chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Near miss- cancelled the vaccine since already received 2 doses; This case was reported by a other health professional via call center representative and described the occurrence of intercepted drug administration error in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug administration error. On an unknown date, the outcome of the intercepted drug administration error was unknown.  Additional details were provided as follows: The reporter pulled a shingrix and corresponding diluent vial out of the refrigerator to begin mixing to give to a patient, as punctured the diluent, the patient cancelled the vaccine since she had already received 2 doses and was mistaken on needing it, which led to intercepted drug administration error. No further details provided on web form. The reporter asked if it was ok to still use the dose. It immediately went back into the refrigerator and had only been out of it for a minute or 2. The reporter consented to follow up.
painful on her arm; painful / back and shoulders; painful / shoulders; cold sore; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, back pain, shoulder pain and cold sores. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the back pain, shoulder pain and cold sores were unknown.   It was unknown if the reporter considered the pain in arm, back pain, shoulder pain and cold sores to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced painful on her arm, back and shoulders and cold sore.  The reporter was in a hurry and did not provide much details. The reporter did not consent to follow up.
Diverticulitis with LLQ abdominal pain and fever.    Treated with antibiotics, liquid diet.  Resolved in 4 days.
The patient called the pharmacy the day after her vaccine stating that the arm she had received the vaccine in  was red and inflamed in a 2-inch area around the injection site. She did not have a fever. I instructed her to apply ice to the area and take TYLENOL. I contacted her again the next day and she stated the redness had gone down. Her arm was still slightly sore, but had greatly improved.
15  hours of severe diarrhea, and headache and fatigue treated headache with Tylenol   Drank liquids to hydrate , No issues after the diarrhea stopped, other than being dehydrated
Mild L sided facial swelling onset 1/12/21, L arm red + mild swelling size est. slightly larger than a quarter onset about 1/11/21. Pt had no difficulty breathing or throat swelling.  She was  on lisinopril which has since been discontinued as that could have caused her facial swelling.
Pt did not have a adverse event. The patient was asked if this was his first or second dose on assessment sheet and he said first. The patients first dose was Moderna and second dose was Pfizer
Pt presented to vaccination site and requested Moderna COVID vaccine 2nd additional dose. Patient received Moderna 1st dose on 3/16/21, Moderna 2nd dose on 4/13/21, Moderna additional dose 10/13/21. RN 1 submitted a medical consult via withheld to Clinical Project Coordinators requesting to proceed with Moderna COVID vaccine 2nd additional dose. Clinical Project Coordinator RN 2 elevated request to medical consult team. MD 1 from medical consult team approved request for Moderna COVID vaccine 2nd additional dose. On 3/21/22, patient received Moderna COVID vaccine (LOT# 045L21A) 2nd additional dose at 1607. EMT 1 educated patient on signs and symptoms of adverse reactions, when to seek emergency care, and to register on V-Safe. At approximately 1625, patient left facility with unlabored respirations and steady gait.
I started having pneumonia symptoms. I could not breathe. I had shortness of breath and a fever. I went to urgent care on 08/27/2021. The doctors put me on a nebulizer, Albuterol Inhaler and some medications for coughing. At the time I tested negative for COVID-19. They did chest X-rays, which showed the pneumonia.
Stomach trouble; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach trouble) and PAIN (Aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach trouble) and PAIN (Aches). At the time of the report, ABDOMINAL DISCOMFORT (Stomach trouble) and PAIN (Aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Pt w/hx of GBS vaccinated with Pneumovax 23 experienced numbness & increased weakness in his legs, numbness in his hands.
Cough  Headache  New loss of taste or smell  Congestion or running nose
The customer was given the second dose of the Pfizer vaccine that was expired. No adverse events were reported.
12 yr old received Pfizer vaccine, within 5 minutes pt lost conscious and became unresponsive with possible mild seizure. Patient received 0.15mg EpiPen -within minutes patient become more responsive. EMS arrived and transported patient to nearest hospital.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications were not reported. On 11-APR-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (dose, route of administration, lot number were not reported). No adverse events were reported. This is one of several cases reported by the same source. Additional information has been requested.
w/in 2 days of receiving a dose of Td, pt devel swelling in lt deltoid; w/in 4 days, marked induration & warmth were noted @ inject site; w/in 6 days, bloody, purulent discharge was noted @ site; rxn abated w/in 3 wks of inject;
pt inadvertently vax w/1st dose of 0.5ml of Hep B vax instead of 0.25 on 20NOV93; 27NOV93 devel a rash & vomiting; pt was not seen by MD; As of December 1993, pt had completely recovered;
Guillain-Barre Syndrome; allergic type of reaction; He has been given shingles, pneumonia an flu vaccines and this [transverse myelitis] happened several years after the swine flu.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as age: 71; unit: unknown) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (tradename unspecified, solution for injection in pre-filled syringe, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history included swine flu. Concomitant medications included swine flu shot, and shingles vaccine. Patient was calling to see if he is a candidate for the Covid vaccine. He stated that he has heard of a number of cases transverse myelitis that happened after a vaccine. He stated he heard that it can be considered that transverse myelitis may have been from a vaccine but he doesn't believe that to be true. He has been given shingles (vaccine), pneumonia flu vaccines and this [transverse myelitis] happened several years after the swine flu; maybe it laid dormant and then reacted but he has been iffy of this as a possible answer. His wife seemed to think he received a flu shot prior to getting this diagnosis. The shot [flu vaccine] he remembered having was close to a year prior to this. It was a good distance of time before this diagnosis and he had no symptoms at least a year post vaccination. His wife seemed to think it was correlated but he did not. He can never receive a flu shot again because originally he was diagnosed with Guillain-Barre Syndrome on an unknown date and then later it was changed to transverse myelitis (1997). He stated it seemed to be more anomalous, a very fine number that had contracted GBS from the swine flu shot but "they" had to post it and that was why he cannot get a flu shot. He stated he supposed this reaction would be considered an allergic type of reaction (date unknown) . He asked if there was any data on this and asked on the way this vaccine was developed different from the flu shot. He asked why he can get a shingles shot and not this (covid vaccine). He stated he only has mild flu like symptoms with the shingles vaccine. He asked if this covid vaccine structured the same way as the flu shot. He stated understanding this was beyond his understanding. It was explained that agent was unbale to compare the ingredients/chemical structure of the flu shot or shingles shot with this Covid vaccine and was provided with instructions on how to access the prescribing information so that he can have more information about the ingredients and chemical structure and other details he may be interested in writing and can compare it with other vaccines he is interested in looking into. Patient was referred to HCP to assist with this comparison. The outcome of the events Guillain-Barre Syndrome, transverse myelitis and allergic type of reaction was unknown.   Information on Lot/Batch number has been requested.
Patient was administered 1st known dose of Hepatitis A vaccine as part of an outreach project at a recovery center. Vaccine given at approx. 3:55 in left deltoid. At approx. 4:25, patient returned to the vaccination area to report she had a rash. Localized area of erythema noted on outer aspect of left forearm below the thumb, approx. 4 inches in length and 2 inches in width at widest point. Reported some mild itching. Injection site clear, no erythema or edema noted. Patient denied any difficulty breathing or shortness of breath. No other complaints. Administered Diphenhydramine 25mg po at approx. 4:28 and advised client that she would be monitored for at least the next hour. Advised to notify a health department. employee immediately for any shortness of breath, difficulty breathing, or if any additional signs and symptoms were noted or if rash/itching worsened. Patient verbalized understanding. Patient continued to work without difficulty. Checked on patient frequently as able as she had to walk several area within the building to complete her work. At 4:35 patient stated "I feel fine. I think it's better now". Rash was still present, but not spreading. Stated itching had improved. At 4:55 patient reported continued improvement in itching, rash present, but not spreading. At 5:15 patient reported no longer itching. Rash not spreading. Advised patient to seek medical attention if rash spreads or does not resolve in 24 hours, seek immediate medical attention for any shortness of breath, difficulty breathing, dizziness or lightheadedness, or if any signs and symptoms of anaphylaxis occur. Patient verbalized understanding. Alert and oriented, ambulatory, and continuing her work without difficulty. Unable to contact patient again before end of outreach due to she had to leave the area for her work. Call to patient on 3/13/19 at 11:26 to check status. No answer, left voicemail to contact this nurse for update.
First dose: he felt out of it; First dose: Weakness; First dose: Pain in the arms; First dose: kind of fuzzy mind; First dose: car accident; First dose: he was not as focused, it took him a long time to focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 25Aug2021 at 15:00 as dose 1, single (Lot number: EWQ171) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "First dose: he felt out of it"; ASTHENIA (non-serious), outcome "recovered", described as "First dose: Weakness"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "First dose: Pain in the arms"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "First dose: kind of fuzzy mind"; ROAD TRAFFIC ACCIDENT (non-serious), outcome "recovered", described as "First dose: car accident"; DISTURBANCE IN ATTENTION (non-serious), outcome "recovered", described as "First dose: he was not as focused, it took him a long time to focus".  Additional information: Patient felt out of it, pain in the arms, 2 weeks of kind of feeling general kind of weakness, kind of fuzzy mind, and that was the first time he had a car accident. He was walking outside, he has a farm, and he was not as focused, it took him a long time to focus. Outcome of these events as far as he knows he recovered completely from them all, but who knows, he could have just gotten used to it.  Patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He never had any side effects prior to vaccination, the area hurts a little after but he never remembers anything else. All of his family had the same Pfizer Covid Vaccines, like 4 of them and none of them had any major side effects besides some weakness, like feeling like getting a little bit sick the day after as far as they told him.   No follow-up attempts are possible. No further information is expected.
Next day post vax, the pt experienced an extreme rushing sound and an episode of extreme pressure in her right ear. This pressure clouded her hearing temporarily and caused her profound disorientation. The pressure was also associated with high-pitched cadence and accompanied by nausea but with no vomiting. The episode reoccurred two to three more times that day, lessening in severity each time. She reports that she has since experienced approximately seven more episodes as described above. Each episode renders her feeling raw and unable to function and she treats the episode by lying down and resting for one to three days. She has been examined by an internist who has given her a dx of precursor to Meniere's syndrome. The most recent information received indicates that the events are intermittently ongoing.
Increased Fatigue, Bradycardia, unable to arouse pt. Sent to emergency room, admitted for observation and testing.
1-2hr p/vax devel fever 103, mild shaking & purple discoloration of distal extremities;
that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021.  HCP told Caller to watch for infection per Caller; that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021.  HCP told Caller to watch for infection per Caller; arm really hurts; headache; had insomnia for 3 hours last night, and couldn't sleep; booster vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 86 years as dose 3(booster), single for covid-19 immunization. Relevant medical history included: "asthma lung issues" (unspecified if ongoing); "injected Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose, Lot GN5318,), administration date: 11Feb2021, for COVID-19 Immunization; Bnt162b2 (1st Dose, lot number EL1283), administration date: 21Jan2021, for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) all with onset 21Nov2021, outcome "unknown" and all described as "that was mixed earlier and sat out too long and that the HCP stated that it was mixed the day before on 20NOV2021. HCP told Caller to watch for infection per Caller"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "not recovered", described as "arm really hurts"; HEADACHE (non-serious) with onset 21Nov2021, outcome "not recovered", described as "headache"; INSOMNIA (non-serious) with onset 21Nov2021, outcome "not recovered", described as "had insomnia for 3 hours last night, and couldn't sleep"; IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "booster vaccine".  Additional information: Prior Vaccinations (within 4 weeks): flu vaccination 4 weeks prior on 19 Oct 2021. She got the flu vaccine in her right arm. The patient stated that had insomnia for 3 hours last night and couldn't sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received PREVNAR 13 (lot number and expiration date not provided) and influenza vaccine both via unspecified routes of administration on unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and pain below the application site on an unspecified date. Outcome of the events was unknown. Information on lot/batch number has been requested.
swelling on arm; warmth on arm; itching on arm; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 11th July 2019, the patient received Shingrix (intramuscular). On 13th July 2019, 2 days after receiving Shingrix, the patient experienced swelling arm, skin warm and itchy upper limbs. In July 2019, the patient experienced erythema. On an unknown date, the outcome of the swelling arm, skin warm, itchy upper limbs and erythema were unknown.   It was unknown if the reporter considered the swelling arm, skin warm, itchy upper limbs and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced warmth, itching, and swelling on the arm below the injection site of the left deltoid and above the elbow. The pharmacist also reported redness below the injection site, near the elbow, appeared to be spreading.
Patient became sweaty and pale  and nauseous shortly after the administration of the vaccines.  She was laid down on the bench in the room, feet put up and given apple juice.  She and he mother said in the room with me for approximately 15 minutes prior to us sitting patient up for a short time then to a standing position prior to her leaving the clinic.
hands are swelling; joints and muscles ache like heck; joints and muscles ache like heck; This is a spontaneous report from a Pfizer sponsored program COVAX Support consumer(patient) reported for himself that: A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on as single dose for COVID-19 immunization. Medical history included covid-19. Concomitant medications were not reported. It was reported that Would like to speak to someone about a reaction to covid vaccine. Said hands are swelling, joints and muscles ache like heck. also did have covid before getting 1st dose of covid vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received the first dose of Moderna COVID vaccine on 4/22/2021. Upon reporting vaccine to state registry, pharmacist noticed he had previously received Johnson & Johnson COVID vaccine on  03/10/2021 at another facility. This information was not volunteered by the patient at the time his Moderna vaccine was administered, but was confirmed with the patient after the vaccine (Moderna) was administered. The patient will not be receiving the second dose of the Moderna vaccine, due to the fact that he was not indicated to receive both Modera and Johnson & Johnson vaccines. The patient reported low-grade fever, headache, nausea, and dizziness lasting for 1 day beginning the day after vaccine administration of Moderna vaccine. No treatment was necessary, and patient fully recovered from this adverse effects.
Information has been receiving from a physician's office manager and her co-worker concerning a 26 year old white female positive for high risk papilloma viral infection and no known allergies who on 11-JUN-2008 at approximately 12:00PM was vaccinated in her left deltoid with the first dose of GARDASIL (LOT# 660393/0067X). Concomitant therapy included DEPO-PROVERA. After the vaccination, the patient sat for about 10-15 minutes in the waiting room to make sure that she did not have an reaction to the injection. the patient "was absolutely fine" when she left the physician's office. About 1/2 hour after leaving the office, she went to pick up her kids and she started to experience flu-like symptoms. she felt to then cold. She got a headache and felt dizzy. She almost fainted and almost had a wreck in her car on her way home. She got home and slept for 4 hours. when she woke up, she took some aspirin and drank tea to help her feel better. She did not feel better until the next day. The patient did not seek medical treatment at a hospital or from any other doctor for these symptoms, nor did she call the physician's office. The other vaccines within a month before or after getting GARDASIL. No tests were ordered by any doctor or medical facility to try to determine her ailment at this time. On 08-AUG-2008, the patient called the physician's office. She wanted to cancel her scheduled appointment for her second vaccination. additional information is not expected.
Sites where the shot were given were red and swollen. Pt had a mild fever and had body aches. She area of the sites also had itching. Symptoms lasted approx. 24 hours and pt was treated with fever reducers.
Abscess on my gum; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL ABSCESS in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. BB 4323666) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GINGIVAL ABSCESS. At the time of the report, GINGIVAL ABSCESS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Chills, fingers turned white, lips turned purple. Woke up at 1:30 am with headache and racing heart beat.