chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to clinic on 4/18/23 for physical and to update  immunizations . Provider documented that immunization record was reviewed and after discussing with pt, it was recommended to start the HPV series to which the pt agreed. Pt was alone at visit. Pt's mother later contacted clinic via Patient portal, on 4/20/23 with a copy of an immunization record showing that pt had previously completed the HPV series with dates 11/24/15, 2/15/16, and 6/7/16, making the 4/18/23 dose, the 4th dose.
Right kidney feels like its getting swelling (bigger) more than left; Right bother me a lot/ felt something in kidneys after two days; A spontaneous report was received from a consumer concerning (himself), a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right kidney feels like its getting swelling (bigger) more than left and right bother me a lot/ felt something in kidneys after two days (Hydronephrosis and Renal pain).   The consumer's medical history was not provided.   Relevant concomitant medication was reported as esomeprazole sodium (nexium).  On 28-FEB-2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 02-MAR-2021, the consumer experienced the events right kidney feels like it was getting swelled (bigger) more than left and right bother him  a lot/ felt something in kidneys after two days.  No treatment information for the events was provided.   Action taken with mRNA-1273 in response to the event s was unknown.  On an unknown date, the outcome of events, events right kidney feels like it was getting swelled (bigger) more than left and right bother him  a lot/ felt something in kidneys after two days was resolved.; Reporter's Comments: This case concerns an 83 Y/O M with serious unexpected events of hydronephrosis and nonserious unexpected renal pain. Event onset 6 days after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Information regarding influenza virus vaccine (manufacturer unknown) was received from a consumer regarding a 50 year old female patient who experienced symptoms of a head cold with a runny nose and nasal congestion.  The patient received a dose on an unspecified date in 2002.  No additional information was available at the date of this report.
On 5/19/09 when making a follow-up call to patient, the patient reported: Approx. 6 hours after receiving vaccine,  she felt "bronchitis-type" symptoms: hoarse throat, cough. About 6 hours after this she experienced generalized itchiness and has had worse sleep quality at night since then. No medical attention sought. Has taken benadryl with some relief of itching, but voice is still quite hoarse. Felt a little better 9/19/09 than during the previous day. Called pt. today at 9:07 a.m., she stated she feels a little better than she did yesterday. Voice is clearer than yesterday.
On the day of the H1N1 injection, pain and bruising began. For the past eight days, the bruise has enlarged, and is now about a 3 inch circle. The site is very sore and hard. The pain also radiates down to my left hand and up to my left shoulder. The left arm feels shaky and weak.
Difficulty breathing 5 minutes after receiving first dose of Covid-19 vaccine by Pfizer/BioNTech, small erythematous spots to bilateral arms.
11-09-2011 - Pain in RUQ. 12-08-2011 - Seen Dr for pain in RUQ, shoulder, back, neck, ear, head (gave me a prescription for an anti-inflammatory. 1-18-2012 - Seen primary Dr. for my symptoms. He sent me to physiatrist. 1-23-2012 He put me on TRILEPTAL, went off medication & I am now taking it again for the pain. I also took PI before going to physiatrist.
Headache onset within 10 min of receiving shot, lasted all day. Vertigo for 48+ hrs (currently still experiencing it)
3 to 4 hours after administration child developed swelling of the eyes and a blotchy rash throughout her body.  Went to the ER where she was given Benadryl and the rash and symptoms subsided.  3 days later child stopped eating.  Was seen in my office 3 days later for persistently not eating well.  Was found to be rejecting the bottle.  Went to the hospital and was admitted for work-up.  Was found to have swelling of her tonsils and lymph nodes on the left side.  Symptoms resolved and child started eating again.
Four hours after shot I came down with it. Took 6 weeks to get back on my feet.
After 7 days of no symptoms (other than a sore arm on day 2), I suddenly experienced extreme itchiness at the injection site and has a large, firm welt about 2 inches in diameter that appear inflamed and white. This lasted for 2 days. I reported it to my employee health department at Hospital and the triage nurse did not seemed concerned but recommended I go to urgent care if I felt that I needed to be seen (which I did not). I asked if anyone might follow up with me and she did not seem to think it was necessary.
felt off and weak; Flushed; heart rate went up; whole body started shaking; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed), HEART RATE INCREASED (heart rate went up), TREMOR (whole body started shaking) and ASTHENIA (felt off and weak) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING (Flushed), HEART RATE INCREASED (heart rate went up) and TREMOR (whole body started shaking). On 15-Jan-2021, the patient experienced ASTHENIA (felt off and weak). On 14-Jan-2021, FLUSHING (Flushed), HEART RATE INCREASED (heart rate went up) and TREMOR (whole body started shaking) had resolved. On 15-Jan-2021, ASTHENIA (felt off and weak) had 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.   She was not treated any medication, rather she was given some juice.   Reporter did not allow further contact
I had a skin rash, hives all over my body about 7 days after the first dose of Moderna. It went away with 3 days.
Acute pericarditis without pericardial effusion. Presented with approx 48 hrs of chest pain relieved by NSAIDs. Acute pericarditis on EKG, normal labs and echo.
2nd dose - documentation says 1mL adminsitered; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (2nd dose - documentation says 1mL adminsitered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 29-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (2nd dose - documentation says 1mL adminsitered). At the time of the report, ACCIDENTAL OVERDOSE (2nd dose - documentation says 1mL adminsitered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. It was reported that on 29 March 2021 patient had 2nd dose of 0.5mL for which documentation says 1 mL administered. No treatment details were reported.   This case was linked to MOD-2022-532364, MOD-2022-532418 (Patient Link).
Covid vaccine #1 given 2/9/2021 Moderna, lot # n/a patient died in the hospital from COPD, failure to thrive, not a covid infection
3 adults received booster doses from the monovalent pediatric primary series; doses were administered beyond 30-day use by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series), EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and NO ADVERSE EVENT (no adverse event) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series), EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series), EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (3 adults received booster doses from the monovalent pediatric primary series) and EXPIRED PRODUCT ADMINISTERED (doses were administered beyond 30-day use by date).    No concomitant medication was reported. No treatment medication was reported.
she was running a low grade fever 2 days after; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Unknown, Batch/Lot number: Unknown), via an unspecified route of administration on 30Jan2021 as a, 1st dose single for covid-19 immunization. The patient's Medical History and concomitant medications were not reported. Patient reported that she received the 1st dose of the vaccine last Saturday morning and experienced no side effects other than she thought she was running a low-grade fever 2 days after on 01Feb2021. The Outcome event was unknown.  Follow-up attempts are completed. No further information is expected.
ACUTE PULMONARY EMBOLISM 9/29/2021 CKD STAGE 3A (GFR 45-59)
Pt given varicella vaccine on 9/27/11. Approximately one week after vaccine, pt contracted moderate to severe case of varicella disease.
Patient is 36, Female DOB: 08/24/1984; Allergies: Penicillin (rash), Zinc (bloating). Received Moderna Vaccine at 11:45 am Right Deltoid. Observed for 15 mins. At that time, inmate stated she was having blurred vision. Inmate to be observed for 15 mins more, but at 12:07pm, inmate states to have scratchy throat along with blurred vision and now black specs aka floaters. Manual BP: 128/80 HR 88 inmate noted to have a slight tremble and blotchy bilateral upper arms. Inmate was assessed by RN; no resp. distress noted, no hives, lungs clear, bronchial sounds clear, no stridor noted. Inmate was moved to medical room laid in supine position with feet elevated. Manual BP 120/75 HR 108 inmate states to still have scratchy tight throat and blurred vision with floaters. @12:16pm Dr. called, and orders received per standing orders to give the inmate Diphenhydramine and then monitor inmate for 30mins more. @12:30pm manual BP 140/90 HR WNL. @12:34pm 50mg Diphenhydramine IM given to Left Deltoid. @12:50pm BP 143/103 HR 95. @ 1:10pm BP 163/95 HR 92. Inmate states to still have scratchy throat and blurred vision is worse with bigger floaters. @ 1:16pm Dr. called again to update, and orders given to follow through with  standing orders and send inmate to the ER via EMS. @1:28p, 911 was called and around @1:50pm EMS arrived and patient was taken to ER for further evaluation. Entire process was explained to patient.
Gave patient his shot, told him to stick around for 15 minutes, after about 5 minutes he came up to the counter very pale and sweating, I brought him into the consultation room to sit down and gave him water. After about 20 minutes he was okay to leave, he walked here so I asked him to get someone to pick him up, his mom came to pick him up. I tried to call later that day to check on him but no answer
Tingling  and numbness around mouth Fever Chills Aches Nausea
Tachycardia beginning three hours after injection, lasting 3-4 hours intermittently then constant for 2-3 hours. Resting heart rate measured at up to 120 BPM, sometimes lower. Frequent stools with urgency. Elevated baseline temperature. Chills.  Very dry mouth. nausea. Loss of appetite.   24 hours after injection, tachycardia resumed for 3 hours, constant, resting heart rate measured at 110 BPM. Pain at injection site began.   Tachycardia stopped and temperature returned to baseline 27 hours after injection. Pain at injection site resumed with no other symptoms until about 48 hours after.
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. This case is reported for 3rd patient out of 20 patients. No treatment information was provided.
No adverse event, but vaccine was found to be expired. Removed from freezer on 7.20.2021 expired on 8.20.2021 and given on 8.24.2021.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, medical history, drug reactions or allergies provided. On 15-DEC-2016, the patient was vaccinated with GARDASIL 9 injection, intramuscularly, lot # M005714, expiration date: 03-OCT-2017 (dose was not reported) which was improperly-stored. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of loss of consciousness in a 41-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). Concomitant products included MOBIC and TOPAMAX. On 16th November 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 16th November 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced loss of consciousness (serious criteria hospitalization, disability, GSK medically significant, life threatening and other: As per reporter). On an unknown date, the outcome of the loss of consciousness was recovering/resolving. The reporter considered the loss of consciousness to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by GlaxoSmithKline Nurse Practitioner (NP). The patient received FLULAVAL QUADRIVALENT in the right arm. The patient was taken from the GSK vaccine administration site by emergency medical room (EMS) and was hospitalized for three days. The nurse practitioner reported that the patient stated that the physician at the hospital said that the loss of consciousness was related to the FLULAVAL QUADRIVALENT.    This case was reported by a nurse via call center representative and described the occurrence of loss of consciousness in a 41-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). Concomitant products included MOBIC and TOPAMAX. On 16th November 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 16th November 2016, less than a day after receiving of FLULAVAL QUADRIVALENT, the patient experienced loss of consciousness (serious criteria hospitalization, disability, GSK medically significant, life threatening and other: As per reporter). On an unknown date, the outcome of the loss of consciousness was recovering/resolving. The reporter considered the loss of consciousness to be possibly related to of FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was reported by GlaxoSmithKline Nurse Practitioner (NP). The patient received FLULAVAL QUADRIVALENT in the right arm. The patient was taken from the GSK vaccine administration site by emergency medical room (EMS) and was hospitalized for three days. The nurse practitioner reported that the patient stated that the physician at the hospital said that the loss of consciousness was related to the FLULAVAL QUADRIVALENT.
Patient reported to RN on date of receipt feeling "odd" but denied specific symptoms when questioned re: shortness of breath, itchiness, etc. Patient then reported on 10/23/23 having had chest tightness/pressure and shortness of breath since the vaccination that caused him to see the doctor and visit the ER. The ER doctor referred patient to a cardiologist. Medical workup is ongoing.
She got her vaccine, she fell asleep.  At around 3:30-4:00 AM they heard knocking and it was her, she was trying to get their attention, she could not talk, her heart was racing, and was throwing up.  They rushed her to the hospital to  Hospital.  At the hospital her heart rate was over 130, fever of 102.  Before they could do anything they had to break her fever, gave her Ibuprofen and fluids.  She could not leave until her heart rate was under 100.  It finally went to 97 after 4-5 hours.  She came home and slept even up until the next day.  She seems to be OK now, but mother is watching her carefully.  She is to see her PCP for FU.   They did a respiratory panel on her, blood work and everything was negative.  She is not running fever and seems to be OK now.  She was told to continue to take the Ibuprofen.
On exactly day 8 since the shot, my left upper part of my arm was swelling, was hot, and a bit hard.  It was like I was having an allergic reaction.   It's at least the size of my hand.  No other symptoms are occurring.
No adverse event; Expired vaccine ROTATEQ administered to patient.; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, and previous drugs reactions and allergies were not reported.  On 21-JAN-2021, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), by oral route, lot # S012679, expiration date reported as 17-JAN-2021, but upon internal validation established as 07-JAN-2021; for prophylaxis (expired product administered). Additionally, the vaccine did not experience a temperature excursion. No adverse event.    The outcome of expired product administered and no adverse event was unknown.
The immediate reactions to both Covid vaccinations were a sore arm. However, after I injected my Aimovig dose on April 8, I had an injection site swelling of about 5 mm with itching, which never happened over the previous year of taking this medication. Then, on April 17, I got a Tetanus (Tdap) vaccination and got the same exact type of injection site reaction, which I never got previously. Both of these reactions did not get any worse and went away within a couple of days. I assume this reaction was due to a heightened immune system response, especially while in the middle of a hives outbreak (which is being conrolled with antihistamines). Although this was a mild reaction, I think it is worth noting.
Chest area itching and burning. Used eucerin cream. no relief. Skin lesion on right hand  2mm red itchy irritated. hydrocortisone applied no relief.
Two different kinds of eczema; itchy blisters on feet and hands, spots on torso that got worse with each subsequent shot. Eczema appeared on torso when he was about 2-4 weeks old. Took to pcp who then told us to go to a dermatologist. Dermatologist did a bacteria culture, prescribed an oral (amoxicillin) and a topical (mupirocin) antibiotic, an antifungal and later a sulphur based antibiotic as they thought it was impetigo. All of this within the first six months of life.
I had a feeling that something was in my throat, and it would make me cough. It continued for a while and was very persistent, I decided to make an appointment with my doctor to find out what could possibly be causing this cough to go on for so long. The doctor ordered a chest x-ray that showed I had nodules in my lungs. He then ordered a CT scan that I had on October 19, 2022, that showed I had clusters of nodules with inflammation. I had two more CT scans that also showed that I have the nodules with inflammation. Each CT scan shows the clusters as either bigger or smaller clusters they are never gone just the size is different.
She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; did get the second dose after hospitalization/so she got her second dose yesterday, 05May2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported for a 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8736, Expiration Date: Jul2021, NDC not known), via an unspecified route of administration on 05May2021 16:00 as 2ND DOSE, SINGLE (age at vaccination: 73 years) for covid-19 immunisation. The patient's medical history included breast cancer, ongoing thyroid disorder, ongoing lung issues, cough, headache, tiredness, sickness from 01Feb2021 (Tested positive for the Covid 19 virus on 03Feb2021. The caller's wife started having symptoms. She had a cough, headache, sinus issues and tiredness.), bronchitis (Gets bronchitis easy). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021, Lot number: EL3246, 1ST DOSE for covid-19 immunisation and had feels like she has a lot of weight on her chest, sinus issues on 01Feb2021 and tested positive for the Covid 19 virus on 03Feb2021. On 05May2021, the patient did get the second dose after hospitalization. She is still having weakness, coughing, and breathing issues. The patient underwent lab test and procedures included COVID-19 virus test positive on 03Feb2021 and Chest X-ray on an unknown date had unknown result. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.