chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle irregular (Instead of normal 28 day (4 week) cycle; it began coming every 3 weeks; This is a spontaneous report received from a non-contactable consumer, the patient.   A 35 year-old female patient (not pregnant) received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN via an unspecified route of administration in the left arm on 15Sep2021 at 14:30 (Lot number: unknown) at the age of 35 years as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: first dose of COVID-19 vaccine (Anatomical site: Left arm; Manufacturer unknown), on 18Aug2021 at 14:00 for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 24Sep2021, outcome "recovered" in 2021, described as "Menstrual cycle irregular (Instead of normal 28 day (4 week) cycle; it began coming every 3 weeks". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: 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. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. THIS CASE IS LINKED WITH 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 ((same reporter, same vaccine, same lot number)). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE Quadrivalent (batch number: UI669AA, expiration date: 30 June 2017, site: unknown and dose was not reported) intramuscularly, 04 October 2016 (also reported over the past month). Previous doses were reported as unknown. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient had some headaches, fever and body aches (site and systemic reactions). It was also reported that patient "Called in sick to work 10/6/16". It was reported that the patient required emergency room/doctor visit. Lab data was not reported. Patient received no corrective treatment (sought out treatment). The outcome of the events was reported as unknown. List of documents held by sender: none.
Submandibular swelling on right side. Diagnosed as parotitis. Later had a high fever and started on antibiotic. On 7/6/14 swelling was found on left side. Not clear if this is a reaction or another sequelae.
Pt vaccinated with TD experienced fatigue, tinnitus, vertigo starting approx 20 hrs post vaccination.
redness and swelling that wrapped around bicep, also a bruise at injection site over the course of 1 to 2 days
When the patient made the appointment for the vaccine , his date of birth was entered as 02/03/2001. During  the vaccination information was entered into the computer, I realized his date of birth on his ID was different which was 02/03/2004.
Slight petechiae to face and neck and light headed. BP 118/76. Per wife pt experiences rash like symptoms with each new medication. After observation pt discharged home with wife.
Patient had a breakthrough case of Covid-19; Patient had a breakthrough case of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16May2022, outcome "unknown", COVID-19 (medically significant) with onset 16May2022, outcome "not recovered" and all described as "Patient had a breakthrough case of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient had a breakthrough case of COVID-19. It was unknown if therapeutic measures were taken as a result of covid-19.Clinical Course: If other vaccine in four weeks Unknown. If covid prior vaccination was Unknown. If covid tested post vaccination was Yes. Covid test type post vaccination was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Report 2001009942-1 described lump in the throat in a 22 year old female who received Hepatitis B vaccine recombinant (Engerix B) for prophylaxis of Hepatitis B. Reportedly, the vaccinee had no known drug allergies or medical history and received no concomitant medications. No adverse events were reported following the administration of doses 1 and 2 of Engerix B. On 04/17/01, the vaccinee received her 3rd "adult" dose of Engerix B. Ten to fifteen minutes post-immunization, she complained of "severe" chills, headache, dizziness, hot flashes, and a lump in her throat. She had shortness of breath. She was treated with Epinephrine ".3" SC, 1 dose on 4/17/01, oxygen via nasal cannula at 4 liters/minute and Benadryl 50mg IM, 1 dose on 4/17/01. The vaccinee's symptoms resolved the same day, following treatment. The reporter considered the allergic reaction to be severe in intensity and related to Engerix-B. As of 5/3/01, the allergic reaction resolved. This case is considered to be an "Other Important Medical Event". As a result of follow-up info received on 5/3/01, this report has been re-classified as serious expected.
Symptoms similar to a fibromyalgia flare. Sudden pain and stiffness in neck and back about 7 minutes after initial injection. Low blood pressure 86/60 20 minutes after injection. No shortness of breath or difficulty breathing.  Ice pack used on neck and back. Fatigue set in 2 hours after injection.
Thoracic itching and pain. Mostly itching in the T4/5 dermatome.
I have started having hypertension.  I have always had low blood pressure but now it is inconsistent and extremely high at time.
This case was considered medically important. Follow-up information provided recovery status. Information regarding PREVNAR was received form a consumer and confirmed by a healthcare professional regarding a 3-year-old female patient who had received 4 doses of PREVNAR (completing her primary series on 15-Nov-2004). The patient's titers determined that the vaccines had failed. The patient additionally experienced pneumonia, inner ear infections and sinusitis. On 15-Nov-2004, the patient received a fourth dose of PREVNAR, which completed her primary series. At the age of about 3 years (approximately 2006), the patient became chronically ill with pneumonia, inner ear infections and sinusitis occurring about every 6 weeks. In Feb-2008, the patient's titers determined that the vaccines had failed (vaccination failure). On 06-Mar-2008, the physician opted to give a fifth dose of PREVNAR. On 08-Mar-2008, the physician noted she gave the patient a "HIB" and "DTAP" booster and "pneumo-23". On 24-Apr-2008 titers were drawn (see laboratory results). The physician stated the patient showed an "excellent response". As of 20-Jan-2009, the patient had recovered. No additional information was available at the time of this report.
This spontaneous retrospective pregnancy report has been received from a 50 year old female patient via agency (manufacturer local reference # MK23575), for ZOSTAVAX, a Pregnancy Registry product, concerning herself. The consumer started ZOSTAVAX (lot # was not reported), unknown dose was administered once, on an unknown date in February 2013 for cold sores. Her relevant medical history included seizures, arthritis, allergies, and asthma. Her relevant concomitant medication included TOPAMAX. Her relevant drug history was unknown. Sometime in February 2013, she received a vaccination with ZOSTAVAX while 2 to 3 months pregnant. She had a miscarriage in March 2013. In addition, she had been exposed to 2 infants, while babysitting. Her relevant laboratory data was unknown. As of 07-MAR-2013, it was unknown if she would continue to take ZOSTAVAX. The outcome of her exposure to 2 infants was unknown. The outcome of miscarriage was unknown and the relatedness of miscarriage was unknown for ZOSTAVAX. Upon internal review, miscarriage was considered as medically significant events. Additional information has been requested.
pt reports tightness in chest and throat she reports palpatations and she felt she couldn't breath.
Patient received shot in arm on 10/14/2009 in the afternoon. A few days later she was in pain in arm where shot was given. Christmas time pain started to get really bad. Pt feeling numbness and tingling in arm. She saw Doctor after the Holidays. MD said when shot was given. A nerve was hit and pain she is feeling is nerve healing. Late March 2010 she informed the pharmacy.
4/20/21 Approximately 20 min after the vaccine, noticed bottom of feet and mouth tingling. 4/21/21 flu-like symptoms with fever began. 4/22/21 woke up with rash all over body-red raised with weeping blisters (lesions are in mouth also).
Skin to this day is sore to the touch. Constant paid at a level 5 on a scale of 0-10 in armpit and chest of right side of body.  Continues headache since day after shot.  Muscles still sore.
Received 2nd dose of Covid vaccine on 1/6. On 1/7 at 0130 woke up with chills, severe headache, and body aches, but no fever. She took Advil, which helped but on 1/8 she still has headache and fatigue.
Approx 4 hours after receiving FLUZONE vaccine, pt experienced swelling of eyelids & lips - advised to take diphenhydramine and seek physician if not resolved.
Dizziness described as lightheadedness initially but then progressed to "room spinning" sensation.  Sat for few minutes, they was helped to lie down due to severe dizziness and lost consciousness for about 30 seconds.  Smelling salts used to successfully rouse the patient.
This non-serious medically confirmed report (initial receipt 26-Jun-2014) concerns a female patient. On an unspecified date, the patient received the influenza vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed hives to the influenza vaccine. It was reported as an allergy. Outcome was recovered.
Pt received DTaP, IPV, Comvax, and Prevnar at approx 10:30AM and within 2 hrs right leg was red and swollen and infant had fever of 107 degrees F (rectal). Mother  gave infant Tylenol, which did not control the fever. She took pt to ER at Hospital at 1:30PM where fever was 107F (Rectal). Children's Motrin was given and within 1 hr fever was down to 100F. Fever controlled by Motrin after that was given for 4-5 days.
Patient given vaccin afternoon of 8/21/09. She bgan itching "everywhere" abou 8pm that evening. At 9pm she began to notice a generalized rash. About 10 pm she took 2 x 25 mg diphenhydramine. On the morning of 8/22/09 she was still itching and repeated the 2 x 25 mg diphenhydramine about 10:15 am. She returned to the pharmacy and was referred to urgent care asa she had non current PCP.
"Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minutes post vaccine, my tongue went numb for approximately 30 minutes, then it resolved. 6 hours post vaccine I became very dizzy and flushed and began to feel achy. The following morning I felt well enough to come into work but then felt increasingly weak, achy, and tired and had to go home at 12pm. All side effects were resolved by 5pm. "
Nerve pain is really flaring up and hurting her a lot was reported as worsened.; Nerve pain is really flaring up and hurting her a lot; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in arm right on 25Jan2021 (at the age of 69 years) as single for covid-19 immunization. Medical history included ongoing diabetes mellitus and was diagnosed when she was around 40 years old. It is under control. It has never been bad. She goes through her doctor all the time. It was under control, shingles a couple of years ago, burning sensation and after pain from an unknown date and unknown if ongoing and explains had gone away but left after pain and she gets burning sometimes. There were no concomitant medications. Historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm left on unspecified date as single for covid-19 immunization. On 26Jan2021 the patient experienced pain started. patient had it from her naval to her back and patient would get little flares by her naval but nothing she could not deal with. But the pain flared up so bad in her nerves that she could not stand it, making her feel like she had going back to the beginning when she was getting over the shingles. It was so bad. It had been some years since then. Patient tried Tylenol which helped and was more like a mellow pain, which she was used to and what she can deal with. The outcome of the event Nerve pain is really flaring up and hurting her a lot was not recovered and outcome of the event Nerve pain is really flaring up and hurting her a lot was reported as worsened was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Since 19-JAN-2015 the patients were vaccinated with ROTATEQ (dose: 2 ml, administered orally) which were improperly stored. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
administered Shingrix with Merck diluent; administered Shingrix with Merck diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) (batch number 729PH, expiry date 9th April 2023) for prophylaxis.   On 27th December 2021, the patient received Shingrix. On 27th December 2021, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix where Merck diluent was used which led to the inappropriate reconstitution technique and incorrect dose administered. Consent to follow up was granted.
This spontaneous report as received from a pharmacist refers to a 61 year old patient of unknown gender. Medical history and drug reactions/allergies were not reported. On 21-APR-2014, the patient was vaccinated with VARIVAX (Merck), 0.5 ml subcutaneous (lot not reported), in place of ZOSTAVAX. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1405USA013190). Additional information has been requested.
Viral Infection; left arm still has soreness; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral Infection) and VACCINATION SITE PAIN (left arm still has soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included ACYCLOVIR [ACICLOVIR] from 17-Feb-2021 to 17-Feb-2021 for Viral infection.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VIRAL INFECTION (Viral Infection) and VACCINATION SITE PAIN (left arm still has soreness). At the time of the report, VIRAL INFECTION (Viral Infection) outcome was unknown and VACCINATION SITE PAIN (left arm still has soreness) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported he took acyclovir 800 mg three times a day five days after first dose of vaccine and one day after the second dose of vaccine for one day. No other concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-053267 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053267:Crosslinked with dose 2
Ileocolic intussusception -- 2/20/2018 -- successful pneumatic reduction (ER visit, hospitalized 2/19 - 2/20). Recurrent ileocolic intussusception, hospitalized 2/26/2018 - 2/28/2018, successful pneumatic reduction.
DTAP-IPV administered to patient under the age of 4. No Sx or Tx currently needed.
Breakthrough COVID infection. Patient fully vaccinated on May 19, 2021. Patient positive COVID test on Aug 21, 2021.
cried, high pitched shrieking cry nonstop for 8hrs; gagged & choked towards the end; slight fever, stated mom;
Patient recieved a Flublock vaccine on at 1:25-1:46PM on November 5, 2020. I, the pharmacist-in-charge and certified immunizer, recieved a call from the patient around 3:15-3:30PM , stating that she was expericing nausea and vomiting shortly after leaving the pharmacy. The patient belived that this event was due to her recieving the flu vaccine. I told her I was not aware that vomiting was an adverse event associated with the flu vaccination. I recommended that she immediately contact her primary care physician regarding this event. The patient stated that he suggested she contact the pharmacy wher she recieved the vaccine. I called my attending district supervisor, and nottified her of what was going on. I then contacted the patient's PCP office, in which I left a message with his medical staff. After reporting the event, I contacted the patient, and she did not anwser. I then called several times and still no response.  After a few attempts, I reached out to her husband, the patient's husband on 11/5/20, becuase he was scheduled for a flu shot the same day, he notified me that the paramedics were at their home tending to the patient, his wife. The EMT stated that they didn't know what the contributing factor was to her vomiting and that her blood pressure was elevated. I called the patient to confirm information for the report and she stated she follwed up with her PCP office.
Blisters in mouth area, red rash down left side old site. 1st shot site swelled up after 2nd shot. Shoulder sore.
severe pain in her lower left side; Abdominal pain that feels like a cramp at first but the pain intensifies when you try to move.; This is a spontaneous report from a contactable health care professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 05Jan2021 at 12:00 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient was not diagnosed of COVID-19 prior to vaccination. The patient did not have any other vaccines in the last four weeks. The patient's concomitant medications were not reported.  The patient experienced severe pain in her lower left side on 07Jan2021. The patient also reported abdominal pain that feels like a cramp at first but the pain intensifies when you try to move on 07Jan2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.  Information about lot and batch number was requested.
In late November I was diagnosed with a sinus infection.  I had a headache for 3 straight days.  I got congested and developed a cough and a sore throat.  I went to urgent care on November 13, 2022, and then again on November 18, 2022.  I went twice because my symptoms continued to get worse.  I was given an antibiotic.
p/vax pt mom reported child devel a large localized inj site rxn the size of a softball in lt vastus lateralis muscle w/redness, swelling & tenderness;no tx necessary;5 days p/onset pt recovered;
Information has been received from a healthcare professional concerning a 41 year old female pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalnet (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a "severe local reaction," swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The pt was treated with Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01591 through 0209USA01593) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.