chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site warm; Injection site hardness; Injection site redness; A spontaneous report was received from a 36-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced injection site redness, site warm to touch and hardness.  The patient's medical history was not provided. Concomitant medications are Wellbutrin and Doxycycline for Unknown indications.  On 22 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011J20A) in the left arm for prophylaxis of COVID-19 infection at Hospital.  On 28 Dec 2020, after receiving the vaccine, the patient experienced injection site reaction on the left arm, injection site redness, site warm to touch and hardness. Treatment for the events were Benadryl and Pepcid.   On 05 Jan 2021 patient reported the treatment was not helping and the left upper arm is red and warm to touch. Treatment for the event is Unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The outcome for the events is Not recovered/Not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
everytime I got a Flu Shot I got sicker; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of an unknown demographics who got sicker everytime after getting a flu shot (illness), while being treated with vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient got sicker everytime after getting a flu shot (illness).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Had shingle vaccine also got shingles/ Suspected vaccination failure; Shingles; Worst pain ever had; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingle vaccine also got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Worst pain ever had). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2023 This case was reported by consumer via interactive digital media. The reporter reported that after receiving Shingle vaccine he or she got shingles three years later. The reporter reported that he or she had worst pain ever. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow up.
flu; Initial information was received on 14-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for prophylaxis.  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
No additional AE; Caller reported 2nd dose of VAQTA was administered too early.; This spontaneous report was received from a nurse and refers to an 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-JUN-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 05-DEC-2022, the patient was vaccinated too early with the second dose of hepatitis a vaccine, inactivated (VAQTA) (Inappropriate schedule of product administration) intramuscular injection, 0.5 milliliter, valid lot #W002894, expiration date: 06-MAR-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported (No adverse event).
He received his vaccination on Monday April 13 around noon time. A fever began within 6- 8 hours after shots (102.5 F), sleepy and very irritable throughout the night crying hysterically on and off. His hunger is diminished although he is still eating. Tuesday he breaks out with a slight rash. Tuesday evening he has great trouble waking up. We don't hear him breathing as normal. Normally you can hear him breathe but Tuesday you can't hear him. My wife comes over to the bed and can't wake him up. It's as though he is unconscious. After running downstairs and doing everything he finally wakes up and begins to cry during feedings. Cry hysterically during feedings! He isn't latching on to his bottle as normal. Doesn't focus when looking around anymore and looks like as if he is staring around into the abyss. The following afternoon Wednesday April 15, his rash is breaking out all over. Once again we cannot wake him up. We call the doctor, and they urge us to bring him in. On the way to the doctor he falls back into his unconscious state. We can't hear him breathe. We can't wake him up! We are in a car going down the highway trying to get our son to open his eyes he does not. We can't hear him breathe. We call the doctor, they advise that we call 911 and have an ambulance come to our location. I suggest we just go to the hospital which is close by. Upon arrival at ER we explain to Doctor that he just had his shots. The chief doctor from the Children's Medical Group suggest he has an infection and recommend 3 things. 1. blood test, 2.Urine test, 3. Spinal tap. Spinal tap for Meningitis! I suggested that all these symptoms happened right after the shot and would like the doctors to consider that. They refuse to do so! They will not acknowledge that the shot could have something to do with it. They did acknowledge that he had a 99.1 fever and that he was pale at time of arrival and not alert.  5/14/2009 hospital records received DOS 4/15/09 to 4/16/09. FINAL DIAGNOSIS: R/O sepsis Post vaccination: epsodes of unresponsiveness and bluish discoloration. Fever. Diffuse rash. Swollen leg/foot due to IV infusion.
Chest pain periodically 11/03-11/06/2022, always while resting in bed or sitting----not while exercising. Minor recurrence 11/10/2022 in evening.
It is hard for the patient to turn her head on the side she got the injection; The injection site was hard; She had more pain in her arm; Fever; Pain at the injection site; This is a spontaneous report via a Pfizer-sponsored program by a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports.  A 67-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X64930, expiration date: Nov2020), intramuscular on 25Mar2019 19:30 on left deltoid at 0.5 ml, single for pneumonia. Medical history included high cholesterol and dry eye. It was reported that on 25Mar2019, around 7:30 PM, the patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) injection.  Around, 9:00 PM, the patient had pain at the injection site, and the next morning the injection site was hard and the pain was worse at the injection site.  It was hard for the patient to turn her head on the side that she got the injection and that last night (27Mar2019), the patient had more pain and fever. She also had more pain in her arm (states that the patient reported that if 10 is the highest number for pain, the pain she is experiencing is 8).  All of the adverse events are improving a little bit but not a lot. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019046468 same reporter/drug, similar event, different patient
lump near her collar bone on left side; This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump near her collar bone on left side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MASS (lump near her collar bone on left side). At the time of the report, MASS (lump near her collar bone on left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Not treatment information was provided.
Pt. had the usual sore arm begin a few hours after the shot, but a 7pm started experiencing extreme chills followed by a very high fever he guessed to be about 103-104, but he was so debilitated he could not get out of bed to get a thermometer to read it. He said it broke about 3 am. He started to feel a little better after that and was continuing to feel better as time passed.
1 minute loss of consciousness with rapid return to normal. Vital signs monitored oriented x3 after event. Lungs clear Skin clear significant medical history listed of end-stage heart failure. (DNR & in hospice.) History of brief syncope in past. 16% E.F. hx of arahythmia cardiomyopathy Recent hospitalizations for CHF. Vitals 12:20, BP 118/58, P 90, Resp. 12 Pulse ox 96%. 12:25 BP 112/64, P 96, Resp. 12 Pulse ox 97%. BP 104/58 P 64 Resp. 12 Pulse ox 100%
Pt recv vax on 6/22/95; on 1/13/99 pt exp chicken pox
Information has been received from a health professional concerning a 38 month old female with a penicillin allergy and no other pertinent medical history who on 12/20/2002 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  There was no concomitant medication.  On 02/21/2005 the patient developed a case of breakthrough varicella rash, with spots all over including in her mouth and on the bottoms of her feet.  The patient was afebrile.  Unspecified medical attention was sought.  On 02/21/2005 the patient started on acyclovir.  There were no lab diagnostic studies performed.  At the time of the report the patients spots were still continuing to spread the patient was considered to be not yet recovered.  There was no product quality complaint involved.  Additional information has been requested.
Patient stated that she had symptoms similar to a stomach virus, but did not give details. She said she will be going to the doctor for the stomach illness.
A few minutes after Receiving vaccination patient complained of scratchy throat. No other symptoms reported. Pt was seen by urgent care provider and sent home.
Developer Tinnitus right after taking shots. At first it was very mild. But after taking my second shot, I feel like my tinnitus symptoms have worsened. I never had history of hearing problems before.
The pt experienced a 2" x 2" red, hot, ecchymosis lesion on the site of injection (left deltoid) No adenopathy,no abscess noted.
shingles; This is a spontaneous report from a contactable other hcp (patient himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E49899, expiration date not reported), intramuscularly, administered on the left arm on 26Dec2020 09:45 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient previously took aspirin and experienced allergy with aspirin. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced fever of 99.4 degrees, fatigue, muscle pain in left hip with radiating burning pain along posterior aspect of leg running from hip to calf , burning pain running across top of foot, blistering on left arch of foot, second, and forth toe; which was later diagnosed as shingles on 27Dec2020 19:30. The patient underwent lab tests and procedures which included body temperature: 99.4 degrees fahrenheit (fever) on 27Dec2020. Patient consulted a physician and treatment was received as a result of the event reported (reported as culture taken to confirm shingles). Events were assessed as non-serious by the reporter. The outcome of the event was recovered with sequalae.  Follow-up attempts are completed. No further information is expected.
No additional AE information provided; the patient was administered an improperly stored dose of MMRII; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not provided. Concomitant medication included sterile diluent (STERILE DILUENT) (lot number R001254, expiration date 20-SEP-2020) that was properly stored.      On 26-FEB-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status rHA (recombinant Human albumin) (lot number R030813, expiration date 24-OCT-2020; route, strength, dose and frequency unknown) for prophylaxis (product storage error).   The storage temperature of the vaccine was above 47 degrees Fahrenheit (54.5 degrees Fahrenheit) for a time frame of 2 hours 25 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event information was reported.
Td clinic 10/5/11 (L) arm upper deltoid with 17x22 cm area of erythema, induration onset 8-12 hours after Tdap. T 101. No pain.
Immediately after administration of the vaccine, patients face became flushed and he developed cyanosis. O2 saturations were 91%. Patient was given 0.3mg of epinephrine and 25mg of BENADRYL. An 02 tank was called for but O2 saturations increased to 99%. Heart rate rose from 80-112. EMS was called for and patient was transported to Hospital Emergency room.
Patient received first dose of Janssen J&J, minutes later the patient started shaking and unable to talk. He has cold clammy skin and complained of being cold.  He was put in supine position and legs were elevated, VS taken with hypotension noted 88/48, 02 sat and PR were within normal range.  Blood sugar taken - 62, offered orange juice and tolerated well, Blood sugar went up to 102.  Patient denied having allergic reactions nor vasovagal on previous vaccinations.  Patient left the facility accompanied with friends stable, alert and oriented x4.
On December 1st, that night, I got very tired and got very achy and my skin hurt. It progressed into chills, and I was unable to get warm. The next day I was still very cold and went to get tested. I tested positive for COVID-19 on December 2, 2022. On Saturday I got a fever and the highest was 102. I called my doctor. I kept taking TYLENOL for my fever. Sunday my fever broke. I also had a lot of sinus pain that lasted a few more days. I had a loss of taste and smell. As of today, I feel like I am fully recovered.
Client states she began to develop symptoms the night of vaccination. Symptoms included low grade fever, headache, dizziness, and ABD pain. States she had similar symptoms with last dose of Moderna but they did not last as long. Symptoms have been occurring for over a week now.
ADVERSE REACTIONS; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Pulmonary Embolism, symptoms started 3/14/21, diagnosed 3/15/21
Pt recvd vax 14MAY92 & 19MAY92 devel chicken pox; pt recovered in approx 1 wk; On 26MAy92 devel a pruritic red morbilliform type rash;
12/6/99:Pt. rcvd vaccine.12/13/99:Pt. seen by physician for severe itching,rash,& warmth in right deltoid at injection site.
blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: Reporter also knew of two people that had blood clots.  The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received.
High fever first two days ranging 101.7 to 103.9 F,  and severe fatigue and body aches all over and loss of appetite. Fever was highest around 2AM to 7AM.  Symptoms still continue more than 48 hours after vaccination.   Important:  I had Covid infection in March 2020 with2 weeks of high fever and cough and fatigue.
Information has been received from a pharmacist concerning an approximately 67 year old female with a history of shingles who in May 2009, was vaccinated with ZOSTAVAX (Merck) (lot # not reported) in the past. It was reported that the patient currently had shingles. The patient's shingles persisted. The patient sought medical attention by contacting pharmacist. Additional information has been requested.
After second shot/dose getting spasms in left arm.  Comes and goes does not hurt but very annoying.
Child broke out with chicken pox 11-2-99. Parents giving Benadryl, Tylenol and Aveno bath.
This spontaneous report as received from a pharmacist refers to a 65 years old female patient with hypercholesterolemia and diabetes and no drug reactions/allergies. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# not reported) subcutaneously into right deltoid on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that at the same date (09-AUG-2012) the patient received ZOSTAVAX, the patient developed soreness and redness at the injection site. The pharmacist reported that the patient presented to the pharmacy yesterday, 12-AUG-2012, to inquire about the injection site reaction, and the pharmacist reported that the injection site was "swollen to the size of a baseball", red, and warm to the touch. The pharmacist also stated that there did not seem to be a rash, but she did say that the red and swollen area looked "rough". The pharmacist did not know if the patient had reported this adverse experience to her prescribing physician. No treatment was given. At the time of reporting, the patient was not recovered. Additional information has been requested.
Fever of 100 degrees, pain at injection site, fatigue, muscle aches, difficulty breathing
pt recvd vax on 2JUN93 & that day devel localized edema on rt arm & swelling & redness underarm;  1 wk later pt recovered;
Hyperventilation , tachychardia, and abnormal fatigue during and after mundane activities.  Occassional light headedness.  Swelling and edema in lower extremities.  Aches/discomfort in both arms at times.
Moderna COVID-19 Vaccine EUN  Red, swollen rash appeared  at the shot site on left arm  one week after the shot; intermittent itching.
11/12/10 - vaccine given 11/15/10 - woke w/pink eye -> given Tobramycin by PMD. 11/16/10 - ZPAK for h/a, aches, chills, temp, sore throat 11/18/10 - ER for URI - FLONASE. 11/20/10 - Put on LEVAQUIN & VIGAMOX.
Was given immunization on 08-15-2006, parent noticed swelling and redness on 08-16-2006 was seen in office on 08-17-2006 and there was swelling and redness was warm to touch.  Treatment plan is ice when needed, BENADRYL when needed and MOTRIN when needed.  Site was left deltoid.
Coughing after taking a deep breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after taking a deep breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced COUGH (Coughing after taking a deep breath). At the time of the report, COUGH (Coughing after taking a deep breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Swelling, redness, tenderness, hard under skin, warm, shortness of breath.