chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23. On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Dizziness; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WENT TO OPTHALMOLOGIST I WAS DIAGNOSED WITH A POSTERIOR VITREAL DETACHMENT
Fatigue and headache started shortly after the vaccine. There was a sense of heat and chills.  At 3:00 am, woke up with squeezing chest pain,  sharp stomach pain , dizziness and presyncope.  Magnesium cream was applied to the chest wall and to the abdominal wall.  Thiamine and Rhodiola and probiotics were given.  Symptoms improved today.
This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerning a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when turned upside down upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Patient reported she was experiencing pain in her administration arm shortly after receiving the vaccination. She had full range of motion, but noted it was painful to move her arm. The pain was localized to the upper arm/shoulder area. It did not seem to be tender to touch, but was affected with movement of her arm at the shoulder joint.
Patient reported feeling like she had a pinching nerve pain on the left side of her neck/shoulder. BP: 193/107; 226/130; 187/110. Patient was transported to the Emergency room following EMS assessment.
I woke up the day after receiving the vaccine with full body aches and severe joint pain, especially in the hips making it difficult to walk comfortably.  I also had a moderate to severe headache.  I was unable to work that day.  The pain lessened with ibuprofen but returned later in the day.  By the next day, symptoms were a lot better and after 2 days the symptoms completely resolved
Erythema to site of vaccine approx 5 minutes after administration. BENADRYL 12.5 mg chewable 1 tab given at 3:56 pm.
Chief Complaint  Pt with weakness and cough.  History of Present Illness  Patient is a pleasant 99-year-old female patient of Dr. with a past medical history as listed and reviewed below who presented to our emergency department tonight via EMS with reports that she has been more somnolent with a loose cough.  Normally she uses a walker but was apparently requiring more assistance today and she endorses "my legs aren't very strong."  She relates that she had at least one loose BM earlier today as well as anorexia.  In the emergency department, she was noted to have low oxygen saturations as low as 87% to the low 90s on room air, which corrected with a nasal cannula.  She demonstrated a slight leukocytosis, with lymphopenia and tested positive for COVID-19.  Electrolytes also reveal an AKI on her CKD 3.  Review of records indicates that she had at least 1 dose of the Moderna SARS-CoV-2 vaccine on March 4.  Patient is admitted for further evaluation and management.
ACHY; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821281 expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUL-2021, the subject experienced achy. On 02-JUL-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and injection site pain on 03-JUL-2021. This report was non-serious. This case, from the same reporter is linked to 20210738857.
First dose: She reported GI issues (diarrhea) that lasted 4 hours  and experienced arm pain. Second dose: The patient reported headache and arm pain.
Intussusception. 01/06/2009 MR received for DOS 11/20-23/2008 with D/C DX:  Intussusception. Pt initially presented to PCP with c/o bilious emesis x3, refusing po, irritability and crying. Pale, mottled and lethargic. Sent to ER for transport to higher level of care. PE (+) for decreased activity, back arching, abdominal tenderness, single macule on suprapubic skin. IS (+) on BE but unable to reduce.  Taken to OR for Irreducible Ileocolic IS-laparoscopy.  Reduction of IS. Appendectomy. Post-op uneventful and d/c home.
The person lied about their birthdate, making them eligible to receive the vaccine.  They put down they were DOB was a specific date and their actual DOB is different  At the time the person was not eligible to receive the vaccine based on FDA guidance.
Hives and itching  all over since 4-13-21. Had 2nd Pfizer vaccine on 4-10-21. Only goes away if I take Xyzal (levocetirizine).  Has had intermittent hives since April 13. I  had my  second Covid vaccination April 10. Had no reaction of the first vaccine nor an immediate reaction to the second vaccine. not any  any dietary or environmental changes.  No new medications or supplements. No sinus congestion or allergies. No cough, shortness of breath or wheezing. No abdominal pain. I Feel well otherwise. I have been taking Xyzal(levocetirizine)  at least every second or third day which will temporarily make the hives go away. Has never had a reaction like this in the past.
Pt. initially crying with vaccines, but once vaccines were finished, pt. stopped crying, her face became still, lips drooped downward. She was looking at nurse but not blinking. Developed a dusky appearance, episode lasted less than 30 sec. Child loosened up, smiled and laid head on mom's chest. Normal color returned O2 sat 98%.
1st shot 12/30/2020   approx 1 hour after 1st shot started with a bad headache that i have been fighting with every day since then.  I have been to the doctor, been placed on steriods, I have had an MRI, I have had an appointment with a Neurologist, I've been given some new medicine to try at night and I was also given an infusion.  2nd shot 01/27/21   still continue to have bad to severe headaches on a daily basis.  Approx a few days after 2nd shot started with cold sweats, fatigue, not able to get up out of bed, would be freezing but my clothes would be soaked.  i was given more steriods and antibiotic and a covid test with was neg.  still feeling extremely week, body aches, ear aches, throat hurts.
Shingles; This is a spontaneous report from a contactable consumer or other non hcp.   A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 as a SINGLE DOSE for covid-19 immunization. The patient's medical history included hypertension. The patient previously took diphenhydramine and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810, Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 07Fb2021 12:15PM, as a SINGLE DOSE for covid-19 immunization. Concomitant medications included Benazepril, baclofen, Hydrochlorothiazide and cyanocobalamin (B-12). No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On an unspecified date Mar2021, the patient experienced shingles. No treatment taken for adverse event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Cellulitis - red, warm, 5.5x4 inches. Treated with Cephalexin 500 mg.
Patient states that she experienced a fever for the next 2 days after receiving the vaccine. Every day since then, her left arm (where she received the vaccination) feels tight - she stated that the pressure feels like a blood pressure cuff squeezing her arm. This occurs on and off. She also experiences tingling down to her finger tips a lot of the time. It has not stopped since she received the vaccination.
Rectal Bleed; Exacerbation of psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal Bleed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis since an unknown date.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RECTAL HAEMORRHAGE (Rectal Bleed) (seriousness criterion medically significant) and PSORIASIS (Exacerbation of psoriasis). At the time of the report, RECTAL HAEMORRHAGE (Rectal Bleed) and PSORIASIS (Exacerbation of psoriasis) outcome was unknown.
10/11/21-Uncertain how pain was related to the other events, but  experienced severe right deltoid/shoulder pain (in opposite arm shot was given); pain was an intense, deep ache that became severe with movement of the arm in certain positions.  10/13/21 Left upper abdominal pain, bloating and nausea occurred;  right arm pain seemed to immediately and completely resolve 10/14/21-Left upper abdominal pain very gradually moved downward to middle abdomen 10/15/21-Focal area of right medial chest pain developed overnight; pain was more noticeable when lying down or breathing in moderately or deeply.  Abdominal pain became more diffuse and across entire lower abdomen. Was seen by Dr; EKG was normal and no further diagnostic testing was indicated. 10/16/21-Lower abdominal pain; fullness; pressure; frequent urination continued, worsened and became more notable the lower right abdomen.
Lt deltoid, redness, swelling over 15cm x 15cm area hard lump inject site 1.5cm + 1.5cm & enlarged lymph node lt axilla;
He is experiencing swelling in the left arm; first dose 18May2021 and second dose 01Jun2021; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 01Jun2021 (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation and first dose on 18May2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Jun2021, the patient had 1st shot was given 18May2021 and 2nd dose was given 01Jun2021, on an unspecified date, the patient experienced swelling in the left arm. The patient wanted to check how many days he can get the pneumococcal vaccine after getting the 2nd dose of the COVID-19 vaccine. The outcome of the event swelling in the left arm was not recovered and had 1st shot was given 18May2021 and 2nd dose was given 01Jun2021 was unknown.  Information about lot/batch number has been requested.
This case was reported by a consumer via sales rep and described the occurrence of tiredness in a male patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the tiredness and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that, the patient received SHINGRIX in the deltoid last Saturday before the date of reporting. The patient felt tired for a few days and his arm hurt so they had given his arm a good rub. At the time of this report, the patient stated that he was feeling better and he was glad that he received the vaccine.
he developed pretty severe raynauds within days of getting the vaccine.  Of note the patient actually had COVID in July
she said she didn't receive the entire dose. Some of it dripped down her arm; she said she didn't receive the entire dose. Some of it dripped down her arm; A spontaneous report was received from a consumer concerning a female patient (age: unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and didn't receive the entire dose. Some of it dripped down her arm (underdose and syringe issue).  The patient's medical history was not provided. Concomitant medications reported were unknown.   On 26 MAR 2021, prior to the onset of the events the patient received her first of the two planned vaccine doses of mRNA-1273 (lot/batch : unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient said that she didn't receive the entire dose. Some of it dripped down her arm and she wants to know how this will effect the efficacy of the entire dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event didn't receive the entire dose, some of it dripped down her arm, was considered unknown.; Reporter's Comments: This report refers to a case of Underdose and syringe issue, for mRNA-1273, lot # unknown,  with no associated AEs.
About 12hours after dose fever chills and joint pain with side of headache lasting untill Saturday Mar 13th.
This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received the first dose of PREVNAR 13 (Lot Number: R49358, NDC number: 00005197102, Expiry Date: Apr2018), on 08May2017 at 0,5ml single dose for immunization via intramuscular route in the right deltoid. The patient had no medical history or concomitant medications. On unknown date in May2017 the patient experienced redness, soreness, itchiness and warmness all at the injection site after administration of vaccine. The symptoms began within 24 hours of receiving the vaccine. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
Subacute Thyroiditis Following mRNA Vaccine for COVID-19; This is a literature report.  A 40-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation. Clinical Case: A patient with no significant medical history presented with signs and symptoms of thyrotoxicosis after receiving the Pfizer COVID-19 vaccine. Symptoms began 3 days after receiving the second vaccine dose and included 9 kg unintentional weight loss, arthralgia in both knees, palpitations, fatigue, bilateral thigh weakness, and diffuse neck swelling, pain, and tenderness. Initial treatment with antibiotics for presumed upper respiratory infection did not improve symptoms, and PCR testing for COVID-19 infection was negative. Thyroid ultrasound obtained 15 days after symptoms onset revealed a 4 cm nodule in the left lobe of the thyroid gland. Testing 30 days after onset of symptoms demonstrated TSH<0.005 uIU/mL (ref: 0.45-4.50 uIU/mL), elevated free T4 of 2.53 ng/dL (ref: 0.82-1.77 ng/dL), and elevated erythrocyte sedimentation rate of 42 mm/hr (ref: 0-15 mm/hr). Repeat labs and imaging 9 days later demonstrated improvement with a TSH of 0.071 uIU/mL and free T4 of 1.04 ng/dL as well as decreased nodule size (2.5 cm). At this time, the patient reported resolution of all symptoms and return to baseline weight. Thyroid ultrasound obtained 3 months after symptoms onset demonstrated normal thyroid without detectable nodules or enlargement, and complete normalization of TSH and free T4 levels to 4.250 uIU/mL and 1.22 ng/dL, respectively.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Subacute Thyroiditis cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Herpetic rash on fingers; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0170) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient had no Covid prior vaccination. The patient had Covid tested post vaccination. Concomitant medication(s) included: ZOLOFT; TRILEPTAL; WELLBUTRIN. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: RASH VESICULAR (hospitalization) with onset 28May2021, outcome "not recovered", described as "Herpetic rash on fingers". The patient was hospitalized for rash vesicular (hospitalization duration: 1 day(s)). The event "herpetic rash on fingers" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (04Aug2021) negative, notes: Nasal Swab; sars-cov-2 test: (13Aug2021) negative, notes: Nasal Swab. Therapeutic measures (Intravenous antibiotic) were taken as a result of rash vesicular.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (reported for a female) via Pfizer sponsored program support.A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (Nyquil) taken for an unspecified indication from 15Mar2021 to an unspecified date. On an unspecified date, patient experienced cold, mucus or nasal discharge (secretion discharge, rhinorrhoea) and congestion. Caller stated that his fiance and himself received their first dose on 23Feb2021. They have colds and mucus or nasal discharge; inquired as if they should continue to get second dose on 16Mar2021. Therapeutic measures were taken as a result of events which included treatment with Nyquil for congestion on 15Mar2021. The outcome of events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained.
18JUL96 3hr p/vax pt c/o severe rash  last 3 days;
Intractable vomiting for 4 hours with extreme dizziness and sweating until hair and clothes wet
*ADMINISTRATION ERROR*  48 Y/O MALE PATIENT RECEIVES SECOND BOOSTER (MODERNA) BEFORE 50 YEARS OF AGE AS RECOMMENDED BY CDC.
Pt vaccinated with DTP experienced limp, white & blue around mouth, seen in ER after transport from ambulance, alert but subdued increased temp, admitted for observation.
Rash on body, itching, swollen neck, burning pain in neck. As of 9/19/16 on prednisone and hydroxyzine still. Only symptoms is itching feeling and burning neck pain.
All of sudden I couldn't bare any weight on my right leg. I went to urgent care. The doctor stated I had a meniscus tear in my leg. In June 22 my other leg collapse and went to doctors again and they did an X-ray. My cartilage in my leg disappeared rapidly. My conditions became worse. My doctor did an MRI and found out my cartilage was gone and abscess on the bone.