chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eye Swelling; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye Swelling) and ABDOMINAL PAIN UPPER (Stomach ache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye Swelling) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, EYE SWELLING (Eye Swelling) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient reported arm red and swollen and pain to touch at area of injection on arm. Patient also reported breathing difficulty previous night. Due to breathing issue told patient to seek immediate care. Also advised patient to use antihistamine and ice packs at site of injection. Also counseled to use ibuprofen for inflammation. I will follow up with patient next day.
The nurse that injected me for the second shot did not place a sticker on the CDC vaccination record card.  I did not notice that until I filled out this form.
This spontaneous report was received from a physician via company representatives and refers to patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 07-AUG-2014, the patient was vaccinated with 0.5 ml dose of PNEUMOVAX 23 "10 single DS 0.5 ml LVis 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccines was improperly stored exposed to temperature excursion for a sum of 48 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), single dose, for COVID-19 immunisation. Medical history included migraine sufferer (unspecified if ongoing). The patient's concomitant medications not reported. The patient had a rash, fatigue/lot of fatigue and migraine (migraine; "I'm a migraine sufferer but it threw me straight into a headache"), with outcome of unknown. Additional information: Patient was fine after the vaccination and fine for 24 hours thereafter. The pharmacist said "if you are going to have a reaction, would happen 24 hours after." After the first shot, patient had a lot of fatigue and got a migraine. Patient was a migraine sufferer. It went straight into a headache. Then yesterday a rash popped up all over their body and had fatigue. The rash persisted for a full 24 hours now. The only thing that seems to be kind of keeping this under control was Benadryl treatment. Follow-up (Sep 10, 2021): Follow-up attempts  completed. No further information expected.
The patient reported that they were experiencing tightness in their arm and believed it swelled initially. They left the pharmacy area and went to get Tylenol that was recommended by the pharmacist. They then began to get lightheaded and had syncope, attempted to get back up and the cashier asked to if they wanted to sit, but fell again. It was not clear initially to the employee who was helping them they had received the vaccine. 911 was called and the employee helping them let the pharmacist know they had just gotten their vaccine. The immunizing pharmacist went to check on the patient. EMTs were already helping the patient and had taken his blood pressure which was normal the lightheadedness had stopped and both sitting and standing blood pressure was the same. He had an elevated heart rate per the patient but didn't know any of the numbers the EMTs had taken. His father was driving him. He was not experiencing any symptoms and the injection site had no swelling and was otherwise unremarkable.
3-4 bouts of nasty diarrhea the past 3 days, intermittent chills, swelling of lymph nodes, temp 99.1-99.5...
BACK PAIN; CHILLS; HEADACHE; SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and  has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced back pain, chills, headache, and soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, back pain, headache and soreness at the injection site was not reported. This report was non-serious.
pt recv vax 1OCT97 & w/in 2min of vax pt exp a sz (jaw tight, eyes rolled back, ashen colored, incontinent) for a duration of approx 2min;@ 5min p/vax pt became conscious & aware of name;pt taken to ER & reported vomited;hosp 2 days
Approximately two weeks after receiving the second dose I began to notice abdominal pain that worsened when breathing or laying down. The pain became more severe over the course of the next few days that I admitted myself to the emergency room of the  Hospital. A CT scan showed a pulmonary embolism located in my lower right-hand lung, which would have killed me if left untreated. I was admitted to the hospital and treated for pain and given intravenous blood thinners for 3-4 days. I was discharged with orders to follow up with a pulmonologist, cardiologist, and PCP. I was unable to schedule visits with the specialists due to financial constraints. After leaving the hospital my condition began to improve and has continued to improve since. As I understand it, the tissue in my lung may never heal and as a result i suffer diminished lung capacity.
redness at injection site; pain at injection site.; muscle pain all over body; She had to lower head between knees and deep breath for a few minutes; felt as if she were about to faint(almost fainted); felt blood rushing out of head; sweating; pain in arm and hand; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 5th October 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). On 5th October 2021, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced head discomfort, sweating, difficulty breathing and presyncope. On 6th October 2021, the patient experienced injection site erythema, injection site pain and generalized muscle aches. In October 2021, the patient experienced pain in hand. On an unknown date, the outcome of the injection site erythema, head discomfort, sweating, pain in hand, generalized muscle aches and presyncope were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the difficulty breathing was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, head discomfort, sweating, pain in hand, generalized muscle aches, difficulty breathing and presyncope to be related to Shingrix. It was unknown if the reporter considered the head discomfort, sweating, pain in hand, generalized muscle aches, difficulty breathing and presyncope to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by patient herself. The patient received dose 1 of Shingrix in left arm and high dose Flu vaccine in right arm on same day. The patient received the flu shot first with no issues and then received Shingrix in left arm and within seconds felt the blood rush out of her head.  The patient was sweating, she felt as if she was about to faint.  She had to lower head between knees and deep breath for a few minutes.  She also mentioned the next day she had redness, and pain at the injection site (left arm) where she had the Shingrix shot.  The patient still had some pain in arm since then.  The patient had muscle pain all over body and less than 3 weeks after vaccination, had pain in hand.  The reporter did not consent to follow-up.
Urinary tract infection; This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced urinary tract infection. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated she was currently on an antibiotic for Urinary tract infection.   The patient was asking if she could get second dose of Shingrix. No other information was provided.  The reporter did not consent to follow up.
Patient is experiencing deep pain in torso after receiving moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Patient is experiencing deep pain in torso after receiving moderna vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Patient is experiencing deep pain in torso after receiving moderna vaccine.). At the time of the report, PAIN (Patient is experiencing deep pain in torso after receiving moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Patient developed fever on May 15, 2011. Mother of patient reports temperature of 104.7F axillary. Mother of patient reports she gave a dose of Tylenol and took patient to the ER on May 15, 2011. At the ER, the doctor did a chest xray and drew blood. The doctor also gave Motrin. The ER doctor released the patient after three hours and advised to see family doctor in 24hrs.
10:05am injection of moderna covid vaccine into left arm 1010am- started with tingling of left fingers 10:15 tingling increasing up arm, pressure feeling on left side of head and tongue 10:20am tongue feeling numb on left side 10:21am Benadryl 50 mg given PO Liquid 1030am Cetirizine 10 mg tablet given PO Physician observation for 30 minutes, symptoms resolved, still felt groggy, sent home
Initial report received from a nurse practitioner on 28 April 2011. A 39-year-old female patient had received a first intramuscular right deltoid injection of MENACTRA (lot number U3709AA), and a first subcutaneous left deltoid injection of YF-VAX (lot number UF804AA) on 25 April 2011. Two days later, the patient reported to the nurse practitioner that she had a 2 inch induration on the right arm at the injection site where MENACTRA was administered, and she had flu-like symptoms with body aches, fever, and fatigue. The next day she had additional symptom of cough. It was not reported whether the patient required medical attention. The patient has no known allergies, and had no concurrent illnesses or use of other medications at the time of vaccinations. At the time of this report, the patient had not recovered. Documents held by sender: None.
Myalgia, Arthralgia, fatigue Narrative:  Other Relevant History:
Moderna COVID-19 Vaccine EUA - On Sept.15, I was given the injection, and felt nothing!  No needle pick, nothing. Felt fine the rest of the night.  Got up twice during the night to use the bathroom and get a drink of water, as I read to stay HYDRATED!  Awoke at 7:00 a.m. Sept. 16, and was feeling weak, fatigued, nauseous (had the dry heaves off and on until 9:00 a.m.) with chills and sweats, achy joints, dull headache and just overall, terrible!  I went back to bed and slept until 2:00 p.m.  Upon getting up, I knew I needed to get fluids in my body so I drank a 16 ounce bottle of water with a packet of Emergen-C dissolved in it.  This helped to jump start my electrolytes and from then until bedtime, I consumed a total of 64 ounces of water.  At dinner time (evening meal) I had a bowl of Lipton chicken noodle soup and 5 soda crackers.  This was the only meal I had all day.   I slept well that night, but woke up with a dull headache on Friday, Sept. 17th.  I still didn't have an appetite, so I didn't take any pills that day, either.  I did have a cup of coffee and a small portion of cottage cheese and sliced peaches.   I guess I did take Tylenol on the night of Sept. 16th.  I had a low grade temp of 99.4 on the 17th.
This spontaneous report has been received from a pharmacist via a company field representative referring to a 72 year old male patient. Information about pertinent medical history was not reported. The patient had no drug reactions/allergies. The concomitant medication included Blood pressure medication, Vitamin D, Acid Reflux medication, Benign Prostatic Hyperplasia (BPH) medication. On an unknown date (reported as several weeks ago), the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (route, lot # and expiration date were unknown). On an unknown date, shortly after vaccination, the patient experienced swelling, irritation, and tenderness in an unspecified arm and down to the elbow. No lab diagnostics studies were performed. At the time of the report, the outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was unknown.
No known adverse effects; a patient received an expired dose of PROQUAD; Information has been received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent condition and concomitant medication were not reported.   On 26-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose unknown; lot # N029155 with expiration date 16-APR-2019 ) subcutaneously for prophylaxis.  No known adverse effects were reported.
UTI; Blood in urine; This is a spontaneous report from a contactable Pharmacist. This reporter reported 2 reports for similar event; this is the second of 2 reports. A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced urinary tract infection (UTI) and blood in urine on an unspecified date. Seriousness for events was hospitalization. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the known properties and safety profile of suspect product, there is no evidence or argument to suggest a causal relationship between the events 'urinary tract infection' and 'blood in urine' and the vaccine bnt162b2.  Events most likely represent intercurrent medical conditions. This case will be re-assessed if additional information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021130811 same reporter/drug, different patient;US-PFIZER INC-2021130811 same reporter/drug, different patient, similar event
Patient came in for Shingrix vaccination and was given COVID19 vaccination on accident. Patient had completed 2 doses of COVID19 with the second dose being on 3/6/21. Patient stayed for 15 minutes after and was monitored. Patient's doctor was contacted and made aware of the situation.
No additional AE/No PQC; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 11/1/2022.; Inappropriate age at vaccine administration; This spontaneous report has been received from another reporter and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 01-NOV-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml) (valid lot number U039261 [expiration date 09-JUN-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error). Additionally, the patient was also administered outside the indications, regarding administration between the ages of 12 months to 12 years (product administered to patient of inappropriate age).  No adverse effects reported.
About 8 minute after injection patient begin to get dizzy and become unresponsive for about 2 minute, her blood pressure was taken and was 80/90 EMS arrived about 417pm  by then she was sitting up and responding to command
Tested positive for COVID-19 on 4/15/2021. Mild symptoms. Lost taste/smell. Has stuffy nose.
Patient presented to pharmacy to receive their 2nd dose of Pfizer covid vaccine. Per patients father no adverse event reported with previous vaccination or any vaccination. Patient received the vaccine in the right arm and as we started to fill out the vaccine card the patient stood up to be closer to his father and fainted. The father prevented the patient from hitting his head on the ground and the patient had already woken up by the time of pharmacist getting to him. Patient was disoriented but began to respond to questions and asked what happened. The patient remained laying down for 5 minutes and attempted to sit in a chair. Was given orange juice and water as he had not eaten or drank since lunch around 2 pm He continued Upon sitting in the chair it was observed he began to breath heavier. Patient stated he felt dizzy and was again instructed to lie down and raise legs. Epipen was not administered but brought out in case of further reaction. Technician was called in to be ready to dial 911 if any other symptoms started. Patient was given 25 mg of Benadryl as it was the closet to vaccine room. He stated he was improving and did not have any more dizziness. Patient was kept lying down for 10 more minutes. Patient was then raised to a seated position against the wall and monitored for any more symptoms. After another 10 minutes patient felt well enough to stand. Father and pharmacist helped patient to his feet and held on to his arms in case of another reaction. Patient then sat in chair for another 5-10 minutes and was given a second dose of benadryl when discovered it was the 25 mg dose. Patient felt good and reported no symptoms after another 5-10 minutes and felt he could walk on his own. Patient was walked out while pharmacist carried an epi pen with the to ensure it was available if needed. Patient stated they felt no more symptoms and. Father was asked if he had any questions or concerns. Instructed father that if any other symptoms start again he is to be taken to emergency room. Father said he understood. In total around 45 minutes to 1 hour of attention were given to patient to ensure treatment was readily available.
Information has been received from a physician concerning a female who on 12-DEC-2006 was vaccinated with 0.5 ml injection of Gardasil. In early March 2007, the patient passed out. The patient attributed the fainting to the Gardasil dose she received on 12-DEC-2006. Subsequently, the patient recovered. Additional information has been requested.
Had covid Jan 21, symptoms were twice as bad,  don't  think Ii will get second  shot
I was sick for two days after the second shot of Moderna: vomiting, diarrhea, body aches and so forth. The symptoms receded after Day 2, but the body aches and nausea and fatigue remained. Roughly one month after the second shot, I got my period, even though I have gone through menopause and have not had a period in roughly three years. I would also like to add that I am pro-vaccine as my father was a prominent pharmaceutical scientist. I was in perfect health through the entire pandemic and menopause and do believe my menstrual cycle was somehow changed or restarted by the vaccine.
Evening post vaccination, pt began experiencing mild flu-like symptoms. Morning post vaccination pt been experiencing redness/warmth/swelling beneath (L) deltoid muscle. Otherwise pt feels fine, no SOB. Symptoms are resolving.
On 5/11/16 pt. seen for laceration left thumb and received tetanus. Came back on 5/19/16 to have stitches removed and c/o (L) upper arm sore and tender to touch. No redness.
Patient received third dose from an expired vial; patient received a third dose from this vial that was left unpunctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received third dose from an expired vial) and OFF LABEL USE (patient received a third dose from this vial that was left unpunctured) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 031L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary embolism, Neuropathy and Epilepsy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received third dose from an expired vial) and OFF LABEL USE (patient received a third dose from this vial that was left unpunctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received third dose from an expired vial) and OFF LABEL USE (patient received a third dose from this vial that was left unpunctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.