chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Chills, cold hands, high fever  (102.4) Rectal...persisting now  over 12  hours...treated with tylenol and  advil; alternating doses  with only partial and  temporary relief...We  were told  about possible fever but not  how  high  it might go...
Lactating women; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating women) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (patient currently lactating).    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating women). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating women) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: NNI
INJECTION SITE BECAME SWOLLEN AND ITCHY, BROKE OUT IN RAISED RASH OVER BODY AND ITCHING SPREAD OVER BODY.  PATIENT DID NOT KNOW HOW LONG RASH LASTED.  NO RASH NOTED AT NEXT VISIT, 05/15/2014.
Patient received pneumococcal vaccine polyvalent and flu vaccine on 10/21/13. Pt returned to clinic 10/23/13 with cellulitis left arm and fever. Pt treated with Keflex.
Patient came to the pharmacy on Tues Oct 20th and brought 2 prescriptions.  She told me the day before she had received her flu vaccination and was experiencing  pain at the injection site and her shoulder.  She thought the vaccination was given too high on the arm.  She had seen  Dr and he  had prescribed  two prescriptions for  tramadol and cyclobenzaprine.  The patient was counseled on how to take the medications.  I called the patient on Wednesday Oct 21st and  left a voicemail for her to call the pharmacy.  Patient did not return call.  On Friday Oct 23rd I called the patient and again left a voicemail asking her to call the pharmacy so we could check on her reaction.  Patient did not return call.  On Saturday Oct 24th I called  the patient and was able to speak with her.  The patient reported still experiencing pain and did not feel like the medications were helping. She had missed several days of work due to the arm pain.  She is going to follow up with her physician.
Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 15 months old male patient who received an 0.5 ml dose of vaccine ACT-HIB (lot U6111AA) reconstituted with sterile water instead of 0.4 NaCl, via intramuscular route in thigh (unknown what side), on 14-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; and VARIVAX II for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
metal taste in her mouth; This is a spontaneous report from a Pfizer sponsored Program received from consumer (patient herself) reported that a 60-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that she has received both of the Pfizer Covid 19 Vaccines. With the first vaccine on an unspecified date, she experienced a metal taste in her mouth as soon as she received the vaccine. With the second vaccine she experienced a little soreness in her arm and the metal taste continued. Caller stated it was like I ate hot soup. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pfizer-BioNTech COVID- 19 Vaccine EUA:Patient with significant PMHx of alcoholism, AFIB, CHF, COPD, DM, GERD, MI, HTN, pacemaker placement stroke, and hyperlipidemia who presents to the ED with CC of dizziness. Pt states that two days prior he slipped and fell and hit his head, and was unable to ambulate after the fall.  Pt denies any LOC, but states he is currently on Xarelto.  Pt currently c/o back pain. Pt went for his first COVID-19 immunization 1/22/2021 when he became suddenly dizzy. Patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, fever, chills, or any other acute complaints. Progress Note: "Dizziness, near-syncope: Onset following injection of COVID-19 vaccination.
Pt developed nose bleeds, petechial rash, dx with ITP platelet 8,000 getting IVIG.
This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency and therapy route were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
fever day of and day after vaccine, with sore arm and generalized fatigue. Fatigue became more intense during the first weekend and continued with times of tingling in extremities and feeling of very heavy arms and legs. Palpitations started a few days later and severe heartburn 3 weeks later. After 3 weeks from 1st shot, generalized weakness is still present.  Did not take the second shot out of fear it will get worse
Full body rash and bumps, covering legs and arms. Very itchy. Face also gets a rash, very dry spots on cheeks.  No bumps on my feet but they are on my hands.
It was reported that a male patient received a Menomune A/C/Y/W-135 vaccination and a test (manufacturer unknown) on 10-Mar-2001. Reportedly developed rash, high fever-103F, chills, malaise, weakness and stiff neck-unresolved. Patient seen by health care professional-blood work done (Lyme test-negative)
My heart was racing; I was tired, I guess it will make you little tired also; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06May2021 14:00 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), administration date: 15Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 07May2021 03:00, outcome "recovering", described as "I was tired, I guess it will make you little tired also"; PALPITATIONS (non-serious) with onset 07May2021 05:30, outcome "recovering", described as "My heart was racing". Therapeutic measures were taken as a result of fatigue, palpitations.  Additional information:  Consumer stated, " I had my second Pfizer shot yesterday around 02:00 p.m. I guess, the first one I didn't have much of reaction to I know the second one is said to a little bit stronger, I don't know maybe I, around 05:00 I get home like from work like 02:00 in the morning, I work in a Casino. I have something to eat around 3 or so I was tired, I guess it will make you little tired also I , 05:30 in the morning I woke up and my heart was racing and I was little worried I don't it was maybe something I ate before at work, before I went to work maybe I should have had something strong or yogurt or I had Walnut with some blueberries. I had it woke me up I immediately had the little brochure you have from the Pfizer from where I got the shot and then I took a Ibuprofen 200 mg is that the right thing to do, or kind a calm my heart down?" Name of the Product : Consumer stated, "Yes I had the Pfizer shot (Pfizer COVID 19 Vaccine, confirmed), yes it says, no it says in the brochure that I get I did read out it here that'd have if you have any problems or something you supposed to take Ibuprofen or something. I took the, no I had 200mg of it, without its yesterday, you are supposed to do that if you had some type of side effects or something with the fast heartbeat that would make you better, it seems to be a better after that." Consumer was informed about Pfizer Medical Information Department : Consumer stated, "Oh I thought you are a pharmacist so maybe that you were able to, what's the number?" Consumer was informed about the Pfizer Medical Information and provided with the number. Consumer stated, "Yeah that's good I was, I rather speak to a higher person for." For further probing : Consumer stated, "Well really not to be honest with you I got a I kind of work early today, I am sorry."  No follow-up attempts are possible. No further information is expected.
Weakness and tingling in your extremities Issues maintaining body temps.   Blood sugar hitting crazy numbers on 12 hour fast Tired and sore, left rear neck tingling with head aces
Menactra exposed to 27F for more than 3 hours due to  temperature was manually changed in the refrigerator, no advesre event; Initial information was received on 01-Jul-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174880, 2020SA174885, 2020SA174942, 2020SA174911, 2020SA174941, 2020SA174910, 2020SA174932, 2020SA174906 and 2020SA173110 (same reporter).   This case involves a vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6594AB and expiration date 21-May-2021) which was exposed to 27 degree F for more than 3 hours and this vaccine was administered to a 11 year old male patient via an unknown route at an unknown administration site on 13-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.   The patient's concomitant medication was not reported.  It was an actual medication error case due to product storage error temperature too low. This error occurred due to temp was manually changed in the refrigerator (human error).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
pt recvd vax & had 2 episodes of v 4 hrs post ofc visit; had fever; was irritable & tired for 24 hrs;
I had a fever of 104 and also I had severe sinus pressure. The next day I was very fatigued & had a lot of sinus pressure. I did a home COVID test & it was positive so I called my Dr. & was given PAXLOVID.
Patient presented in the pharmacy to get COVID19 Pfizer shot but instead the patient was given flu vaccine.  No adverse event was stated by the parent as of 12/7/21 as initial screening  Will continue to follow up with the family
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID hospitalization.
After the first dose I noticed swollen glands, gradually worsening burning/electrical pain and discomfort in the left arm, from my neck down to my fingers. I am also  having tingling, numbness, weakness, and loss of strength in Left the arm. I received the second dose of Moderna on 6/17/21 on the right arm lot 054C211A. I had constant pain and swollen glands under my right arm and my right breast that lasted 48 hours. After that now the pain, tingling, numbness, weakness is similar on both arms, in addition to neck and back pain that feels the same as the arms.  My glands are swollen and sore on my neck,  clavicle, shoulders, under my arms. In addition,  I have had achiness, tingling, and numbness on both legs, from my knees down to my toes for the last 5 days.  Today I have had generalized body aches, chills, and weakness.  I went to Quick care urgent care on 6/26 and the prescribed Prednisone 10mg daily x 3 days. It helped, but I feel worse today after I ran out of medicine. I have been taking Ibuprofen otc and using topical otc medicines. I have an appointment scheduled with my PCP on 7/1.
06/10/03 IN OFFICE WITH RASH >50 POX    MOM CALLED ON 06/11/03STATING CHILD HAD SEVERAL POX WITH PUSTULES.
pain in the left arm (injected arm).; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (pain in the left arm (injected arm).) in a 68-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor of the patient was reported as none.     In January 2023, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In January 2023, the patient experienced VACCINATION SITE PAIN (pain in the left arm (injected arm).). At the time of the report, VACCINATION SITE PAIN (pain in the left arm (injected arm).) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: did not reveal anything abnormal.         Concomitant product use was not provided by the reporter.  It was reported that patient had received another 4 doses of Moderna COVID-19 vaccine (Lot number and Exp. Date was unknown). The last shot was administered on Jan-2023 at a local pharmacy. Since Jan-2023 patient was having pain in the left arm (injected arm). Vaccination card was not handy at the time of reporting. Patient had visited a magnetic resonance imaging (MRI) was performed which did not reveal anything abnormal.  Treatment information was not provided.   Reporter did not allow further contact
lower back pain; It went from his hip to lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and ARTHRALGIA (It went from his hip to lower back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B(or8)21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced BACK PAIN (lower back pain) and ARTHRALGIA (It went from his hip to lower back). At the time of the report, BACK PAIN (lower back pain) and ARTHRALGIA (It went from his hip to lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
I began to experience muscle or nerve pain in my legs, from glutes to ankles.  It became more severe over time and has lasted one month.
3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". The patient date of death was unknown. Reported cause of death: "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". It was not reported if an autopsy was performed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200625894 same reporter/ drug/ event, different patient;US-PFIZER INC-202200625895 same reporter/ drug/ event, different patient; Reported Cause(s) of Death: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine
Having trouble breathing; Blood pressure is out of control; Fatigue; Constant headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 12Oct2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included active epstein-barr virus infection (EVB), cytomegalovirus infection (CMV) and hypertension. The patient had no known allergies.  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. Concomitant medications included colecalciferol (CHOLECALCIFEROL), lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ADULT LOW DOSE ASPIRIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 21Sep2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021, the patient experienced trouble breathing, blood pressure was out of control, fatigue and constant headaches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events trouble breathing, blood pressure was out of control, fatigue and constant headaches were not resolved at the time of this report.
Pt. started oral typhoid at approx 10 pm 1-14-14 woke up 1-15-14 with headache. Took second pill with large amt water approx 8:30 pm 1-16-14. Headache worse today 1-17-14. Taken to doctor for shot of morphine. Given Rx - hydrocodone every 4 hrs. which has helped.
patient received 5-11y/o booster when should have received adult bivalent booster. patient later received adult bivalent booster dose on 11/3/22.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Severe
Pfizer 12+ Bivalent booster vaccine was administered instead of Pfizer 12+ monovalent vaccine for 2nd dose in primary series. No symptoms are adverse reactions.
Information has been received from a physician concerning a 2 month old female who was vaccinated PO with her first 2.0 ml dose of Rotateq. Concomitant vaccinations included "4 other vaccinations at the same time." Subsequently the patient developed a bloody stool. Unspecified medical attention was sought. Lab diagnostics studies performed included "stool samples and an upper GI". The patient's recovery status was unknown. There was no product quality complaint. Upon internal review, a bloody stool was determined to be an other important medical event. Additional information has been requested.
PATIENT STATES "HER WHOLE BODY SHUT DOWN" WHEN SHE GOT ALL 3 SHOTS AT ONCE (CANT EAT, THROWING UP, LOST 7 POUNDS), she also went to the hospital.
The patient stated he was feeling dizzy and hot after within 10 minutes of receiving the vaccine. Patient requested water. Vitals taken and initially BP 80/56, HR 51, Temp 98.7, RR 18, 97%. Continued to monitor patient longer and put a fan on the patient. Re took vitals 10 minutes later BP 134/87, RR 18, Temp 98.7, O2 98%. Patient stated feeling better. Vitals and patient were stable before patient left.
MD felt was the pertussis;lt leg swollen w/fever 102;could not tolerate touching legs & did not bear weight on it;started crying & screaming could not be comforted-lasted for 24hr;cried non-stop 2-3hr;refused to eat
soreness, aches, pains; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness, aches, pains) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00-B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (soreness, aches, pains) and FATIGUE (fatigue). At the time of the report, PAIN (soreness, aches, pains) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided. treatment to the events not provided.
Dizzy/sweaty. Has not eaten today. Glucose tab administered with water.  SXS improved. No further intervention needed. Declines any allergy.
Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago.  By Monday left eye swollen shut.   Saw opthmologist prescribed Acyclovir.  Over a couple days swelling dissapeared and burning, itching subsided.  The thing is, I had my second COVID dose on 02/10/2021,  10:00AM Pitzer Lot #9581.  On 02/18/2021 late evening, started to feel burning in left eye nose area again, next morning eye swollen shut.  Saw Dr, said I was having an allergic reaction and put me on prednesone and Amoxicylin.  No reduction of swelling and burning, blisters were forming.  Went to Urgent Care on 2/20/2021 and was prescribed Acyclovir again.  Swelling now gone and itching burning diminished.
The roof of my mouth became very painful.   It was difficult to eat.  Two days after initial symptoms I went to a dentist to find out what was going on.  The Dentist indicated that I had chicken pox sores in my mouth,.  She took photos and showed them to me.   I had chicken pox as a child but had the full series of Shingrix vaccine about 2 years ago,  The Dentist prescribed Acyclovir 400 MG 3 x a day for 10 days and a gargle with  Dexamethasone 0.5mg/5ML 4 x a day for for 2 min each.  Symptoms resolved in about 8 days.
The patient received the vaccine and after about 5 minutes, she started feeling like she was going to pass out.  Her face turned white, and I could tell she was feeling faint.  We assisted her to a safe place to lie down.  A physician on duty at the clinic attached to the pharmacy examined her. We sat in the room with her for several more minutes.  She started feeling better after about 10 minutes and was able to stand with no problem.  We had her call her spouse to pick her up.