chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with rotavirus vaccine live (human-bovine) PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomiting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GT specialist. Additional information has been requested.
Fever of unknown orgin, every single night from 9/13/2016 between the hours of 8pm to 1am our son gets a fever of 100.5 to 101. Hes unconsolable, fussy, crying, in pain, high fever, bloody stools and seizures.
throat swelled up; Face swelled up; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281762, 2019SA281763 and 2019SA281531 (same reporter).  This case involves a patient who experienced throat swelled up (pharyngeal swelling) and face swelled up (swelling face), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, the patient had throat swelled up (pharyngeal swelling) and face swelled up (swelling face) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was pharyngeal swelling and swelling face.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for pharyngeal swelling and swelling face.  List of document held by sender: none.
vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization.  The following information was reported: VITILIGO (non-serious) with onset 2023, outcome "unknown".  Additional information: Caller states that his son has received all the recommended Pfizer COVID 19 vaccines, on schedule, when they became available. His last vaccination was months ago and he has now been diagnosed with vitiligo (auto-immune disease) this summer.   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.
PAIN AND TIGHTNESS IN THE LEFT UPPER CHEST. SWOLLEN LYMPH NODE UNDER THE LEFT ARMPIT
Immediately after the vaccination I had no side effects. First effects appeared when I went to bed at around 10:30-11pm, I had shivers, trembling and fever of above 37 degrees Celsius for the whole night. The next day I felt extremely tired with fever and chills the whole day. On the second day after vaccination I had an enlarged lymph node under my left arm. My movements were restricted, I couldn't lift my arm because of a strong pain under my arm pit. 10 days after the vaccination I still feel a strained muscle like feeling on my left-hand chest side.
1/15/22  Pt is a 19 yr/o female who presents with shortness of air, cough, chills, body aches.  Reports that she has not felt well since earlier in the month.  States that she went to clinic and had a COVID test and an x-ray and was told that she had pneumonia and was placed on antibiotics.  Patient states that she really has not gotten much better despite all of this.  Did report that they did a COVID test and was negative.  Patient also reports she took a negative rapid test.  States since that time she has not felt as well I did report that she had a fever on 7 January but no fever since that time.  Patient states that she felt better after being sick on the fourth for a few days but then started getting ill again on the 11th.  States at that time she had sore throat, cough, congestion, headache, body aches.  Patient reports no significant medical problems.  No other complaints this time Review of Systems  Constitutional: Positive for chills and fever.  HENT: Negative.   Eyes: Negative.   Respiratory: Positive for cough and shortness of breath. Negative for wheezing.   Cardiovascular: Negative.  Negative for chest pain.  Gastrointestinal: Negative.  Negative for abdominal pain, diarrhea and nausea.  Genitourinary: Negative.   Musculoskeletal: Positive for myalgias.  Skin: Negative.  Negative for rash.  Neurological: Negative.   Psychiatric/Behavioral: Negative.  Negative for confusion.
I have a severe rash in multiple large areas on my body including buttocks, legs, and hands. These are extremely itchy, red, blistery, and the area under the skin is hard and painful to the touch. They have been growing every day since since the onset on Saturday (now it is Wednesday).   some of them ha
Drop in A1C; Extreme Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (Drop in A1C) and FATIGUE (Extreme Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (Drop in A1C) and FATIGUE (Extreme Fatigue). At the time of the report, BLOOD GLUCOSE DECREASED (Drop in A1C) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin decreased: 5.5% Low.         This case was linked to MOD-2021-086500 (E2B Linked Report).; Sender's Comments:  MOD-2021-086500:1ST DOSE
My arm hurt and I had a rash from just below the injection site to my elbow.  this lasted about 3-4 days. By 11am on the 23rd, I was freezing and could not get warm, my head was aching and I was exhausted. By 7:30p I had a temp of 101.5.  I was still freezing with a bad headache so I called the Er Covid line and talked to a nurse who basically said I was going through the vaccine reaction and not to worry unless my temp reached 104.  Fever broke at 12:30am and I stopped shivering and was able to sleep  That morning, my arm was very sore and the headache was still there but the fever was gone and I just progressively got better over the next couple days. hh
alot of swelling under my armpit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (alot of swelling under my armpit) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (alot of swelling under my armpit). At the time of the report, SWELLING (alot of swelling under my armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 27-JUN-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot # not provided)(dose not provided). No other co suspects were reported. No concomitant therapy was reported. On 27-JUN-2013 when the patient received ZOSTAVAX and she had a red, itchy rash that resembled a gardening type of rash. The nurse stated the rash became more painful 2 days after the patient received ZOSTAVAX and the patient was then diagnosed to have shingles. The patient sought medical attention at office visit. The outcome of the patient was then diagnosed to have shingles, the rash became more painful, itchy rash and she had a red was unknown. Additional information has been requested.
Came with AKI after he received first dose; AIN; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (PEMBROLIZUMAB), (Batch/Lot number: unknown) for lung adenocarcinoma. The patient's relevant medical history included: "Lung adenocarcinoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "recovered", described as "Came with AKI after he received first dose"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "recovered", described as "AIN". The patient underwent the following laboratory tests and procedures: Biopsy kidney: Showed AIN, notes: Acute interstitial nephritis (AIN); Blood creatinine: 1.1 mg/dl, notes: b/1; 7.65 mg/dl; declined sharply; 1.7 mg/dl, notes: imrproved; SARS-CoV-2 test: Negative. The action taken for pembrolizumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of acute kidney injury, tubulointerstitial nephritis.  Clinical information. ICPi was stopped and oral prednisone (1 mg/kg) was started. Rechallenge with ICPi was defered.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201326258 Same article/drug/event different patient;US-PFIZER INC-202201326257 Same article/drug/event different patient;US-PFIZER INC-202201326257 Same article/drug/event different patient;US-PFIZER INC-202201326258 Same article/drug/event different patient;
Pt recvd HIB on 30APR91 & on 5MAY91 pt devel bacteremia & pneumonia; pt's exp was considered life-threatening;
Developed pain, redness and swelling in left upper arm muscles and shoulder muscles. Became unable to stretch arm outward or upward and could not pick up objects till days later [left arm]. Has had small improvement in the intensity of the pain but I hear her groan several times a day whether moving or not. Using her left arm to IE hold a book, reading, is hurtful at least. She insists on doing dishes but has accepted my helping her. The pain is mild to intense; quite variable but always present. We had hoped using the arm would improve it but there is no apparent relaxing of the above symptoms. Note: we were having coffee out side and for no reason her left hand involuntarily released her cup breaking it???? She is having more difficulty using her walker as the left arm pain tends to increase pushing it. This vaccine injury has caused her additional depression by adding this disability to the multiple sclerosis she has had for 30 + years and is a progressive situation IE when we went to a store, she used the wheeled basket as a walker but now she seldom goes out because it's only by wheelchair now. Due to the decrease in strength of legs and all muscles generally since the flu shot has made it harder for her to get in & out of bed and I set up a portapotty by her bed each night so she does not need to try and make it to the bathroom. The overall situation is grim at best. Today at the doctors she was given a cortisone shot today [04/26/07][12 noon] and she just told me [7PM] "it does not feel any better". She states she feels her nervous system has been affected. IE left arm and legs weakness, walking more difficult, balance unreliable, dizziness more frequent, pain and discomfort in left arm unyielding and unforgiving.
Hives on arms and legs; Sever Shortness of Breath; Body aches; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 05:15 (Lot number: FE3594) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Right, Vaccine Administration Time: 09:15 AM), administration date: 29Apr2021, when the patient was 23 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 09:45 AM), administration date: 06Apr2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Jan2022 05:15, outcome "unknown", described as "booster"; DYSPNOEA (non-serious) with onset 02Jan2022 17:15, outcome "recovered" (03Jan2022 17:15), described as "Sever Shortness of Breath"; PAIN (non-serious) with onset 02Jan2022 17:15, outcome "recovered" (03Jan2022 17:15), described as "Body aches"; URTICARIA (non-serious) with onset 03Jan2022 05:15, outcome "recovering", described as "Hives on arms and legs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, pain. Therapeutic measures were taken as a result of urticaria.  Additional information: Patient did not received any other vaccine in four weeks and no other medications in two weeks. Sever shortness of breath and body aches 12 hours after booster lasting 24 hours. Hives on arms and legs 24 hours after booster, only relieved with benydryl. No covid prior vaccination. No known allergies.
pt received 2nd dose 18 days after the 1st; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 7th May 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient received the 2nd dose of Twinrix 18 days after the 1st dose. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose Twinrix, earlier than the recommended schedule, which led to shortening of vaccination schedule.
Within 30 min of the shot, my arm began to swell and itch. My face and some part of my body began to itch as well. Within the next hour, my jaw began to lock and my throat began to burn/tighten. Within this timespan, my body, especially my back began to ache as well as my chest feeling tight.  After three hours, I went to the on-campus clinic and they gave me 50mg of Benadryl.
L upper arm tenderness, warmth and redness, cellulitis. Cool compress, Tylenol and Augmentin 400mg BID x 10 days.
PAIN IN ARM/SORENESS IN ARM; Headache; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and pain in arm was not reported. This report was non-serious..
bleeding; headaches; facial pain; hot flushes; breathlessness; severe body aches; upset stomach; skull pain; numbness in lips; blurred vision; This is a spontaneous report received  from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 04May2021 17:30 (Batch/Lot Number: EW0165) (age at vaccination: 31 years old) as single dose for COVD-19 immunisation. The patient had received dose 1 of BNT162b2 on 13Apr2021 17:00 (Batch/lot number: EW0162) administered in left arm for COVID-19 immunization. The patient had no relevant history, no prior drug, no known allergies. The patient's concomitant medications were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient had not had COVID prior to the vaccination, unknown if tested post the vaccination. The patient experienced severe headaches, facial pain, hot flushes, bleeding, breathlessness, severe body aches, upset stomach, skull pain, numbness in lips, blurred vision. Event onset date wsa 07May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It's unknown if any treatment was received for the events. The events were not resolved.
RIGHT ARM PAIN EVER SINCE GOT VACCINATED AND THAT PAIN EXACERBATED WHEN BUMPED INTO OR SLEPT ON; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced right arm pain ever since got vaccinated and that pain exacerbated when bumped into or slept on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain ever since got vaccinated and that pain exacerbated when bumped into or slept on. This report was non-serious.
muscle spasms, weakness in rt leg; noticed sx worsened; numbness, tingling on both legs;dx myopathy, MS; 60 day follow-up dated 11/6/00 provided no additional data. Annual follow-up dated 1/24/01 states the pt is being treated for demyelination of the spine that was due to the vaccine.
no adverse event; vaccine that underwent temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not provided.  On 08-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025369, expiration date 01-DEC-2022 (dose, route and site of administration was not reported) which underwent a temperature excursion.  No additional adverse events were reported.
Fainting spell 10 minutes after vaccine. Had received catch up vaccines at same time sxs cleared within 10 minutes.
Patient received ZOSTAVAX at approximately 10:30am and was monitored for 30 minutes with no sign of reaction. At approximately 2:45pm, patient was trying to have a BM when she felt faint and nauseated while still at facility. She called for help. Temperature, heart rate, pulse, respiratory rate, and BP were all within normal limits. Patient was given ZOFRAN 2mg IM in left hip. EKG was performed and was normal.
Muscle weakness; sweating; overheating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Muscle weakness"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; HEAT STROKE (non-serious), outcome "unknown", described as "overheating".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Feeling exhausted; Real bad muscle aches one night / horrible pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling exhausted) and MYALGIA (Real bad muscle aches one night / horrible pain in muscles) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.   On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In 2021, the patient experienced FATIGUE (Feeling exhausted) and MYALGIA (Real bad muscle aches one night / horrible pain in muscles). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. In December 2021, FATIGUE (Feeling exhausted) and MYALGIA (Real bad muscle aches one night / horrible pain in muscles) had resolved.            Concomitant medications included unknown Thyroid medication.  It was reported that the patient was fine after 5 days.   This case was linked to MOD-2021-404069, MOD-2021-404070 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up information received included significant information events outcome updated.