chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare student refers to a female patient of unknown age. On 2004, the patient was vaccinated with ZOSTAVAX (lot number not provided) (route and dosage not provided). On 2012 the patient experienced two outbreaks of shingles, with the last outbreak occurring approximately 8 months ago. The outcome of two outbreaks of shingles is unknown. The reporter did not assess the relationship between the event and ZOSTAVAX. Additional information is not expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacture (Pfizer) concerned a 27 year old female. The patient's height, and weight were not reported. Patient was taking other medications within 2 weeks of starting COVID-19 treatment. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 01 in total administered to left arm on 23-MAR-2021 for prophylactic vaccination.  Age at time of vaccination 25 years old. The batch number was not reported and has been requested. On 15-OCT-2021 the patient received additional non-company suspect vaccine included: Spikevax (elasomeran) (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. Concomitant medications included Vitamin B,D and herbal supplement.  On 10-MAY-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: Unknown and expiry: unknown) dose not reported for treatment of COVID-19. The patient received the Paxlovid treatment for 4 days and discontinued on 14-MAY-2022. The patient also taking Wormwood pill. After discontinuation of Paxlovid within four days patient's covid symptoms re-emerged which were severe congestion, headache, fatigue and sore throat (suspected covid-19 infection) (dose number in series 2) which led to suspected clinical vaccination failure (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s, and Spikevax (elasomeran) was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report associated with product quality complaint:90000233850.; Sender's Comments: V0:20220601716-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Initial misuse report received from a healthcare professional on 06 January 2014. A 09-month-old patient (whose gender, medical history and concomitant medications were not reported) had received a dose of DAPTACEL and a dose of ACT-HIB on 02 January 2014. The patient had received third dose of DAPTACEL and a dose of ACT-HIB on 19 October 2013, thus inappropriate schedule of vaccination was administered. No adverse event was reported. List of documents held by sender: none.
Red swollen arm (left arm), 100 degree temp, pain in left arm  Pt told to use Tylenol, ice packs, & Benadryl to reduce pain/swelling
INJECTION SITE RASH; INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING  Information has been received from a physician concerning a 4 year old female who on 10-OCT-2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston0 (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot# 654041/0662F). Subsequently the patient experienced redness, swelling, and small bumps at the injection site. It was reported that the patient recovered.  Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Monday morning woke up with arm soreness, headache, fatigue and feeling slightly warm. After a few hours, and a nap, I had a fever of 101.9 along with chills, severe fatigue and severe nausea.  After a 2 more hours my fever raised to 103.3, I had muscle cramping in my legs, nausea, headache and fatigue.  All of those symptoms lasted until 9pm that night when the fever resolved.  The following day I still had slight warmness, a temperature of 99 and headache, chills and fatigue/weakness.  All of those symptoms, continued until Thursday evening.  On Friday morning I woke up with no headache (only mild intermittent head pains), mild fatigue and arm soreness.  Every day this week my heartrate has been higher than normal with the average rate around 120-130BPM. This was at rest, without any caffeine or other stimulants.  I took alternating tylenol (1000mg) and ibuprofen (800mg) all 4 days.
Fever of 101.8. Body aches. Dizzy. Blurred vision.
Injection site was hurting bad; Not able to move her shoulder; Itching all over her body and now her face; This is a spontaneous report received from a contactable consumer. A 62-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date in Mar2021, reported as 10 days ago (as of 22Mar2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated his wife got the COVID vaccine 10 days ago (as of 22Mar2021) and the injection site was hurting bad for two days and she was not able to move her shoulder for two days. She also had itching all over her body and now her face (as of 22Mar2021) and it comes and goes. The reporter inquired how long it would last and was concerned if she got the second dose it might be worse; further inquiring what he should do. He reported he spoke with his doctor about his wife's side effects and his concern about her getting the second shot and whether or not he should get the vaccine, but his doctor didn't know anything. He stated Pfizer should give guidance on what to do about side effects. The clinical outcomes of injection site was hurting bad, not able to move her shoulder and itching all over her body and now her face were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Had the shots, 3 years later has shingles; Shingles a bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that his/her sister had the shots and 3 years later had shingles a bad case. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Information was received from a physician's assistant concerning a patient (gender unknown). The physician's assistant reported that the patient, aged 8 months and 13 days old, received a third dose of ROTATEQ (dosage, lot number, expiration date, and route of administration not provided) on 17-JAN-2017.  Dates of prior doses not provided.  No information was provided regarding the patient's medical history or concomitant medication.  No side effects were reported.  No further information was available. Additional information has been requested.
Vaccine was three days pass the stated expiration date. The Moderna team did an analyse on the lot number and determined that the vaccine was still valid and effective at the time of the adminestration.  No advers reaction from the client.
heavy menstrual periods/ spotting bleeding lasted for at least three week; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported) via intramuscular, in Left arm, on 25May2021 at 11:00 (at the age of 39-year-old ), as DOSE 1, SINGLE for covid-19 immunization in a pharmacy. There was no medical history and concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On 07Jun2021, the patient was having heavy menstrual periods for 2.5 weeks further reported as the patient got her period and it was very heavy but it lasted easily, over two and half days. The patient guessed the bleeding lasted for a normal time but spotting bleeding where, patient think the uterine line was shedding, lasted for at least three weeks. The patient wanted to know if this is normal and if she can go ahead and receive the 2nd dose. The patient was scheduled to receive the 2nd dose on 28Jun2021 and it was confirmed that the patient did receive it on that day. No treatment has been taken for the event. The patient stated that, she was fine. The outcome of the event was recovered in Jun2021.  Information about lot/batch number has been requested. .
Left arm near injection site was normal for 7 days. On 8th day muscle area became very red, swollen, hard, achy, hot to the touch
After the second dose of the Pfizer vaccine, approximately 48- 72 hours after she developed genital ulcers.  Very painful, sore, reddened sores in the vaginal area. She did test positive for Covid on 2/5/2021
Charley-horse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Charley-horse) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (Undetectable HIV).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Charley-horse). At the time of the report, MUSCLE SPASMS (Charley-horse) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-419280, MOD-2021-419320 (Patient Link).
Pain and swelling of lymph nodes in both armpits this began day after shot. Pain is gone but swelling still there under left armpit. Rash on face 1 week after shot and have not turned into welts.   I was unable to get into the doctor but plan to next week if this persists.
Red circle appeared  RUA at injection site, itchy ?under the skin? on Friday,. Saturday it was about 1 inch  round.   Probably grew to about 2 inches round at 4 days post injection. Started getting smaller/better  on day 5 (Tues)?1 week after injection red spot is small and more like a bruise., but still a little itchy. We treated it with Tylenol, Ice to site,  benadryl for itching.
Red, swollen, warm to touch, hard feeling covering a large are on my arm. I have also experienced, diarrhea vomiting, and  light headed.
Noticed tingling and numbness in both my feet first, then it moved into both my hands.   best way to describe it would be if your hands and feet fell asleep then you start to use them for the first time as all the blood starts to flow.   I thought i might of had a pinched nerve so i started chiropractic treatments.  after two weeks with no relief i went to my primary care doctor.  He referred me to a neurologist.  by the time i was able to see a neurologist my strength in my hands has diminished pretty rapidly as well as it was difficult to walk as my legs were weakening as well.   After initial visit with Neurologist the Dr. suspected a neuropathy and called it GBS.  Guillian-Barre Syndrome.  She scheduled a nerve test and after the nerve test she confirmed the GBS and scheduled me for IGIV treatment.  Treatment was about 4hours per day for 5 straight days.   Since treatment i have seen some improvement in strength, but feet and hands are still tingling and numb.  Time Frame.  June 7th noticed symptoms, June 23rd started Chiro Treatments,   Saw Primary Care Doc June June 28th,  Saw Neurologist July 13,  Performed Nerve Test July 14,  Started IGIV July 19 and finished IGIV on July 23.
The patient presented with a small bruise at the injection site along with bruising below the deltoid going across the arm. In addition, the patient is asthmatic and she reported increase shortness of breath after receiving the shot.
after vaccination with fever; headache; body aches; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 4th of 6th reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and body aches on an unspecified date. Event took place after use of product. The outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
prior to 12AUG94 pt recvd vax & 12AUG93 devel a fine red rash over entire body; parents state this began w/2 small red bumps on pt cheek; pt has been afebrile since inject; dx ear infect 16AUG94;
Presented w/chills, body ache, SOB. Admit for COVID PNA. Hx of HTN, lung CA in remission. Tx with supplemental O2, steroids, abx, convalescent plasma. At time of DC pt on RA. DC'd home.
I've developed serious itchy skin/hives starting 12 days after I received my moderna booster shot. My hives started on Feb 2nd. After a few days, I followed up with an urgent care as I thought it was a rash or random allergic reaction to something I ate. They prescribed me an oral steroid 6 day pack. After I finished the steroids, I went back, as nothing had changed. They then prescribed an additional stronger steroid, which also did not change anything. This has been the 25th day of having hives consecutively. I did not have hives on February 21st, which happened to be the day that I had a lot of symptoms of covid-19 and had tested positive. The itching is extremely uncomfortable and the hives pop up all over my body, including feet, thighs, arms, back, stomach, face, neck.
14 Y/O F hx of lightheadness post vaccine, laying supine for 5 minutes before onset of nausea. Provided emsis bag for episode of emsis lasting approx. 3 minutes. road test conducted at 10 minutes after pt stabilized. V/S WNL.
Patient received a flu shot at 3:30pm.  Returned to the flu shot table at 3:45pm complaining of tachycardia.  Asked patient to rest for several minutes.  BP taken for patient at 3:55pm with a reading of 145 or 149/98 at the BP station.  When we checked the patient, he stated his pulse rate was very high and informed us he had an angiogram ~ 2 weeks ago.  Patient returned to the flu shot station to rest again.  Questioned patient if he had any chest pains and if they were radiating?  Patient confirmed yes and stated pain radiating to the left side.  Visible signs of diaphoresis.  Offered to call 911 at least 3 times during the course of events, at which the patient declined.  Patient asked us to wait 5 minutes as he thought the tachycardia will subside.  Patient requested that if the tachycardia does not subside, he would inform us to call 911.  At ~4pm, patient got up and left the flu shot station.  Followed the patient downstairs to the hotel lobby and called 911.  Patient requested aspirin and one Bayer 325mg aspirin was administered at 4:05pm 12/8/09 & 12/11/09:  ED records received for date of service 10/26/09.  Dx:  SVT.  Pt. received flu shot and developed sweating, lightheadedness, and palpotations as well as substernal chest pressure.  BP 140/100 and HR 215.  911 called and pt. chewed an aspirin.  SVT noted by EMS, no resolution with vagal maneuvers.  Adenosine 6 mg. given in the field resulting to conversion to sinus rhythm and resolution of all sx. Seen in the ED, sx. resolved, d/c to home.
3 days after 2nd dose of pfizer vaccine my left arm was bruised from my should to just aove the elbow. Bruise was deep purple and was 4" wide by 6" long. No other side effects was present.
No adverse event, but patient and her husband (both fully immunized) tested positive for COVID19 on 4/24/2021. Patient's symptoms started April 14 (cough only)
0.2 ml of undiluted Pfizer Covid (5-11y) vaccine was given, fatigue was the only reported side effect.
Severe shoulder pain in injection arm, to the point of almost not being able to use my arm for several days; Several days of moderate full body joint pain; Exhaustion for several days and challenging to complete low-energy activities without needing a break (i.e., gardening); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol/ etonogestrel (NUVARING) and vitamin d nos (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. On an unknown date in Apr2021 at 20:00, the patient experienced severe shoulder pain in injection arm, to the point of almost not being able to use her arm for several days, several days of moderate full body joint pain and exhaustion for several days and challenging to complete low-energy activities without needing a break (i.e., gardening). The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shoulder pain in injection arm, to the point of almost not being able to use her arm for several days, moderate full body joint pain, exhaustion for several days and challenging to complete low-energy activities without needing a break were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Started on the fifth day (3/30) after the shot, lymph nodes under right armpit got swollen. It got worse on 3/31, swollen area was getting larger and more pain. The symptom relived on its own (without taking any over counter pain medicine) gradually starting from 4/2 .
Within 24 hours of immunizations given 12/13/2004, patient had temperature of 100.4 degrees F (rectal) and 2 episodes of rhythmic clonic activity, decreased responsiveness for 5-10 seconds.
several days p/vax pt reportedly died d/t resp complications; blood test on autopsy indicated a pos hep B surface antigen; attempting to obtain further details;
Patient began feeling anxious and depressed later that afternoon.  Feeling of impending doom or danger.  Very out of character or not normal for her.  Worsened the following day and lasted for approximately 4 days.  Did not want to socialize with family, friends, or strangers.  Would not answer phone or associate with anyone.  Sat in the dark for a few days.  Said it felt like a dream as of Sunday, like it never even happened.  Does feel back to normal now.
Developed redness and warmth at site day of vaccine. Sx progressed and now 4 1/2 inches x 5 inches area of erythema and warmth right upper arm. Instructed to use ice, elevate (R) arm. Also ZYRTEC 10 mg daily.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Considering revax
18x11 cm area of redness surrounding injection site. Tx-ZYRTEC, cool packs as needed.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in arm), back pain and arthralgia (knee pain/hip pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included pain (has pain from pre-diagnosed medical conditions). On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, patient experienced pain in extremity (soreness in arm). On an unknown date, patient experienced back pain and arthralgia (knee pain/hip pain). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. On Mar 27, 2021, pain in extremity (soreness in arm) resolved. At the time of the report, back pain and arthralgia (knee pain/hip pain) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. After his completion on the Moderna vaccination, he will schedule surgery. No concomitant medications reported.
Extremely high fever which included loss of consciousness. Dizzy, blurred vision, chills, and diarrhea overnight. Began about 9/10 hours after receiving shot. Next more body aches and arm soreness continued for 24 hours.  72 hours arm soreness and fatigue. One week later (now) still feel fatigued, short of breath,  and experience moments of weakness. Sleep up to 12 hours (haven?t done that in many years) and feel achy in mornings.
Had both types of vx. Had shingles twice; Had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice on an unknown day before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had both types of vaccines and still had Shingles twice. The reporter stated that neither type of shot will keep oneself from getting shingles again and will just keep them from being so severe. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.