chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient reports a "chicken-pox like" rash that is itchy and red-spotted with small pustules. It starts above the knees and runs down to her feet on both legs. States it started 2-3 days post vaccination and has worsened some since. She has been treating it mainly with benadryl at night which has helped some, but is now using a leftover medrol dose pack as of today (5/20/21). She has a appointment to get the rash looked at next week.
Lethargy x 4 days, slight dizziness upper left arm red and swollen for 4 days then resumed to normal.
6 Days after first dose- Rash on extremities; This is a spontaneous case from a contactable consumer (Patient) reported for himself that: A 58-years-old male patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:00 (Batch/Lot Number: EN6205) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 58 years). The patient past medical history included Anemic from an unknown date and unknown if ongoing, Neuropathy peripheral from an unknown date and unknown if ongoing, High BP from an unknown date and unknown if ongoing and Borderline Diabetic from an unknown date and unknown if ongoing. There were no allergies reported. Concomitant medication included Gabapentin taken for an unspecified indication, start and stop date were not reported, Lisinopril taken for an unspecified indication, start and stop date were not reported, Atorvastatin taken for an unspecified indication, start and stop date were not reported and Allopurinol taken for an unspecified indication, start and stop date were not reported. Facility type vaccine: Pharmacy or drug store. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 02Mar2021,6 Days after first dose- Rash on extremities- following second shot came back worse- Almost 4 weeks after 2nd shot it appears to cover much more of my body and itches worse than any other time. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was reported. The event outcome was Not recovered.  The patient received 2nd Dose on 25Mar2021 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left for COVID-19 immunization.  No follow-up attempts are possible. No further information is expected.
Day of injection:  Sore Arm First  Day after Injection: weakness, tiredness, had to sleep or doze throughout the day, feeling sick and ill, no energy, sapped of strength Second Day after Injection:  alarming redness and swelling in arm where injection was given
pt recv vax & was found to be 3-4 wk pregnant; lab eval 26DEC93 revealed neg anti-HBS; smoked 10 cigarettes per day during pregnancy & devel hypertension; baby born & placed on phototherapy for jaundice
Swelling of the face started late Friday after dose was given, approximately 6-8 hours later. Swelling of face persisted still on Monday.
arm swelling ( shoulder to elbow), sore arm, fatigue, headache, general sick feeling
joint is quite stiff and swollen; joint is quite stiff and swollen; Lot of pain in joint; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (joint is quite stiff and swollen), JOINT SWELLING (joint is quite stiff and swollen) and ARTHRALGIA (Lot of pain in joint) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Previously administered products included for Inflammation NOS: Prednisone. Past adverse reactions to the above products included No adverse event with Prednisone. Concurrent medical conditions included Inflammation NOS. Concomitant products included OMEPRAZOLE for an unknown indication.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (joint is quite stiff and swollen), JOINT SWELLING (joint is quite stiff and swollen) and ARTHRALGIA (Lot of pain in joint). At the time of the report, JOINT STIFFNESS (joint is quite stiff and swollen) and JOINT SWELLING (joint is quite stiff and swollen) outcome was unknown and ARTHRALGIA (Lot of pain in joint) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for an unknown indication. Patient received PNEUMOVAX 23 two years in a row. There were no adverse effects reported. No further information was reported. Additional information is not expected.
Received first Pfizer Covid-19 vaccination today and shortly      thereafter with tightness in throat, itching. No generalized      rash, itching, dyspnea, wheezing, swelling of lips, tongue and      no dizziness. Has not seen a provider for a while.  Medication name: benadryl inj Dose: 50mg/1ml  Route: IM  DIAGNOSIS  Adverse reaction to Pfizer Covid-19 vaccine  Hypertension  Obesity  DM type 2    PLAN: Feels better after RX. Has HTN and DM type 2. Begin Lisinopril, Metformin,  follow-up with PCMC, would defer 2nd Covid vaccine unless premedicated and in  monitored setting.  Per Dr. Note Site: right deltoid Time of administration: 0908  Medication name: solu-medrol inj Dose: 125mg/2ml  Route: IM  Site: right glute maximus Time of administration: 0910
Patient states that he started with burning sensation in both eyes followed coughing and swelling of the mouth and tongue.
blurred vision; This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th June 2019, 1 days after receiving Shingrix, the patient experienced blurred vision. On 5th June 2019, the outcome of the blurred vision was recovered/resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on left arm and the following day post vaccination, the patient experienced blurred vision all day. The patient recovered the day after. No further details were provided This case was linked to case US2019101108 reported to same reporter.
rheumatoid arthritis through entire body, weak, tired, sl h/a-swelling in hands & face-body aches all over;sx occurred 2 wk post vax & sx cont to present;
10 to 12 hrs p/vax pt devel t101, mom noted spell where pt pale, unresponsive, diffuse jerking that could not be stopped w/pressure; tongue appeared abn in position as if gagging w/abn sound; duration 5 mins; resolved w/no treatment; no se;
Patient experienced extreme myalgia in upper right leg which persisted for 48 hours, then the pain subsided very slowly over the next 4 days. This started 4 hours after administration of the vaccine. (The date of vaccination entered in Question 10  approximate, actual date was within 10 days of 10/18/2005)
Pertinent Medical History: "might have a low immune system"; Caller states she had shingles 3 times with the last occurrence in 2000.; Caller is unsure if she has already had the vaccine but remembers getting an injection after the second time she had it but the date is unknown.; This spontaneous report was received from a consumer, referring to herself as a female patient of unknown age. The patient's pertinent medical history and previous drug reactions or allergies were not reported. The patient stated the she the took blood pressure medication.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), to prevent shingles, the route of vaccination was reported as 'injection" (formulation, strength, dose, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were not reported).  The patient stated, that she had shingles 3 times with the last occurrence in 2000 (herpes zoster) (conflicting information, also reported as "AE Onset Date: "about 6 years ago"). In addition, she also stated that she was unsure if she had already had the vaccine, but she remembered getting an injection after the second time (circumstance or information capable of leading to medication error).   She also reported that, she "might have a low immune system" (immune system disorder).  The patient did not sought medical attention, and she did not received treatment for the adverse events.   The outcome of herpes zoster and immune system disorder was reported as recovered. The causality assessment between zoster vaccine live (ZOSTAVAX) with the aforementioned events was not provided.
1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea
Had shots at around 10AM, at 3PM mother noted fine red raised rash on torso, neck, some on back.
Arm pain in upper muscle rt arm since vaccine was given. Did not have redness or swelling. No nodes noted. Point tenderness on deltoid area. Radiology report-no radiographic, abnormality rt humerlis. Treatment-Ibuprofen 400-600mg tid with food 1 month.
Felt ill; Fatigue; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Discontinued. On an unknown date, the patient experienced MALAISE (Felt ill), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MALAISE (Felt ill), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown and CHILLS (Chills) and HEADACHE (Headache) had resolved.            Concomitant Medication use information was not provided by reporter.  On unknown dates, the patient experienced felt chills, fatigue, felt ill, patient was not getting better on humira, felt headache and fever. on unknown dates, felt chills and felt headache resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality of humira for the event of felt chills, patient was not getting better on humira and felt headache with humira(adalimumab) was no reasonable possibility. Also, causality for the event of fatigue, felt ill and fever was not provided.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was inadvertently vaccinated SC with a 0.5 ml dose of live (Merck) VARIVAX (lot # 669645/0033AA) on 04-JAN-2013 that had expired on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Onset of vaccine: 17:19 Onset of symptoms at 17:25 with tongue tingling to entire tongue Onset of other sx at 17:27: red hands  Patient opted to stay in waiting room until hand concern She ambulated without assistance to medical center She was given Benadryl 25 mg po with water, tolerated well at 17:47  VS taken and stable 128/74 RR: 14 Pulse 82  At 18:00, sx of tongue tingling improved, but tinnitus BL worsened - this is common for patient She was discharged to home at 18:07 with her partner Instructed to call PCP in AM, and watch for other developing sx of allergy/anaphylaxis overnight
Began with a piercing headache, all-over body aches, and joint pain that was near debilitating. These started at 7 hours and 15 min post-injection (felt completely normal up until symptoms began). Injection site EXTREMELY sore. These symptoms lasted for 48 hours from onset despite alternating Tylenol and Motrin every 3-4 hours. 48 hours after injection, I began running a fever (101) which only lasted about 8 hours.
Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: Pt states they hadn't eaten and were dehydrated. pt definitley fell to ground from seated position. possible seizure activity for <1 mins
Client was in the clinic for her first dose of Moderna vaccine, received at 1248. At 1315, while seated in observation, she reported to observation staff that she felt itching and heat under her chin. Visual assessment by RN showed a raised red rash to the area. There was no s/s swelling/redness to lips or face and there was no s/s respiratory distress. RN and MA brought Client to the curtained area, where she laid down on cot.  At 1320, RN administered 50mg of Benadryl PO. RN and doctor entered area at this time. VS at 1320 were: BP 186/106 laying, HR 86, SPO2 98% RA. Client denied a history of hypertension and reported a sensation of heat to her face in addition to the itchiness under her chin, but denied any other s/s. Doctor educated client, recommending that the client still receive her second dose, but that she should report this reaction and wait 30 minutes for observation at her next appointment. VS at 1325: BP 154/84 laying, HR 82, SPO2 98% RA.  At 1328, Client reports that she felt ?a little better? and the rash to her chin was visibly improving. She also reports that she has a history of anaphylaxis after ant bites when she was younger. At 1335, Client reported that her upper lip was ?a little tingly/numb?, that her face continued to be hot and that she had a slight headache. When asked by doctor, she reported that the inside of her mouth felt fine. No respiratory distress noted, the rash to her chin was resolved, and the client denied any other s/s.  VS at 1335: BP laying 145/96, HR 79, SPO2 98%. RN provided education to Client regarding s/s to watch for and when to seek out medical care after she exited facility today. Client verbalized understanding. VS at 1345: BP laying 152/90, HR 67, SPO2 98% RA. Client was advised to avoid driving and that she may feel sleepy/sedated r/t Benadryl dose, verbalized understanding. Client was cleared to exit facility at 1350 by doctor. Exited at 1355 accompanied by husband, who will drive and monitor her at
Rash that comes and goes over several areas of the body every night . Rash is not alleviated unless treated with cortisone . Since September
Patient's left foot began to toe inward.  He denied any pain and there was no trauma, injury, splinter or bruising.  Passive movement was all intact and non-painful.  He walked on the lateral aspect of his foot for about 48 hours before the gait abnormality resolved.  This occurred 17 days after he received the MMR vaccine.  (The vaccine was also administered on the left side which may or may not be related.) No other neurological symptoms occurred at the time or since the abnormality.
Pt admitted with sepsis related covid and periapical abscess. Pt reamained on room air, pt discharged on antibiotics. IV hydration given for Aqute kidney injury.
Initial report received from a health care professional on 29 October 2008. A 37-year-old pregnant female patient had received a left deltoid intramuscular booster injection of ADACEL at the health department on 11 August 2008. Date of patient's last menstrual period was 28 June 2008 and estimated date of confinement is 04 April 2009. The patient reported that his is a twin pregnancy. The patient also reported having "tests" done (not specified). At the time of the report, the patient had not experienced any adverse events since she received ADACEL. Follow-up information received 09 February 2009 from a health care professional. The patient's date of last menstrual period was 27 June 2008 (previously reported as 28 June 2008) and her past obstetric history included one previous pregnancy which resulted in a live birth with no congenital anomalies. The patient is a health care professional and was receiving additional evaluation by another obstetrical facility due to advanced maternal age with twin gestation. The patient developed a urinary tract infection (date not specified) and received corrective treatment with KEFLEX (dose not specified) and MACROBID 100 mg b.i.d. on 20 October 2008. The patient subsequently developed an upper respiratory infection (date not specified) and received a Z-PACK (dose not specified) as corrective treatment on 14 November 2008. The patient also received PROTONIX 40 mg q.d. on 10 December 2008, and ZANTAC 150 mg b.i.d. on 15 December 2008 for acid reflux. Additional maternal drug exposures included CELEXA for depression?, nausea and vomiting were not reported. Relevant laboratory and diagnostic test results for alpha feto protein, serologies, serial (multiple) ultrasound, and genetic screening (AFP and Level II US) were normal. According to the reporter, the patient had not reported any adverse events secondary to the vaccine. The patient had been 28 weeks gestation, and was "living and well" at the time of the report. Documents held by sender: None.
GARDASIL #2 given 10/11/11, on 10/26/11, had episode awakening confused, abnormal speech x10 minutes, bloody tongue. EEG performed & was normal. 2/1/12, had 2nd episode. MRI normal, Lyme (-), electrolytes normal. Will get neuro consult.
Anxious with injections, felt lightheaded, then near syncope, placed to floor by staff with recovery, BP 80/50 in OBS- felt better, BP 84/54 at time of discharge and normal  condition
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 17-JUL-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M042849, expiration date 18-JAN-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to temperature excursion of -13 degrees Celsius for 8 hours and the data logger was involved. There was no previous temperature excursion. Sterile diluent (MERCK STERILE DILUENT) was stored properly. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006150: