chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up around 8am with a scratchy throat. My husband tested positive that day but I was negative. It felt like I had a bad cold. On Saturday I was so tired. I went a head and did another test and tested positive.  I called the doctor and I was given the paxilivid.
pt recvd vax & began having hives on arms, chest; devel chills & shivering; escorted to ER for an allergic rxn to MMR; tx DPH elixir (given in Employee hlth) Ventolin tx, Epi & DPH
p/vax pt let out ear piercing scream;mom took pt out of car seat;saw eyes rolling back in head;drove to ER;seen by MD;low grade temp 100.3 to 101.8, runny nose;febrile sz r/t virus;
Severe menstrual bleeding. Periods that were only 2-3 weeks apart. Then bleeding for a month. Bloodwork was done to see if it was due to menopause, not the case. Ultrasound found a fibroid. Considered surgical removal after seeing MD in May with constant bleeding, but decided to wait. Bleeding subsided and periods more normal by August 2021. Also had significant under arm (lymph node swelling).  Seemed resolved until flu shot in October 2021, bleeding and inflammation returned.
No adverse effects reported; improperly stored vaccine, ROTATEQ has been administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 12-AUG-2019, the patient had been administered an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027191 (verified to be a valid lot number), expiration date reported and established as 15-JUL-2020, by oral route, for prophylaxis. The vaccine was improperly stored at a temperature of 29.3°F, during a time frame of 7 hours and 57 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA006617:
Patient received a first dose of the vaccine on 01/15/21. Reported to PCP on 1/22/21 that on 1/17/21 patient developed sore throat and mild cough, then loose stools. Patient developed worsening of symptoms on 1/23/21 and was admitted to Hospital on 01/27/21  for weakness, renal insufficiency, Pneumonia, anemia, diarrhea and COVID-19 infection. Patient was discharged home after 3 days.
Vision in right eye has become more blurry and corrective eye glasses need to be updated.  Please note previous concomitant vision issues prior to vaccine related to MS diagnosis.  For example, Flu  vaccine had previously had the same effects but had resolved in 3 weeks.  Pfizer COVID-19 vaccine has not resolved since onset of vision blurriness of vision.
3 Phantom periods in July. where I have all the premenstral symptoms and get intense mental cramps, but never get my period; 3 Phantom periods in July.   where I have all the premenstral symptoms and get intense mental cramps, but never get my period.; My breasts have been swollen and tender for at least 4 weeks....; breasts have been swollen and tender for at least 4 weeks; premenstral symptoms; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 10Jun2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0182) via an unspecified route of administration in the arm right on 08May2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 30Jun2021, the patient experienced three phantom periods in Jul2021, where the patient had all the premenstral symptoms and got intense menstrual cramps, but never got period. The patient's breasts had been swollen and tender for at least four weeks at the time of this report. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had been tested for COVID-19. On 02Jun2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 16Jun2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 08Jul2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. On 14Jul2021, the patient underwent polymerase chain reaction (PCR) test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the event three phantom periods where the patient had all the premenstral symptoms and got intense menstrual cramps, but never got period, breasts had been swollen and tender for at least four weeks, was not resolved at the time of this report.
Diagnosed with Bell's palsy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: BELL'S PALSY (medically significant), outcome "unknown", described as "Diagnosed with Bell's palsy". Clinical course: Event took place after use of product.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Phone call from mom on 3/9/07 stating child has red, raised rash to abdomen, back and buttocks after getting shots 2 days ago. Took child to MD who gave "Benadryl and a steroid." States rash had spread to legs by the time she got to doctor's office. Denies fever.
This case was reported by a nurse and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 7th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced rash. The patient was treated with Hydrocortisone 1% and BENADRYL. On 11th May 2018, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: After vaccination with SHINGRIX, the patient experienced rash on both the arms with no itching and no pain. The patient was taken Hydrocortisone cream 1 percentage, and took 50 mg of BENADRYL. This case was linked to US2018GSK102821, reported by the same reporter for different patient.
Local reaction at injection site of 2" started 24 hours after injection. Face became bright red with whelps on both cheeks 2h hours after shot. Face is pruritic.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient jerked body away as I was administering vaccine I scratched him and told the mom and showed her. She sat in front of the pharmacy and I checked his temperature she said he was feeling light headed, after I gave him a lolipop he seemed much better and the dad and mom said it was due to seeing blood and he is completely fine. I called in about an hour and spoke to the mom and she said he is doing great.
Extreme panic that seemed to come out of no where (I was not anxious to receive the shot), burning in my right upper arm, followed by numb sensation from my right upper arm up the right side of my neck and into my right cheek. The numbness and burning sensation in my right arm, neck and face lasted for about 1 month. On 03/15/21 and 03/20/21 I woke up in the middle of the night and was not able to move my right arm at all. It had not fallen asleep, and my neuromuscular connection was not working properly. It took about 1 minute to be able to lift my arm both times times this happened.
Paresthesia in left arm about 36 hours after injection. Starting at level of injection and goes down to fingers. Painful pins and needles feeling, like hitting the "funny bone". Not helped by NSAIDs, ice, or elevation. This has continued to present, affecting work and sleep. I'll go to the doctor if this does not subside soon.
pt recv vax 4DEC96 & approx 4mo later pt exp herpes zoster w/vesicular lesions on rt arm & lt trunk;pt was treated w/acyclovir codeine;pt recovered;
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Panic attack 186/80, 128,98% 162/84, 96, 96% 156/78,94,98%
This case was reported by a healthcare professional and described the occurrence of swelling of limb in a 6-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history include birth twin. There were no concurrent medications. On 17 October 2006 the subject received 4th dose of Infanrix in the right thigh. On 17 October 2006, the subject was also injected with inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) in the left thigh. On 20 October 2006, 3 days after vaccination with Infanrix, the subject experienced swelling of the right limb, injection site redness and injection site warmth at the site of the Infanrix injection. The subject was seen at a physician's office. At the time of initial reporting, 20 October 2006, the events were ongoing. The healthcare professional considered the events probably related to vaccination with Infanrix.
Left arm pain, redness, and swelling with warmth on the day following injection lasting two weeks with gradual improvement.
Patient and wife came in to receive flu shots. Wife was supposed to get Fluad and patient being reported was to get Fluvax. The patient actually received Fluad instead of Fluvax.
almost blacked out; blood pressure was 185/127; This is a spontaneous report from a contactable consumer.   A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported)), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021, at 14:30  as single dose for covid-19 immunization.  Medical history included colon cancer from an unknown date, chemotherapy in 2017 to an unknown date. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization in 26Feb2021.  The patient previously took codeine and caffeine and experienced drug allergies.  On 21Mar2021, at  15:00 patient  experienced blood pressure was 185/127 and almost blacked out. The details were noted as follows:  after the injection as the patient was driving he almost blacked out. He parked his car and went back to the site; paramedics assisted him. His blood pressure was 185/127 on 21Mar2021 . He noted that he almost blacked out a second time. Doctor visits two days and three days after injection day was noted.  The outcome of events was recovering, with no noted treatments. No Covid test post vaccination was noted.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
The Patient has bruising redness and swelling at the site, states arm is extremely sore and feels feverish. The area around the injection site is red and seems to feel hot to the touch
Flu like symptoms. Arm pain. Redness at injection site that has not stopped spreading since receiving vaccine.
Pt. states that after receiving the 1st dose of Moderna 08/12/2021, started experiencing symptoms that evening of muscle pain, joint pain, fatigue, headache, and weakness. 08/13/2021 Primary visit recommendation Time off/rest. Symptoms have subsided with lingering pain in the muscles and headaches periodically.
Due to limited space, 2 different doses of Moderna COVID 19 vaccine stored in same basket.  One dose was missing, leading the nurse to believe Spikevax (12yr+ vaccine) was the only pediatric vaccine.  She reviewed documentation and gave the appropriate 0.25ml dose.   Patient and parent given appropriate education and side effect information.
The evening the vax given pt had an unusual high pitch, pale, listless, felt warm to touch & irritable for 5 hrs; the next AM pt improved, sl fussy;
10 days post vax, red bumps-face. Fever of 104.9. By evening entire body covered w/ red bumps. Dxed with measles at after-hrs clinic. Behavior chged, mastered skills lost, not responding to name, learning capabiities ceased, no eye contact.  60 day follow up dated 10/10/00 states that the child has autism and it has no cure. She has "metal retardation" and it is stated that it is a direct result of the MMR.
Patient received 2 doses of the Moderna COVID-19 vaccine, one in Feb 2021 and one in Mar 21, and tested positive for COVID-19 on 9/23/2021
Male patient (date of birth: 02/05/1962) received the 1st COVID Vaccine (Pfizer, Lot #: ER8731 and expiration date: 08/2021) on 04/09/2021 at 12:45PM. Client returned to the vaccine site on 04/30/2021, for his second dose. Client was checked in by the ancillary staff and then sat down with a nurse vaccinator at one of the vaccination stations. As the vaccinator screened the client, some medical concerns came up so the vaccinator went over to the lead nurse for a consult. Nurse received a brief report from the vaccinator, and then walked over to the vaccination station to talk to the client. The client explained to Nurse that he received his first dose on his left arm and about 2 days later, he developed "numbness and tingling" in that same arm and it has not resolved. As Nurse asked further questions, she discovered that the client also started to develop that same sensation, of numbness and tingling, in his right hand. The client described that it is painful, if poked in those areas. Nurse also asked if this feeling radiates anywhere else and the client explained that, if he sits for a prolonged period of time, the numbness and tingling will develop in both of his lower extremities and he needs to get up and walk around. Client reported that it is not painful in a way that he can rate it on a pain scale of zero to ten, but he did describe it as being "abnormal for him" and "not comfortable." Client denied any known drug allergies as well as denied any past medical history. He stated he had his left index finger amputated "years ago, but that is it." Nurse explained to the client that there are some concerns regarding the new onset of symptoms after receiving the vaccine and that she would like to get a medical consult before deciding how to proceed with the second dose. Client agreed. Nurse sent a text message for a medical consult received an answer about 45 minutes later. The medical team recommended waiting to give the second dose until the client is assessed by either a primary care provider or neurologist. They also gave the client the option of receiving the JOHNSON and JOHNSON vaccine 28 days after the first dose, if the client does not wish to receive PFIZER again. Nurse then educated the client on the recommendations. The client expressed to Nurse that he is "very healthy and does not go anywhere," so he does not wish to be seen by a medical provider right now. The client asked questions regarding vaccine efficacy in the first and second doses and Nurse addressed them. The client told Nurse that at this time, he would like to hold off on getting a medical assessment and did not wish to reschedule for a JOHNSON and JOHNSON vaccine. Nurse respectfully acknowledged his decision and educated him on V- safe and how to proceed if he changes his mind later down the road.
RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 65 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949990.
Pt states about 8 days after vaccine her left leg started hurting.  She developed a red spot on her calf that was swelling.  It was about the size of a quarter that started hurting, turning red and was hot to the touch.  It grew from the size of a quarter to about the size of her fist. She went to her doctor and was diagnosed with thrombosis and told to take 3-4 baby aspirin a day for 10 days and to prop her leg up.  She can still see where the blood clot was on leg however the clot is no longer there.   She can see the vein now which she was not able to see before.  She has been denied to get the second dose due to this condition.
6 week old patient was given vaccinations that he was not due for. MMR, Hep A and Varicella.
itchy swelling throat and tongue; patient was taken to the ED and treated with Pepcid, Decadron and Benadryl. Patient was prescribed three days of Claritin and Prednisone to prevent rebound symptoms.
No adverse events related to the vaccine.  A pinched nerve in the neck caused by degenerative changes in the cervical spine caused the pain.  I answered the question  asked in the survey, which did not specify problems related to the vaccine but to my medical conditions.
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown). The sum of hours of the vaccine excursion was 184 hours and the lowest recorded temperature reported was 33F (0.555555556 Celsius degrees). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient (2 yrs.) stuck his hand down in the sharps container - most needles were retractable. Mom not watching child & he was sticking hand into - no apparent sticks or Rxn. She wants to go to MD and get him checked out!
Uncontrolled bladder leakage.  On the 18th of August, two days after the vaccination I was sitting in my office and when I stood up I looked down and I have urine all over, running down my legs and my chair was soaked.  Since then I have been having to wear poise pads.  It has not had any change. I have no warning of when it will happen or have any feeling of having to urinate. I have to change pads every 2 hours sometimes sooner.  Can not sleep through the night with out getting up to shange pads.
It started on July 20th with hip pain and a head ache, which happened when I had Covid the first time, then I felt ok for a couple of days and then on 07/27/2021 I developed a congestion, body aches, fever, and fatigue. I also lost my taste and smell. So I went to get a PCR test on 07/29/2021 and it came back positive on 07/30/2021. I continued to have congestion until 08/04/2021. Yesterday 08/10/2021 I started coughing. I lost my voice from the 07/27 to the 07/30. I was tested for antibodies after vaccination and I did not have any. But I got tested on 08/02/2021 and I was positive for IGG.
Incorrect route of administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medications were reported.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: Fp4554) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "high BP" (unspecified if ongoing); "known allergies: Allergic to shellfish" (unspecified if ongoing); "known allergies:kiwi fruit" (unspecified if ongoing); "known allergies: mold" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; SYNTHROID; ESCITALOPRAM; RAMIPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.