chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness started around 11pm.  11/20/2010: around 3pm unable to activate anterior, middle, or posterior deltoid muscle.  Pt was able to use arm again by 11/21/10 4pm
Patient has been experiencing diarrhea, feverish symptoms, "hot flashes". She has been advised to take Imodium for diarrhea and Tylenol for the fever
s/p vaccine c/o sudden onset of lightheadedness, itching all over, no rash. Received PO Benadryl. Symptoms resolved.
Systemic: Abdominal Pain-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Called 911 once I discovered pt. Pt was vomitting severely and had her laying on her side on the floor. She complained of abdominal pain and severe nausea when I initially got to her. Paramedics arrived about 10-15 mins from initial discovery of the patient fainting. The paramedics took over the care of the patient.
This 10 year old female child received varicella virus vaccine 1 ml SQ in her left arm on 12Aug2010. On 13Aug2010 the child had a 2x3 inch red itch area at the injection site.  The mother of the child reported that on 13Aug2010 the area also had small little blisters. On 14Aug2010 the small little blisters were not present. On 14 Aug2010, the child was treated with Benadryl which helped with the itch. No further treatment was needed.
Redness at injection site occurred immediately but continued to worsen over time left leg was red, swollen and hot to touch. Induration was 15 cm x 9 cm.
Bloodshot itchy eyes, tightness in chest, difficulty taking deep breaths, unable to focus, weakness.
Information has been received from a physician concerning a 54 year old male with diabetes mellitus who on 11:05 on Oct 26 2004 was vaccinated intramuscularly with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). On Oct 27 2004, the patient developed a severe local reaction including an area of swelling at the injection site of approximately 12cm in diameter, a rash that covered the upper deltoid to armpit and erythema. Unspecified medical attention was sought. On Oct 30 2004, the patient recovered. No additional information is expected.
Tuesday morning on 11/2/2021 around 2:30 I started to have chest pains. At 3:30 I went to the ER. When I was there, they ran tests on me. They didn't diagnose me with anything but told me take Advil. The chest pains have not subsided. I take Advil every 6 hours, but that doesn't seem to be helping with the pains. I am still having the exact same pain. On 11/3/2021 I did experience some light headiness, so I just worked from home that day.
Itching started in 24-48hrs. Developed rash on 7 days later (April 2nd). Went to urgent care on April 3 and was diagnosed with Shingles.
I received the J&J COVID-19 vaccine for my first dose. My booster was the Moderna vaccine. About 4 months after receiving my booster, I started to notice discomfort in my chest. When I went to the doctor, I had already been experiencing this for about a week. They tested for troponin. My level was high, which indicated heart issues and I was told to go to the hospital. I had multiple procedures include a nuclear stress test and an echocardiogram that indicated no heart issues. My blood pressure was volatile during my hospital stay. I was put on Norvasc 2.5 mg daily and my BP seems to have now stabilized. I will be following up with my physician as well as my cardiologist.
4-6 cm reddened, indurated area developed at injection site over 2 days following injection. Pt advised to take Benadryl, placed in Keplex for possible cellulitis. Seen in office by MD.
13 month old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 2 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022183610:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183612:Same reporter US-GSK-US2022183615:Same reporter
pt states on 3/4/2021 she noticed a hard lump on the left arm around the injection site.  On 3/5/2021 pt states the lump has become itchy, swollen, red and warm to the touch.  Pt drew a line around the area to watch for any changes in size and will call her PCP if it gets any larger.
Left side body pain, with no prior injury. Shot was given in left arm. 12 pm: Sinus pain. 11/22: 5 am: Sore throat, bodyache, extreme fatigue. 11/23: 5 am: Sore throat, sinus pain, bodyache, non-productive cough, chest pain. 11/24: 7 am: Extreme dizziness/numbness to the point I felt like I was going to fall over or pass out if I did not sit down. No SOB.
High fever of 103.8 F experienced.  Injection site became raised, red, swollen, and painful (area measured 11cm X 6.5cm).  Child was lethargic and nauseated.
vision went blurry; arm all the way to hand started to go numb; hand is still numb and tingly.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the right arm on 13Apr2021 at 10:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included inflammatory bowel syndrome and known allergy to latex. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 10:30, immediately following the vaccine the patient experienced vision went blurry and arm all the way to hand started to go numb, could barely lift phone and at the time of reporting, arm was feeling somewhat back to normal but hand was still numb and tingly. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event vision went blurry, numb hand and tingly was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Problems with hearing, ears filled with fluid morning after shot and continued after that.  Took antihistamines to help.  Some tingling or buzzing sounds in ears.  Hearing seems diminished.
MISSED TO TAKE THIRD DOSE ON DUE DATE; This case (PVX2019-2158) was received from a pharmacist on 23-Aug-2019. It described a 33-year-old male consumer who "missed to take third dose on due date" (PT: Product dose omission), while being on Vivotif for an unknown indication  Case report: The consumer missed to take the third dose of Vivotif that was due on 21-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take third dose on due date" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third dose on due date" was considered as not applicable.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2012. On 16-Jan-2012, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 02-Apr-2012 and incorporated into the narrative: Patient demographics and no late occurring adverse event.
Hospitalized 9/25/2021. Symptoms include fever, muscle aches, runny nose, wheezing, headache, fatigue, diarrhea, loss of taste/smell, and inability to wake or stay awake
Onset of fever, chills, backache and extreme sensitivity to touch of skin, the morning after vaccine administered.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013134: US-009507513-1701USA013135: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013139: US-009507513-1701USA013132: US-009507513-1701USA013136: US-009507513-1701USA013133:
Fever started within 3 hours with chills and dizziness. Fever broke aprox 12 hours later but dizziness persisted for another 24 hours.  Localized pain to injection site  but no swelling or redness noted
Within 2 hours of receiving flu vaccine, client was observed by parents to have (L) sided facial drooping, (L) arm numbness, drowsiness, & c/o headache. Brought to ER by mother at 4 pm with reported slurred speech & muscle spasms. Hospitalized overnight for testing per mother.
This spontaneous report as received from an unknown reporter via company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported. On an unknown dates, the patient was vaccinated with a first and second dose of GARDASIL (dose, lot #, expiration date and route were not reported) for prophylaxis. Later on unknown date, the patient received one dose of GARDASIL 9 (dose, lot #, expiration date and route were not reported) for prophylaxis. No adverse effects were reported.
tongue tingling, hot flashes, sweating, tachycardia, hypertension. improved after benadryl
Emesis, rash; monitored for >20 minutes. F/u call 2 hours later
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 24-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a negative HHV6 PCR in late March. I had Moderna vaccine on March 24 and April 17. On May 3, I had a positive HHV6 PCR test and last week ~May 20, I had a HHV-6 quantitative PCR positive and above range.  I have a history of reactivated HHV6 after my 2014 stage 3 cancer treatment, which triggered my ME/CFS. I subsequently went on IVIG every three weeks which I continue to this day, and I was on 20 months of Valcyte, as I had PCR positive Epstein-Barr as well as HSV-2 outbreaks. I was on Rituximab from May 2019 to February 2020 for my autoimmune conditions, and have 5% of normal B cells. I have been noticing increased fatigue, and I suspect that this HHV-6 reactivation might be a reason.  This is a serious event and puts all the substantial gains in my ME/CFS at risk.  I am now back on Valcyte, but one of the treatments I was using to help me, as I have a history of low NK cell function, was thymosin alpha 1, which has been shown to be effective in stimulating T cell and NK cell function, the FDA helpfully banned in February of this year and now I cannot access it. I have an incompetent immune system and this vaccine has created harm that I don't know how to undo. What do I do now?
SORENESS FROM STOMACH DOWN AND BACK; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: high blood pressure, and stroke, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced soreness from stomach down and back. On 04-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of soreness from stomach down and back was not reported. This report was non-serious.
10 years old patient received 5th dose of expired Daptacel vaccine; 10 years old patient received 5th dose of expired Daptacel vaccine; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone.   This case involves a 10 years old patient (gender not reported) who was vaccinated with expired 0.5 ml fifth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number: C517AA and expiry date: 23-Mar-2019) on 16-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration.  It was unknown if any adverse event was occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Time between her two Moderna vaccines was 11 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time between her two Moderna vaccines was 11 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time between her two Moderna vaccines was 11 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time between her two Moderna vaccines was 11 weeks) had resolved.            concomitant medication was not provided. Treatment information was not provided.
approx 1/3 of pts treated w/Engerix-B failed to respond or had borderline titer levels produced p/the 3rd dose; 60 to 70 pts have been treated to date;
pt recv vax & exp breakthrough chicken pox;3 pt w/this exp were reported @ this site;
Patient describes arm pain following administration of vaccine. She also described limited mobility of her arm the following day. She said that since then she has improved the mobility of her arm through physical therapy but still experiences pain.
pt recv vax & exp a burning sensation & tingling in arms, chest, shoulder, back & legs;these sx were more severe on lt side of body;also felt weak & fatigued;referred to a neuro dx neuropathy;1JUL97 sx persisted;
Patient developed a rash on abdomen and bilateral lower extremities a few hours after vaccination- pt returned back to clinic to be seen by MD, rash resolved on it's own about 30 mins after onset, no tx was needed.
Patient developed a fever of 103 and taken to the emergency room for evaluation.  Triaged and evaluated by a physician then sent home.  No labs done.
No adverse effect reported; Patient was inadvertently administered one dose of PROQUAD intramuscularly instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to a 38-year-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, allergies, drug reactions and concomitant medications was provided.  On 25-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), intramuscularly, one dose (lot#, expiration date, albumin status, exact dose were not provided) for prophylaxis. The vaccine was inadvertently administered intramuscularly instead of subcutaneously(incorrect route of product administration). No adverse effects were reported. The outcome of incorrect route of product administration was unknown.
pt recvd vax; pt devel headache; aching arm; low range fever; vomit x 1; erythema of arm 3-4 inches from ctr of inject site; 5-6 top to bottom, itching of arm; painful at inject site; hard at center;
Given in upper left thigh.  after 7 days, redness and ache disappeared and now have itchy feeling and redness with some slight swelling
About 15-20 minutes after receiving the shot, he reported feeling warm and clammy. He mentioned that was similiar to the beginning of his other reaction.  Because he has had a reaction to epinephrine in the past, an ambulance was offered to be called for him, however, he declined.  He was offered a 25mg dose of Benadryl with some cold water, and upon afterwards he felt better. It was noted that he had only ate a piece of toast that morning (it was now around 1pm). His wife was called so she would be able to drive him home. Patient stayed for another 30 minutes after before his wife came to pick him up.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not reported.   Treatment information was not provided.   Reporter did not allow further contact
increase in Afib/Paroxysmal Afib that increased to AFib; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Paroxysmal Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "increase in Afib/Paroxysmal Afib that increased to AFib". The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200248143 same reporter/drug/event, different patient
Two days after Dtap immunization given on right thigh, erythema, redness pain developed at injection site.
Chicken pox like blisters with itching appearing on mostly face but some isolated on other parts of body with leaving scars w/o any healing interference. Pain to the touch along nerves inside of thighs, along outside of arm, on face with moderate touch.
The day following her first does of the COVID-19 vaccine We were battling fevers up and down all day but right before we put her to bed, she was behaving abnormally and was very lethargic. We kept her up until we were able to give her another dose of TYLENOL. When we put her to bed, we put her pulse oxygen monitor on. While she was sleeping her levels dropped into the 70's. When we went to check on her, she was not responding in the way we had hoped. Her temperature was at 103.5 and it is believed that she had a fever induced seizure. Paramedics came to our home and we noticed that she was unresponsive and they advised that we take her directly to the emergency room. Once she was evaluated at the emergency room they gave her a dose of ibuprofen as her temperature was still elevated. They monitored her for an hour or so after that and determined that she was safe to be sent home. She continued to run fevers for a few days after and is finally getting back to normal levels as of today 06.28.
Dose #3  given too early. Dose #1 was given on 7/28/2022.  Dose #2 was given on 8/25/2022.  Parent aware. Mom reported that patient had a sore throat and fever the night of 9/15/22.
I tested positive for COVID 1 month after my 4th dose of Pfizer vaccine.
mom reported high fever, high fever first day of vax then 3AUG noted pt appeared not to see can't hold head up & legs drawing up occurring every 30 mins; mom advised to take pt for med eval 3AUg but did not f/u;
Within 7 hours of shot - 102? fever, chills, shaking, nausea, diarrhea, fatigue, horrible insomnia, blinding headache. Significant illness, worse than I?ve ever felt in my life. Lasted over 24 hours straight.   Within 36 hours of shot - head congestion, deep and persistent cough, constantly sneezing, pounding headache made worse by sneezing, muscle pain and weakness. Lasted for 48 hours after onset.
Big red hot swollen bump at injection site Fever Hot sweats Muscle aches Fatigue  Nauseous  Dizzy