chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs.; Itching of (pre-existent) eczema; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Medical history included eczema, taste disorder, gastro-intestinal reflux, arthritis, drug allergy (sulfa drugs) and breast cancer (small lump). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 23Feb2021 at 10:00, as a single dose for COVID-19 immunisation. Concomitant medications included losartan (MANUFACTURER UNKOWN), pantoprazole (MANUFACTURER UNKOWN), rosuvastatin (MANUFACTURER UNKOWN) and sucralfate (MANUFACTURER UNKOWN) all for an unknown indication from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00, the patient experienced inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs. The patient self-administered EUCRISA and hydrocortisone was given as treatment for the events. The clinical outcomes of the events insomnia and itching were recovering.   No follow-up attempts are possible. No further information is expected.
A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Received Moderna vaccine 2/10/21 a pharmacy. Daughter called 3/10/21 to report that pt had stroke 3/2/21 and was admitted to hospital.
Mom reports febrile illness of 103.5/R Sat (07/27/02) evening T 102 thru Sun (07/28/02), Irritable, very fussy, Went to urgent care/walk in clinic (07/28/02) Alternating use of Tylenol and Motrin. Afebrile by 07/29/02.  Follow uP:  No site irritation.
The R thigh where the vaccine was administered had a raised area 3" in diameter and was very itchy for approximately 4 days.
Swelled up and turned into knot, bigger than golf ball size. Was very red and hot. Fever and aches, fatigue, upset stomach. General feeling of being unwell. Have taken Benadryl and Advil.
This spontaneous report was received from a healthcare professional via Pfizer (manufacturer control # 2016343366) and refers to an 18 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patient was vaccinated with a dose of HPV (manufacturer unknown) (exact dose, route of administration, lot # and expiration date were not reported) and with a dose of TRUMENBA (0.5 ml, route of administration, lot # and expiration date were not reported). On an unknown date, after the use of the products, the patient almost passed out. His legs were elevated and he felt better. The outcome of the event was reported as recovering/resolving. The relatedness between the event and HPV (manufacturer unknown) was not reported. Additional information has been requested.
Patient complained of tingling on left side of his neck, arm, and leg. Onsite EMS was called vitals BP 128/44 HR 68 98% O2  BG 121. No throat swelling or rash, lungs clear. She was encorgaged to follow up with your MD. Relesed to go home.
headache, rash on face neck and chest, fever greater than 103F, fatigue. dishydrotic eczema,  sudden onset menopause, shingles, sudden environmental allergies
Heartburn; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 17Feb2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) and ceftriaxone sodium (ROCEPHIN) for unknown indication and on unknown date and experienced drug allergy. Concomitant medications included birth Control (MANUFACTURER UNKNOWN) and daily multi-vitamin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. 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 19Feb2021, the patient experienced heartburn. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event heartburn was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a Registered Nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) and subsequently developed shingles. At the time of the report the patient's status was unknown. It was unspecified if medical attention was sought. There was no product quality complaint involved, no additional information was provided. Additional information requested. This is one of several reports from the same source.
palpitations, heart racing only at night; This is a spontaneous report from a contactable consumer reporting for herself. A 60-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:00 (at the age of 60-years-old) as dose 1, single for covid-19 immunization at other facility. The patient was not pregnant at the time of vaccination. Medical history included gastrooesophageal reflux disease (severe acid reflux disease, GERD) from an unknown date and unknown if ongoing. Concomitant medications in 2 weeks included esomeprazole sodium (NEXIUM) and levothyroxine taken for an unspecified indication, start and stop date were not reported. Known allergies, other vaccine in four weeks, covid prior vaccination included none. The patient experienced palpitations, heart racing only at night on 22Apr2021 00:30 (12:30 AM). The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03May2021 (covid test post vaccination). Clinical outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Blood filled small blister; This is a spontaneous report from a contactable patient. A 66 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown), via an unspecified route of administration in left arm on 04Mar2021 at 00:00 as a single dose for COVID-19 immunisation (at the age of 66 years). Patients medical history included high blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown), via an unspecified route of administration in left arm on 21Jan2021 at 00:00 as a single dose for COVID-19 immunisation and the events are not reported . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested positive for COVID-19. The patient reported no allergies to medications, food, or other products. The patient experienced blood blister on 18Mar2021 at 00:00. The patient reported that area of blister has spread slightly. Therapeutic measures were not taken. The clinical outcome of blood blister was not resolved at the time of the report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Headache started 5 weeks after 2nd dose. Was migraine like, tightness, didn't respond to anything, continued for 6 weeks , needed er visit, ct scan, mri , spinal tap, multiple iv meds, finally resolved for 4 weeks only to come back after 4 weeks break, now again having it for 2 weeks without response to anything
PATIENT WAS ABLE TO FILL OUT THE FORM AND ANSWER ALL THE QUESTIONS.  ABOUT 30MINS-45MINS AFTER RECEIVING THE SHOT SHE WAS DISORIENTED.  UPON WHICH, HER FRIENDS CALLED THE PARAMEDICS AND TOOK HER.  SHE WAS DISORIENTED AND WAS SLIGHTLY FLUSHED WITH SLURRED SPEECH
Red, warm, itchy patch appeared an inch or so below injection site on 8th day after injection. Approx 3 inches diameter.
Received vaccine on 07/02/2021 at 9:00am. Woke up on 07/05/2021 with hearing loss in right ear.  Arm soreness starting 07/04/2021.  Chills and full body aches started 07/02/2021 in the evening and again 07/03/2021 in the evening but only in the evenings.
pt recvd vax 8MAY91, on 16MAY t104, APAP given & seen by MD 19MAY91; Rash present, tx Bactrim; Rash faded 21MAY eve cont to have severe h/a, held head, screamed when touched p/fever subsided;
Erythemous, macular rash around place of injection approx 5cm x 4 cm wa site. Not tender on palpation.
Initial report received on 26 SEPTEMBER 2013 from a health care professional. A female patient whose age, medical history and concomitant medications were not reported, received a dose of FLUZONE ID, lot number, route and site of vaccination was not reported) on an unspecified date.  It was reported that a patient have received the FLUZONE ID. On September 2013. Patient reported numbness from below the elbow to her fingertips. List of documents held by sender: None.
previous hospitalization approximately 1 wk prior to this one; was hospitalized with ARF with Hypoxia, positive test for COVID, reactive airway disease; was treated with steroids, remdesivir, DuoNebs, and O2 supplementation and was dc'd to home on O2 via NC; seen again in ED with inability to maintain O2 saturations (84% on 4L); coughing and more SOB than previously; admitted to hospital; progression of COVID pneumonia; treated with Baricitinib; pt's condition worsened and he was made comfort measures; he passed away in the hospital
Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 1 received a dose of HEPLISAV-B.  Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This "affected 5-10 patients," but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This case was reported by a healthcare professional to sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix, GlaxoSmithKline).  On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The subject was seen in the emergency room. The outcome of the events was not reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Heart racing and pounding 30 minutes after injection. Intermittent heart pain, heart pressure, left arm pain, palpitations, heart fluttering continuing for 10+ days following vaccination. EKG revealed short PR interval of 110.
The husband was also on the line, informed that he also had covid twice.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The husband was also on the line, informed that he also had covid twice.) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (The husband was also on the line, informed that he also had covid twice.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (The husband was also on the line, informed that he also had covid twice.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-747310 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747310:Wife case (master case)
Welts started on 04/22/2018 in AM. Pt mother states welts were over upper body, chest and arms. Pt mother states large in size and multiple. Pt mother states pt did develop fever 101 for 2 days after injection given but treated with MOTRIN and pt had not other issues. Fever also noted after pt first injection in series of MMRV and PEDIARIX on 01/12/2018 but subsided 2 days later. Pt mother gave pt BENADRYL on 04/22/18 for welts and pt tolerated well. Pt mother denies pt having any other issues or complaints. Pt mother states then this AM (4/24/18) welts moved to lower body and only one small one on upper body. Pt mother states again pt denies any discomfort or other signs or symptoms other than some itching. Pt mother did apply hydrocortisone cream to areas and also gave pt BENADRYL and sent pt to school. Dr. aware of situation. Pt mother states will contact office if any changes noted or pt does not get better.
EXTRA DOSE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a male of unspecified age. 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: Unknown, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021, and dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. The batch number for second dose was not reported and has been requested. No concomitant medications were reported. On 23-SEP-2021, the patient experienced extra dose administered. On 23-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extra dose administered and off label use was not reported. This report was non-serious.
Fever, headache, stiff neck, several hours after Menactra.  Erythema and swelling of left arm/shoulder at injection site.  Afebrile by 06/23/ but still stiff neck.
This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with TWINRIX, manufacturer unspecified.  On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml.  At the time of injection with TWINRIX, the subject experienced arm pain and shoulder pain.  The reporter stated that this seems to be a recent problem, not experienced in the past and that it seems to occur irrespective of the person giving the vaccination or the technique used.  Subjects complain of a sudden, brief, but significant pain that shoots down the arm to the elbow or sometimes up into the shoulder and neck.  The reporter felt that a logical explanation would seem to be the fact that the TWINRIX vaccine uses a larger volume (1.0ml) than many other vaccines (0.5ml), but it does not explain why these events have not happened in the past with this vaccine or why it does not happen when the same vaccines are given as separate injections.  This was considered to be a product complaint.  At the time time of reporting the outcome of the events was unspecified.  These events occurred in a number of different subjects from the same source, but with different contacts.  Case A0732483A serves as the master and other linked cases include A0732491A and A0732492A.  Additional linked cases include A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Febrile seizure, evaluated in ED.  No labs or tests performed.  No treatments given.  Seizure resolved and he returned to baseline.
This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 54-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than year after receiving SHINGRIX, the patient experienced myalgia and pain. On an unknown date, the outcome of the myalgia and pain were unknown. It was unknown if the reporter considered the myalgia and pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist said that the patient did not want to receive the 2nd dose due to the adverse reactions experienced after 1st dose. The health care professional was asking what the vaccine efficacy was for SHINGRIX after 1st dose. The health care professional was driving in his car so he did not have any additional details on the patients demographics or lot number since health care professional was not calling from the pharmacy and was calling while driving. No further information was provided. This case has been linked with case US2018071840, reported by the same reporter.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (2.5 mL/five dose vial, lot # J015868, expiration date 25-FEB-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours. The lowest recorded temperature was 32 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
I received the vaccine on Jan. 8, 2021.  48 hours later, I was suffering from diarrhea, abdominal pain and fatigue.  The s/s continue but are less severe until the present (1/18/2021.)  No treatment except lots of fluids and gut rest.
Diarrhea; Nausea; This is a spontaneous report from a contactable nurse or other health care professional (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient reported she is a licensed practical nurse and she had her first shot last Thursday. She has been experiencing nausea and diarrhea since. Asking how long is going to last as she needs to go back to work. She had to call off work today and it is not looking good for going to work tomorrow. She also wants to know if this may happen again when she will get her second dose. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Nasal congestion; rash on torso/back; itchiness on torso/back; malaise; difficulty falling asleep.
She felt fine aside from a sore arm at the site; This is a spontaneous report based on the information received by Pfizer from Merck & co, inc (Ref Case Number: 01838313). A contactable other healthcare professional reported for a female patient of unspecified age (her friend/nurse) received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her friend, who is a nurse, posted  on 06Jan2021 that she had gotten her first dose of the vaccine (date of administration unspecified) and then later in a text message said she felt fine aside from a sore arm at the site on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient said her arm was red, swollen, and hot.  She said she went to a doctor , he diagnosed her with cellulitis, and put her on an antibiotic.