chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, and 2011-11233. "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding or adverse health events following immunizations". A 74-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported) INFLUENZA vaccine and PPSV. The patient had a medical history of chronic proctitis. On an unknown date the patient developed acute polyneuropathy 1 day after the vaccines. The causality was reported as possible. The outcome was not reported. Documents held by sender: None.
Nausea at 11:30am, 23 hours after shot Strong pain in gut at 11:30am Vomiting at 1:00pm Vomiting at 2:00pm Fever, chills, muscle ache at 3:30pm Vomiting at 5:00pm Vomiting at 7:00pm Chills & muscle ache go away at 9:30pm Fever goes away over night Nausea temporarily goes away over night Vomiting from 4:30am to 9:00am on September 29th No chills, fever, or muscle ache this time Nausea & pain in gut persist until sep 30th, 6 days after shot
Pt given both vaccines left deltoid. 15-30 sec after 2nd vaccine, yellow fever, pt became pale. She said she felt fine. She was clammy and damp to touch. Head was reclined BP 122/90, P72. Nose running, face red and blotchy. BP 140/100, P 56. Physician called to room at 1110. BP at 11:15 142/100, P 70. Pt transported to urgent care in house for monitoring. Minimal pink rash at yellow fever injection site. Pt monitored until 11:50. VS returned to NL at 11:20. No progression of symptoms thereafter.
It all started with extreme fatigue, fever, body aches, coughs, chest pain, shortness of breath and brain fog. The fever, body aches has stop but everything else has continue.
Varicella vaccine breakthrough diagnosed with Varicella on 12/06/2006 20 pox. Afebrile.
Subject in pneumococcal vaccine trial, with severe COPD hospitalized for COPD exacerbation. Vaccination took place 10/10/2008. According to physician relationship is 'None'.
Patient developed sudden onset of headache with hypertension (BP 205/112), tachycardia (HR 137), redness and hives around 10 minutes after receiving the Pfizer covid vaccine (time 1600). She described "feeling a wave of heat climbing from her feet up to her face". 911 called and patient was transported to ER at around 1630. Upon arrival her BP trended down to 129/89 with HR of 78. She did not report difficulty breathing, and she did not receive additional medications while in ER. She was monitored for around 2 hours and discharged at 1847.
The day of the vaccine (01/22) I had very mild soreness in my left arm. That night my submandibular lymph nodes were swollen. The following day (01/23) I felt tired throughout the day. I went to work and when I got home my whole body began to ache (especially my legs) and my lymph nodes were swollen again. This morning (01/24) I woke up physically feeling warm but I was heat seeking and had a fever of 100.8F and was dizzy. Currently my temperature is 98.6 and aside from a mild headache and a very sore left arm/axillary area I feel better.
localized reaction including surrounding redness/warmth with central induration persisting at least one week following vaccine
Ascending motor paralysis  6/9/09 Hospital ER records received DOS 5/28/09. Post immunization patient c/o shoulder pain, knee pain, generalized aches, weakness, headache. Discharged.  6/11/09 Vax records and ICD-9 codes received. ICD-9 Codes: 786.50 chest pain, 995.3 allergic reaction unspecified, 732.4 Osgood-Slatter, V40.0 Problem learning, 314.01 Attention deficit disorder with hyperactivity, V65.3 Counseling, dietary / Nutritional Assessment, V20.2 Well Adolescent.
pt recv vax 1NOV96 & 11NOV96 pt devel a mild rash;
12/19- Hep A/B- give LA vaccine from Hep C program. He stated by Thurs 12/11- rash head to toe, red, skin feel lumpy with touch, itchy, HA (headache) 2-3 days. Today 12/16- rash-reddened-not raised before, continues to be itchy. Went to family MD- Fri 12/5 MD felt reaction to shot. Started a new BP(blood pressure) pill, 12/5 COZAAR 50mg.
spotting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:45 (48-years-old at the time of vaccination), (Lot Number: EN6206, expiry date not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included dexlansoprazole (DEXILANT); liraglutide (SAXENDA); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); colecalciferol (VD), Multi Vitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 administered in Arm Left on 17Feb2021 10:00 AM (Lot number EL9266). Patient stated, that she have the Mirena IUD and have not had a period in years. Two days after receiving the vaccine, she was spotting on 12Mr2021 8:00 AM. Patient did not receive any treatment for the event. The clinical outcome of the event was Recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Lt upper arm where the vaccine was given on 10/5/15 -> extremely swollen and red, no fever.
PRE-DOSED WITH 10ML ORAL DIPHENHYDRAMINE LIQUID DUE TO REPORTED REACTION TO 1ST COVID VACCINE DOSE. APPEARED FLUSHED IN THE FACE AND NECK WITHIN 5 MINUTES OF VACCINATION AND REPORTED FEELING ITCHY. NO HIVES NOTED AND NO DIFFICULTY BREATHING REPORTED UPON QUESTIONING.
High fever, started within 2 hours of receiving vaccine. Increased above 105 degrees (105.3) and lasted 60 hours. Vomiting and prolonged crying, reduced appetite, would eat very little until 3 days after vaccine administered.
fatigues; Chill; This is a spontaneous report from a non-contactable consumer, patient. A 42-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration on 23Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021, patient had experienced chills and fatigue. The clinical outcome of the event chills and fatigue were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
stomach feels bad; diarrhea not as watery; cramps; arm sore; severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), IRRITABLE BOWEL SYNDROME (severe diarrhea), DIARRHOEA (diarrhea not as watery), MUSCLE SPASMS (cramps) and ABDOMINAL PAIN UPPER (stomach feels bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and IRRITABLE BOWEL SYNDROME (severe diarrhea). On 31-Mar-2021, the patient experienced DIARRHOEA (diarrhea not as watery) and MUSCLE SPASMS (cramps). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach feels bad). At the time of the report, PAIN IN EXTREMITY (arm sore), IRRITABLE BOWEL SYNDROME (severe diarrhea), DIARRHOEA (diarrhea not as watery), MUSCLE SPASMS (cramps) and ABDOMINAL PAIN UPPER (stomach feels bad) outcome was unknown.            Patient received the first dose with lot #lot 013L20A on 27 Feb 2021. She received second dose on Saturday, March 27 at 4p with lot #047A21A. On Sunday she had a sore arm and severe diarrhea. She has had diarrhea ever since. She will sleep fine and then around 3am her stomach feels bad and diarrhea starts. She goes around 3a, 6a, and 7a. Today her stools don't seem as watery but does have some cramps. Patient stated she did have gastro-intestinal issues on Oct 11 and was in the hospital. She has not had any gastro problems since Oct until now. She wants to know how long still diarrhea goes away. She has a call into HCP. Patient stated it was fine for safety to contact. Narrative
That night right upper arm started turning a little red around injection site of DTaP/IPV.  Yesterday redness spread rapidly - mom drew line around area.  This morning redness spread outside of line and large blister has erupted in the middle of the redness with more smaller blisters appearing.  Very itchy and painful.   Plan:  CEPHALEXIN 250 MG/5ML PO RECON SUSP - 500 mg (10 mL) by mouth twice a day for 5 days and PREDNISOLONE SODIUM PHOSPHATE 15 MG/5ML PO SOLUTION - 22.2 mg (7.4 mL) by mouth twice a day for 3 days.  Keflex x 5 days Orapred to dampen blistering RTC if not improving
Constant crying x 2 days, would not eat x 2 days becoming dehydrated; Fever of 104 when seen @ ER on 3JAN91 even though mother giving APAP;
I am a very healthy person in good shape and a good size. I have never had an adverse reaction to any vaccines before. I have always thought it was best to get vaccines. I will never feel that way again. Within two minutes of receiving the vaccine I became very nauseous. I had the vaccine administered at about 12:30PM. I am a teacher and worked until 4PM. I went home and continued to feel very nauseous and by 9PM I began having pain in my abdomen that radiated from my stomach and spread upwards and down. I also got a severe headache. It became so severe that I could only breathe very slightly. If I moved at all or laid on my left side the pain was so severe it made me very concerned for my health. My lymph nodes began to swell by 11PM the same day all over my body even in my arms. They hurt and became red. This scared me as it had never happened before! Saturday I had the same difficulty breathing, and my entire abdomen still hurt. I was very weak. My insurance is not in effect or normally I would have went to the ER at that point. I have a high pain tolerance and this was a 10 when I moved or breathed deep on a scale of 0 to 10 with 10 being the worst. Sat. night I was concerned I was getting pneumonia. I laid down in the bed on my left side and terrible pain filled my entire body cavity. I painfully turnmed over on my right side and laid very still. As long as I barely breathed I was ok. I told my husband that if I get better as the night goes on I will not go into the ER but if I get worse at all from this point on or do not get better by the wee hours of the night when one of us usually gets up to use the restroom that I will want him to bring me to the ER. Thankfully about 4AM I awoke and I could lay on my left side the same as I could on the right with no pain as long as I didnt move. With movement I still had severe pain. This continually got better at a very slow rate until 11PM Sunday night when all the pain was gone and my lymph nodes began to go down in sixe and redness. I will never again in my life get the flu vaccine or have my husband or three children get it. I really believed I was going to get pneumonia rapidly and die. I am not a worrier and I did not express this previous thought to my family.
10"x16" red, raised area. Diagnosed at local ER as cellulitis. Treated with Augmentin 500mg x7.
Wed 12/15, 9am: Experienced weakness, chills, exhaustion. Wed 12/15, noon: Started experiencing numbness in both feet - not much at first but grew. Wed 12/15, 4pm: Chills so severe, I was literally shaking. Thu 12/16, chills subsided through the day, though some exhaustion remained. Feet/lower leg numbness grew more extensive, estimate about 80% numb. Fri 12/17, by about 2pm, all symptoms had subsided except for numbness which has continued to this moment (9:45pm).
first case of Omicron; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (first case of Omicron) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (first case of Omicron). At the time of the report, COVID-19 (first case of Omicron) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of COVID-19 (AESI). The event occurred on an unknown date, it was reported that patient was fully vaccinated with mRNA-1273 vaccine. Vaccination dates were not disclosed. He said he didn't get that sick and it was real mild. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of COVID-19. The event occurred on an unknown date, it was reported that patient was fully vaccinated with mRNA-1273 vaccine. Vaccination dates were not disclosed. He said he didn't get that sick and it was real mild. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Severe fatigue, severe stomach pain, increased sleep apnea, increased acid reflex, increased sciatica pain.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: He had blurred vision, sweating a lot and dizzeness
Information has been received for a Dr concerning an approximately 12 month old male who was vaccinated with measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation). Concomitant vaccinations included varicella vaccine live (MSD). Three to 4 weeks ago post vaccination, the pt began to lose his hair. The hair loss progressed to total alopecia within 4 weeks. The pt sought unspecified medical attention. Additional info has been requested.
Information has been received on 22-JUN-2018 from a consumer concerning herself. The patient was a 63 years old female with a history of thyroid removal and hysterectomy. The patient also reported treatment with AMBIEN ("years ago") and another unspecified sleep medication because AMBIEN "did not really work anymore." Concomitant medications included biotin, calcium, CLARITIN, FLONASE, LIPITOR, lisinopril (mfr. unk), and SYNTHROID. The patient reported that in August 2012, she was vaccinated with ZOSTAVAX for the prevention of shingles. In 2013 she experienced "difficulty seeing" (no further clarifying information was provided). The patient was seen by an eye doctor in 2014 and was diagnosed as "having a stroke in the back of her left eye." It was not specified how the diagnosis was made. The eye doctor directed her to see an eye specialist (date not specified). On an unspecified date, the patient had a CT scan of both eyes (results not provided). The patient reported that she had cataracts removed from both eyes in 2014. After having the cataracts removed (date not specified) she starting using moisturizing drops (NOS) in both eyes; using the drops anywhere from two to five times per day, in each eye. The patient also reported that she had fat removed from both eyes in 2015. The patient reported that she has not recovered from the adverse events. She also reported that she was pursuing legal action regarding the adverse events she experienced after being vaccinated with ZOSTAVAX. Upon internal review having a stroke in the back of her left eye and cataracts removed from both eyes were considered medically significant events. Additional information has been requested.
my bottom lip has a little puffiness on it; I have a tingling on my lips/ My lip is so tingly; the bottom lips is little swollen; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0172, Expiration Date: not reported), via an unspecified route of administration on 13May2021 (at the age of 78 years old) as second dose, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EP7533), via an unspecified route of administration on 20Apr2021 (at the age of 78 years old) as single dose for COVID-19 immunisation. On 13May2021, when the patient got home after having the second shot of BNT162B2, the patient experienced that her lips was so tingly and the bottom lips was little swollen. On 14May2021, it looked like the patient's bottom lip has a little puffiness on it. Treatment was received in response with the events which included diphenhydramine (BENADRYL, 25mg) about 4 doses about over the night (as reported). Outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Tingling in extremities, surging hot flushing, rapid heart rate, tightening in chest and throat. Passed in about 10 mintues but returned mildly several times throughout the day. Went home and slept from 4:00 PM - 9:30 am the folling day.  Then Felt better.
Patient had to go to the Emergency Room because of having symptoms of chills, head hurt, couldn't stand up, low blood pressure for 3 days.
Woke up hurting all over. Arm swollen with a hard lump. Fever of 101 F. Chills.  Fever broke on the 6th. Injection site still swollen red and itchy
This spontaneous report has been received from a Medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # M043731 and expiration date of 22-JUN-2019 (strength, dose, route of administration and anatomica location were not reported) for prophylaxis. The vaccine was exposed to a temperature of 32°F to 35°F, during 15 hours. The vaccine was also exposed to a previous temperature excursion of 32°F to 35°F during 49 hours. Digital data logger was involved. No adverse effects reported. Additional information has been requested.
wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; eyelids started flaking, itching, peeling; eyelids started flaking, itching, peeling; Made worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, lot unknown), administration date: 23Sep2021, for COVID-19 immunization, reaction(s): "wrists red, inflamed, itching running rash", "eyelids started flaking, itching, peeling"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot unknown), administration date: 16May2022, for COVID-19 immunization, reaction(s): "wrists red, inflamed, itching running rash", "eyelids started flaking/peeling", "eyelids started itching", "Made worse"; Bnt162b2 (DOSE 1, SINGLE, lot unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, lot unknown), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (medically significant) with onset 2022, outcome "unknown", described as "Made worse"; SKIN EXFOLIATION (medically significant), EYELIDS PRURITUS (medically significant) all with onset 2022, outcome "unknown" and all described as "eyelids started flaking, itching, peeling"; RASH (medically significant), PRURITUS (medically significant), ERYTHEMA (medically significant), ARTHRITIS (medically significant) all with onset 2022, outcome "unknown" and all described as "wrists red, inflamed, itching running rash". The events "wrists red, inflamed, itching running rash" and "eyelids started flaking, itching, peeling" required physician office visit. The patient underwent the following laboratory tests and procedures: Allergy test: Unknown results. Therapeutic measures were taken as a result of rash, pruritus, erythema, arthritis, skin exfoliation, eyelids pruritus. Clinical courses: About 2 weeks after 3rd (23Sep2021), eyelids started flaking, itching, peeling. A few months later, wrists red, inflamed, itching running rash.16May2022, 4th. 14Nov2022, 5th. Over last 16 months, 3 dermatologists, allergy tests, multiple doctor visits. No help. 3 Steroid shot helped for about a week. Multiple cortisone topicals. Made worse. 24Feb2023 whole face, chest, wrists.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037618 Same patient/ AE, different drug dose;US-PFIZER INC-202300092268 Same patient/ AE, different drug dose;
Adverse event: whole body rash and itchy, especially the upper front body, lasted two weeks. Treatment: antihistamine(otc)
On 5/18/00, the pt experienced rigors, a frontal headache, muscle aches, and flu-like symptoms.