chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; HARD TO TALK; This spontaneous report received from a patient of an unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose was not reported administered on an unspecified date for prophylactic vaccination.  On 20-DEC-2021, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure and oxygen saturation decreased (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) 1 total, dose was not reported administered on 16-DEC-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 20-DEC-2021 four days after the vaccine, the patient got very sick. Because of the vaccine after 4 days the patient went to the hospital and got Omicron and was in the hospital for 3 nights. The patient's blood was clotted and received shoot to thin blood at the hospital. The patient's oxygen was 87. The patient can walk are talk. For 10 days it was hard for the patient to talk and stayed in bed for 12 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hard to talk on 30-DEC-2021 and the outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220152367.; Sender's Comments: V0:20220161291-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot, hard to talk -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A report was received from a health care professional on 10/20/2003 concerning a 57 year old female vaccinee who experienced a red and swollen are on day after receiving Fluvirin on 10/15/2003. On 10/16/2003, the vaccinee experienced a red and swollen area about 3 inches in diameter after receiving Fluvirin on 10/15/2003. The outcome of the events were unknown at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Reference PJP-2003-00832, PJP-2003-00834, PJP-2003-00836.
pt relates had 2nd dose of Moderna COVID vaccine on 4/8. same day started with body ache, weakness  and feeling of heaviness in b/l LEs from hips to feet. symptoms have been slowly improving -  by 4/13 or 4/14, legs were only affected from knees down, described as continued feeling of heaviness, weakness and numbness/tingling around shins that would come and go. today, 2 weeks since onset, symptoms persist from knees down but have improved each day, only light symptoms now. denies numbness or tingling in feet. symptoms have not impaired pt's ability to perform her daily activities or go about her regular routine.   on exam there was weakness with flexion and extension of toes, especially extension of great toes. monofilament exam b/l feet with sensation intact, but diminished per pt report. strength 5/5 b/l at hip and knee. touch sensation grossly intact. since symptoms were mild and improving, pt was instructed to monitor over the next 2 weeks. I called her for f/u today 5/6. she reports symptoms have continued improving, still present but very mild now and not every day.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: 5 minutes after Covid vaccine administered the patient sttod up alked to drop off said he was feeling ill then passed out and dropped to the ground.  He was unresponsive for approximately 30 seconds to 1 minute.  After that he was alert and talking.  He remembers hitting his head.  Patient was quite pale and sweating.  He sat up against the wall of the drop off.  911 was called immediately after he fainted.  Pharmacist took his BP, 125/90.  Once the paramedics arrived they took vitals, BP 124/80
HIVES RASH; VERTIGO; FLU LIKE SYMPTOMS; FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and non smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 11:50 AM for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced flu like symptoms. On 06-APR-2021, the subject experienced vertigo. On 09-APR-2021 23:30, the subject experienced hives rash. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 05-APR-2021, vertigo on 07-APR-2021, and fatigue on 09-APR-2021, and had not recovered from hives rash. This report was non-serious.
Child received 12 mo immunization on 1/27/03: #31PV, #1MMR< #3 Comvax. Mom repeats increase in temp 102.5 and "red, dry skin rash on his stomach" on 1/28/02. Temp today dropped from 104 to 102. Referred to MD. 1/30 - called mom states she called MD 1/29 instructed her to treat child with Tylenol and Motrin. Was afebrile all day 1/29 but reports fever increased to 102.7 during night. Referred to MD again.
Guillain-Barre Syndrome, neuromuscular/connective/soft tissue complaints c/o muscle weakness. Flu like sx prior to muscle weakness and numbness and tingling 6/20/07-records received from facility for DOS 3/10-3/27/07- DC DX: Guillain-Barre Syndrome. Chief complaint loss of sensation and motor function in extremities. Inability to ejaculate. Presented to hospital on 3/9/07- with 2-3 day complaint of numbness in hands and feet as well as difficulty ambulating. Prior to this he had several weeks of prodromal illness including nausea, headache and fever. On 2/12/07-Fever up to 104 degrees for 1 week. Complained of night sweats, headaches, emesis and nonproductive cough. 3/1/07-complaint of pain in shoulders and hips. Continued to complain of headaches. 3-4 days before admission began having tingling in hands and feet. followed by tingling in groin and perineal region. Decreased sensation while defecating and inability to tell when voiding was complete. PE: decreased distal reflexes in lower extremities. Very mild improvement since treatment with IVG. Requires long term rehabilitation.
Patient presented to clinic for second Pfizer vaccination. The Pfizer vaccination was administered by an MA undiluted.
Child was given both doses of ROTARIX vaccine then 2 mo later hospitalized for positive rotavirus.
At 1 pm on 6/24 woke up from nap with temp of 103.8 F. Mother gave Tylenol to the child at that time and gave child a bath. Child started convulsing one half hour later. Called paramedics. Convulsions occurred off and on for 30 minutes. Mother took child to clinic. No other seizures were noted. Blood and urine testing done. Child diagnosed with Roseola on 6/29/03 by MD.
In bed a lot over the last 6 days; Shakes; Sweating; Vomiting; Huge Headache; Very fatigued; Fever of 103F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), VOMITING (Vomiting) and HEADACHE (Huge Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included No adverse event.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Huge Headache), FATIGUE (Very fatigued), PYREXIA (Fever of 103F) and CHILLS (Chills). On 24-Mar-2021, VOMITING (Vomiting) had resolved. On 30-Mar-2021, BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), HEADACHE (Huge Headache), FATIGUE (Very fatigued), PYREXIA (Fever of 103F) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Second COVID-19 shot is due on 20 Apr 2021. Treatment details included Tylenol.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned an elderly female. Initial information was processed with the additional information received on 29-JUL-2021. 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: unknown) dose was not reported, 1 total, start therapy date was 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 an unspecified date, four months after vaccination, the patient had negative IgM (immunoglobulin M) and negative IgG (immunoglobulin G) (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210760356. This report was associated with product quality complaint: 90000187621.; Sender's Comments: V0:20210761815-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
patient received expired dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Infanrix. On 25-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient received expired dose of Infanrix).  The outcome of the expired vaccine used 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: 26-SEP-2023 The medical assistant reported on that a patient received a dose of Infanrix that had expired which led to expired vaccine used. The reporter enquired should the patient be re vaccinated. The reporter did not consent to follow up.  The vaccine administration facility is the same as primary reporter.
Large welt near shot area. Severe rash spread throughout body. High blood pressure. Minor trouble with breathing and mild urticaria. Given IM, Benadryl/O2.
Fever; CHILLS; Cough; Fatigue; Muscle body ache; Headache; Nausea; Vomiiting; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the right arm on 23Mar2021 at 09:15 (at the age of 29 years) as a single dose for COVID-19 immunisation. The patient's medical history included pre-diabetic and high blood pressure at family medical history. Concomitant medication included ibuprofen (MANUFUTURER UNKNOWN). The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via unspecified route of administration in the right arm on 02Mar2021 at 09:30, as a single dose for COVID-19 immunisation. On 23Mar2021 at 22:00, the patient experienced fever, chills, cough, fatigue, muscle body ache, severe headache, nausea and vomiting. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the adverse event. The clinical outcome of fever, chills, cough, fatigue, muscle body ache, severe headache, nausea and vomiting was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
At 1143 - 17 year old female was sitting with her mom, pt advised staff that she was feeling dizzy. Pt states the room was spinning. Pt was assisted to wheelchair and escorted to designated private patient area. Pt was pale and diaphoretic but was alert and talking to staff, pt was assisted to remove her sweatshirt and assisted to lay down. Pt instantly stated she felt better after laying down. Pt provided wet cloth for comfort and skin color return to WNL . Pt had small sip of water and stated she felt much better. Pt advised she had only eaten two small donut holes and did not drink water prior to arrival at the clinic. Pt skin returned to normal warm and dry, VSS, AOx4 and pt stated she felt much better and was ready to go home. Pt mother will continue to monitor pt and ensure she continues to hydrate and eat after leaving the site.   1145 VS Bp 94/60 HR 51, 16RR 100%   1150 VS Bp 102/64 HR 60, 16RR 98%  1155 VS Bp  102/68 HR 69, 16RR  98%  1200 VS Bp  104/68 HR 73, 16RR 99% sitting
I was sick for about 7-8 days. I had cough, runny nose, fever, body aches, asthma exacerbation. Doctor prescribed a different inhaler which was helpful. Highest fever that I took on thermometer was 101.6.
Info has been received on 7/5/02 from a pharmacist on behalf of an MD concerning a PT who was vax'd w/a 3 dose series of Hep B vax recombinant. Subsequently, 3 wks later, the PT developed "bilateral painless knee effusions." It was reported to be unknown if the PT was an adult or child, however, the PT reportedly was seeing an adult orthopedist. The PT sought unspec'd medical attention. Add'l info has been requested.
Right thigh was reddened, mottled swollen-twice its normal size, hot. Fever was 102.2 orally. All this occurred within 24 hrs.
Patient began to cough, c/o throat pain, difficulty breathing, rash on trunk, wheezing, pulse ox on Room air 93.7. Give SQ epi-nephrine 0.3 ml x 1 (1:1000)
Information has been received from a female patient concerning herself who on 26-APR-2010 was given 3 series of GARDASIL. It was reported that she noticed it was a little swollen and she stated she rubbed her arm to work it and since then she has noticed it was marked-hand and stretched her skin. She stated that she went to doctor's office on 20-MAY-2010. At the time of the report the outcome of the patient was not reported. Additional information has been requested.
(L) arm swollen, red starting about 24 hr after injection, extending from shoulder to mid lower arm, initially tight, improved by the time I saw him, no cellulitis. No fever. Impressive swelling no compartment syndrome.
Information has been received from a father concerning his 12 year old son who was vaccinated with a dose of varicella virus vaccine live. The patient's father reported that his son was diagnosed with autism as he went from talking to not talking for no specific reason. Unspecified medical attention was sought and at the time of this report, the outcome was unknown. The father also reported that his 8 year old son was also diagnosed with autism after being vaccinated with varicella virus vaccine live (WAES0502USA02737). Upon internal review, autism was considered to be an other important medical event (OMIC). No further information is available.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA, expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52F for 95 minutes, 48F for 40 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 13-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006659; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Moderna 1/12/21, 2/5/21, 8/20/21. Positive on 2/1/22
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Ulcerative colitis.    Concurrent medical conditions included Rheumatoid arthritis and Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.   On an unknown date, the patient had COVID. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event of Covid with Adalimumab solution for injection was no reasonable possibility. The reporter's causality for the event of Covid with Moderna COVID-19 vaccine (Elasomeran) was reasonable possibility.  No treatment details were reported.
Fever and constant crying post vaccine, lasting 48 hrs. Test run all normal. 2/22/01 UC pending.
Redness no pain at site. On exam 6x6 cm tender blanchable, erythema was noted over left deltoid. DX: cellulitis. Treatment: Keflex x 10 days.
experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach; hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach) and PRURITUS (hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 012A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 16-Nov-2021, the patient experienced URTICARIA (experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach) and PRURITUS (hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (experience hives on a daily basis/ which were all over her back, neck, arm, legs, and stomach) and PRURITUS (hives are itchy and last anywhere from 45 minutes to a few hours before moving to a different location) outcome was unknown.            No relevant concomitant medications were reported.  9-10 days after receiving the booster dose of the vaccine, patients symptoms started.