chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 2-year old male patient. The patient's pre-existing conditions included sickle cell anemia and reactive airway disease. At the time of vaccination, patient had follow up for pertussis. On 06-AUG-2018, the patient was vaccinated with M-M-R II (lot: N031294; expiry date: 21-AUG-2019) subcutaneously in the right arm, VARIVAX (lot: N027000; expiry date: 28-SEP-2019) subcutaneously in the left arm, PENTACEL (lot: C546119A) in the right thigh, HAVRIX (lot: 24343) in the right thigh and third dose of PREVNAR 13 (lot: T94424) in the right thigh. Patient did not experience any adverse events with the vaccines. The temperature excursion occurred as a result of reading from a Digital Data Logger. This is one of the several cases received from the same reporter.
Rash, slightly raised swelling, warm, itching no pain fever. Slight erythema.
11 by 20 mm area of vesicles developed 5 days after immunization with Varivax around injection site on left leg.
Pt recvd 2 doses of Engerix-B & the next day following dose 1 pt had full body swelling; following dose 2 had less swelling (legs, some facial); given DPH;
SECOND DOSE MIX UP. PFIZER WAS GIVEN AS SECOND DOSE INSTEAD OF MODERNA
A spontaneous report has been received from a consumer concerning a 48 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter stated she and her friend both received a full syringe of FLUMIST QUADRIVALENT in each nostril. Nurse giving vaccine stated beforehand this was the first time she was administering FLUMIST QUADRIVALENT. The outcome of the event of full syringe of FLUMIST QUADRIVALENT administered on both nostrils was unknown. The reporter considered the events full syringe of FLUMIST QUADRIVALENT administered on both nostrils as non-serious.
First day severe muscle and joint pain, second day severe neck and head pain, third day progressed to tachycardia and hypertension that required emergency treatment. Day 6 now and still progressive weakness and fever with all the above symptoms as well. Doctor has given steroids to treat reaction. Just started today. Still very sick with increasing severity of symptoms. 3/3/08 records received C/O weakness, fatigue tachycardia, hypertension, as possible reaction to influenza injection. Unable to keep fluids down, treated with IV fluids.
received the first dose in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31 October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2023 The pharmacist called in to request the information about the usage of Shingrix in a patient who received the first dose in 2020 and wished to get the second dose in 2023.  Partial information about patient, event and vaccine provided. Till the date of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
On the same day of vaccination, patient was experiencing warmness on the arm. Patient was not able to sleep at night. On Tuesday morning, patient experienced fatigue, along with redness and sensitivity to the touch. No febrile symptoms. Symptoms are getting better, she just wanted us to report it.
Information has been received from a physician concerning an approximate 17 weeks old patient who on 15-Jun-2009 was vaccinated with the second dose of ROTATEQ. After the second dose of ROTATEQ, the patient developed diarrhea and screaming. Therapy with ROTATEQ was discontinued. At the time of the report the patient's status was unspecified. Additional information has been requested.
I had a cough, diarrhea  / soft stool.  Wanted to note a low grade fever on the date of vaccination that lasted for a day. My doctor prescribed some Paxlovid and I began taking that evening
Missed 2nd dose allocated time frame; Caught covid end of January/they caught covid and were not able to complete the dosing series; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose allocated time frame) and COVID-19 (Caught covid end of January/they caught covid and were not able to complete the dosing series) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose allocated time frame) and COVID-19 (Caught covid end of January/they caught covid and were not able to complete the dosing series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose allocated time frame) and COVID-19 (Caught covid end of January/they caught covid and were not able to complete the dosing series) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non- significant follow up
I received my 2nd shot around 2pm, by 7pm I had a severe right thigh cramp,  but it went away the next day. I don't recall when it started back up but since then I've had the right thigh cramp on and off almost everyday. I can feel a muscle spasm in the top of my thigh, it sometimes travels to the right side and occasionally to the back. Almost always it is dead center top middle thigh.  Some nights I have to put lidocaine rub to stop the pain to get to sleep.  Walking/stretching does not seem to get rid of it.  Sometimes it subsides for a day or a mild ache but it comes back.   I went to my primary care doctor, he wasn't sure if it was related to the injection and said we can monitor it.
Site injection moderate pain; Site injection discomfort; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported.  On 26Feb2021 at 06:00, the patient experienced site injection moderate pain and discomfort for 2 days, tolerable, not need of pain killers. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event site injection moderate pain and discomfort was resolved on 28Feb2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender not reported). The patient was vaccinated with the first and the second dose of GARDASIL in August 2012 and on 29-AUG-2013, respectively. No adverse effects were reported. Additional information has been requested.
A few days after the first  shot I went for a bike ride. After the ride I could not stop shaking and my blood felt like it had been poisoned. My ears were ringing also. I had to take a week off from exercise. Today, one week later, I tried to workout which I have done on a regular basis all my life. I had to stop halfway through because my body started shaking very badly and my ears rang. I was so out of sorts I had to lay down. This has never happened to me before.  I think this shot has made me very ill.
I developed a large blood clot in the form of a thrombosed hemorrhoid. I have NEVER suffered from hemorrhoids in my 44 years of life. I wholeheartedly believe that this vaccine contributed to my situation. I went to see a specialist on 1/3 and have to return to the office for additional care later this month.
Patient received Monovalent for booster and according to new guidelines starting on 09/01/22 patient should have received Bivalent. Patient called no answer left voicemail informing patient to call back. Patient came into clinic 10/04/22 for doctor's appointment explained she qualifies for Bivalent after 11/01/22, patient declined at this time.
Increasing depression, agitation, anxiety, paranoia, disordered thinking, attention difficulties cognitive deficits beginning shortly after first HPV shot. After second HPV shot began hearing voices with morbid thoughts/paranoid delusions. Within weeks of third shot, was hospitalized for psychosis. Current diagnosis is psychotic NOS; currently being treated with risperdal 2 mg. Hallucinations are gone but cognitive deficits linger. First vaccination was first week september, 2007; second vaccination was nov 6, 2008; third vaccination was mar 6, 2008. Hospitalization was april 25, 2008.  07/08/2008 MR received from psychiatric hospital for DOS 4/25-5/06/2008 with DX:  Psychotic Disorder NOS. Pt transfered from medical hospital with psychotic symptoms including paranoid ideation, ideas of reference, delusions, auditory hallucinations and disorganized thought processes. She had had worsening sx of of worry, anxiety and intusive thoughs over the past 2 weeks to 1 month.  Improved on Risperdal and d/c to day program.
This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with GARDASIL (dose and route not provided). The reporter stated an unspecified number of patients may have received doses of GARDASIL (dose in series unspecified) that were exposed to 25 degrees F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time. No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested, since can contact the physician.
08/04/2008 P/C from client.  C/O constant muscle aching in both legs from hips on down onset two days after receiving Shingles vaccine and continues with same level of discomfort as initially.  Symptoms developed within one day.  Has kept him awake at night.  Rubbing legs doesn't make symptoms worse or better. Denies cramping of legs; denies similar symptoms in the past.   History of discomfort left hip in the past, "not a big problem." Instructed to call private provider is symptoms persist or if he is worried.  Suggested aleeve for discomfort.  P/C to client on 08/08/2008 to see how he is doing.  Left message to call HCHD with update. Client did not call back.  08/18/2008 P/C to client.  States he is doing a lot better now, symptoms were "starting to get quite a bit better" on 08/06/2008.  States still bothers him a little bit, mostly his hips.  He did not call his private provider as "it started getting better on its own."  Instructed we would call him in a week or so to see how he is doing, and to call HCHD as needed for questions or problems.
PT GIVEN COVID VACCINE SHOT, HE PULLED AWAY DURING ADMINISTRATION AND ONLY RECEIVED ROUGHLY 0.3 MLS. NO TREATMENT WAS NECESSARY, AND PER PT REQUEST REMAINDER WAS NOT ADMINISTERED.
C/O significant local reaction - swelling, redness and vesicular rash at site of injection - light ecchymosis at site of reaction
Pregnant female (unknown due date or any complications) received vaccine, and within minutes felt flush, lightheaded, and pre-syncopal symptoms. She was provided with water and food, and felt better in about 20 minutes.
Patient's mother reported, on 08/11/2021, her child had swelling of the face, itching and chest rash. All symptoms were gone the next day.
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I  better about 20 minutes latter.   I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
Coughing, inability to talk, difficulty breathing in , elevated blood pressure elevated heart rate, abdominal pain, slight chest pain
I vaccinated on 9/14 pm and patient presented with redness and swelling 9/16 at 330 pm.
Mother contacted clinic on 3/9/2000 to report that her daughter had a persistent high fever of 102F and was irritable. She consulted her private physician and was told the temperature was vaccine related.
Allergies:  Pneumococcal Vaccines; Allergies: Pneumococcal Vaccines- Swelling; This is a spontaneous report from a contactable nurse via a Pfizer sponsored program. A 69-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (Unknown manufacturer), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient medical history includes allergies: penicillins, milk related compounds and tape. The patient's concomitant medications were not reported.  The patient previously took aspirin (experienced allergies, hives); tramadol and codeine (experienced allergies). The patient experienced allergies: pneumococcal vaccines- swelling on an unspecified date. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
I suddenly began having pain in my right are from my shoulder down to the hand towards the end of September of 2022. After a week, I went straight to my doctor. She had x-rays done and ruled out fractures. I at my request, she started me on physical therapy. I went for a month, but my pain stayed the same and got worse during physical therapy.  She also started me on Tizanidine and Gabapentin. Then I ended the physical therapy. She referred me to a neurologist, and he had a scan and MRI done on me. It revealed a mild carpal tunnel problem. I asked the doctor if a cortisone injection might help the pain and he said we can try it. He referred me to an orthopedist who gave me the injection. It gave me two or three days of relief, but the pain came back. She ordered a MRI on my right shoulder. I was referred to another neurologist who gave me another exam and ruled out neuropathy.  I broke out in hives as well in mid-March of 2023 on my chest at first and now on my shoulder. I now have a topical lotion to put on the rash twice a day.
Lymph node in rt axilla enlarged the day after vaccine.  No local reaction at the injectionsite.
dry skin all over the top part of head; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (dry skin all over the top part of head) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and FENOFIBRATE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DRY SKIN (dry skin all over the top part of head). At the time of the report, DRY SKIN (dry skin all over the top part of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient provided lot number as 013A21A or 013A214. Treatment include Soap.
administering a dose of BOOSTRIX via prefilled syringe using a BD safety glide (25 gauge) needle/Product quality complaint ruled out because Luer Lok needle was not used; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in device usage process in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 4th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. The action taken with Boostrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the wrong technique in device usage process 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 provided as follows: The age at vaccination was not reported. The reporter was administering to the patient a dose of Boostrix via prefilled syringe using a BD safety glide (25 gauge) needle.  She attempted to inject into an unspecified arm, but the plunger would not push which led to wrong technique in device usage process.  She did not think the patient received any medication during the attempted administration, so she prepared another dose using a new syringe from the same box and a new needle and was able to successfully administer a complete dose in the opposite arm. Product quality complaint was ruled out because Luer Lok needle was not used. The reporter failed to obtain patient's gender and date of birth. The vaccine administration facility was the same as primary reporter. This case had been linked with case US2021167026, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167026:Same reporter
Admitted for COVID/sepsis 8/25/21, discharged 8/26/21. Treated with dexamethasone IV daily.
A 12-year-old new male patient visiting the area with his parents presents with a raised, red, somewhat tender area on the left upper arm.  Parents report that he was given 3 different immunizations yesterday by the clinic.  The patient did not have any immediate problems with those immunizations but today when he woke up, they noted this large welt area on his arm.  Mother reports that this is the site of his VARICELLA vaccine.  He did have another vaccine on this arm but it was  somewhat removed from this site.  Also had done a vaccine given in his right arm but is having no problems with that.  He has never had any reactions to immunizations before.  Mother says she called the clinic because she was concerned about this.  She was told that she should bring child in promptly to have this checked so patient is brought in by his parents.  Patient does take ZYRTEC for allergies though he has not had any today.  Parents gave him BENADRYL 25 mg about an hour or so prior to coming to the clinic.  Note that the patient denies any other symptoms.  He denies any shortness of breath or any trouble swallowing.  OBJECTIVE: General:  Well-developed, well-nourished boy in no acute distress.  His blood pressure is 96/60, pulse 72, respiration's 16, temperature 99.  Oropharynx:  There is no edema within the oropharynx.  No swelling of the lips.    Chest:  Lungs are clear.  Heart:  Normal S1, S2, rhythm regular.  Integument:  Inspection of the site of the injection on the left upper arm deltoid shadow area reveals an indurated, raised, erythematous, warm area that is about 7-8 cm in diameter.  Mother says this is the site of his VARICELLA vaccine.  There is no other area of edema or erythema, no streaking of the arms.  Assessment:  Localized reaction to VARICELLA vaccine.  Child is having no systemic symptoms.  Plan:  Reassured parents that this is just a local reaction to the vaccine and does periodically happen.  Discussed that child's lungs are clear and that there is no swelling of his throat so it appears that this will just be a local reaction.  Recommended comfort measures such as AVEENO oatmeal bath, BENADRYL cream, cortisone cream and ice pack.  Discussed that I would expect resolution of this gradually over the next few days.  Will check with the County Health Department and follow up with parents if there are any details related to this that they need to know.
Received 2nd dose @ 9:15 am  on 9/25/21.  I have never had seizure activity.  On 9/29/21 @ 9:00 PM   (108 hours after 2nd dose),  I had a seizure while sitting in my living room.  Was taken to hospital by ambulance.  Blood work, covid test, CAT Scan and other test were run.   Nothing showed any reason to why I had the seizure and was released from ER.    On 10/1/21 around 4:30 pm, I was resting on my bed and had another seizure.  My daughter timed this one it was 2 minutes long and  I was taken back to ER by my husband.   Some test were run again and showed nothing.   Released from ER with Keppra 500MG 2xdaily
Information has been received from a Registered Nurse concerning a female patient who on 28-JUN-2010 was vaccinated with a dose of GARDASIL (Lot# unknown). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and MENACTRA. Nurse reported that the patient's mother called to the physician's office to say her daughter on 28-JUN-2010 was feeling tired, experienced discomfort in her arm and was cold and clammy. The patient sought medical attention by a Doctor's office visit. At the time of the report, the patient's outcome was unknown. No further information is available.
Received flu vaccine evening of Wed 10/30/13 at work and began to have itching in hands. Went home after work: mild itching to hands progressed to severe itching of hands and feet as well as hands and feet becoming very swollen and red continuing through weekend with burning sensation and fatigue and general achiness.
Pt vax w/hepta B w/o incident.  2nd hepta B. given w/MMR II.  pt devel swelling in calf; dx as lymphedema.  MRI scan and doppler normal.
Varicella vaccine breakthrough. Diagnosed 6-1-07 with varicella. Had about 20 lesions. No fever.
Dose of improperly stored product was administered to a patient.; No additional adverse events reported; This spontaneous report has been received from a nurse prescriber concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions drug reactions or allergies and concomitant therapies were not provided.  On 06-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T029550, expiration date not reported, but upon internal review was established as 01-SEP-2022), that underwent a temperature excursion of 55.0 Fahrenheit grades in 2 hours and 24 minutes (product storage error). No additional adverse events were reported.