chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling antsy/cannot relax even though she was tired; can not relax even though she was tired/tiredness; muscle and joint pain; muscle and joint pain; headache was worse/headache very much so; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 21Apr2021 (at the time of 22-year-old) at single dose for COVID-19 immunization. The patient medical history included chronic migraines. Concomitant medications were not reported. The patient previously took acetylsalicylic acid/caffeine/paracetamol (EXCEDRIN) for chronic migraines. On an unspecified date it was reported that patient had the first dose of the Pfizer covid 19 vaccine yesterday, 21Apr2021. She has underlying health issues. She was feeling antsy which only started today. it was not like her heart was racing or beating really hard, just she cannot relax even though she was tired. She has chronic migraines and took Excedrin earlier. It was also reported that maybe the ingredients of the vaccine do not coincide with the caffeine in the Excedrin. She has muscle and joint pain bad today, but her arm was fine. Tiredness and headache very much so. The headache was worse today. She took fiorinal with codeine for the bad headache because the RPh (registered pharmacist) said it was ok. she read side effects and asked the agent if agent was saying that feeling antsy is not a side effect of the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Cellulitis located on right upper arm. Tx with antibiotics.-KEFLEX.
Erythematous blanching pruritic rash on feet and hands.   Rash is on the dorsal and ventral side of feet and hands.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patients pertinent medical history was not reported. ON 11-SEP-2014 the patient was vaccinated with improperly stored ZOSTAVAX (reported as 19400 PFU) (Dose/Frequency: Unspecified, Therapy Route: Unspecified) (lot # K000326 and expiry date: 27-FEB-2015). Concomitant medications were not reported. The temperature excursion for the ZOSTAVAX was found to be unsupported by the in-house stability data. No adverse symptoms reported. No product quality complaint (PQC) was filed for ZOSTAVAX. Additional information has been requested.
Child had to be sent to hospital.Respitory failure/ pneumonia.He almost died!  12/18/07 Reviewed vax record & updated VAERS database.  12/21/07 Reviewed hospital records faxed by CDC which reveal patient experienced irritability, sleep disturbance, cough, fever & respiratory distress X 1 day.  Seen by pcp & admitted to outlying hospital.  There patient vomited & O2 sats decreased.  Respiratory status continued to decline & transferred to higher level of care PICU.  Tx w/IV antibiotics, steroids, nebs.  Intubated x 3 days.  Pulmonary & surgical consults done.  Bronchoscopy done.  No foreign bodies.  Extubated w/o problems but remained in PICU secondary to withdrawal.  Progressed well & d/c to home on continued oral antibiotics & f/u w/pcp & pulmonary. FINAL DX: respiratory failure; pneumonia, presumed; & opiate & benzodiazepine withdrawal.
10:43 am- patient returns to pharmacy with help from a sibling feeling nausea, light headed, throat and chest tightness.  Patient still talking and breathing normally so started monitoring patient  10:50 am- patient chest tightness seems worse, light headed when sitting up and symptoms not subsiding much so EMS called to evaluate.  10:58 am- EMS evaluates patient- EKG, BP, Pulse Oximeter, no signs or symptoms of allergic reaction but patient still complaining of chest tightness, nausea and lump in throat.  11:10 am- patient still with some symptoms but declined ER visit, advised by EMT to take diphenhydramine if needed and/or follow up if symptoms get worse.  1:57pm: Patient doing better per father
A non-serious spontaneous report of half dose of FLUMIST was received from a healthcare professional concerning a 27 year-old. On an unreported date the nurse forgot to pull the clip off the second half of the dose and the patient only received half a dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Extreme vertigo with dizziness, nausea  - room spinning when standing, sitting, & lying down.  Symptoms worsened with turning head, looking up. Unable to walk without assistance. Unable to drie.  Started 8/26/20 at 2:00 am. Symptoms persisted through 8/29/20 at 6:00 pm.
received her first dose in 7/2019.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient, did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
bilateral pneumonia; COPD exacerbation; bronchitis; This initial spontaneous report was received from three lawyers, regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 06-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after vaccination, the patient suffered a severe persistent cough associated with chest discomfort, right rib pain, headache and shortness of breath. The patient was ultimately hospitalized and diagnosed with having bilateral pneumonia, chronic obstructive pulmonary disease exacerbation and bronchitis. The outcome of the events was not reported.  The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event pneumonia was determined to be medically significant.
approx 24hr p/vax pt mom reports pt has red, sl raised rash extending from 3" above umbilicus to base of neck;pt c/o pruritus;pt MD recommended DPH for itch;sx began 8/4/99;
Tinnitus, including Pulsatile tinnitus.  I experienced "low level" bilateral tinnitus for approximately 4 years prior to receiving this vaccine (1-2 level on a scale of 1-10).  Following receipt of the Pfizer Bivalent booster in early October 2022, my tinnitus level increased substantially (now 7-8 on a scale of 1-10), including onset of intermittent Pulsatile tinnitus primarily in my left ear.
fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 6 patients. This is 1st of 6 reports. This 31-year-old female consumer reported.   A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 31-years-old) on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: 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 immunization. On an unspecified date, the patient experienced fever of 101 F and muscle aches 26 hours after receiving her second Pfizer - BioNTech COVID vaccine. Symptoms lasted approximately 7 hours and symptoms were relieved with treatment medication. Patient stated that 5 other individuals within her department also experienced similar symptoms after receiving the second dose. Treatment medication included one dose of Tylenol. The patient underwent lab test and procedures on an unspecified date which included body temperature of 101 F. Outcome of the events was reported was recovered on an unspecified date.   Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157492 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157494 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157495 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157496 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157493 Same reporter/ drug/ event for different patients
This spontaneous report as received from a healthcare worker refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-FEB-2016, the patient was inadvertently vaccinated with a dose of M-M-R II (dose, route of administration and lot # were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
After the first shot my right arm got numb and I got the shot in the left arm though; tingling in my fingers too; After the first shot my right arm got numb and I got the shot in the left arm though; tingling in my fingers too; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection)(at the age of 78-years-old), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 (Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It was reported that Couple of hours after (On 02Mar2021) the first shot her right arm got numb and she got the shot in the left arm though. And tingling in her fingers too. It was a few hours after she got the first shot on 02Mar2021, that is the first dose. Patient received second dose of BNT162B2 (Lot Number: ER2613) on 24Mar2021 for COVID-19 Immunization. Regarding treatment for numbness and tingling Consumer stated, No, it went away after a several hours she guesses. she went to bed and by morning she was fine. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Shots were given on 09/06/2006 and this child's mother called in on 09;07/2006 to report that child had high temp.  Weight is ~23-24 pounds/mom.  She has been giving both Tylenol and Motrin per instructions from her doctor.  The amount she states she is giving is in line with recommendations from the manufacturers of the medications for the child's weight.  Temp has been up to 103 and she is taking temp rectally she states.  Child is also fussy and not eating or drinking well.  This RN advised that mom contact the physician again and arrange an appointment today or go to ER to be certain is not also an illness along with fever from immunizations.  I will contact her tomorrow to monitor.  On 09/08/2006 this RN spoke with mom again and she states child was seen by family physician yesterday and nothing was changed regarding medications by the physician.  He feels that child will be greatly improved in one or two more days and fever is just from shots.  Mom states that physician feels child is well other wise.  Child is drinking much better today.  Not taking alot of "solid" foods.  Encouraged to drink today.  Today the temp was 103 at 6:00 a.m. and was 99.2 at 10:15 a.m.  Advised mom to contact me again if problem continues or anything changes.
Pt reported full arm redness (not hot to the touch), really sore, felt very "flu-like" so much so pt had to rest for a half day.
10pm began convulsive shivering, headache, nausea, diarrhea, back pain, swollen lymphnodes, freezing cold extremities.  2am- 2/26 shivering and cold extremities ended. The rest of the symptoms persisted. Including exhaustion.  730pm- 2/26 pain/tightness in chest and fever 101 as new symptoms . Other symptoms besides shivering remain.
Asthma-like cough/throat constriction - attempted CHLORASEPTIC spray to treat. Dyspnea/tightness in chest.
First moderna shot on 1/12 and due for his second shot, turned away due to being 17 years; A spontaneous report was received from a consumer (patient's mother), regarding a 17 years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), which resulted in, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years (product administered to patient of inappropriate age).  The patient's medical history was not reported. No concomitant medications were reported.  On 12 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  The consumer reported that the patient was given his first Moderna shot on 12 JAN 2021. On 10 FEB 2021, the patient was due for his second shot and turned away due to patient being 17 years. The consumer contacted their primary care physician and trying to find out a way to get the patient his second shot, so the first one does not go waste. The consumer would like to enroll the patient in the trial for the second shot. No treatment medication information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years, was recovered on 12 JAN 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
PERSISTENT CENTRAL AND PERIPHERAL NERVOUS SYSTEM INFLAMMATION; LUMBAR NERVE ROOT ENHANCEMENT/RADICULITIS; This spontaneous report was received from literature. This report concerned a 34 year old female of an unspecified race and ethnicity. The objective of this case series was to report a case of a patient who developed neuro-inflammation following administration of the J and J vaccine (Ad26.COV2.S). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date 2 weeks after J&J covid-19 vaccination, the patient experienced persistent central and peripheral nervous system inflammation, and on an unspecified date experienced lumbar nerve root enhancement/radiculitis. It was reported that the patient developed blurred vision, body aches, paresthesias and urinary retention 2 weeks after J&J covid-19 vaccination, and 3 months later patient developed new enhancing brain lesions with persistent enhancement in the spine. Laboratory data (dates unspecified) included: Magnetic resonance imaging revealed large, mostly enhancing fluffy occipital/parietal lesions, cervical lesion, longitudinally extensive thoracic lesion and lumbar nerve root enhancement, and CSF (cerebrospinal fluid) test revealed neutrophilic pleocytosis and elevated protein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the persistent central and peripheral nervous system inflammation and lumbar nerve root enhancement/radiculitis was not reported. The authors of this case series highlighted that central and peripheral nervous system inflammatory involvement without clear alternative explanation can rarely be seen in close temporal relationship to administration of the J&J COVID-19 vaccine. Unusual feature of this cases was clinical/radiographic worsening and persistent enhancement several months after initial presentation. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20221218576 and 20221219487.; Sender's Comments: V0: 20221219559- persistent central nervous system inflammation, lumbar nerve root enhancement/ radiculitis.   The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
pt passed out after 3rd shot (HPV) awoke quick very pale, lying down on exam table. Dr was called immediately to check patient     ****Computer shuts down before full report is completed/typed ****
Roughly a month after second vaccine it was noted that my blood pressure was 150/110 at a doctors office.
APPROXIMATELY 21 HOURS AFTER INJECTION (R) mid-thigh circumference=27 cm.; (L)= 28.5 cm. (site of injection is clean on the Left anterior thigh); there are spotty ecchymotic lesions on the same anterior thigh & few similar lesions on the (R) lower leg, suggesting a systemic reaction;
Feel pain for my 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Feel pain for my 2nd shot). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient feel pain for his/her 2nd shot for how many days. The patient stated that, thanks god he/she ok now. The follow-up could not be possible as no contact details were available.
Pt is a 48 yr/o male who presents with transient episode of lightheadedness and feeling like he was going to pass out with blurry vision which started while he was driving to work today.  Symptoms have resolved upon arrival to the ED.  He had no other associated symptoms.  Denies headache, numbness tingling weakness, chest pain, palpitations, shortness of breath.  He ate a ham sandwich and drank plenty of water prior to leaving the house.  He states he is often "dehydrated "because he works in a hot warehouse and sweats a lot on the job but had not begun working yet this evening.  He tries to drink lots of water and electrolyte drinks such as Pedialyte when he is at work.  Of note, he states his doctor was concerned recently because of some abnormal liver enzymes and mildly elevated blood glucose readings on routine lab work.
A large marble-sized knot with heat at the site, and soreness; A large marble-sized knot with heat at the site, and soreness; A large marble-sized knot with heat at the site, and soreness; Allergic reaction to flu vaccine; This spontaneous case was received on 04-Nov-2021 from other non-healthcare professional (consumer) via Agency (reference number: SEQW21-05080) and concerned a female patient of an unreported age.  The patient's concurrent condition included malignant neoplasm of unspecified kidney, except renal pelvis. The patient's concomitant medications were not reported. The patient never had a reaction to the vaccine before.  On an unspecified date in Sep-2021, the patient started with non-company co-suspect Lenvima (lenvatinib mesilate; dose: 18 mg, daily (qd), route of administration: oral and anatomical location: not reported) for malignant neoplasm of unspecified kidney, except renal pelvis. The batch number was not reported.  On an unspecified date in 2021, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unspecified date in 2021, reported as recent, an unknown amount of time after receiving influenza virus vaccine polyvalent and non-company co-suspect Lenvima, the patient experienced an allergic reaction to the vaccine, a large marble-sized knot with heat at the site and soreness lasted for two weeks. The patient had treatment with unspecified antibiotics that ended this week, as reported.  The outcome of the events was unknown.  The reporter assessed the events as related to influenza virus vaccine polyvalent as the patient experienced an allergic reaction to the vaccine.   The case was assessed as non-serious.  Company comment: A female patient of an unreported age developed a painful and warm mass at vaccination site (reported as an allergic reaction to the vaccine) after receiving influenza virus vaccine polyvalent. Besides, treatment with non-company co-suspect product Lenvima was initiated an unknown amount of time before vaccination. Due to the lack of information regarding chronology, causality for the reported events is unassessable.; Reporter's Comments: The patient experienced an allergic reaction to the vaccine.; Sender's Comments: A female patient of an unreported age developed a painful and warm mass at vaccination site (reported as an allergic reaction to the vaccine) after receiving influenza virus vaccine polyvalent. Besides, treatment with non-company co-suspect product Lenvima was initiated an unknown amount of time before vaccination. Due to the lack of information regarding chronology, causality for the reported events is unassessable.
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient self-reported that she \"doesn't do well with needles\".  After about 5-10 minutes post-vaccine, she called for help feeling tingling all down her arms into her fingers. She was shaky and it seemed like she fainted but was still somewhat responsive.  She was also dazed and shaking.  After vomiting, she was more lucid but still felt poorly. EMTs arrived on scene and took her blood pressure & found that she was very hypotensive. Recommended that she be transported to hospital due to low BP.
Patient developed a skin rash on bicep and forearm of arm vaccination was administered. Patient reported no shortness of breath. Only symptoms present was itching around rash area. Pt instructed to follow up with primary care provider for potential allergy testing. Notified to contact facility of symptoms change or if rash worsens. Patient gave verbal understanding.