chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Acute hypoxic respiratory failure - Presented with: cough with productive sputum and headache - Symptom onset: 12/3/22 - Positive COVID-19: 12/6/22 at home - Vaccination status: Vaccinated with Pfizer with last dose 1/25/21 - CXR on admission showed without acute process - Oxygen status:Room air  - Decadron: Yes. Expected end date 12/18/22 - Remdesivir: Yes. Expected end date 12/13/22 (Note that patient has been on D2 of Molnupiravir and last dose was 6 am today) - DVT prophylaxis:Currently on full anticoagulation - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No  - encourage pulm toilet with IS, acapella and activity.     Headache -Secondary to persistent coughing and COVID viral syndrome -CTA of the head and neck demonstrated no acute abnormalities.  There was a calcified plaque at the bilateral carotid bifurcations. -Patient has no history of neurological deficits -Headache has improved after given pain meds -Patient will continue with home Pradaxa - resolved    Permanent atrial fibrillation -EKG demonstrated atrial fibrillation at a controlled rate -Continue with Pradaxa -Not on any rate control meds  Essential hypertension -Patient continue with home Cozaar 100 mg daily
Information has been received from an office manager who was the mother of an 18 year old female patient with an unspecified auto immune disorder who in approximately February 2007 was vaccinated with a dose of HPV. The patient developed a "huge" red circle a few inches in diameter on her arm where she was vaccinated. There was a "lot" of swelling and the patient put ice on it all week. Medical attention was sought. The patient was recovering as of the report date. No further information is available.
A non-serious spontaneous report of FLUMIST administration to pregnant female was received from a physician concerning a 27-year-old female patient. On 26-Dec-2008, FLUMIST was administered by mistake to the patient who was 16 weeks pregnant. There was no adverse event associated with this FLUMIST exposure to a pregnant female as of 13-Feb-2009. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Stomach Pain; Difficulty Eating; Uncomfortable; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain), FEEDING DISORDER (Difficulty Eating) and DISCOMFORT (Uncomfortable) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain), FEEDING DISORDER (Difficulty Eating) and DISCOMFORT (Uncomfortable). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain), FEEDING DISORDER (Difficulty Eating) and DISCOMFORT (Uncomfortable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Upon internal review on 27-Sep-2022 case level seriousness was updated. On 03-May-2021: Live follow-up added; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Rash and inflammation the size of a tennis ball manifested 4 inches below site of injection.
received vaccine and approximately 12 hours later large amount of swelling in right armpit- same side as injection.  this swelling was painful and persisted for 72 hours with the large amount of swelling, and now is a small amount and much less painful
This spontaneous report as received from a physician refers to a 17 years old non-pregnant female patient with depression, anxiety and migraine and no drug reactions or allergies. The patient was vaccinated with GARDASIL on 14-NOV-2012 (dose, route, site of administration and lot # not reported). No other co-suspects were reported. Concomitant medications included citalopram, trazodone and propranolol. On 14-NOV-2012, the patient experienced small palpable nodule at injection site that was still painful at the reporting date. The physician also noted mild discolouration at site. NO treatment was given. There was no laboratory diagnostics performed. The patient did not seek medical attention. The relatedness for small palpable nodule at injection site that was still painful and mild discolouration at site was not reported for GARDASIL. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Lot number: ER2613, Expiration Date: Dec2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "Minor bleeding". No follow-up attempts possible. No further information expected.
Woke up with rash on arms, front of torso, posterior upper Leg Present on knees and elbows C/O itching - states looks and feels like mosquito Bites
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SLEEP APNEA HYPOTENSION ACUTE PULMONARY EMBOLISM ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Left thigh swollen, warm to touch one day after receiving PENTACEL , ENGERIX-B - same leg.
Woke up 12/15 feeling not well. Sore throat, headache, and fatigue. Tested negative on at home COVID-19 test. Symptoms continued and added mild fever. Tested positive on 12/18 and called PCP. Was prescribed PAXLOVID and began to see an improvement in symptoms on 12/20. Symptoms have improved each day while on medication.
Patient called on 10/26/11 and stated that she developed a sore two weeks after receiving the flu vaccine. The sore did not resolve and now she has difficulty raising that hand. She informed Dr. so did I. patient said that she took ALEVE, 1 tablet 2 times daily for 1 week but still have the problem.
This spontaneous report was received from a Pharmacist, concerning an approximately 22 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2010, the patient was vaccinated with a dose of GARDASIL, for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The pharmacist reported that on an unknown date in 2014, the patient received another dose of GARDASIL. No adverse effects were reported and product quality complaint was involved.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 06/14/2021 and 07/01/2021. Presented to ED on 1/5/2022 with c/o body aches, cough, and HA since 12/29/2021 but left AMA. Presented to ED again on 1/14/2022 with c/o chest pain and was found to have elevated serial troponins as well as R perihilar pneumonia, transferred to Med Cntr. Admitted for NSTEMI and COVID-19 PNA. Morning of 1/18/2022 had a witnessed collapse where she was hypoxic and unresponsive. Head CT demonstrated large ischemic infarct of the left MCA and smaller stroke in right MCA. Shortly after midnight the patient became asystolic and CPR was initiated, however ROSC was not achieved and patient was pronounced.
4 MO recieved Flulaval QIV; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 02-Dec-2022 Reporter's Comment: The reporter reported that a 4 month old patient received Flulaval QIV . The reporter information was sent by email to team. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that a 4 month old patient received Flulaval QIV, which led to inappropriate age at vaccine administration.
pt recvd vax & awakened w/ fatigue; malaise; midnite severe headache;no fever; n; cold sweats; apap relieved headache;
today I am having dizzy spells; I have chills all night; This case was reported by a consumer and described the occurrence of chills in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (for tolerance to the 1st dose, refer case US2020AMR045702).   On 11th March 2020, the patient received the 2nd dose of Shingrix. On 12th March 2020, 1 days after receiving Shingrix, the patient experienced dizzy spells. In March 2020, the patient experienced chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills was unknown and the outcome of the dizzy spells was not recovered/not resolved.   It was unknown if the reporter considered the chills and dizzy spells to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix late morning and was fine all day and had chills all night. On the day of reporting, the patient had dizzy spells and wanted to know was this normal.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Immediately after I gave her the injection I looked at her face and her eyes rolled up and her pupils were dilated and I said to her Are You OK and that was when her head fell back and and it hit the back of the wall.  I looked at the top of her head and it was red and she was sweating.  Patient was still sitting and we called 911. Paramedics came and checked her out.  She became aware and responsive within minutes.  She stayed about 30 min.
Very red arm, Tender, burning, clavicle lymph nodes swollen, "baseball" lump under arm, feverish.
On July 19th, 2021, patient received both shingrix and moderna. He then tested positive for covid on Wednesday the 21st . He developed a rash on his back and sides with painful blisters like shingles.
The first night he did not feel good, body ache The second day he still felt even worst and it continued until  the 5th day he had more body ache and head ache and his back ache was very bad but now he had low grade fever the 6th day he had fever and his body ache, head ache and back ache were worse. Fever now was 100.2 FH, He had Nausea  the 7th day he had a little less body ache, head ache and back ache no fever and it continues until now the 11th day
The pharmacy student that was working administered the vaccine. Less than 30 seconds after administration, bruising/swelling occurred. The bruise was marble-sized under the skin. I had the patient wait for at least 15 minutes so I could monitor her. During this time period, she felt fine and was not concerned. I think upon injection the pharmacy student hit a capillary or vessel causing the immediate bruising and swelling. About 4 hours after the patient left, I gave her a call to check on her. She stated that the swelling had gone down and her arm felt fine and similar to other post-vaccination periods.
Polyarthralgias, rash 24 hours post injection.  Tx'd with PREDNISONE - developed fever & myalgias - After 1 wk resolved except left wrist pain.
5 minutes after injection my tinnitus started ringing loud. Approx 20 years ago I had steroidal eye drops that set off raging tinnitus that only allowed  me to sleep 20 minutes at a time. Discussion of cutting acoustic nerve even had but couldn?t guarantee would decrease tinnitus. Found alternative doctor that able to turn it down with alternative treatments whereas convention med had only Valium to offer. I cannot risk it getting louder yet again with the second shot.
No additional AE.; Nurse requested an Expired/ Administered ROTATEQ Evaluation / Patient was administered Expired ROTATEQ; This spontaneous report was received from a licensed practical nurse via company representative referring to a 3-month-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 19-APR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot number 1660957 and expiration date of 07-APR-2021 for prophylaxis (dose was not reported).   Separate single dose tubes from the same lot number and expiration date were administered to separate patients at 9:30AM, and then at 10:30AM, on the same date. The nurse was not able to confirm corresponding patient to administration time. No additional adverse event. The nurse requested an expired / administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) evaluation.
Patient took all four doses of Vivotif at once; Stomach upset; Mild symptoms; A spontaneous report was received on 02JUN2021 from a physician.  The physician reported that a patient (gender/age) took all four doses of Vivotif (Typhoid vaccine live oral Ty21A) at once (PT: Inappropriate schedule of product administration). The physician stated that he does not know if the patient experienced any adverse events after taking all the four doses at once. Additionally he has not reached out to the patient yet.   On 09JUN2021, follow up was received from the physician:  Patient demographics, concomitant medications, date of administration and additional adverse events were reported.  It was reported that a 70 year old patient took all four doses of Vivotif on an unknown date in 2018OCT. The patient experienced mild symptoms (PT: Adverse event following immunization) including stomach upset (PT: Abdominal discomfort) which was temporary. At the time of this report, the outcome for the events mild symptoms including stomach upset were reported as resolved. Concomitant medications included Nasonex (mometasone furoate) and aspirin.   No additional information was available at the time of report.   Company Comment: A physician reported that a 70 year old patient (unspecified gender) took all four doses of Vivotif at once on an unknown date in 2018OCT. The patient experienced mild symptoms (PT: Adverse event following immunization) including stomach upset (PT: Abdominal discomfort) which was temporary. At the time of this report, the outcome for the events mild symptoms including stomach upset were reported as resolved. Concomitant medications included Nasonex (mometasone furoate) and aspirin. The reported events of stomach upset and mild symptoms is plausible with Vivotif, however, they are unlisted, these events might have occurred as a result of comorbid conditions (unknown medical history) and/or aspirin intake.  The case is considered non-serious as per medical assessment and case information. There is no change to risk-benefit profile of Vivotif.; Sender's Comments: Company Comment: A physician reported that a 70 year old patient (unspecified gender) took all four doses of Vivotif at once on an unknown date in 2018OCT. The patient experienced mild symptoms (PT: Adverse event following immunization) including stomach upset (PT: Abdominal discomfort) which was temporary. At the time of this report, the outcome for the events mild symptoms including stomach upset were reported as resolved. Concomitant medications included Nasonex (mometasone furoate) and aspirin. The reported events of stomach upset and mild symptoms is plausible with Vivotif, however, they are unlisted, these events might have occurred as a result of comorbid conditions (unknown medical history) and/or aspirin intake.  The case is considered non-serious as per medical assessment and case information. There is no change to risk-benefit profile of Vivotif.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 02-AUG-2017, a 36 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008716: US-009507513-1710USA008717.
This spontaneous report was received from a consumer via Pfizer referring to herself as a 66 year old female. The patient's current condition included osteoporosis. The patient had breast cancer in 2016. On unknown dates in 2016, the patient had 2 surgeries for breast cancer and got recovered in 2016. On an unknown date, the patient received PREVNAR. The patient's concomitant medications included FOSAMAX 70 mg once weekly via oral route for osteoporosis. On March 2017 at 13:00, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, route of administration were unknown) in the arm for prophylaxis, which was stored in an inappropriate temperature. The patient did not have any adverse events. The outcome of product storage error and no adverse event was unknown.
100 deg F Feever, Vomiting, Headache, Tiredness, Hoarseness, Heavy Congestion, Body Aches. 12-07-07 had a yearly physical also T-dao shot and Meningococcal Vaccine at 4:30 by 8:00 Symptoms started to occur seen by doctor Sunday. Also called Doctor Saturday. Somewhat Still Congested
No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date).    No Concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Live non significant follow up- patient name update
Diarrhea, Body aches, Nausea, Headache, Injection site pain
pt recvd 3 doses of Engerix-B & was found to be a non-responder;
employee received the 2nd dose of the Moderna Covid-19 Vaccine on day 12; A spontaneous report was received from a HCP concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient received the 2nd dose of the Moderna's COVID-19 Vaccine on day 12 instead of the usually 24-24days interval between the 1st and 2nd doses.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event of inappropriate schedule of vaccine administration was recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration  without any associated adverse events.
Redness and swelling at vaccine site and shoulder    Swollen glands same side 7 days after dose   10 days later reduced redness after administering cold compresses and taking Advil and Benadryl