chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pfizer Bivalent (booster) dose, instead of 2nd dose Pfizer (primary series). No adverse reaction seen or reported. Patient received 1st dose of Pfizer vaccine on 08/19/2022.
The person administering the vaccine gave it at a 45 degree angle below my 11 year old sons deltoid. Vaccine was leaking out of the injection site after the needle was removed and the skin was blanched showing it was injected subq not IM.  I am a pediatric nurse and I know the vaccine was not administered correctly at the needed 90 degree angle and not in the right location to be in the deltoid.
Pt developed generalized body aches and joint pain 24 hours post vax. 36 hours later, she developed fever, generalized itching, and a rash. Pt seen by physician and given steroid injection and Ultram.
Pt recv vax on 8/26/97; post vax pt exp GI distress, 10 days post vax pt exp rash, 2 wk post vax pt exp arthritis (x 10 days)
1hr p/vax had tonic/clonic sz lasting 1min;ER exam nl;
intense sensations; achy; fever; diarrhea; headache; difficulty sleeping; This is a spontaneous report from a contactable Nurse. This is 1st of two reports. A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Feb2021 (Batch/Lot Number: EN6205) as dose 1, single (at the age of 62 year) for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications was not reported. After receiving the first dose of the Pfizer Covid Vaccine on 28Feb2021 the reaction was very achy, some fever. She had some diarrhea, but it was not intense diarrhea. It was one episode of diarrhea and a big headache after receiving the first dose of Pfizer Covid Vaccine. She reported difficulty sleeping and says the most intense sensations started the morning after on 01Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2020. Outcome of the events was unknown  No follow-up attempts are possible; no further information is expected.
Alert and talkative prior and during vaccine.  Appeared warm, pink and well perfused.   After sitting for 3-4 minutes in recovery area had episode of syncope and fell off chair onto hard floor.  Fall was observed by another patient in recovery as well as pharmacy staff.  Continued 1:1 observation from pharmacy staff for and additional 45 minutes.  Food and fluids were offered.  Patient was alert and talkative as pharmacy staff approached her on floor.  Mild pallor and sweating were noted.  Continued to observe patient the full 45 minutes after event.  At time of discharge had eaten, taken fluids, was alert, talkative and pink.
Extreme tiredness ongoing. Ache in knee with pain radiating up and down my leg. Extreme muscle aches. All ongoing. I have talked to several other people with similar issues. I'm going to guess there are many more people (several people I know have experienced this). My only hope is that it is temporary. I am a very active person, but now I am tired all the time. I walk almost 4 or 5 miles every day and I hike, but now it is not so easy anymore. The tiredness is more like exhaustion and that is a feeling I have rarely experienced in my life. This started the day after the 2nd shot and has not subsided since.
mild headache; muscle sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 30-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date the patient experienced mild headache and muscle sore. The patient did not receive treatment for events. The outcome for the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Swollen injection site, warm and red, tender. Was given BENADRYL by mother; mother reports swelling is "going down".
Severe abdominal pain, nausea, and vomiting requiring hospital visits, office visits, colonoscopy. Have missed several days of work due to this.. Entyvio infusion increased to every 4 weeks from every 8 weeks.
Severe diarrhea started on 5/19/2021, with loose stool and/or stomach cramping until 5/24/2021. On 5/23/201, started breaking out with a rash. This rash was diagnosed as shingles on 5/27/2021.
Had chills during the night of 9/15/21. Woke up with hives on abdomen at 7:00 AM on 9/16/21. Was told to take an antihistamine 2 times daily for at least 2 weeks and to use topical steroid cream for at least 2 weeks. Hives are still present now.
onset fever 7 days p/MMR, sz day 8, rash day 10;
started doing this shaking, almost like a tardive dyskinesia effect or something; started doing this shaking, almost like a tardive dyskinesia effect or something; This is a spontaneous report from a contactable consumer (patient's mother). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included autism. The patient's concomitant medications were not reported. On an unspecified date, the patient started doing this shaking, almost like a tardive dyskinesia effect or something. The reporter wanted to know if this was part of the side effects that people have reported. She has never seen him doing this before. The caller clarified that she was not sure if the tardive dyskinesia was new because he has been kept from her for a year due to COVID, so she doesn't know. She saw her 2 weeks ago and she noticed this behavior. She has never seen this before. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received an unknow COVID-19 vaccine of either Moderna or Janssen outside of the 6 hour window of vaccine vial puncture. Incident was discovered after patient left facility. Patient was called once incident was discovered the same day. Patient was followed up on 23 hours after vaccination as well. Patient stated he had a non-severe headache that he did not need to treat with pain relievers. Patient was given facility after hours phone numbers to contact if other symptoms occurred and was instructed to call 911 if emergency occurred.
Completely uncharacteristic loud screaming, confused, agitated, inconsolable within hours of getting shot. Low grade fever.
Information regarding PREVNAR 13 was received from a physician regarding her (son) 6-month-old male patient who experienced vomiting and crying.  At 6 months of age, the patient received a dose on an unknown day in May-2010.  The patient experienced vomiting and crying in May-2010.  Both events resolved.  No additional information was available at the time of this report.
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale.  Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
Pt walked out of the room and clutched her chest and said it hurt then her entire body turned dark red.  She was struggling to breathe and her skin was itchy.  The pharmacist gave her an Epi Pen shot in her thigh.  She recovered quickly.  Two hours later she had bumps on her neck we went to the ER.  She was completely fine after her first vaccine. This was very scary!  She is a healthy, active girl
muscle soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 16:30 (Lot number: EW0153) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "samter's syndrome" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies". The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle soreness".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The first shot only gave the patient muscle soreness for 3 to 4 days then went away.   No follow-up attempts are possible. No further information is expected.
Start of yeast infection, I had the same reaction with my first injection.  This time I was aware of what was happening and took medication before it turned into a full exacerbation.  The first was right at 48hrs after when I realized what it was, this time was less than 24hrs later that I knew what was happening and took care of it before it got bad.
Recvd vaccine approx 12:45 pm and within 2-3 min began feeling nauseous, dizzy, like I was going to pass out. Broke out in a heavy sweat and felt like I was going to throw up and needed to have a bowel movement. Heart rate and blood pressure were abnormally low. Felt shakey and as if heart was racing even though heart rate was low.
Same day post vax, the pt developed numbness in the fingers of her left arm and an injection site reaction characterized by shooting pains which extended to her left elbow, burning and itching. The numbness and pain resolved, however, the itching at the injection site persisted. This is one of three pts from this facility who experienced an adverse event following receipt of vax.
inj site sl swollen/red (size tennis ball) pea size hive @ needle entry-itching started w/in 4-5hr p/vax; 4NOV98 sx subsiding;
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in left arm and on 26Mar2021 as dose 2, single (Lot number: EP6955) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "former smoker" (unspecified if ongoing), notes: former smoker; "Shrimp" (unspecified if ongoing), notes: known allergies: Shrimp. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as no. other medication in 2weeks was reported as no. anti viral details product was used for COVID 19 Treatment, brand: Paxlovid, treatment start date: 05May2022, treatment stop date: 10May2022, indication: Treatment of COVID-19. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.  No follow-up attempts are possible. No further information is expected.
Vaccine site left thigh with moderate erythema, edema and skin breakdown central about 7-8cm total.  Symptoms occur within 24 hours of immunization.  Treatment with Keflex, Atarax syrup, Ibuprofen, Ice.  Remarkable improvement with rev on 04/16/04.
5-year old patient received COVID-19 Moderna Bivalent Booster currently approved for patients 18 years and older as her initial COVID-19 vaccine. Patient did not experience any adverse reactions, signs, or symptoms.
gen malaise, aches, fever 100.4, lasted 24hr;then cold sx of sore throat, nasal congestion devel & lasted x 5 days;also GI sx 24hr p/vax consisted of diarrhea, abd cramps, nausea;
R29.90 - Abnormal neurological exam R29.810 - Facial droop
Headache, NauseaVomiting, Chills, sore arm Narrative:  Reports chills, nausea HA and sore arm  Other Relevant History:
Severe headache and low grade temp lasted approximately 24 hours. Sx started about 12 -15 h after shot
Rt delt- MMR #2 & polio Rt delt #4.  5x3" induration & redness over rt deltoid.  No tenderness.  Shoulder movt nl.  BENADRYL 1 tsp Q 6, MOTRIN 2 tsp Q 8.
Patient had full seizure for 2 minutes. She recovered fully to alert and oriented x 3 within 10 minutes. Able to walk, talk completely oriented and independent.
Mild tinnitus in the right ear. Lasted approximately 3 hours. Then, subsided and has not recurred. Since the event was relatively brief, I did not seek treatment.
i have experienced head ache, fatigue, fever of 101.2, body ache for 24 hours now , i have been taking Tylenol for the past 24 hours but i cant brake the fever
1st Dose (April 3rd) - Soreness in arm for first few days - Bad fever, headache, fatigue day 4  2nd Dose (April 23rd) - About 12 hours after experienced bad fever (this time measured between 100.5-101.5), headache, chills causing shivering, and fatigue (though couldn't sleep with fever) first night. This continued for two days. - It is now 6 days out, and still experiencing brain fog (days 3-6 so far), which I didn't really notice until fever began reducing on day 2. The fog has also come with general fatigue, though not as bad as during fever period. Can be difficult to concentrate, focus, and feels associated with slight pressure in ears.
Patient  went to the urgent care the day following the PNEUMOVAX vaccination at approximately 5pm on 10/3/17. She was experiencing redness, swelling and heat on her upper left arm from the area where the shot was given down to the elbow. Patient stated that she started having pain in the arm the previous evening and had trouble sleeping, but woke up with the redness and swelling. Dr determined that she had cellulitis and put her on Cephalexin 500mg 2 capsules twice daily for 7 days. Spoke with patient on 10/5/17 at about 11am and she stated that she had been fatigued, but the redness was resolving and she was feeling better.
facial rash, mild swelling and itching beginning 2 days after 1st dose Moderna. Also used new face lotion the two days prior to onset
Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose; Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose; Lymph node is swollen under her armpit; lymph nodes have been swollen after they received vaccination; Fever; Pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 28May2022 as dose 3 (booster), single (Lot number: FP4554, Expiration Date: 14Jun2022) at the age of 11 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (Second dose), administration date: 2022, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset May2022, outcome "unknown", described as "Lymph node is swollen under her armpit; lymph nodes have been swollen after they received vaccination"; PAIN (non-serious) with onset May2022, outcome "unknown"; OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 28May2022, outcome "unknown" and all described as "Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose". Therapeutic measures were taken as a result of pyrexia, pain.  Additional information: Pharmacist stated, He was actually filing in for another pharmacist today and he was noticed something when he was going back with paperwork. One of the Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose. The young  lady happened to be born (withheld) so she was scheduled to turn 12 in this year. But unfortunately she was under the age of 12. She should have received her booster under the orange cap the children dose but the patient in experiencing her Lymph node was swollen under her armpit. She got her vaccination with her mom. The Pharmacist stated treatment included Tylenol and Ibuprofen, Tylenol for the Pain and he guess the Fever, using the Tylenol.  No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: she was sitting for 15 minutes observation she fainted and fell from the chair. She wa unconsious for about few seconds.  called 911 for her. she looked paled. paramedics took her in. checked all her vital sign she was fine , her dad took her home. Spoke to dad at 6 pm in the afternoon. she is home resting and having dinner.
mistakenly mixed with sterile diluent rather than the provided additive; mistakenly mixed with sterile diluent rather than the provided additive / administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   On 28th April 2021, the patient received the 1st dose of Shingrix. On 28th April 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The Shingrix was mistakenly mixed with sterile diluent rather than the provided additive, which led with wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked what steps should be taken from this point. The reporter confirmed that the dose was administered to a patient. The reporter consented to follow up via mail.
Patient had previously received the Pfizer Dose 1 on 1/8/2021 and Pfizer Dose 2 on 1/29/2021.  This violates the guidelines for both vaccine parameters.
Extremely heavy periods with blood clots and fibroids in the breast area that did not exist previously
A report has been received from a health professional concerning a male patient. The patient's concomitant diseases and concomitant medications were unknown. On an unknown date, receiving FLUMIST. The patient was administered of complete FLUMIST dose in one nostril. The action taken of FLUMIST was not applicable. The outcome of the event was unknown. The report was considered to be non-serious by  the reporter. Corrected report 16-Oct-2012: Case has been suppressed due to medication with no AE. Corrected report 06-Dec-2012: Coding of event 'administration of complete FLUMIST dose in one nostril' changed from circumstance or information capable of leading to medication error to drug administration error, narrative updated, reporter details corrected. Corrected report 14-Apr-2014: The has been updated with full data due to term additions for FLUMIST /Q/Laiv. For reference, source document can be found at case 2012SE70762.
Severe arm pain of the arm that was injected. Pain was 9/10 with movement of the affected arm. Had to keep arm immobilized to control pain and consulted Primary Care Provider for telephone/virtual consult visit. Lasted 24 hours prior to pain reducing to 5/10 level pain with limited use of affected arm. 48 hours out arm pain was reduced to a 2/10 level pain. Redness at injection site appeared 24 hours after injected as small an increased to 2 inches x 3 inches in diameter 48 hours out. Itching to site of injection and area of redness began 72 hours after injection.
This spontaneous report was received from a receptionist refers to a unspecified number of patients of unknown age and gender. On unspecified dates since 27-DEC-2013, an unknown number of patients were vaccinated with VAQTA (lot#, expiry not reported) after exposure to temperature outside prescribing information. No adverse events were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
achy, chills, headache, 101.4 fever: lasted less than 24 hours
Patient stated that pain started the day after the vaccine was administered.  doctors noted - local erythema to injection site about 3x3 inch with some warmth to the area
Headaches predominantly; More pan in places where she usually has pain, in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More pan in places where she usually has pain, in back) and HEADACHE (Headaches predominantly) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (More pan in places where she usually has pain, in back) and HEADACHE (Headaches predominantly). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2-3 times, qd. At the time of the report, PAIN (More pan in places where she usually has pain, in back) had resolved and HEADACHE (Headaches predominantly) outcome was unknown.          .
51 year old / inadvertently received an Engerix-B pediatric dose; 51 year old / inadvertently received an Engerix-B pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number 5DN72, expiry date 27th December 2022) for prophylaxis.   On 18th June 2021, the patient received the 1st dose of Engerix B pediatric (intramuscular). On 18th June 2021, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose were unknown.  Additional details were provided as follows: The 51 years old female patient inadvertently received an Engerix-B pediatric dose in the left deltoid, which led to adult use of child product and accidental underdose. The reporter consent to follow up.