chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin feels more firm; injection site is warm to touch; injection site is swollen about hand size; injection site was so painful; The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful; had limited range of motion in that arm/again experiencing reduced range of motion; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful), SKIN TIGHTNESS (skin feels more firm), VACCINATION SITE WARMTH (injection site is warm to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (had limited range of motion in that arm/again experiencing reduced range of motion) and VACCINATION SITE PAIN (injection site was so painful) in a 49-year-old female patient who received mRNA-1273 (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful) and VACCINATION SITE MOVEMENT IMPAIRMENT (had limited range of motion in that arm/again experiencing reduced range of motion). On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was so painful). On 12-Jan-2021, the patient experienced SKIN TIGHTNESS (skin feels more firm), VACCINATION SITE WARMTH (injection site is warm to touch) and VACCINATION SITE SWELLING (injection site is swollen about hand size). On 08-Jan-2021, VACCINATION SITE PAIN (The injection site was painful/same symptoms of pain at injection site/was awakened because my injection site was so painful) had resolved. At the time of the report, SKIN TIGHTNESS (skin feels more firm), VACCINATION SITE WARMTH (injection site is warm to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (had limited range of motion in that arm/again experiencing reduced range of motion), VACCINATION SITE PAIN (injection site was so painful) and VACCINATION SITE SWELLING (injection site is swollen about hand size) outcome was unknown.      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment for the events was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
PATIENT STATES HE WOKE UP AROUND 5 AM THE NEXT MORNING FEELING SEVERE DIZZINESS, TO THE POINT WHERE HE STATES HE "COULD NOT AMBULATE" OR GET OUT OF BED FOR A COUPLE HOURS. HE ALSO SAID HE WAS NAUSEOUS. THESE SIDE/ADVERSE EFFECTS LASTED FOR 5 HOURS. PATIENT ASKED THAT I REPORT.
Patient had received Jynneos vaccine, while waiting in a warm crowded waiting room, patient felt faint, called out to friend and then went syncopal for a few seconds.  Patient regained consciousness after legs raised, cold pack applied to back of neck.  Given water and snacks to eat and felt better afterwards.  Vitals were 118/60 - 61 - 95%.  Glucose 92 mg/dl.  Rose to 129 mg/dl after snack.  Patient monitored x approx 45 min afterwards and left clinic ambulatory with friends.   Patient seen by Dr.
PATIENT ARRIVED TO THE DOCTOR'S OFFICE (WHO ALSO VACCINATED HER 4 DAYS BEFORE) WITH FEVER, LEFT LEG NUMBNESS, AND HEADACHE.
unspecified number of employees recvd Engerix-B w/ 40% nonresponders;
I was 7 weeks and 5 days pregnant when I got the flu vaccine. I have had 2 live births and 1 miscarriage (at 5 weeks, 4 days) prior to this pregnancy.  The first live birth was a 5 lbs, 12 oz girl, full term, 24 hour delivery. The second was a 6 lb 0 oz girl, full term, 3 hours delivery.  I have had COVID-19 but not had the vaccine. My last period for this pregnancy was  Sept 4, 2021. I was 7 weeks and 5 days pregnant and at my first obgyn appointment when I got the flu vaccine. I had an ultrasound on this visit and the baby was showing healthy and exactly on track, growth-wise. Heartbeat was healthy. At the very end of the appointment, I got the vaccine. I had been having morning sickness for the previous two weeks. I had nausea all day, every day (including night time), and aversion to smells and most foods. The day after the vaccine, all nausea and smell/food aversions went away completely for 8 days. I was worried that I may be having another miscarriage. After 8 days, all nausea and food/smell aversions returned just as before. I was also particularly tired in the few days after the flu vaccine. I wanted to report this side effect because the sudden loss of pregnancy symptoms was startling.
the reporter thought that she and her husband received fluzone high dose for this season, in error, the pharmacist gave them the fluzone low dose with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a consumer Via call center and transmitted to Sanofi on 26-Oct-2020.  This case is linked to case 2020SA303708.  This case involves male patient of unknown age for whom it was the reported that his wife and patient received  INFLUENZA VACCINE TRIVALENT [FLUZONE HD] for this season, in error, the pharmacist gave them the INFLUENZA VACCINE TRIVALENT [FLUZONE] (product dispensing error) (dose, route, anatomical location, expiry date and lot number unknown) for prophylactic vaccination on 20-Oct-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not provided.   This is a true medication error case due to product dispensing error (latency same day).   No laboratory data was provided.  At the time of this report, no adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. 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.  There will be no information regarding batch number for the case.
1 week after influenza injection, pt. experienced pain in Left deltoid region after exercise. Pain is now intermittent with movement and has isolated non painful sporadic twitches of deltoid muscle that are not painful but keep him awake at night. From shoulder, neck, arm.
Patient received expired vaccine (6/30/21) and came back next day for another Fluzone.
3rd booster dose; Fatigue; Injection site soreness; Full body soreness; Chills; Non-painful and non-itchy red rash on torso and arms; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 07Oct2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included minerals nos, vitamins nos (CENTRUM), cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE); all for unknown indication from unknown date and unknown if ongoing. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 06Oct2021 for Immunisation within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 29Jan2021 (at the age of 29-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 19Feb2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 07Oct2021, the patient experienced fatigue, injection site soreness, full body soreness, chills and non-painful and non-itchy red rash on torso and arms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, injection site soreness, full body soreness, chills and non-painful and non-itchy red rash on torso and arms was resolved on unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
The timeline of patients COVID vaccinations are: 3/18/21 & 4/9/21. He experienced shortness of breath and palpitations about a week after the second vaccine. The symptoms slowly improved since then, although never completely went away. He was seen by a PCP at this time with normal ECG. He also had antibody titers that was notable for SARS Cov2 spoke IgG quant 882.5 and nucleocapsid IgG negative, confirming no prior history of COVID infection. He did have COVID exposures during the pandemic with a roonmate at college but he tested negative multiple times and was isolated.    After a few months with persistent symptoms he was referred to myself  in cardiology. I performed lab tests with negative hs-TnT and hs-CRP. A cardiac MRI revealed evidence of a focal area of LGE consistent with myocarditis. I also performed a Ziopatch which demonstrated no evidence of arrhythmia, did show type 1 AV block and one episode of Wenkebach.
About 5 pm pt. was asleep in mom's arms 20-30 minutes after a normal feeding. Made a strange, quiet cry, lost color and tone, unresponsive. No unusual movements. Still breathing, but slower and with some retractions and grunting. Tone and alertness began to return in about 5 minutes, while in car on the way returning to my office. color normal about 30 minutes after start of episode. I witnessed a second episode 5 minutes later, same as above. Pupils unresponsive x 2 min. Afebrile. Feedings unchanged. No emesis. Pallor included mucous membranes.  10/2/09 Received hospital medical records for 9/15-9/16/09. FINAL DX: pale limp spell s/p vaccination Records reveal patient experienced prolonged spell of being pale & limp after received vaccinations.  Seen by PCP & observed recurrent episode w/unresponsiveness & pupils non-reactive.  Pulse ox WNL.  Temp 38.1 in ER but otherwise afebrile.  No further episodes or pale limpness while hospitalized.  Work up & examination WNL except for very quiet heart murmur which was felt to be benign. 10/30/09 ICD 9 codes received: 780.60.
Off Label Use; Initial information received on 27-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA523303(CLUSTER) and 2022SA523303(CLUSTER).  This case involves a 52 years old male patient who experienced off label use while receiving vaccines RABIES (VERO) VACCINE [VERORAB] and IPV (VERO) [IMOVAX].  The patient's past medical treatment included SHINGRIX on 01-DEC-2022. The patient's past medical history, vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect IPV (VERO) lot number not reported. On 20-Dec-2022, the patient received a dose 1  dose of suspect RABIES (VERO) VACCINE lot U1F962V via unknown route in the right arm. On 23-Dec-2022 he also received a dose 2  dose of the same vaccine  lot U1F962V via unknown route in the left arm for dog bite.  On 27-DEC-2022 the patient developed a non-serious off label use (unknown latency) following the administration of IPV (VERO) and 7 days following the administration of RABIES (VERO) VACCINE.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event (Off Label Use).  At time of reporting, the outcome was Unknown for the event off label use.
rash lasted 3 days; approx 50 pos on whole body; no fever detected
Bad headache after the 2nd shot of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache after the 2nd shot of vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-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 25-Mar-2021, the patient experienced HEADACHE (Bad headache after the 2nd shot of vaccine). At the time of the report, HEADACHE (Bad headache after the 2nd shot of vaccine) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.
Pt returned in 5 days with complaint of rash and itching. No fever, chills, SOB, nausea, vomiting, and diarrhea, treated with atarax.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (Nausea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (Backache), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Backache), HEADACHE (Headache), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Onset of fever 7 days after vaccines (4-10-02 onset fever) on 04/12/2002, temperature to 105 degrees F. 04/12/2002 office visit On exam, temperature (?)  lymph nodes, mild red throat. Received Roccaphin X 2.
31hrs after receiving vaccine I developed chills, they lasted about 3 hrs, afebrile until 2hrs after the chills ended and temp was 100, took Tylenol , slept well, woke feeling fine Injection site  reddened and swollen, even on this day (day 4) and site itchy, warm  today
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (side effects getting worse) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In July 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In 2021, patient experienced vaccination complication (side effects getting worse). At the time of the report, vaccination complication (side effects getting worse) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The patient's side effects seemed to get worse and a little better at times. No concomitant medication or treatment information reported.
Patient received vaccine at department POD, located across the street from the department. Patient finished 15 minute monitoring and nurse approached car to advise that patient could leave. It was at that time that patient notified nurse, that the left side of her face was numb. Nurse initiated emergency response. Vital signs were obtained. Patient reported headache and began exhibiting erythema and edema on left side of face and upper left arm. Epinephrine and IM Benadryl were both given. patient was transported to local hospital via EMS.
Nausea, syncope, difficulty breathing, wheezing, hives Tx - Albuterol, BENADRYL, Epinephrine, O2.
On 09/14/2001, lab report indicate Hep BSAgt eventhough HBIG and series of 3 Hep B vaccine given within approx. time frame. HBIG and HBV#1 given on 07/29/2000, HBV #2, and HBV#3.
He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 010A21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Joint pain (Joint sore), Joint stiffness (Joint stuff) and Arthritis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better). On 30-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (He noticed something different in the joints of his left hand. Before it used to be really sore and stuff, but it cleared up and it is not sore anymore. It is a whole lot better) had resolved.            No concomitant medications are provided.  It was reported that patient before it was used to be really joint sore and stuff, but it cleared up and it was not sore anymore. It was a whole lot better. He believed that he have (or had) arthritis and that was not there anymore. He said that he could felt it a little bit but nothing like it was before.    No treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: follow-up  received contains No new information.
fever; Headache; Extreme fatigue; Body aches; I spent 48hrs vomiting; Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old non-pregnant female patient (consumer) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:15 (age was 41-year-old and was non-pregnant at the time of vaccination) as DOSE 2, SINGLE for Covid-19 immunisation. The medical history included Occipital and Trigeminal neuralgia, and the known allergies included Penicillin, Phenergan (phenagren), codiene, and mustard, egg, sweet potato, walnuts as food allergies from an unknown date and unknown if ongoing. The patient previously took Phenergan [Promethazine] for drug hypersensitivity and Codeine for drug hypersensitivity. The historical vaccine included BNT162b2 for Covid-19 Immunisation on 15Jan2021 at 2.00 PM. The concomitant medication included gabapentin (GABAPENTIN) taken for an unspecified indication as other medications in two weeks, start and stop date were not reported. The patient stated that the first dose caused a horrible headache (or neuralgia attack) the day after and lasted about 24hrs. The day after the second dose on 06Feb2021 at 02:00, the patient developed a fever, headache, extreme fatigue and body-aches. Thereafter, the patient mentioned she spent 48hrs suffering from symptoms including vomiting, nauseated and with diarrhoea which started on 06Feb2021. Those symptoms lasted about 48hrs. The patient had to get tested before returning to work at the Covid call center. The patient underwent lab tests and procedures which included sars-cov-2 test (Covid test post vaccination) which was found to be negative on 12Feb2021. Covid test type post vaccination was done by Nasal Swab and Covid test name post vaccination was by PCR. There was no treatment received for the events. Patient did not have Covid prior vaccination. The outcome of events was reported as recovered for all the events in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Starting the first  day I had muscle aches, swollen glands, headache, tiredness  and chills, this lasted for three days.  Then I did feel better for a few days but had some tiredness.   Then Sunday the 28th my body seemed over whelmed with sweats and chills, I developed a rash in my groin area and realized that I had a yeast infection that was affecting my vaginal area, groin, and mouth.  I have been treating this with a natural yeast complex and Monistat.   I am starting to do better today but felt that I needed to report it to see if others were having the same problem.  I feel that the injection adversely affected my body's normal  hemostasis and the yeast was the results.  I am not looking forward to getting the next shot.  I think I did have Covid 19 in late January or early February before it  was widely known  and there were no tests.   I will keep treating myself with natural remedies as chemicals will just inflame the yeast at this time.  This is not life threatening but wanted to report the abnormal reaction I have experienced.
Within 24 hours of vaccine administration, patient started with dizziness, headache, stomach upset, and waves of heat.  Patient was instructed by MD to rest, increase fluids.
Very tender arm and headache for first 24 hours, 36 hours post injection, pain and headache were accompanied by nausea, chills and extreme tiredness
Information has been received from a physician concerning a 5 year old female who on 10-MAY-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. The physician reported that the practice ordered Varivax and Zostavax was sent by the pharmacy. The vaccine was put in the freezer where Varicella is normally kept and the medical assistant administered the vaccine assuming it was Varivax. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Second booster. 3rd day after, fatigue and flu-like symptoms (sore throat, slight cough, intense headache; sweats and chills); 5th day after, fever (peaked at 100.6) and insomnia; 6th day, throat and chest no longer sore; upset stomach begins (cramps and runs); 8-9 days after, strength returning but still under par.