chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer who is a registered nurse concerning her 3 month old granddaughter who at birth was vaccinated with a 1st dose and at one month of age with a 2nd dose of Hepatitis B recombinant. It was reported that after the 1st dose the patient developed a macular papular rash which developed into a vesicular rash. The rash is on the patient's trunk, scalp, and face. The rash seemed to be getting better until the 2nd dose of Hepatitis B vaccine recombinant was given along with other concomitant vaccines. The patient  sought unspecified medical attention and the physician feels that the rash was eczema. No further info is available.
fever 102 x 3 days;diarrhea x 3 days;vomiting x 3 days;advil every 4hr;kaopectate-1x;
A pulsing in the vein or muscle in point under the front of my right knee; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 27Aug2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 29Jul2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Aug2021, the patient underwent COVID-19 test (Polymerase Chain Reaction (PCR)) and the result was negative. On 30Aug2021 at 12:00, the patient experienced a pulsing in the vein or muscle in point under the front of the right knee. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event pulsing in the vein or muscle in point under the front of the right knee was not resolved at the time of this report.
Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination.  / aches with no fever 24 hours after vaccination lasting 12 hours; Chills; Swollen lymph node in armpit of vaccinated arm 48 hours after vaccination.; Vivid nightmares 14 hours after vaccination.; This is a spontaneous report from a non-contactable other healthcare professional (patient).  A non-pregnant 44-years-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3247, via an unspecified route of administration on 06Feb2021 09:45  (at the age of 44 years old) at SINGLE DOSE in the left arm for COVID-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient had no allergies.Historical vaccine information included BNT162B2, Lot EL9269, on 16Jan2021 10:00 AM in the Left arm, Dose number 1.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 21:00, the patient experienced chills and aches with no fever 12 hours after the vaccination, sleeplessness throughout the night.  The chills and aches with no fever 24 hours after vaccination lasting 12 hours. Patient experienced vivid nightmares 14 hours on unspecified date in Feb2021 after vaccination. Patient experienced swollen lymph node in armpit of vaccinated arm 48 hours on unspecified date in Feb2021 after vaccination. No treatment was received for the events. Outcome of the vivid nightmares, Ache , Sleeplessness throughout the night, chills, Swollen lymph node in armpit  was recovered in Feb2021.  No follow up attempts are possible. No further information is expected.
Information has been received from a registered nurse (R.N.) concerning a adult male patient who on 17-OCT-2006 was vaccinated with a dose of Recombivax. It was reported that the Recombivax was improperly stored. Also, after vaccination the patient developed numbness and tingling in th arm in which he was vaccinated. Unspecified medical attention was sought. He was seen by the physician for follow-up on 24-OCT-2006, no outcome was reported. No product quality complaint was involved. Additional information is not expected.
pain at injection site (immediately, continuing for 4 days) fatigue (starting about 13 hours after injection, lasting 48 hours) nausea (about 18 hours after injection, lasting 4 hours) malaise (about 18 hours after, lasting 72 hours) headache (about 18 hours after injection, lasting 72 hours) chills (about 18 hours after injection, lasting about 4 hours)
1630 on 24APR95 pt c/o sore throat, swollen glands, feeling achy all over, esp in lower back, kidney area; c/o feeling feverish; sx gradually inc from 1630 & c/o restless noc; feeling tired;
A few hours after my Moderna vaccine, My arms felt "dead". It felt like I had no control over them and I could barely lift anything. I started to feel a little out of breath during that time as well. The feeling went away then about 30 mins later, it came back. about 2 days after the vaccine, I experienced severe back pain. I could not do anything for about 2 weeks. I visited the ER on 11/11/2022 due to the back pain and was prescribed pain medication. A few weeks later it felt fine, no lingering effects. I was also diagnosed with breast cancer recently.
Swollen, erythema at site, hot, tender  Warm compress, Motrin, Benadryl
Pt felt nausea and dizzy after vaccine 15:45:  pt complains of dizziness "hot" nausea, given jice, water  BP 98/64, HR 64. 16:11 triage: BP 100/64 HR 64 99% RA 16:14 Blood glucose 124 16:20 Zofran 4mg, PO by EMT 16:38:  BP 104/62 HR 70 99%RA 17:03: 105/68, HR 75, 99%RA 17:20 DC home stable
A single hive appeared on right cheek on face at 10 AM.  Monitored for 30 min. No other hives on body or other symptoms. Pediatrician ordered 0.5 tsp (3.75mL) liquid oral pediatric diphenhydramine which the mother administered.
Feeling tired; Nausea; Fatigue; Fever (100.4); Chills; Cough; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via intramuscular route of administration in the left arm on 27Sep2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and shellfish allergy. 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. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), taken for an unspecified indication from an unknown date and unknown if ongoing. On 27Sep2021 at 23:00, the patient experienced feeling tired, nausea, fatigue, fever (100.4), chills and cough. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 27Sep2021 at 23:00, the patient underwent body temperature test and the result was 100.4 (unspecified units). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events feeling tired, nausea, fatigue, fever (100.4), chills and cough was resolving at the time of this report.
dizziness, disorientation, nausea, vomiting, ataxia, seizures
Bleeding after the 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding after the 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding after the 2nd shot) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Bleeding after the 2nd shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Very limited information regarding this event (hemorrhage) has been provided at this time. Details regarding vaccination date and the type of bleeding are required for further assessment.; Sender's Comments: Very limited information regarding this event (hemorrhage) has been provided at this time. Details regarding vaccination date and the type of bleeding are required for further assessment.
Information has been received from a 38 year old female pharmacist with no pertinent medical history and no drug allergies/drug reactions. She reported that on 04-FEB-2013 when she pulled the syringe out of the ZOSTAVAX vial (lot # H018510, expiration date 15-JAN-20140, she got some of the liquid on her skin and a rash developed on the same day. There was no concomitant therapy reported. The reporter accepted VZVIP packet. Laboratory studies were not performed. At the time of the report the patient was recovering from the event. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # M033611 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011239: US-009507513-1708USA004959: US-009507513-1708USA011238:
"little stabbing pain" in his heart; Swelling in the armpit up to his nipple area; Sore Injection Site; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN ("little stabbing pain" in his heart), PYREXIA (Fever), HEADACHE (Headache), AXILLARY PAIN (Swelling in the armpit up to his nipple area) and VACCINATION SITE PAIN (Sore Injection Site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Injection Site). On 03-Apr-2021, the patient experienced CHEST PAIN ("little stabbing pain" in his heart) and AXILLARY PAIN (Swelling in the armpit up to his nipple area). At the time of the report, CHEST PAIN ("little stabbing pain" in his heart), PYREXIA (Fever), HEADACHE (Headache), AXILLARY PAIN (Swelling in the armpit up to his nipple area) and VACCINATION SITE PAIN (Sore Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Passed out, loss of unconsciousness; Aching; Felt unwell, very sick; Shaky; Feverish; Fatigue; Nauseated; A spontaneous report was received from a 49-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, and nauseated.  The patient's medical history was not provided. Concomitant medication was Loratadine.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 25 Jan 2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot Number: 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, after receiving the vaccine the patient experienced loss of consciousness, aching, fatigue, felt unwell, very sick, shaky, feverish, nauseated.   On 29 Jan 2021, the patient was experiencing fatigue. Treatment for the event was not provided.  Action taken with the mRNA-1273 was withdrawn.   The outcome for the events, loss of consciousness, aching, shaky, feverish and nauseated was Unknown and the outcome for the events, fatigue, felt unwell, very sick was considered Not resolved.; Reporter's Comments: This case concerns a 49 year old female patient experienced a serious unexpected event of loss of consciousness and NS unexpected events of aching, fatigue, felt unwell, very sick, shaky, feverish and nauseated. The events occurred after first dose of the study medication administration on the same day.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive 2nd dose within recommended time frame/product dose omission issue and experienced 2 busted blood vessel in left eye/eye hemorrhage, throat burning sensation/throat irritation, nasal irritation/nasal discomfort, breast burning/breast pain and red spots on face and face turned bright red randomly/erythema. The patient's medical history included cataract surgery. Products known to have been used by the patient, within two weeks prior to the event, include Loteprednol etabonate, Bromfenac Sodium, and Gentamicin Sulfate. On 05Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch: 041120A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient did not receive 2nd dose within recommended time frame. On 02 Feb 2021, patient had red spots on face and on 04 Feb 2021, her face turned bright red randomly, throat, nose and breast were burning and on 10 Feb 2021, she had 2 busted blood vessel in left eye. The event 2 busted blood vessel in left eye was considered as medically significant. Treatment medication for the event included Diphenhydramine, unspecified steroid and Cortisone cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event did not receive 2nd dose within recommended time frame was resolved on an unspecified date, throat, nose, breast burning was resolved on 11 Feb 2021, 2 busted blood vessel in left eye was resolved on 15 Feb 2021 and red spots on face and face turned bright red randomly was not resolved at the time of this report. Reporter's Comments: Based on the HCP reporter's assessment  the events are assessed as unlikely related to mRNA-1273.The patient had eye surgery and was on medications causing the reported events as side effects.
Rash Narrative:  Patient had COVID-19 approximately 60 days prior to vaccination. Day after vaccination, had chills that resolved with acetaminophen then a rash the following day that resolved one day later.
Patient complained of pain to (R) leg. Dad noticed it was swollen. 14cm x 17cm area of erythema & warmth. (R) leg measure 27cm circumference while (L) leg is 24cm. Patient was given 1 tsp BENADRYL and checked out by physician.
Swelling, itchy red rash at injection site. Rash grew in size. Fever 101 F.
A report has been received from physician concerning an 8 year old, female patient. The patient's concurrent diseases included upper respiratory infection. The patient had been receiving FLUMIST (intranasal) started on 28-Jan-2009. Bilateral weakness in legs and urinary difficulty, starting 2 weeks after vaccinations. Patient was hospitalized, supportive care, symptoms self-resolved. 4/20/09 MR received for DOS 2/13-16/2009 with D/C DX: Acute infective polyneuritis. Pt presented several times to PCP with c/o bilateral leg pain and weakness with difficulty urinating. PE (+) for decreased strength in legs, shotty nodes and tenderness to palpation below the knees. DTRs intact. Concern for GBS (Guillain-Barre syndrome). Referred to ER. Admitted to R/O GBS/Myositis. Pt developed neck pain 2 days s/p vax then progressed as above. F/U 2/18/09. Now able to walk on own, no urinary difficulties but still with some pain in feet. Lab data: ESR 72 mm/hr. Labs and Diagnostics: UA WNL. UC (-). CK 70. CRP 0.16. Alk Phos 240. Total protein 9.0. Albumin 5.2. CBC with WBC 12.5. ESR initially 72 then down to 16. Phosphate 5.4 (H). Mg++ 2.1 (H). X-ray lower extremities WNL. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. The reporter assessed the event Guillain-Barre syndrome to be serious with criteria of hospitalised.
Myalgia & Fever Narrative:  dose 1-day 1-fatigue/tired dose 2-day 1-3-  pain/swelling/redness; day 1-3-muscle  ache;fever;chills;fatigue   Other Relevant History:
asymptomatic liver function elevation of the SGPT to 96 & GGT 274;
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
joint pain; tiredness; anywhere from upper 99+ to just above 100 +; stiffness; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves Elderly male patient who experienced joint pain, tiredness, anywhere from upper 99+ to just above 100 + and stiffness after receiving vaccine influenza usp trival a-b high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2023, the patient received a dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  On 27-Oct-2023 the patient developed joint pain (arthralgia), tiredness (fatigue), anywhere from upper 99+ to just above 100 + (pyrexia) and stiffness (musculoskeletal stiffness) (latency- 1 day) following the administration of influenza usp trival a-b high dose subvirion vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date: [anywhere from upper 99+ to just above 100 +]  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Had severe diarrhea on 2/10/21 a few hours after receiving the vaccine.  This continued until the first week of June.  Contacted my PCP who initially recommended standard diarrhea rx protocol which was not effective. Used Immodium and IB guard to control it to be able to continue my normal activities. Found it was not as bad if I skipped breakfast and lunch and just ate dinner.  MD then ordered stool sample lab work which all came back negative.  I did lose 15 lbs after a month or two at the beginning of this. Weight has now stabilized and for the past 2 weeks I have only had 1 episode of diarrhea.  Prior to the vaccine, I had never had an issue with this.
severe diarrhea; This case was reported by a consumer and described the occurrence of diarrhea in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2021, the patient received Shingrix. On 4th January 2021, 1 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix in afternoon of a day before reporting. On the next day, at the time of reporting, the patient had severe diarrhea.
4/3/15 - sensitive/sore at injection site. 4/4/15- red, inflammation, pain, warm and itchy at injection site, about 3 inches wide. Ibuprofen 400 mg taken with no relief. Denied fever. Advised to delineate border w new sharpie to ensure eyrthema not expanding.  Encourage Benadryl 25-50mg PO q 6 hours x 2 days, Motrin 400mg PO TID prn, and an ice pack.
25 year old female exhibited signs of mild allergic reaction to Moderna covid-19 vaccine. Rash on upper R arm and anterior throat. Nausea, dizziness. BP 148/85, pulse 93, SPO2 95% with room air. C/O mild throat discomfort,  nausea, fatigue, dizziness and mild itching at rash sites. Administered Benadryl 50mg oral by EMT. Patient was monitored in clinic for 20 minutes by EMT's along with PA. Patient complained of nausea, dizziness, hoarseness and discomfort in her throat. Patient's mother agreed to have her transported to the ER for evaluation by ED staff. Patient agreed as well. Ambulance was called to the site and patient was evaluated and transported by paramedics at 10:40am PA gave verbal transfer of care as senior medical staff on site.  4-13-21 RN tried to call patient twice to follow up. No answer and can't leave message
This spontaneous report as received from a 77 year old female consumer referring to herself. She had the shingles virus sometime during 2013. On 02-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were not reported) injection subcutaneously. Concomitant drug was not reported. On 27-FEB-2016, the patient developed a blister-like rash covering her shoulder blades down to her hips. She went to urgent care, where she was diagnosed with shingles, and was given treatment with VALTREX and another unspecified cream. Outcome of the event was reported as recovering. The causality was not reported. Additional information has been requested.
On April 16 patient came home fatigue, pale and  legs hurting. The next day complained of right knee pain, Fatigue and looked pale. He woke up in the middle of the night complaining of right calf tightness and pain. On Sunday 18th he started to limp and when we looked at his calf it was double in size, warm to touch, and redness. We then went to the ER and had an ultrasound and CT scan . We were told he has multiple blood clots in the right leg and clots in both lungs.  He was then transported to a hospital and given blood thinner shots in stomach. He was released from the hospital 4/20 and given blood thinners and assigned a hematologist. He?ll be on blood thinners 6-12 months, out of work a month and tested regularly to check platelets.