chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 5 year old female with no remarkable medical history who on 02-APR-2007 at 3:20pm was vaccinated with a first 0.5ml intramuscular dose of VAQTA (Lot # "02484:) in the right thigh. Concomitant vaccine administered on the same day included a fifth dose of IPOL. There was no illness at the time of vaccination and no adverse events following prior vaccination. The following day after receiving VAQTA, on 03-APR-2007, the patient developed a large rash at the injection site. The patient was treated with BENADRYL for the reaction. Unspecified medical attention was sought. There was no laboratory or diagnostic tests performed. No further information was provided at the time of this report. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a physician stated that the patient experienced severe redness and swelling of the right thigh from the right anterior superior iliac spine down to the knee. The patient recovered, however, the reporter "can not recall" the date. The event of redness and swelling of the right thigh was determined to be an other important medical event by the investigator.
pt recvd vax & exp muscle cramps, stiffness & tightness in legs; 23SEP sx also in arms; afebrile; lab results pending;
A nearly 2 year old white female had a 10 day history of cough and congestion. She was initially treated symptomatically. She was current on her immunizations and had received 4 doses of pertussis vaccination. Two days prior to hospitalization, her cough had progressed resulting in paroxysms severe enough to produce laryngeal spasm and episodes of perioral cyanosis. Exam showed her to have an erythematous pharynx, palpable cervical adenopathy and reduced air flow in all lung fields with basilar rales. She was dx'd with a pneumonic process and given 50,000 units/kg of LA Bicillin. Her 13 year old sister was concurrent ill with cold symptoms and paroxysms of cough. Over the next 3 days, her symptoms intensified with paroxysm of cough causing choking on respiratory secretions. Her mother noted that the episodes would produce apnea and cyanosis. Her temperature ranged from 39C to 39.5C. Exam was remarkable for reduced airflow in the right lung with basilar rales. She was admitted for further evaluation and treatment of pneumonitis. She was placed on humidified 30% oxygen by tent and started on IV fluids. Her oximeter reading was 95%-98%. She was started on ampicillin 100mg/kg/day IV divided every 6 hours. She was taken out of the mist. Choking episodes were reduced but still several occurred each day. Gradually, they became less severe. She was feeling well. A repeat Bordetella FA was negative after 4 days of treatment and culture showed no Bordetella growth. She was discharged home with instructions to take azithromycin 12mg/kg/day for 5 days. She continues to do well at routine follow-up. Her sister had no testing performed and seemed to return to normal without sequelae. Linked with case U2002-00574.
Doses administered after 30-day use by date; Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The vial was initially stored in the refrigerator on 17-Dec-2021. The vial did not undergo any temperature excursions. BUD for the vaccine was on 16-Jan-2022. Treatment information was not provided.
Pt recv vax on 10/23/98; on 10/27/98 pt exp sore arm, stomach cramps & pain, vomit, diarrhea x 5 day
No further AE information provided.; HCP notes with patient details on administration of improperly stored vaccines.; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022), as prophylaxis (product storage error) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). Concomitant therapies included the sterile diluent (lot number and expiration date were not provided).  Additionally, it was reported that the suspect vaccines was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F for a time frame of 50 minutes, as recorded by the digital data logger. There was a previous temperature excursion reported as between 6 degrees F to 14 degrees F (8.47 degrees F) for a time frame of 30 minutes. No further adverse event information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000749: US-009507513-2009USA000777: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA000826: US-009507513-2009USA000894: US-009507513-2009USA000971: US-009507513-2009USA000976: US-009507513-2009USA001003: US-009507513-2009USA001123: US-009507513-2009USA001194:
Chills, myalgias, headache, malaise, fatigue; severe enough to take sick day from work.  Rapid flu test negative.  Treated with naproxen, acetaminophen, prednisone 10 mg, rest.  Improved towards end of day, and largely resolved next day except for minor right deltoid soreness.
Overall flu like symptoms; Weakness; Extreme muscle aches; Slight headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021 at 23:00, the patient experienced extreme muscle aches, weakness, slight headache, fatigue, overall flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle aches, weakness, slight headache, fatigue, overall flu like symptoms was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The day after the vaccine I experienced flu like symptoms. I was prepared for this and rested/ stayed in bed. Along with my chills, aches and fatigue, diarrhea developed. I wasn?t too concerned, since I was clearly having immune response to the vaccine. But now, two weeks later, I have very bad diarrhea still. It?s honestly hard to carry on with normal life. It?s very unusual for me and not any symptom I?ve ever experienced for this long.
patient indicated that she had not received any previous covid 19 vaccinations upon screening and during patient interview and received her 1st dose of Mederna Covid-19 vaccine.  Upon processing her shot and billing insurance it was flagged that she received the Janssen vacccine 4/27/2021.  This was confirmed via regulatory authority and the pharmacy that administered the previous vaccine and later with the patient herself who confirmed she was seeking additional vaccination .
As soon as I injected the patient his injection site swelled up and it formed a lump. It lasted 10-15 minutes in which the patient didnt feel any pain but the site continued to stay swollen. He left. During the 10-15 minutes that he stayed at the pharmacy under supervision of myself and the other pharmacist, we iced the injection site to help the swelling go down.
Narrative: COVID infection following COVID vaccine series 06/23, Pfizer, dose #1 07/14, Pfizer, dose #2 1/12 COVID swab, result: detected 08/03 pt cc: mild cough, mild body aches, mild subjective fever/chills exposure: unknown 12/30 pt admit to ED cc: mild cough, mild body aches, mild subjective fever/chills dx: COVID Viral Infection, unspecified LOS: 1 day clinically resolved.
This is a 76-year-old male with dementia who is well cared for at home by his wife who brought him in the the ER on 4/16/21 for  for altered mental status and not acting right.  Patient is wife states he had his second Moderna Covid vaccine 2 weeks ago and has been declining steadily ever since.  She notes he has had brain "fog" with increased confusion weakness and fatigue where he is no longer doing his baseline activities.  She has noticed him getting more winded and tired with routine activity and then sleeps a lot.  she feels like his dementia suddenly went on a rapid escalation.  The morning of his ER visit her concern was he was acting as if his blood sugar was low described him as being sweaty, he was shaking, he was very weak and lethargic.  She noted his temp at that point was 92.5 his blood pressure was 139/70 his heart rate was 70 and his blood sugar sugar was over 200.  Patient also has a history of diabetes  in addition to the dementia and he had a history of alcohol use disorder until 4 years ago when he suddenly stopped drinking. Her main concern was the rapid change since his Covid vaccine and now he is not sleeping at night and he is sleeping more significantly during the day and she is nearing exhaustion at this point. She saw the PCP and they said there is nothing they can do and told her to bring him to the ER
This spontaneous report was received from a healthcare worker regarding unspecified number of patients whose demographics were unknown. The medical history of patients and concurrent conditions were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K010211, expiry date: 17-JAN-2016) dose number, dose, route unknown. Concomitant medications were not reported. No adverse symptoms reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
REDNESS AT INJECTION SITE AROUND 12 NOON; PAIN AT INJECTION SITE AROUND 12 NOON; RIGHT HAND SWELLING AROUND 12 NOON; BODY FEELS HOT "LIKE  FIRE" BUT WORSE IN THE ARMS/HANDS AROUND 12 NOON; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included weak immune system, penicillin allergy, latex tape allergy, sulfa allergy, bactrim allergy, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with venlafaxine hydrochloride, and ondansetron.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: 02-MAY-2021) dose was not reported, administered on 13-MAR-2021  around 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced redness at injection site around 12 noon. On 13-MAR-2021, the subject experienced pain at injection site around 12 noon. On 13-MAR-2021, the subject experienced right hand swelling around 12 noon. On 13-MAR-2021, the subject experienced body feels hot "like fire" but worse in the arms/hands around 12 noon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at injection site around 12 noon, pain at injection site around 12 noon, right hand swelling around 12 noon, and body feels hot "like fire" but worse in the arms/hands around 12 noon. This report was non-serious.
15 lesions, red base, vesicular surface continuing to erupt; afebrile.
Heart palpitations and resting heart rate most days is above 100.  EKG monitor shows that I have tachychardia.  Thus far no treatment has been taken, since resting heart rate is so high the only thing that i have done is to lay down to bring the heart rate down.  As a direct result of the high resting heart rate I have severe chest pains.
loose black stool; loose black stool; she is feeling wobbly; her stomach feels a little funny; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (loose black stool), DIARRHOEA (loose black stool), FEELING ABNORMAL (she is feeling wobbly), ABDOMINAL DISCOMFORT (her stomach feels a little funny) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0428212A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FAECES DISCOLOURED (loose black stool), DIARRHOEA (loose black stool), FEELING ABNORMAL (she is feeling wobbly), ABDOMINAL DISCOMFORT (her stomach feels a little funny) and FATIGUE (fatigue). At the time of the report, FAECES DISCOLOURED (loose black stool), DIARRHOEA (loose black stool), FEELING ABNORMAL (she is feeling wobbly), ABDOMINAL DISCOMFORT (her stomach feels a little funny) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatments were reported.
Received the first dose on 12/22/2020, which was associated with left arm soreness. Received 2nd dose on 01/19/2021 afternoon. Experienced self-limited mild tingling sensation and pruritus in the lower back for 2 hours.  No rash. Next AM, experiencing right arm soreness, tenderness, mild chills, and mild discomfort in the long bones. No fever or rash.
This spontaneous report as received from a pharmacy technician refers to two patients of unknown age and gender. On 23-OCT-2014, patients were vaccinated with GARDASIL lot number K009811, expiration date 19-JUN-2014 (dose, strength and frequency were not reported), that were improperly stored. No adverse effects were reported. Additional information has been requested.
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) 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 flu-like symptoms. The action taken with covid-19 vaccine was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Feel Like Passing Out; Fast Heartbeat; Weight Loss; Fever; Body Aches/aching; Chills; Stomach Discomfort; Diarrhea; Loss of Appetite; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2019, 2 days after receiving Shingrix, the patient experienced fever, general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue and weight loss. On 30th April 2019, the patient experienced feeling bad and heartbeats increased. The patient was treated with ibuprofen (Advil). On 29th April 2019, the outcome of the fever and chills were recovered/resolved. On 1st May 2019, the outcome of the general body pain was recovered/resolved. On 2nd May 2019, the outcome of the stomach discomfort, diarrhea and fatigue were recovered/resolved. In May 2019, the outcome of the appetite lost was recovered/resolved. On an unknown date, the outcome of the feeling bad, heartbeats increased and weight loss were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue, feeling bad, heartbeats increased and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever (101 degree farenheit), general body pain, chills, stomach discomfort, diarrhea, appetite lost, fatigue, feeling bad, heartbeats increased and weight loss. Fever was relived after treatment with advil.
Some of the liquid came out of arm when they removed the needle after vaccine administration; Did not have any reaction on the skin that was exposed to the vaccine; A report was received from a nurse concerning male patient of unknown age who received Moderna's COVID-19 vaccine and experienced some of the liquid came out of arm when they removed the needle after vaccine administration and did not have any reaction on the skin that was exposed to the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 27 Dec 2020.   On 27 Dec 2020, just prior to onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the reporter stated that some of the liquid came out of the arm when they removed the needle after administration of the vaccine. It was reported that the patient did not have any reaction on the skin that was exposed to the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, some of the liquid came out of arm when they removed the needle after vaccine administration and did not have any reaction on the skin that was exposed to the vaccine, were considered resolved on 27 Dec 2020.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 037K20A), reporting Incomplete dose administered and exposure via skin contact without any associated adverse events. Both the events occurred same day after the first dose of Moderna COVID-19 Vaccine. The reporter did not provide the causality assessment for the events.
Systemic: mild chest pain, vitals ok, bp ok, o2 ok, etc, shot site no heat/swelling/redness. history of panic attacks; symptoms lasted 0 days
Patient awoke around 4AM with hard chills and felt hot to touch(no thermoneter).  Chills lasted 20-30 minutes. She denied headache,nausea.  Complained of lassitude until around 11AM.  She then slept most of the day.
pt recv vax 6OCT95 & p/vax pt devel a swollen, red area @ inj site;also exp pain in arm radiating to breast;tx w/hot compresses, & sx subsided;
No additional AE reported; Patient received recommended pediatric dose of RECOMBIVAX HB instead of the adult dose on 9 JUN 2022.; This spontaneous report was received from a certified medical assistant concerning a 62-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 09-JUN-2022, the patient received a pediatric dose instead of the adult dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 ml, lot # T018888, expiration date 03-NOV-2022, for prophylaxis (route of administration and anatomical vaccination location were not reported) (Product administered to patient of inappropriate age). No additional adverse events were reported (No adverse event).
Anaphylaxis recorded by onsite observers. Provided Epi pen and benadryl per SDO.
Patient reports that approximately 1 hour after receiving Pneumovax 23 his right deltoid started swelling until at around 10 PM his shoulder was swollen to the size of a grapefruit and he had swelling in his arm and clear into his shoulder blade with decreased ability to move his arm.
Initial misuse report received from a healthcare professional on 16 July 2013. It was reported that the vaccine was too long in shipping and was being replaced, but one dose was given in error. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, NauseaVomiting, injection site soreness Narrative: Employee received second dose of dose of Moderna vaccine on 09/09/21 at 1030am, and began experiencing symptoms the following morning around 0600am. Reported symptoms included injection side soreness, chills, fever, headaches, joint pain, body aches, fatigue, nausea, swollen glands, cough, sore throat, and "problems talking." Reports history of latent tuberculosis but was not given any treatment due to enlarged fatty liver. No other family members reporting similar symptoms. Was advised to increase fluids, take cough medications and either Tylenol or Motrin. Employee had not used any medications for symptom relief prior to speaking to employee occupational health. Will be getting COVID-19 test. Results unknown (not reported) as of date of entry.
Receiving a 100mcg/0.5ml booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Receiving a 100mcg/0.5ml booster dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025l21b, 008c21a and 016b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Receiving a 100mcg/0.5ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Receiving a 100mcg/0.5ml booster dose) outcome was unknown.            No concomitant / treatment medication were provided.   This case was linked to MOD-2022-492676.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Non-significant follow-up received.