chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold sweats; hot and cold flashes; dizziness worse; Patient has no balance; cannot hold solid foods down; headache; nausea; vomiting; cold flash; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance) and DYSPHAGIA (cannot hold solid foods down) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Balance disorder since October 2020 and Dizziness in October 2020. Concomitant products included INSULIN for Diabetes, MECLIZINE HCL, TOPIRAMATE and ONDANSETRON for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance), DYSPHAGIA (cannot hold solid foods down), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (cold flash). At the time of the report, COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance), DYSPHAGIA (cannot hold solid foods down), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (cold flash) outcome was unknown.            Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-054907 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054907:crosslink
Hard, red, whelp in arm pt rec'd varicella in, nickel size, slightly tender, slightly swollen around red area. Mom first noticed yesterday. Stated not sure if from shot or a bug bite. Has not done anything re: treatment of site.
12/30/2021 No adverse events occurred immediately after vaccination.  1/4/2022 Mother reports child felt, "run down and lethargic and had and achy arm for about 1 day after but that was it."
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2021 as dose 2 (booster), single (Batch/Lot number: unknown), on 22Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 21Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) and on 20Mar2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Enteropathic Arthritis" (unspecified if ongoing); "Spinal Stenosis" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Dose 1 Janssen, Dsoe 2,3,4,5 are pfizer. Concomitant medication(s) included: HUMIRA, start date: 23May2022, stop date: 23May2022; NEURONTIN; GABAPENTIN; CYCLOBENZAPRINE. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin"; Morphine, reaction(s): "Drug allergy"; Hydromorphone, reaction(s): "Drug allergy"; Phenothiazines, reaction(s): "Drug allergy"; Metronidazole, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Tested positive via both rapid antigen and health care administered PCR test on 05Jun2022; (05Jun2022) positive, notes: Tested positive via both rapid antigen and health care administered PCR test on 05Jun2022; (12Jun2022) Negative, notes: Tested negative via rapid antigen test on 12Jun2022 (day 7); (16Jun2022) positive, notes: Tested positive via rapid antigen test on 16Jun (day 11). Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 04Jun2022, treatment stop date: 09Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose 1:  Moderate Pain in the arm, moderate swelling approx 4-5 hours after injection Dose 2:  Severe pain in the arm, moderate swelling approx 4-5 hours after injection,  approx 20 hours after injection:  continued arm swelling/pain, joint pain, body aches, chills, nausea, x1 vomiting, headache, fatigue, fever.  Slept 20 hours.  Approx 44 hours after injection:  same symptoms but mild, swollen axillary lymph node left arm (same as injection arm) this has lasted until today so far (2/16/2021).
Severe vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING (Severe vomiting) 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.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced VOMITING (Severe vomiting). At the time of the report, VOMITING (Severe vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  The reporter reported case for daughter and asked whether vomiting was normal after vaccination or was vomiting noted in clinical trials.
the patient has been crying since the day he received the vaccine; problems caused by the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CRYING (the patient has been crying since the day he received the vaccine) and VACCINATION COMPLICATION (problems caused by the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRYING (the patient has been crying since the day he received the vaccine) and VACCINATION COMPLICATION (problems caused by the vaccine). At the time of the report, CRYING (the patient has been crying since the day he received the vaccine) had not resolved and VACCINATION COMPLICATION (problems caused by the vaccine) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. Treatment reported was unknown. Reporter did not allow further contact
PT C/O TIGHTNESS OF THE THROAT O/E BP 109/57 PULSE 75 O2SAT 99%,NO SOB,NO RESPITORY DISTRESS,PT WAS OFFERED DRINK AND ACCEPTED, CONTINUE TO MONITOR.PT WAS STABLE AND WAS ABLE TO DRIVE HOME.
Was in his USOH until this morning whilst he was at work.  He noticed that he was having difficulty finding his words and that he felt spaced out.  Decided to schedule appointment see his PCP early afternoon.  He was brought to the emergency room for further evaluation due to concern of an underlying stroke.   On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem.  Not placed on any anti-platelet or anticoagulants.  Does mention that he has a family history of this.   Recently had the COVID-19 vaccine. Notes that he did have some body aches and fatigue.  The symptoms cleared up by yesterday was went to work.  He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell.  He was able to get up unassisted.  About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate.  States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension.  He states that he is on Cardizem for treatment of atrial fibrillation
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 22-OCT-2013 at 11:30 the patient was administered with a MMR II (lot number J002505, expiry date 28-FEB-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the MMR II was exposed approximately for 9.5 hours at temperature of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:25 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7 degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
Patient started with arm swelling in the left arm the night he received the vaccine. Reported as "blotchy" and the next day appeared to have fluid under them and resembled blisters.  On the night of 5/22, patient complained that his legs hurt, upon looking at them they were red, swollen, and blistered.  Patient went to his doctor on the morning of 5/23 in which he was diagnosed with shingles. Patient filled a prescription for a seven day course of valacylovir this morning.
pt recv vax 31JUL96 & 14AUG96 pt devel a crop of 5 to 10 chickenpox on face & a low grade fever;rash healed & since that time, 2 additional crops developed;each crop healed before the next appeared;
1/10/23  I had been chronically losing weight. I went to the doctor and was diagnosed with Graves Disease.
Acute onset tachycardia with palpitations 21 hours after the second dose of Moderna for Covid 19.  I had a pulse oximeter reading heart rate 170 and O2 saturation of 94%.  I took aspirin 81mg po once. After 15 minutes, I had left sided parasternal chest pain. I called my husband to take me to the Emergency Department. In the ED, EKG confirmed sinus tachycardia; cardiac enzymes were normal. I was given aspirin 162mg and nitroglycerin sublingual with relief within 30 minutes. Bedside echocardiogram did not reveal pericardial effusion or pericarditis. CT Angiogram of Chest did not identify pulmonary embolism. Chest xray was normal, no pneumonia or pneumonitis. D-dimer was slightly elevated. I asked asked to stay for 23 hour observation admission.
SORE LEFT ARM AND NECK,  LETHARGIC, LIGHT HEADNESS, HEADACHE, SOME SOB TX- SLEPT/ REST MORE  AND DRANK EXTRA FLUIDS
Approximately a few days after my 1st dose vaccination I experienced the following symptoms: headache (daily). I took Ibuprofen for treatment. I consulted with my doctor but he did not correlate it to the vaccine. As of today 04/29/2022 - I still experience headaches every now and then.
This is a spontaneous report from a contactable physician and medical assistant via a Pfizer Company representative reporting similar events for two patients. This is the second of two reports. A 18-year-old male patient received on 03Aug2016 09:56 am TRUMENBA (Batch/Lot: N16808PMP) at 0.5 ml single dose via intramuscular route on the right deltoid and second dose of MENVEO, (Manufacturer: Novartis, Lot#: M15149PMP) at 1 DF single, via intramuscular route on the left deltoid both for immunization. Relevant medical history and concomitant medications were not reported. On 03Aug2016, the patient had body ache, fever, joint pain and diffulty in moving and speaking. The patient recovered from the events. The events did not require an emergency room or physician visit. The reporters were wondering if the events occurred because the patient received the vaccines together. Follow-up (07Oct2016): additional information received from the physician includes date of vaccination, batch/Lot of the vaccine, route of administration, anatomical location of the administration of the vaccine, outcome of the events. Sender's Comments: Linked Report(s): US-PFIZER INC-2016407735 same reporter/drug, similar events, different patient.
>15 mins/25 mins post-vaccination: facial hives Subsequent four days: fatigue, body aches, swollen/painful left lymph node in armpit
Joint Pain; Sore Arm; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic back pain. Concomitant products included oxycodone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain, pain in arm and fatigue. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the joint pain, pain in arm and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had sore arm, fatigue and joint pain. The reporter did state that they had some of the side effects after the first dose but that the second dose side effects were more extreme. The reporter consented to follow up. The reporter did not have the lot or expiry of their dose.  For tolerances of 2nd dose, refer case US2020104604, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020104604:Same reporter
Episode with altered mental status. Without seizure or loss of tone about 8-9 hours after immunization lasting 2 hours at the most. Medical evaluation normal.
Pt experienced pain in the left shoulder. Sometimes so bad that he dropped items he was picking up or carrying.
This spontaneous report was received from a Registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Information has been received from a nurse concerning a 17 year old female with no pertinent medication and no drug allergies who on 17-NOV-2010 was vaccinated IM in her left arm with her second 0.5ml dose of GARDASIL (lot # 666595/0992Z). There was no concomitant medication. The nurse reported that the mother of the female patient informed the office today that her daughter's arm was sore for 2 months after receiving the vaccination. The mother also told the nurse that her daughter could not move her arm that much. The nurse reported no treatment was given. The patient did not seek medical attention. At the time of the report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Fatigue Narrative: Patient experienced fatigue in particular after exercising after receiving his first dose of vaccine. has continued beyond 1 week so far.
4 year old present for vaccines. Pt had received hib at 9m, 11m, and 2 years of age. Per catch up schedule child did not need any more Hib doses.  Child was given Pentacel 8/26/21.  Parent called and notified. There were no side effects noted.
This spontaneous report was received from a medical refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored oral, ROTATEQ (lot # L004466, exp. 02-AUG-2016, dose and route of administration not provided). No concomitant therapy was reported. No symptoms were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
began @ noon w/ a few hives worsened @ 10Pm call made to ER told by ER personnel DPH should be given to relieve itching;itching described as intense by client;saw MD in MA;came to hlth dept facility next;
I was exposed to COVID-19, I had a cough, sore throat and mild chills, nauseous, body aches. I used a home COVID-19 test that came back positive. I called my Primary Care Physician who prescribed Paxlovid, that I started taking Friday night. I still a bit fatigued but other than that I feel better.
I developed a sensation that my throat was tight and swollen. I never experienced difficulty breathing but the throat sensation was very pronounced and took several hours to resolve. I stayed on the vaccine administration site for an hour to ensure I did not experience an anaphylactic reaction.
shot itself was "very painful."; her arm remains very painful./quite painful in the arm and has been hurting ever since; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date was not provided), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Patient had questions about side effects of arm pain lasting 2 weeks. Patient had both doses of her Pfizer COVID-19 vaccinations. The 1st dose she had "zero pain and zero complications." She stated the 2nd injection was given 2 weeks ago (full 2 weeks noted to be at 15:00 today) was "substantially different in relation to the initial." Patient stated the shot itself was "very painful." She thought she would give it the "full 2 weeks" however her arm remains very painful. Patient would like to know had we heard of this, had projection of days it should go away and also wanted to know what can be done about her symptoms. Patient noted that she will be seeing a new doctor for the 1st time next week. Advised patient adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain and muscle pain. Adverse Reactions in Post Authorization Experience. pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. Encouraged patient to contact her HCP due to ongoing bothersome side effects. Advised the patient that yes, we have heard of these side effects in clinical trials and through self-reporting. Patient again stated, the second dose was with a different person and when they gave the shot, it was quite painful in the arm and been hurting ever since. She was not quite sure how this had anything to do with the pain in her arm. She needs to run out the door in a few minutes. Waited until today to call. Just wants to know what was suggested, given this company was who provided the vaccine. The outcome of event her arm remains very painful/quite painful in the arm and has been hurting ever since was not recovered and another event outcome was unknown.  Information on lot/batch number has been requested.
PATIENT WAITED 30 MINUTES AFTER VACCINE WITH NO COMPLAINTS, THEN WENT TO HER CLINIC TO WORK.  AT 1050A ABOUT  2 HR 10 MINUTES AFTER LEFT VACCINE CLINIC SHE TOLD STAFF SHE WAS NOT FEELING WELL AND THAT SHE COULD PASS OUT. BP WAS 142/90 P82 O2 SAT 98% RA SHE THEN TOOK A COUPLE SIPS OF SPRITE SHE THEN C/O EPISODES OF LIGHT HEADEDNESS, DIZZINESS AND CHEST FELT TIGHT WITH COUGH. SHE USED HER PERSONAL INHALER AND NOTED SOME IMPROVEMENT. AT 1100AM SHE HAD DIZZINESS WITH TINGLING AROUND HER LIPS DENIED ANY THROAT TIGHTNESS, SHE WAS GIVEN BENADRYL 50MG IM. 1110 AM PATIENT CONTINUES TO HAVE EPISODES OF DIZZINESS TINGLING AROUND LIPS , COUGH TICKLE IN THROAT AND CHEST TIGHTNESS. SHE C/O WHEEZING. PER PROVIDER LUNGS CLEAR P78-85 O2 SAT 97%-98% PATIENT THEN HAD DUO NEB TRATMENT, PATIENT STATED " I FEEL LIKE I CAN TAKE A DEEPER BREATH WITHOUT TIGHTNESS FEELING, LIKE I'M MORE RELAXED."PATIENR WAS THEN RESTING COMFORTABLY WITHOUT ANY COMPLAINTS. HUSBAND CAME AND PICKED HER UP, SHE DECLINED WHEELCHAIR AND AMBULATED TO VEHICLE WITHOUT DIFFICULTY.
Bleeding at injection site; growing bruise at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) and VACCINATION SITE BRUISING (growing bruise at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) and VACCINATION SITE BRUISING (growing bruise at injection site). On 06-Apr-2021, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (growing bruise at injection site) had not 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.   Treatment information not reported. No concomitant medications were reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, concurrent conditions and medical history reported. On 26-JAN-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # L024129, expiry date 21-JAN-2017, intramuscularly for prophylaxis. No adverse effect was reported. Additional information has been requested.