chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph node in neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1 single), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph node in neck".  Additional information: Swollen lymph node in neck occurred after dose 2 in primary series as well. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain, redness, warmth, swelling, diagnosed in urgent care with mild cellulitis and treated with oral antibiotics.
Pain in arm toward shoulder and down toward elbow left. Arm gets weak with internal vise like squeezing, similar to a blood pressure cuff action. Red rash from wrist up to shoulder, internal itching, symptoms still in arm.
One week after the vaccination, my left arm began to itch, and it was swollen, red, and hot to the touch. This lasted about five days before the inflammation and swelling went away. I also experienced a little bit of sort of light- headedness or sort of feeling just a little like my balance was off. As of today, Feb. 22, my arm is much better, but I am still a little bit light-headed. I have Rosacea, and that has also flared up horribly, and my face is a little bit red and inflamed
Patient received a dose of Pfizer COVID-19Vaccine  Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the Agency, due to lack of stability data, it was advised to revaccinate the patient.
Tested PCR positive for COVID-19 on 6/2/2021, more than 2 weeks after receiving the first dose of the Pfizer Covid-19 Vaccine on 04/06/2021 and the second dose on 04/27/2021.
Developed 105 cm x 70 cm area of redness at site of MMR, & itching. Treating with cold compresses & BENADRYL.
Next Morning after shot  i got up the injection site was swollen and real red, itchy burning feeling in it. ache all over and real tired stomach was upset . this morning I woke up with a scratchy throat, sneezing and headache and of and on upset stomach . I have not taken anything for it. only cool rags on it. Blood sugars are running higher than normal.
Severe joint pain in fingers and toes; Unable to use hands at times due to severity of pain. Pain was more severe than the time I broke my finger; Unable to use hands at times due to severity of pain. Pain was more severe than the time I broke my finger; Menstrual bleeding that lasted three months; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 36-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Ew0196) via an unspecified route of administration, administered in arm left on 07Jul2021 at 18:00 (at the age of 36 years old) as dose 2, single for COVID-19 immunization. Medical history included chronic fatigue syndrome and post-traumatic stress disorder. Concomitant medications included baclofen and clobazam. No known allergies. The patient previously received BNT162B2 (Lot number: Ew0191) administered on arm left on 18Jun2021 (at the age of 36 years old) as dose 1, single for COVID-19 immunization. On 30Jul2021, the patient experienced severe joint pain in fingers and toes, unable to use hands at times due to severity of pain and that pain was more severe than the time patient broke her finger and menstrual bleeding that lasted three months. The patient underwent lab tests and procedures which included nasal swab: negative on an unspecified date. Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and was COVID test post vaccination. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered with no treatment received.
Right arm is painful, cannot even raise her arm by 3 inches, cannot move it side way either. Tried hot compress but does not help.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EZ9264), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 76 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2005, stop date: 2005; "Total knee replacement", start date: 2021, stop date: 2021. Concomitant medication(s) included: PRAVASTATIN, start date: Sep2016; ALENDRONATE SODIUM, start date: Sep2020. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, latency 1 year 3 months 7 days after the suspect product(s) administration, outcome "recovering" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical course: The patient had no known allergies. On an unspecified date in May2022, the patient experienced suspected COVID-19 and led to drug ineffective. From 20May2022 to 25May2022, the patient received unspecified treatment for COVID-19 (lot number: GA1190). As part of the simplification process, the following Complaint Records were classified as Product Use Attributes / Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in UNKNOWN. Refer to the below table for details. The complaint for Lack of Effect of the PFIZER/BIONTECH COVID-19 VACCINE lot FF2589 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318 and the final scope included the reported finished goods lot EN6200; fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts were possible. No further information was expected.
Developed severe L lateral and anterior thigh pain, later associated with a rash and diagnosed as shingles- around 1 week out from the booster
refused to get 2nd shot, past a year; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year prior to the reporting date).   On an unknown date, the patients 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 reported as follows: The age at vaccination was not applicable for this report. The reporter had several patients who had chosen not to get their 2nd Shingrix shot in the appropriate time frame. Now it had even been past a year and till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked did we restart series, or just give just the 2nd dose if it had been over the year mark. The follow-up would not possible as no contact details were available.
I tested positive for COVID-19 on 6/24/22. I had a bad fever and a sore arm after my shot and I was sick for about a week. I was very tired as well.
Information has been received from a physician concerning a 68 year old female with hypertension and hypercholesterolemia who was vaccinated with two complete series RECOMBIVAX HB and a booster (dates and Lot# unknown). In 2005 a seventh dose of RECOMBIVAX HB was administered as a booster. Concomitant therapy included CRESTOR and NORVASC. The patient reported that she had low anti-HBs titer. She was not able to confirm if RECOMBIVAX HB was used for either series or booster. The patient did not seek medical attention. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
What I have noticed is that I have swelling and sensitivity along my shoulder line towards the back of my neck. How it shows itself is that I look swollen. I usually have a very fine and slender neck and now it looks like it?s swollen. The other thing that started happening was that bra straps began to irritate me. Before I noticed It, they started to leave marks on my skin. The marks now cut the skin and it?s red and has to heal. I had to start using coco butter to make sure the cuts don?t become permanent. The bras I was using may have been too tight, so I started using sports bras, but now the lines and cuts are everywhere the bras have touched on my shoulders. I mentioned this to another doctor prior, and he gave me a neck x-ray and he told me I had arthritis. I?m not having issues with arthritis. It?s not affecting the skin breaks at my shoulders. I?m not sure what the next step is. I mentioned it to my primary care and I?m not sure if she noted it. She did do some blood work. Hemogram, TSH and Lipid panel, and Cortisol. I have those results, but I haven?t looked at them yet. She said she would recommend some stretching stuff for the neck. She recommended that I cry CBD oil as a calming substance. She mentioned to reduce stress and walk. She gave me some things to help with the anxiety, but she didn?t mention anything about my neck and shoulder because they can only note so much.
He felt fine the day of the vaccine and then felt some mild flu symptoms the next day that lasted most of the day and he napped a bit. Then 3 days after the vaccine his hands were blue, and not like a fresh bruise but blue in a sense of a healing bruise (aqua blue). He had no other symptoms at the time and  it cleared up within about 20 minutes it started to lessen and cleared up completely within the hour. He had no other areas of his  body (lips, feet) that appeared blue, and he said it was just his hands. He was not overly concerned by it, but I was. I discussed it with the Doctor but by the time I got home there was nothing on him to examine. I do have some pictures.
Case number PHHY2011US35723 is an initial spontaneous report received from a nurse on 18 Apr 2011. This report concerns a 16-year-old male patient. He was vaccinated with MENVEO (batch number: 090901, expiry date: Sep 2011) 1 DF, on 11 Apr 2011. The patient received only the Men CYW-135 liquid conjugate without the Men A lyophilized powder conjugate. No adverse reaction was reported following this drug administration error.
POTS; autonomic dysfunction; orthostatic intolerance; fatigue; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender (no demographic information was provided). No information regarding the patient's medical history was provided. On 18-JUL-2013 the patient was vaccinated with dose 2 of GARDASIL, valid lot # 0298AA, which had been expired on 21-JUN-2013. The first dose was received on 15-MAY-2013. No concomitant medications was reported. No adverse symptoms were reported. No outcome was reported. Additional information has been requested.
Two weeks post 2nd dose of vax, the pt experienced arthritic-type symptoms in his shoulders and hips. Treatment included prednisone and cortisone.
Symptoms: Itchiness and intermittent/migrating hives on all parts of body.  Tightness in throat / trouble swallowing at times.  Right arm and right leg pain. Treatment: First treated with benedryl then doctor prescribed the following - montelukast (SINGULAIR) 10 mg tablet, predniSONE (DELTASONE) 20 mg tablet (taper from 60mg  for 5 days, 40 mg for 5 days, etc), famotidine (PEPCID) 40 mg tablet, Zyrtec (over-the-counter) Outcome: 3 1/2 weeks later I am still on all 4 medications - symptoms are less severe.  Will begin to come off medications shortly.
A consumer report has been received. The report concerns a 3 year old, male consumer, who has been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported the patient sneezed and liquid came out after first intranasal administration which started on 10-NOV-2014. The outcome of the event of patient sneezed and liquid came out after first intranasal administration is unknown. The report was considered to be non-serious.
A report has been received from a Physician concerns a patient of unknown gender. No information regarding relevant history and concomitant medication was provided. The patient received FLUMIST (intranasal), 0.2 millilitres started on 09-Oct-2015. Reporter received complaint from a physician who contracted a flu-like syndrome shortly after receiving FLUMIST 09-Oct-2015. The patient received a dose from lot FJ2073 and started feeling ill with stuffy nose and sore throat, that evening. He had subsequently developed fevers, myalgias, arthralgias and headache along with persistent URI symptoms. Customer was planning to obtain a respiratory viral panel on 13-Oct-2015. Product quality complaint was reported for the patient. Action taken with FLUMIST was unknown. The outcome of URI symptoms, fever, arthralgia, sore throat, stuffy nose, myalgia, headache, feeling ill, flu-like syndrome and product quality complaint was unknown. The company physician assessed URI symptoms to be serious with seriousness criteria as important medical event and stuffy nose, fever, myalgia, arthralgia, headache, feeling ill, sore throat were assessed as non serious. Product quality complaint was identified from the additional source document and assessed as serious event with seriousness criteria of important medical event. The event of flu-like syndrome have been identified by the company physician from the source documents and added as non-serious adverse event.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Covid19 breakthrough.  Vaccinated on 7/31/2021.  69 yo PMH Asthma, HTN, CKD, MDD, PTSD, arthritis, Right eye removal, AV replacement originally tested Covid + 2 weeks ago, retested 1 week ago and still positive.  Pt was trying to manage symptoms at home but presented to ER after 4 days of worsening SOB and coughing.  O2 sats at home 60's.  CXR-mild CHF.  Treated with Steroids and Remdesivir.
Patient states that she has developed "shooting, burning" pain that occurs intermittently in her arm, hand, and behind the ear after the administration of her first dose of the Pfizer vaccine. I encouraged her to seek medical care for evaluation of what sounds as if it could be neuropathy. This encounter with the patient occurred 7/26/21 when she came into the pharmacy to inform me of her symptoms and asked for medical advice. I also encouraged her to report to VSAFE and VAERS, as well. She has not sought medical treatment yet as she is uninsured, but was encouraged to reach out to the local department ASAP.
Chills; Migraine; Lethargy; Menstrual cycle that lasts 3-4 weeks,; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 22:00, the patient experienced chills, migraine and lethargy lasting 2 days following the 2nd dose and also menstrual cycle that lasted for 3-4 weeks, following the 2nd dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, migraine, lethargy and menstrual cycle that lasted for 3-4 weeks were resolved on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
Low-level continuous burning sensation at the injection site; Bit unsettling.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the arm left on 22Mar2021 at 14:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 for COVID -19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: e9264l) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced low-level continuous burning sensation at the injection site. It was not painful or debilitating but it was a bit unsettling. The clinical outcome of low-level continuous burning sensation at the injection site and bit unsettling were not recovered.  No follow-up attempts are needed. No further information is expected.
Bitter taste and itching (General)  Received Benadryl 50 mg and improved
Patient started coughing and saying he couldn't catch his breath. He said it felt like he was being strangled and couldn't breathe.
Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report (United States) was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Mom noticed pt is straining to have  bowel movement, noticed red, stringy blood in stool- started today. 06/05/2020. Bowel movements prior to today have been normal per mom.
This spontaneous report was received from a medical assistant, concerning an unknown number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored M-M-R II (lot #, expiration date, strength, dose, route of administration and anatomical location were not reported), for prophylaxis. The storage temperature excursion was reported as 1.2 degrees Celsius (°C) for a time frame of 4 hours and 3 min. There was no previous temperature excursion. No adverse effects were reported in any patients. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008764: US-009507513-1704USA008770: