chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm sensation; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm sensation), PYREXIA (Fever) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 14-Apr-2021 at 12:00 PM, the patient experienced FEELING HOT (warm sensation) and CHILLS (chills). At the time of the report, FEELING HOT (warm sensation), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 99.2 (High) 99.2 at the time of report and 100.6 (High) 100.6, at 5 pm.         No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-076215 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received and updated Event outcome for all the events  Feeling hot, Pyrexia and Chills from Unknown to Recovered
Patient presented in obs area after receiving 2nd dose, started complaining of left arm injection site numbness that radiated down to left hand, also complained of tongue numbness, vitals: 156/101 right arm, HR 91, SpO2 98% room air, respiratory rate 22, 0/10 pain. Pt began feeling worse, assessed lung sounds, expiratory wheezing noted, pt had home dose inhaler on hand, self-administered 2 puffs of albuterol HFA inhaler, states relief, pt did not complained of respiratory distress at any time.  EMS left with patient at 1140 to local hospital, pt alert, oriented and cooperative at all times. Left alert and oriented, in no apparent distress. No epi or benadryl administered.
Cellulitis to L arm with swelling, redness, pain. Mild temperature increase (99.2). Started on oral antibiotics, warm compress and antihistamine today.
Stomach pain; Sick feeling in her stomach; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 30-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration, administered in Arm Left on 21Apr2021 17:35 (at the age of 30-years-old) as dose 1, single for covid-19 immunisation. Medical history included anxiety and depression from Apr2020 and ongoing, abdominal pain upper, asthma from an unknown date and unknown if ongoing Patient has asthma and she was high risk. Concomitant medication(s) included lorazepam (LORAZEPAM) taken for anxiety, abdominal pain upper from 14May2021 to an unspecified stop date, escitalopram (ESCITALOPRAM) taken for anxiety, depression from 14May2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got Vaccination Facility in pharmacy. The patient experienced stomach pain, sick feeling in her stomach on 21Apr2021 with outcome of recovering. Therapeutic measures were taken as a result of stomach pain, sick feeling in her stomach. Caller states she got her second vaccine on Friday. She just told her doctor, her effect was not going away. After second dose ever since she got the shot, she has been had weird jaw pain and stiffness and feels like her jaw was tight constantly. She did not had any other side effects, but this effect has been very noticeable and has not eased up. Patient went to the emergency room on 12May2021 and she went to the doctor on 13May2021 and was discharged, she went for an office visit the day after her emergency room visit and her doctor started her on medications, during her visit for her stomach pain. Caller states she has a history of stomach issues, and about a half hour after the first vaccine, she had a sick feeling in her stomach. Patient states it was getting better but it still ongoing. Patient reported that she was unsure what medications to report and she postponed her second vaccine because she was sick and had stomach pain. She saw her doctor on 13May2021 and she started on some new medications about a week before her second vaccine. She received intravenous fluids, and Zofran or Reglan in the emergency room and these medications improved her symptoms slightly. Caller states she has messaged her doctor but did not had a visit with her today. Caller contacted her doctor about her recent effect, jaw pain. Caller was not sure if it could be an effect from her new medication or a different side effect, of the vaccine. The outcome of the events was reported as recovering.  Description of complaint: Caller was reporting on the Pfizer Covid vaccine and mentions the following: Reclarified, Caller states she has taken Ibuprofen and Advil, and neither of them had any effect, on her discomfort. Caller clarifies that Ibuprofen and Advil, did not had any effect on her symptoms. Caller states she took them at work and got the medications from a coworker and it was name brand and she took the usual doses.
Much more than usual, extreme shortness of breath. Unable to walk from one room to another. Having oxygen constant.  Chest pain. Shoulder and arm pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 90-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Stage 3 renal failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Got COVID end of Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
dose given less than 1 month; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 42-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAB (Twinrix).   On 23rd June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd June 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 details were provded as follows: The patient received 1st dose of Twinrix on 4th June 2021. The nurse reported that, the patient received 2nd dose of Twinrix, less than 1 month from 1st dose. which led to shortening of vaccination schedule. The reporter consented to follow up. This case was linked with case US2021165606, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165606:same reporter
I tested positive for COVID-19 on 1/23/23. I had a fever, body aches, fever, sore throat, coughing up phlegm, and chills. My throat was very sore, and it felt like it was closing at times. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. I am feeling much better now.
TWINRIX, Tdap and inject typhoid given-two days later patient experienced 2hrs of extreme anger. Had issues in past which he has been working on. Last episode was 2 yrs ago.
Felt warm and flush.  Was concerned was anxiety.  On Site ALS and BLS providers attended to client and provided supportive care. Client evaluated x 30 minutes and left  ambulatory
I was on a cruise ship April 3rd-April 15th. Experienced sore throat on April 15th. Did at home test which was returned positive. Had tele visit with doctor on April 15th where doctor suggested MAB therapy. I was in (Privacy) at the time and unable to receive that treatment. I drove home and was prescribed Paxlovid by my PCP.
eye irritation; extreme itchiness, itchiness around the eyes; redness around the eyes; wrinkles around the eyes; extreme discomfort; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eye irritation), EYE PRURITUS (extreme itchiness, itchiness around the eyes), OCULAR HYPERAEMIA (redness around the eyes), SKIN WRINKLING (wrinkles around the eyes) and OCULAR DISCOMFORT (extreme discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE IRRITATION (eye irritation), EYE PRURITUS (extreme itchiness, itchiness around the eyes), OCULAR HYPERAEMIA (redness around the eyes), SKIN WRINKLING (wrinkles around the eyes) and OCULAR DISCOMFORT (extreme discomfort). At the time of the report, EYE IRRITATION (eye irritation) and EYE PRURITUS (extreme itchiness, itchiness around the eyes) had not resolved and OCULAR HYPERAEMIA (redness around the eyes), SKIN WRINKLING (wrinkles around the eyes) and OCULAR DISCOMFORT (extreme discomfort) outcome was unknown.            No concomitant medications were provided by the reporter. It was reported that patient experienced extreme itchiness after the booster dose, It is still ongoing, patient have seen pcp and a dermatologist. eye reactions and they do not exactly fit description, itchiness and redness and wrinkles around the eyes causing extreme discomfort. Patient took  steroids and other prescribed meds with no help.      This case was linked to MOD-2022-567946 (Patient Link).
No additional AE details were provided and no additional AE's were reported.; Patient that received a dose of PROQUAD intramuscularly instead of subcutaneously.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 19-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliters, intramuscularly,  lot number U019288 had been verified to be a valid number; expiration date 15-DEC-2022, and upon internal validation established as the same date, for prophylaxis (vaccination scheme, frequency, and anatomical site of injection were not reported), the vaccination was intramuscularly instead of subcutaneously (incorrect route of product administration).
MESS ME UP BIG TIME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced mess me up big time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mess me up big time was not reported. This report was non-serious.
Hours after shot I noticed a large red swollen lump. On 12/31/2020 I showed this to one of my providers and he told me to give him a call if it had not disappeared by 1/4/2021. The redness was slightly better on 1/4 but then became drastically worse on 1/5/2021. I had a low grade fever(100.7), spreading redness, pain, itching, and swelling of left arm, on 1/5/2021 and was told to go to urgent care. I went to urgent care on 1/6/2021 and was diagnosed with cellulitis. My injection site was measured and I was instructed to go to the hospital if after given first and second dose of antibiotic, symptoms did not improve. Redness began to decrease and I did not go to the hospital. As of today, 1/9/2021 my left arm is mildly red and swollen.
This case was reported by a nurse via call center representative and described the occurrence of pain in hand in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced numbness in hand. On 20th November 2018, the patient experienced pain in hand and injection site erythema. The patient was treated with PARACETAMOL (TYLENOL). SHINGRIX was discontinued. On an unknown date, the outcome of the pain in hand and injection site erythema were recovered/resolved and the outcome of the numbness in hand was not recovered/not resolved. It was unknown if the reporter considered the pain in hand, injection site erythema and numbness in hand to be related to SHINGRIX. Additional details were provided as follows: It was reported that within 24 hours after vaccination the patient experienced severe bilateral hand pain with redness to the injection site for 10 days that dulled with Tylenol. After 10 days the patient experienced numbness of the left thumb and index finger and to the third finger on the right hand and any pressure on these fingers was still painful. The patient asked if it was the normal vaccine reaction and asked whether she could receive the 2nd dose of SHINGRIX and the nurse advised her not to receive the 2nd dose of SHINGRIX and recommended to report this as a reaction and asked if there was any data on the reaction like this.
I received the vaccine on Monday. Tuesday I felt like I had the virus again-tiredness, slight temperature, chills, intense pain at injection site, slight stomach discomfort. What surprised me and the reason I am reporting this is the symptoms, though gradually better, persisted until Friday-4 days. I was expecting to be down for a day or two, but length of the aftereffects surprised me. I had a strong case of Covid in January 2020.
Witnessed tonic-clonic seizure at home 3/18/21 Hospitalized 3/18-3/24/19 for seizure, lactic acidosis
-my first dose of pfizer I got my period even though I am on continuous birth control, so I shouldn?t lot #: EN6205 -each dose takes me about 2 weeks to recover from, but the 3rd dose is taking longer to recover  -with the 3rd dose only I got terrible nausea and diarrhea, I am 15 days out and still getting bad diarrhea off an on, my stomach is so messed up I can?t take my adhd meds and I?m have trouble eating, I will be fine and then randomly get very sick to my stomach, it is not consistent -I noticed this the most with the 3rd dose, but I am having awful depression, much worse than usual almost to the point of suicidal thoughts, I have no motivation to do anything, terrible fatigue and depression, also very angry and irritated
On May 5th 2021 I went into what appeared to be Sepsis, I was taken to Medical Center with a high white blood cell count. I was  shaking and they told me I was in Sepsis, they put me on 3 different antibiotics. My blood sugars were swinging from very high to very low, I was very very sick. They called in my ENDO DR and they reassessed my insulin pump. He lowered my insulin pump adjustments. I also started bruising extensively while in the hospital as well. I was getting a tremendous amount of bruising and even now, even if my dog just leans on me then I bruise. I also have extensive headaches that do not stop since May 5th. The regular migraine medicines are not even touching this head pain or relieve it. I went to the ER in August as well and they had to give me morphine to break the migraine pain. I was at my neurologist this past week and he got approval to give me a new medication as well. Additionally, I have been seeing a hematologist since June 2021 to try and identify why I have been having this bruising. They have done extensive testing and they cannot identify it, nothing is coming back as positive on tests. I have never had proliferative retinopathy in my eyes and then in the last few months, I have had two laser surgeries. I was at risk of losing complete vision in my right eye. I had my last surgery just this past Thursday and this is October. So between the headaches, the bruising and severe bleeding behind my eye, that all started within weeks of having that second covid shot.
Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of HPV (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 04-Apr-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 20-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   This case was linked to MOD-2021-364937.
tingleng in lower right leg and feet. Tingling numbness in right arm. Currently taking 2 aleves every 12 hours for next 5 days as per doctor.
Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported "numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation", "bulbar reaction with clearing of throat and tightness of chest" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related.   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 RA, IEC, as appropriate.