chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable healthcare professional. This report was received via a Pfizer sales representative.  A male patient of an unspecified age (over the age of 1 years-old, not further specified), race, and ethnicity received two doses of PREVNAR 13 on an unknown date and on 26Sep2016, respectively; both via unspecified routes of administration at single doses for immunisation. The patient's medical history and concomitant medications were not reported.  On 30Sep2016, the patient was diagnosed with pneumonia in the right middle lobe , left lower lobe, and possibly the right upper lobe. On an unknown date in 2016, it was also reported that the patient experienced inappropriate schedule of vaccine administered. This was further elaborated as the patient had only received two doses of the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) when he should have had 4 doses by his current age. The clinical outcome of the events, drug ineffective, pneumonia, and inappropriate schedule of vaccine administered, was unknown. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Mom noticed redness and swelling on Right Upper Arm the afternoon of 05/11/11. Hot to the touch. Came into office on 05/12/2011 swelling had decreased dramatically per mom warm to the touch but very mildly and no longer painful.
slight fever 99.8; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZZER COVID VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 17Jan2021 18:00 at a single dose for covid-19 immunisation. Medical history included penicillin allergies. The patient did not receive any other vaccine in the last 4 weeks. Concomitant medication included levothyroxine (LEVOTHYROXINE) and bupropion hydrochloride (WELLBUTRIN). The patient experienced slight fever 99.8 [unit unspecified] and headache the next morning (18Jan2021 06:00). No treatment was received. The outcome of the events was recovered on Jan2021.  The following information on the batch/lot number has been requested.
Dizzy, light headed, sweating, dry heaving, vomiting, chills, very tired, exhausted. Past 36 hours and is continuing
My chest began to hurt the night of my vaccination. My chest continues to hurt, but it is due to whole body inflammation resulting from a chronic negative immune system response to the Janssen vaccine. It has officially been diagnosed as Costochondritis.
Flushed face and chest, blotchy arms, and scratchy throat, tight feeling in throat
patient is currently immunosuppressed; hard, painful rash down the injected arm for several weeks; Patient never finished the GARDASIL 9 series.; This spontaneous report was received from nurse and refers to female patient who was 34-year-old at the reporting time. The patient concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2015, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) into arm as a routine vaccination (strength, dose, frequency, route of administration, lot#, expiry date were not reported).  On an unknown date, the patient experienced a hard, painful rash down the injected arm for several weeks. Moreover, patient never finished the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (Incomplete course of vaccination). Healthcare professional (HCP) also stated that patient was immunosuppressed at the reporting time. On an unknown date, the patient recovered from rash (also reported as the rash subsided after a few weeks). The outcome of immunosuppression was not reported. The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was drug withdrawn.  The reporter considered that immunosuppression was not related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The causal relationship between rash and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event immunosuppression was determined to be medically significant. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARDASIL 9 vaccine and the reported event of immunosuppression cannot be established. Additional information regarding the patient's medical history, concurrent conditions, concomitant therapies, clarification of vaccination date, event onset date, the detailed clinical course, diagnostic workup results, and outcome is needed for further assessment.  Company Comment- No changes to the GARDASIL 9 product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product.
This patient without history of pancreatitis developed abdominal pain, nausea, and diarrhea post third Pfizer Covid 19 vaccine; emergency department workup revealed elevated lipase.
This spontaneous report as received from a certified medical assistant refers to an unspecified amount of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, unspecified amount of patients were vaccinated with improperly stored ZOSTAVAX lot # K009772, expiration date 09-OCT-2015, (dose, route, anatomical location and dose number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. Additional information is not expected because the reporter refused additional contact.
High fever- 102.9 degrees F in the evening on 6/15/18, High fever -104.0 degrees F in the evening on 6/16/18. Controlled with TYLENOL. Rash starting on her face then moved down her neck and on to her stomach. Rash doesn't seem to bother her. 6/17/18- took her temperature before bed - 98.9 degrees F. Rash still present.
her face was swollen; Extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode; Swollen legs accompanied brusing rash; brusing rash; Swollen legs accompanied brusing rash; Effects were similar to blood clot symptoms; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) at 2nd dose, single for COVID-19 immunization. The patient's medical history included migraines. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on unspecified date for COVID-19 Immunization. The patient experienced side effects after getting the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE, 2nd dose was given on 30Apr2021. The patient had a bad reaction, she called to report it last night, she may have a CT scan for follow-up of the residual vaccine,  the effects were similar to blood clot symptoms, she had a extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode, she almost went to the emergency room (ER). Assuming all these side effects were attributed effects that may be similar to blood clotting symptoms. Side effects experienced were as follows: Extreme headache characterized by a painful somehow compared to by the patient as she was grabbing her head and thought it would explode. She almost went to the ER for this and the pain lasted for 9 hours starting from the same night at 21:30, when she got the vaccine (30Apr2021). She mentioned she took Ibuprofen 600 mg for this and it slowly eases the pain until it went away. Swollen legs accompanied by bruising rash. This happened alongside the extreme headache (30Apr2021). Her face was swollen as well the next day (01May2021). She thought that all the mentioned above side effects were characteristics of blood clotting side effect. The outcome of the event headache was recovered on 01May2021; and unknown outcome for the other events.  Information on the lot/batch number has been requested.
Swelling in left rib cage and pain that travels from left breast into left arm.  I have had an ultrasound to rule out swollen lymph nodes  and breast cancer. I have breast implants as well.  I work for a Plastic surgeon,  I know this is not my implants. My mammogram in early January,(before my first vaccine shot) showed no issues. I also had a Thermagram for more views after my first Moderna vaccine and that showed my breast was clear. I have continued to have pain and pressure in my left rib cage when moving my left arm. It has been going on for three weeks. I had my shot in the opposite arm. I see a specialist on Monday March 5th. My blood work I had last week showed my total T3 was very low.  I am sure this all started after my first shot. I have never had a breathing issue or left rib cage swelling with left arm pain.
The patient received 0.4cc of Infants Tylenol. An hour later she received DTAP, IPV, Hepatitis B, Haemophilus Inf. B, Prevnar and Rotateq. The patient was fussy after the shots were given. Two hours after vaccine administration,  she became stiff all over, stopped breathing, saliva was coming out of her mouth and her skin turned red.  All of this lasted about 20 seconds during which time the mother started patting her back. She was given 2 ounces of formula and fell asleep.
itchiness around vaccine 5-10 mins - resolved with cold compress intermittent dizziness (did resolve) + headache (did not resolve) at 15 mins - 60 mins
Patient already received one dose of Shingrix on 9/29/18 and one dose of Shingrix on 12/31/18.  Patient received third dose on 5/21/22. Patient says she had no side effects from dose on 5/21/22.
MISSED THE FOURTH DOSE; A spontaneous case report was received from a consumer on 14-Jun-2019 for four consumer.  Based on the information obtained from the consumer, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes an 11-year-old child male consumer who "missed the fourth dose", while being on Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 07-Jun-2019 and missed his fourth dose which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000497:
Extreme fatigue; Severe swelling of left arm pit lymph nodes; Headaches; Joint pain in shoulders, knees and neck; Dizziness; Extreme fatigue, severe swelling of left arm pit lymph nodes, minor swelling of right arm out lymph nodes, headaches, joint pain in shoulders, knees and neck, dizziness,; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 47 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 15:30 (Batch/Lot Number: Er8731) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 5:45 (Batch/Lot Number: Ep6955 ) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing , pain from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , sleep apnoea syndrome from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; metformin hcl (METFORMIN HCL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced extreme fatigue on 20Apr2021 18:30 with outcome of not recovered , severe swelling of left arm pit lymph nodes causing lymphadenopathy on 20Apr2021 18:30 with outcome of not recovered, headache on 20Apr2021 18:30 with outcome of not recovered , joint pain in shoulders, knees and neck causing arthralgia on 20Apr2021 18:30 with outcome of not recovered , dizziness on 20Apr2021 18:30 with outcome of not recovered, extreme fatigue, severe swelling of left arm pit lymph nodes, minor swelling of right arm out lymph nodes, headache, joint pain in shoulders, knees and neck, dizziness, and peripheral swelling on 20Apr2021 18:30 with outcome of not recovered.    No follow-up attempts are needed; No further information is expected.
Branch retinal artery occlusion of right eye (small stroke).  Saw what appeared to be a blind spot in my vision in my right eye upon waking up on 1/31/21.  Thought it was a floater so didn't think much of it.  Worked on 2/1/21 but it was still there and bothering me so on 2/2/21 when it didn't go away, I called my eye doctor who sent me to a specialist to have a look.  That's where I was diagnosed with the occlusion.  I was sent for blood work, additional physician visits (primary care, neuro, cardio and hemotology) and various CTs/MRI's.  No further occlusions were found.  I'm now on low dose asprin, a multivitamin and cholesterol medication.  I've been advised not to get boosted at this time.
Took flumist for the first time in october6, 2005. I have been having multiple joint aches, pains that I did not have prior to this vaccine. After months of speaking with the vaccine supervior, she recommended that I enter this report and not take the flumist again.
Progress Notes  Date:  3/8/2021                                                                                          Subjective Patient is a 71 y.o. female who was seen at the clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied difficulty breathing, difficulty swallowing, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress.   PMH: htn, hld, eczema, hypothyroidism, prediabetes     ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness ("lightheaded")   Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives and itching of skin       Previous Reactions: none    Objective    Vitals Vitals:   03/08/21 0929 03/08/21 0937 03/08/21 0950 BP: (!) 153/53 (!) 154/60 (!) 153/54 BP Location: Left arm     Patient Position: Sitting     Pulse: 58     SpO2: 99%            Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: She is well-developed. She is not diaphoretic.     Comments: Appeared to not feel well upon arrival. After water and snacks, improved.  HENT:     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Lightheadedness.   Pt observed in the medical bay for approx 20 minutes. She was able to stand from wheelchair w/o lightheadedness/dizziness. She states she feels much better and is ready to go home.  Pt provided handwritten instructions on monitoring her bp at home and when to follow up with pcp.  She was taken out to the front accompanied by her husband by RN.  She and husband both voice appreciation of today's care.        3/8/2021 9:36 AM
Symptoms started within 20 minutes of administration and progressed in severity over following week, remained for 1 month, and gradually diminished the month of November, but still not returned to baseline. Decreased dexterity left hand with numbness, itching, and icy sensation along inner aspect of left arm from axilla to palmar aspect left hand/fingers that interfered with normal use of hand, and joint pain & swelling of hands, hips, knees, lymph node swelling L axilla/neck. Early onset: lungs felt tight, palpitations, cough, nausea--resolved after 2 wks, but continued to have irritating dry cough. Headache, fatigue, dizziness persisted x 1 month. Similar symptoms after first COVID vaccine, but much less severe.
Chills; fatigue; pain in left under-arm; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Apr2021 at 16:15 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021, the patient experienced chills, fatigue and pain in left under-arm. 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 chills, fatigue and pain in left under-arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, fatigue and pain in left under-arm was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Per nursing notes (8/28 at 1830): Patient c/o pain to R upper arm at site where pna shot was given on 8/28 site red, swollen red area approx 10x4 inches.  site marked.  MD paged.  Vanco ordered and apply hot packs. Patient has remained afebrile.  Received vanco 1g x 1 on 9/29 at 2300.  11/20/2007 MR receved for DOS 8/28-30/2007 with Discharge DX: Right neck nodule.  Local allergic reactions to Pneumovax RUE. Pt initially admitted for abdominal pain received Pneumovax prior to D/C.  Subsequently developed an area of erythema at injection site. Afebrile.  D/C delayed x 1 day for tx with abx.
"I"was shivering, actually shaking for 3 hrs during the first night; "I" was shivering, actually shaking for 3 hrs during the first night.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; The next day "I "didn't feel good with an upsetstomach, didn't want to eat.; The next day "I" didn't feel good with an upsetstomach, didn't want to eat.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 18Feb2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Feb2021, the patient experienced night sweats as she had gotten out of a pool. On 19Feb2021 at 02:30, the patient experienced shivering and shaking for 3 hours during the first night. On 19Feb2021,the next day, the patient did not feel good with an upset stomach and did not want to eat. The adverse events did not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events night sweats, did not feel good with an upset stomach, did not want to eat and shivering were resolved on an unknown date in Feb2021, while the event shaking was resolved on 19Feb2021 at 05:30, after the duration of 3 hours.   No follow-up attempts are needed. No further information is expected.
Very sensitive skin in shot location left arm on first day approximately 7 hours after vaccination. Then slight itching on subsequent days after vaccination. Finally, on 03/29/2021 approximately 4 inch red rash on skin in location of vaccination.
Pt recv vax on 10/14/97; 30 min later pt exp vertigo, dizziness & increased blood pressure.