chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning her 18 year old daughter with penicillin and sulfonamide allergy, attention deficit/hyperactivity disorder, anxiety and migraine who on 15-MAR-2007 was vaccinated, intramuscularly, with a dose of Gardasil. Concomitant therapy included TOPAMAX, STRATTERA and ZOLOFT. On 18-MAR-2007 the patient experienced "soreness in her legs" and her "knees and ankles began to hurt. "The patient took ibuprofen for the symptoms. On 20-MAR-2007, the patient was not able to attend school. It was reported that she was "not walking normally" and "walking like an old lady." Unspecified medical attention was sought. There was no laboratory or diagnostic test performed. At the time of the report, the symptoms had not resolved. The physician considered "knees and ankles began to hurt" and "soreness in her legs" to be disabling events.
Arm swollen raised up and hard, very red and very very hot to touch and arm very painful along with shoulder pain and and scapula very painful
24 hours after injections, left deltoid area became red, warm and painful to 50 cent size. Mom told to monitor temp (see MD if increases to 103 degrees), offer TYLENOL or ADVIL (age-related dosing) and apply cool compresses. On 5-2 area pain and warmth area decreased in size.
This spontaneous case, was initially received from other health professional (nurse) on 29-Sep-2017, concerning a 21-year old female pregnant patient. On 28-Sep-2017, the patient (pregnant woman) was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00644623A, expiry date: 30-Jun-2018, route of administration and anatomical location: not reported). The reporter assessed the report as non-serious. Non-significant case correction received with IRD 29-Sep-2017: Batch no. (00644623A) was captured in the case form and narrative was amended accordingly. Non-significant follow-up received on 23-Feb-2018: Added reference number in the additional information tab (Med Info Number: SEQ17-3436). No changes were made in the narrative.
This spontaneous report was received from a nurse and refers to unspecified number of patients with unknown demographics. Information about the patients' pertinent medical history, drug reactions allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # L006385 with expiration date 25-FEB-2017, (dose number and route of administration were not provided). No adverse effects were reported. On 26-JUL-2016, the vaccines experienced a initial temperature excursion of 16.2 F for 12 hours. The aforementioned one was identified due to a data logger. No doses were given following the recent excursion reported on 14-NOV-2016. Furthermore, no product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 19-MAY-2015, the patient was vaccinated with an improperly stored dose of VAQTA 25U/0.5 ml injection (lot# K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
9 year old patient had received quadracel with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old female patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid (Kinrix) for Prophylactic vaccination.  On 14-Apr-2023, the patient received a dose of 0.5 ml (dose 2) once of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot C6002BA; expiry date: 18-May-2024; strength: standard) via intramuscular route in the left deltoid for immunization.  On 14-Apr-2023, 9 years old female patient had received quadracel with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, "Nurse would like to like guidance on how to proceed since this is not indicated for Patients 9 years of age. Transferred nurse who reported 9 year old patient had received QUADRACEL ON 14-apr-2023. She had been given Kenrix on 18-MAR-2022. She asked what is appropriate follow-up. What is follow-up after non-Sanofi vaccine has been given prior."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received second of 2 required injections of SHINGRIX for shingles. Side effects included soreness, redness and minor swelling at injection site, mild nausea, significant body aches, head ache. Side effects lasted aprox. 36 hours.
Child was to receive a DTaP, child was given Hib vaccine in error. Patient had already received 3 Hib vaccines.
Left arm pain; Chills; Body aches; Headache; Feeling feverish; Tired; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: FG3527) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medication included: AMLODIPINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3247; Anatomical site: unspecified; Route of administration: unspecified), administration date: 22Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3247; Anatomical site: left arm; Route of administration: intramuscular), administration date: 15Mar2021, when the patient was 44 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Left arm pain"; CHILLS (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Feeling feverish"; FATIGUE (non-serious) with onset 08Dec2021 at 22:00, outcome "not recovered", described as "Tired". Therapeutic measures were taken as a result of pain in extremity, chills, pain, headache, pyrexia and fatigue.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment included Ibuprofen for pain in extremity, chills, pain, headache, pyrexia and fatigue.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2012, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles with complications. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Injection site pain. Then overnight (after getting shot), armpit lymph node swelled. Felt a little fatigued and nauseous (11/7/2021-11/8/2021). The next day (11/9/2021), had a slight fever. Treatment: use cold and heat compress. Found out also I had a sinus infection and had to take antibiotics.
5-10 minutes after vaccines given, rash appeared to lower legs, small whelps. No resp. difficulty. PO Benadryl/Orapred given. No further rxn noted - left clinic 30-45 minutes after vaccines.
Pt received HPV vaccine. After pt sat for approx 10 mins she stood up and passed out. PT hit head, treated with ice, supine for aprox 45 mins. ED eval for neck pain.
28 hours after shot High fever; Muscle aches on entire side of body as the shot; Large lump under shot arm; Extremely painful; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 08Sep2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (ESTROGEN) and zolpidem tartrate (AMBIEN) from unknown dates for unknown indications and unknown if ongoing. On 09Sep2021 at 16:00, 28 hours after the shot, the patient experienced high fever, muscle aches on entire side of her body as the shot and a large lump under the shot arm and extremely painful. Therapeutic  measures were not taken for the reported events. Since the vaccination, the patient was not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events 28 hours after the shot high fever, muscle aches on entire side of body as the shot, large lump under the shot arm and extremely painful were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program Support. This consumer reported similar events for six patients. This is the fifth of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101332906 same reporter/drug/event, different patients
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported.  On an unspecified date, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine  was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
This case was reported by a consumer and described the occurrence of hives in a 51-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes, high blood pressure and hypothyroidism. Concurrent medications included Insulin, CARDIZEM and Levothyroxin. On 21 September 2010 the subject received unspecified dose of Flu vaccine at 0.5 ml in the left arm. On 21 September 2010, less than one day after vaccination with Flu vaccine, the subject experienced hive. The subject was treated with prednisolone and BENADRYL. At the time of reporting the event was unresolved.
Information has been received from a health professional concerning an 8 year old male who on an unspecified date was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot unk). Subsequently, it was reported that on 6/15/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
After I got the vaccine my sinus felt pressure and then went home, I lay down and rested. When I woke up, I saw a red spot on the left arm. Next day, about 11:30am - 12pm I tried to eat something and I felt something hard in my throat and my nose was swelling and got bigger. I went to ER and 3 hrs. after I did not want to wait longer, I was afraid to get COVID-19. I left and went home and took some Motrin. No fever, my temperature was 98.6 but my normal temperature is 97.1. Then, my sinus continued and yesterday I woke up and started coughing. I have an appointment for blood work for next week (2/9).
On 20-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-jan-2021, The patient experienced a bad rash and itching . He states the itching was mostly in his inguinal area, chest, and back. He also clarified that he has hives mostly on his back and red itching in inguinal area and chest.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 20-jan-2021, the outcome of the events like rash, pruritus, urticaria and erythema. was unknown. At the time of this report, the outcome of the events like rash, pruritus, urticaria and erythema  was unknown.
Symptoms of nausea began day of, were moderate for several days.  Did not eat much the day of the vaccine due to these symptoms. Numb feeling, tingling in extremities for 2-3 days post vaccination.  Still some occasional numbness and tingling in nose, facial area, and back of head/neck.  Diarrhea for a couple of days.  Continue to experience mild nausea 1.5 weeks later.  Did not have problems with nausea previously.   Moderate fatigue for about a week following vaccination.  Still noticing mild fatigue, getting tired easily and earlier than usual.   Arm was sore from the day after vaccination until about 4-5 days had passed.  Still otice an occasional pain  when moving arm around a certain way.   For 4-5 days following vaccination noticed various body pains.  Pain in lower back- not muscle pain but something else.   Chest wall pain when breathing in from 1-2 days to about a week post vaccination. Headache for a day.  Brain fog feeling, forgetfulness beginning the day after vaccination and was noticeable for about a week.  Still noticing this mildly and feeling more lightheaded than usual.   Over the last few days, I've noticed chest tightness and some mild coughing.  It's also below zero here, so this could be related to weather and dry air, or possibly related to the vaccine.   Generally, I recognize that the above symptoms are possible after this vaccination.  However, the existing literature seems to suggest these symptoms should last 1-3 days and be mild.  My experience has been that they were worse than mild, most lasted at least a week, and some seem to be continuing.   I am also breastfeeding a 19 month old.  He had a brief bout of redness on about half of his body (underarms, forearms, thighs, knees) for about 30 minutes a week after I received the vaccine.  He has never had that before for no apparent reason, and it did not continue, although he has reacted to lotions and certain brands of diaper wipes in this way previously.  We have also noticed that he's been more irritable lately- throwing tantrums easily, sleeping more often, and getting inconsolable.  We haven't tied this to any illness, although we do recognize that toddlers can through periods where they have more challenging behaviors.  This is unusual for him though, he's generally happy and agreeable.  I thought I'd mention it just in case there's been some sort of pattern that other breastfeeding moms have noticed.
Heart palpitations, dizziness, blurry vision, insomnia, inability to exercise, inability perform daily functions, tinnitis  Treated for anxiety and panic disorder but symptoms still persist after anxiety and panic disorder have resolved.
Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination
This case was received from a health professional on 09 June 2009. A 49-year-old male patient, with a history of seasonal allergies, received an injection of FLUZONE SV '2005-'2006 USP (lot number U1753AA) on 27 October 2005. Two days post-vaccination, on 29 October 2005, he experienced malignant hypertension, tachycardia, "hot and cold" sensations, and ringing in the ears. He was treated with three courses of prednisone, and underwent a full cardiac work-up (results not provided). The "hot and cold" sensation and ringing in the ears remained ongoing. Of note, the patient had also received a flu vaccine (manufacturer and lot number not reported) in January 2005. In addition, this reporter noted that the patient's sister also experienced a similar event after receiving FLUZONE (lot number U1846AA) in 2005. That event is captured in case number 2009-02506.
Temporary inflammation of lips. Had filler (Juvaderm) 12 months prior to vaccine.  Symptoms lasted only 3 or 4 days.
During yesterday afternoon, when I was bathing, I felt a lump in the neck area on the left side of by body. On the same side were the vaccine was administered. When looking for data in the internet, I found that it is due to swollen lymph nodes and that it should be reported.
This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received a 3rd dose / Caller is not immunocompromised and has not received an organ transplant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 3 doses of the moderna covid-19 vaccine by injection on 17FEB2021 (023M20A), 19MAR2021 (046A21A), and 18AUG2021 (052E21A).) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 046A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced OFF LABEL USE (Received a 3rd dose / Caller is not immunocompromised and has not received an organ transplant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 3 doses of the moderna covid-19 vaccine by injection on 17FEB2021 (023M20A), 19MAR2021 (046A21A), and 18AUG2021 (052E21A).). At the time of the report, OFF LABEL USE (Received a 3rd dose / Caller is not immunocompromised and has not received an organ transplant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 3 doses of the moderna covid-19 vaccine by injection on 17FEB2021 (023M20A), 19MAR2021 (046A21A), and 18AUG2021 (052E21A).) had resolved.            concomitant and treatment drugs were not provided
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K011800, exp date 21-AUG-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.