chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, she felt like she could barely walk about 2 weeks after the vaccine.  She was real weak and she just was like a different person.  She does not know if it affected her bipolar disorder too, but she thought she was better from that.  She does have dizzy spells, but that got worse.  She was real weak and did not feel like herself.  She feels her fibromyalgia got worse because it was not as bad as it is now.  It was bothering her then, but moreso since the vaccine.  She felt like she was not in the room when she was, and things were going past her and she was just watching it is how she felt.  She saw her pain management doctor and she told him that she believes it from the vaccine.    She did go She went to the doctor after that and some of them they told that they did not want to hear it, they ignored her.  She was not given any treatment for her symptoms.  She went to a Clinic and she no longer goes there and goes to another Hospital clinic.  She has now memory problems, and she cannot remember a lot of stuff.  She has a hard time picking her words, and people have to finish whatever she is telling them as she cannot do it.  She is going to be checked to see if she has dementia as her mother has it as well, and is doing what she needs to do, but doing it slower.  She has fatigue so bad that it is not funny.  At that time she was not sleeping through the night either, and it was months before she got sleep and was taking Seroquel up to 400 mg and still not sleeping.  She is now able to sleep.  She is taking Nortriptyline now from her PCP.   She is now a completely different person.  She goes through a healthcare system now and has a new counselor and has an appointment with him tomorrow.  She was smoking marijuana at that time for the symptoms of her fibromyalgia.  Her pain management doctor now has given her other things to help for the fibromyalgia and that has not helped.    She is now scheduled to see a hematologist.  Her platelet count is low now, and has to wait until it is over 100,000 to get treatment for the pain.
Sinus surgery; Sinus infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482130-00.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162623) at unk, (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS OPERATION (medically significant) with onset 2019, outcome "unknown", described as "Sinus surgery"; SINUSITIS (non-serious), outcome "recovered", described as "Sinus infection". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "sinus surgery" and "sinus infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of Sinus Surgery, Sinus infection and Flu symptoms was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of Sinus infection and Flu symptoms are related to Humira (Adalimumab). AbbVie's opinion is that the event of Sinus infection is not assessable.  Clinical information: In 2019, patient had sinus surgery. She had sinus infection for 2 weeks. Second covid injection made her feel sick flu symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information available, the causal relation between the reported events and suspect drug cannot be excluded.  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 received his first dose of Pfizer covid vaccine and it had been mixed in a vial with 1.8 sterile diluent (sterile water) instead of 1.8 normal saline
For the past 36+ hours, I have has some pain/tenderness, puffiness/swelling  above my left collarbone.  It is noticeable to the eye and the touch.  I did not experience this after my first or second covod shot.
Pt was waiting required 15 minutes in a chair. About 8 minutes after receiving the vaccine, his girlfriend yelled "help". I ran over to pt and he was losing consciousness. His eyes rolled back in his head and he began to fall to the ground. Pt lost consciousness. 911 was called.  Pharmacist administered EPIPEN immediately in thigh. He responded immediately and regained consciousness. Within a few minutes, he was able to say his name and respond to questions etc. 911 arrived and assessed pt. He did not go to ER and stayed another 20 minutes until he felt okay to leave with his girlfriend.
Employee states left deltoid muscle pain worsening since 9/26/13. PCP recommends PT, NSAIDS.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA005606: US-009507513-1709USA009440: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
This spontaneous report as received from a physician refers to an 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
This spontaneous report was received from a physician via medical records and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2000, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# reported as 1919H, dose and injection site were not provided), intramuscularly. On 12-MAR-2000, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot# reported as 0291K, dose and injection site were not provided), intramuscularly and on 21-MAR-2000, he received a third dose of RECOMBIVAX HB (lot# reported as 1637K, dose and injection site were not provided), intramuscularly. On 24-FEB-2017, the patient's laboratory results showed that hepatitis B Surface antibody was non-reactive. This result confirmed that despite the patient have received 3 doses of RECOMBIVAX HB in childhood, he had no immunity to Hepatitis B. The results from the same day also showed that Epstein-Barr capsid antigen antibody/IgM was positive and Epstein-Barr capsid antigen antibody/IgG was negative. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not provided. This is one of the two reports received from the same reporter. All available medical records will be provided upon request. Additional information has been requested. Sender's Comments: US-009507513-1702USA011530.
This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine), batch# 012A21A) for COVID-19 immunization. The patient's past medical history included bone fracture bone in 2020. Concomitant products included levothyroxine for an unknown indication. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 12, 2021, patient experienced herpes zoster (shingles). At the time of the report, herpes zoster (shingles): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. The treatment for the shingles event included antiviral medication and Advil.
reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient; reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA955A, expiry date 31-JUL-2024) for prophylaxis.   On 04-AUG-2023, the patient received Menveo (right deltoid). On 04-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient) and inappropriate dose of vaccine administered (Verbatim: reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 The reporter was medical assistant. The reporter called to inquire any guidance. No additional details were reported. The reporter did not consent to follow-up. The reporter reported that they had the diluent component of Menveo left and thought that the lyophilized component had been reconstituted with normal saline and administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.
Breakthrough case admission after 2 vaccines Pfizer 3/11/21 Lot# EN6199;  Pfizer 11/17/21 LOt# 33026BD
1512 - Pfizer dose reconstitution expiration time  1522 - Pfizer dose drawn on demand from vial, which was stored at 73 degrees F, and administered to patient, IM, right deltoid. 1525 - Pfizer dose noted to be expired per EUA recommendations.   Call placed to Pfizer, they cannot make recommendations outside EUA but have data to support reconstitution expiration extension by 18 hours for a total of 24 hours.
No adverse event of symptoms, wrong vaccine given. In clinic 1hr. Past injection with no problems.
1 1/2 hr p/inject pt devel high pitched cry; lasted for 6 hrs; t102 gave APAP stayed down p/APAP;
This is a spontaneous report from a contactable consumer (patient). A 57-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0175), at the age of 57, via an unspecified route of administration, in right arm, on May 7, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history not reported. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medication included Synthroid (levothyroxine sodium), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On May 7, 2021, at 13:30, patient experienced dizziness, lightheadedness, headache, stomach pain, leg pain, sore arm and nausea. The events did not result in doctor/other health care professional office/clinic visit/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of dizziness, lightheadedness, headache, stomach pain, leg pain, sore arm and nausea: resolving (at the time of report). No follow-up attempts needed. No further information expected.
Received Hep B shot 11/4/15. Noticed soreness not improving within 3-4 days. Swelling in arm noticed Thurs 11/12/15. Decreased ROM noticed on 11/10/15. Not improving.
Seen 9/7/2016 - open fx (L) wrist. To OR for repair. Discharge same day.
achy, headache, fatigue for 48 hrs after injection, then mid fatigue and on /off headache; day 6 after injection developed total body rash (hives, large red patches, burning sensation, paresthesia (felt line pins and needles under skin); took benadry 50mgs x2 with good response; next day same rash, but worse then previous day; took same amount of Benadryl and added Zantac x2; currently continue to have the burning sensation all over body but no visible rash
reaction was  noted on first dose of covid vacc. Injection site is red, swollen, painful and raise, more so than after the first shot. pt also had upper back pain that radiated to right breast. Patient had same type of pain after first vacc. Pt. has contacted pcp.
2 inch red circle around injection site that is warm to the touch.  Hard lump under skin about the same size of the red spot that hurts when you put pressure on it.
47 year old was administrated Infanrix.; meant to receive Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.  Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.  On 12th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was meant to receive a dose of Boostrix but inadvertently administrated with Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events was reported The reporter consented to follow up. The HCP (Health care professional) agreed to be contacted for follow up.
Fever, chills, body aches, headache.  Symptoms began with redness and swelling at site of injection.
Patient received Tdap, covid and influenza vaccines simultaneously. Approximately 72 hours later developed gradual onset delayed hypersensitivity reaction progressing to confluent urticaria all over entire body including palms and scalp with severe angioedema particularly of the face over the course of one week. Patient continues to have progression of symptoms at week two. Patient is being prescribed loratadine, famotidine, prednisone and epinephrine prn.   Reaction is steroid responsive but patient rebounds when withdrawn.   Suspect autoimmune process triggered by vaccine or receiving three vaccines simultaneously.    Patient is being referred to specialist.
This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, 3 years after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient itself. The patient got Shingles 3 years after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
WOKE UP CRYING WITH 103.9 FEVER. BROUGHT TO HOSPITAL GIVEN TYENOL & MOTRIN. STILL HAS FEVER TODAY. GIVING MEDS EVERY FOUR HOURS.
3x2 inch area of skin where vaccine was administered in upper left arm is raised, red, and warm to the touch
Within a few minutes after receiving the vaccine, I became very warm and started to sweat. My face felt very flushed (like burning up) and I felt like I was going to pass out. I put my head between my knees and took deep breaths. I also took sips of water. I was feeling fine within another ten minutes.
Chronic dermatitis of lips and area surrounding lips resulting in blistering, constant peeling of skin, and ongoing irritation.
Despite having a dedicated vaccination station for teenagers where only Pfizer Vaccine is provided, this patient apparently indicated to our vaccinator that he was there for Moderna (as his entire family had already received that).   The patient appeared several years older than his actual age of 16 and the vaccinator said that he stated he was over 18.  However, the vaccinator neglected to check his date of birth in the system to confirm it.  The patient's mother was in the room but was not present at the vaccination station where he was seated.  Believing the patient was an adult, the vaccinator walked two tables away to retrieve a dose of Moderna and vaccinated the patient with it.  Within minutes our team recognized that we had one dose too many of Pfizer and one too few of Moderna and we realized what had happened.   The patient had absolutely no adverse reaction whatsoever but this error was quite disconcerting to my entire team.  This incident was fully discussed afterwards with the patient's mother who, interestingly, appeared pleased that he had received the Moderna vaccine as his whole family already had as well.  Clearly the family doesn't recognize the mandates and safety measures implemented by the CDC and vaccine manufacturers but that is a separate issue.  We have a strict policy in place that patients don't request one vaccine over another.  They are administered in a thoughtful, meticulous fashion based on CDC and manufacturer guidelines.  We don't take requests and we don't breach those guidelines.   Additional training was provided to this vaccinator and to my entire staff to ensure this never happens again.
Increasing 'discomfort' at injection site, headache starting yesterday.   Currently running a 101 temp.
Patients guardian signed and dated consent form indicating patients date of birth and specifically indicated on the form that they were 12 years old . Upon verbally questioning and confirming date of birth it was again indicated as written. After running the form through insurance and getting a date of birth rejection the parents and pediatrician were called to verify date of birth of patient . No response from parents but pediatrician confirmed date of birth as incorrectly written on form  No adverse reaction reported yet .
Dad notified swelling redness Lt arm on 5/22/03 pm, Seen in the office 5/23/03 10am, area of redness no swelling at injection site 4"x2".  No other reaction.
RASH ON NECK AND PARTS OF SHOULDERS AND CHEST WITHIN MINUTES OF VACCINATION
Persistent itchiness, welts, environmental allergies, hair loss, throat closure (different from asthma) Began shortly after 2nd dose and has persisted for nearly two years
GENERAL WEAKNESS, DIZZINESS, VOMITING AND EXCESSIVE SWEATING.
Initial report received on 24 June 2008 from a health care professional. A 20-year-old female patient whose past medical history includes the current pregnancy, had received a 0.5 mL intramuscular deltoid injection of ADACEL (Lot # not provided) on 15 April 2008. The patient had no prior obstetrical history. The date of the patient's last menstrual period was on 17 March 2008, and her expected date of delivery is on 22 December 2008. It was not known the patient was pregnant at the time of the vaccination with ADACEL on 15 April 2008. At the time of this report, the patient had not experienced any adverse events. Follow-up information received on 13 February 2009 from a health care professional. Per the reporter, the patient received the "first" dose of ADACEL in the left deltoid on 15 April 2008 prior to knowing that she was pregnant. The patient had two episodes of bleeding while pregnant which were not described. It was not reported whether the patient required any specific activity limitations or treatment for the bleeding. On 09 June 2008 serology testing was completed that was normal. On 22 July 2008 an ultrasound was completed that was normal. On 16 December 2008, the patient delivered via vaginal delivery a single female baby at 39 weeks gestation. The baby weight and length was reported as "7.1". The baby had no congenital anomalies. The baby's Apgar scores were eight at one minute and nine at five minutes. Pregnancy complications were identified as toxemia; however, it was not reported whether the patient suffered any effects from the toxemia, or if she required any treatment. It was reported the patient had an uneventful pregnancy and delivery. Follow-up information was received 04 May 2009 from a health care professional. The patient's bleeding occurred prior to 14 weeks gestation and the patient and fetus suffered no adverse effects. The patient sought care two days after the second episode resolved. For the event of toxemia, the reporter only knew that MgSO4 was administered post-partum and no other data was available. Documents held by sender: None.