball sized area of swelling, redness, and warmth to injection site. Sore muscles around injection site. Congestion and low-grade fever.
Suspected seizure lasted about 4 minutes. patient was not responsive to friend and was "foaming at mouth and choking on tongue" with described post ictal period
Case number PHEH2014US003819 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow-up received on 07 Apr 2014: This report refers to a 12-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on 27 Dec 2013 at 2.51 pm. This was the initial application of FLUCELVAX. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow-up received from the pharmacist on 07 Apr 2014: Updated time of vaccination and batch number of FLUCELVAX. Following an interval review on 18 Aug 2014, a significant correction was done for the information received on 07 April 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child.
At the reported date, I had a general feeling of being unwell and a bit of muscle stiffness during my runs. I also felt some mild depression in the following week (10/2-8) that I did not have before the shot. My symptoms began improving over the course of that week. However, starting  around 10/9, my back and neck muscles progressively became more sore, and I felt a little muscle fatigue. Then, on midday 10/11, I started to feel more muscle aches (particular in the upper back and shoulders), lightheadedness, headache, and stomach upset. These symptoms were similar to what I felt the week prior, but they increased in their severity on 10/11. In the following days, I continued to have muscle aches and stiffness in my upper back, shoulders, and neck, felt easily agitated/anxious, and had one bout of diarrhea (on 10/21). My symptoms gradually began to improve after 10/21, but the back pain and anxiety have not completely resolved.
Patient reported swelling, redness, and itching locally around injection site. Instructed them to take BENADRYL 50 mg STAT then 25 mg every 4-6 hours.
After receiving the SHINGRIX vaccine, I developed a rash which covered approx 30% of my body.
Began to feel extremely cold and couldn't stop shaking.  Took a two hour nap and woke up with a fever of 104.6.  Showered and the fever dropped to 102.4.  Took Tylenol and Motrin and fever broke about three hours later.  The fevers continued and I was admitted back into the hospital for four days.  Tylenol and Motrin worked to break the fever, but the fever would come back once the medicine wore off.  Fevers fluctuated between 99.6 and 102.4 for more than a week.  The blood cultures taken showed that my white blood cell count was elevated, but they couldn't not find an infection.
About five minutes after injection my head began to tingle felt heavy.; About five minutes after injection my head began to tingle felt heavy.; Then my tongue felt tingly on both sides.; Developed chest tightness; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration, administered in left arm on 29Jan2021 (at the age of 65 years old) as dose number unknown, single for covid-19 immunisation. Medical history included cardiovascular disease, hypertension, fibromyalgia, asthma, apnea, high cholesterol, hypothyroidism and known allergy to IVP dye, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient previously took levofloxacin (LEVAQUIN) and oxybutynin hydrochloride (DITROPAN), and experienced known allergy to both. Patient also had flu shot (date unknown) for immunization and experienced known allergy to it. Patient had other medications in two weeks which were unspecified. The patient had no other vaccine in four weeks. The Covid-19 vaccine was administered in hospital. It was reported that about five minutes after injection on 29Jan2021, patient's head began to tingle felt heavy and then tongue felt tingly on both sides and then developed chest tightness. Adverse events (AEs) resulted in emergency room/department or urgent care, physician office visit hospitalization on unknown dates in 2021 (with reported 1 day hospitalization). Therapeutic measures were taken as a result of the events reported which included Benadryl and steroids. The patient had no Covid prior vaccination and was not tested for Covid post vaccination. The outcome of the events was recovered on an unspecified date in 2021.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Leg cramps on & off involving her left leg after second shot; Hard to walk after second shot/Needs a walker to walk after second shot; Pelvis hurts when walking after second shot; Hard to walk after second shot/Needs a walker to walk after second shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps on & off involving her left leg after second shot), GAIT DISTURBANCE (Hard to walk after second shot/Needs a walker to walk after second shot), PELVIC PAIN (Pelvis hurts when walking after second shot) and WALKING AID USER (Hard to walk after second shot/Needs a walker to walk after second shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced MUSCLE SPASMS (Leg cramps on & off involving her left leg after second shot), GAIT DISTURBANCE (Hard to walk after second shot/Needs a walker to walk after second shot), PELVIC PAIN (Pelvis hurts when walking after second shot) and WALKING AID USER (Hard to walk after second shot/Needs a walker to walk after second shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Leg cramps on & off involving her left leg after second shot), GAIT DISTURBANCE (Hard to walk after second shot/Needs a walker to walk after second shot), PELVIC PAIN (Pelvis hurts when walking after second shot) and WALKING AID USER (Hard to walk after second shot/Needs a walker to walk after second shot) outcome was unknown. No Concomitant medications were provided by the reporter.
I started feeling the normal achy nausea headache. Got aspirin. Went back to sleep. About 9am went to kitchen and felt nauseous. Made tea and toast and then passed out. My husband came to help me up. I regained consciousness but everything was foggy. I needed to vomit after drinking water. I went back to bed. Husband called ambulance. EMTs came and my blood pressure was low. They took me to the local hospital. I went through testing and monitoring. My pulse and oxygen went up and down. I stayed at hospital for about 5 hours and was released. I did not pass out again but still had a headache. Within one more day I was fine, symptom free.