chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness under her left Arm; swollen lymph node; Chills; chest tightness; Dizziness; A spontaneous report was received from a healthcare professional concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chest tightness/chest discomfort, dizziness, chills, soreness under her left arm/pain in extremity, swollen lymph node/lymphadenopathy.  The patient's medical history included asthma. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) chest tightness, dizziness, chills. On 24 Feb 2021, the patient experienced the event(s) soreness under her left arm, swollen lymph node.  Treatment details included rescue inhaler.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Feb 2021 the outcome of event(s), chest tightness, dizziness, chills was resolved. The outcome of event(s), soreness under her left arm, swollen lymph node was unknown.
This spontaneous report as received from a registered nurse refers to her husband who was the 56 years old male patient with high cholesterol. The patient was vaccinated with a dose of ZOSTAVAX on the left deltoid on 03-DEC-2012. No other co-suspects were reported. Concomitant medications included: LIPITOR. His past drug history included heaviness when he had the flu vaccine. On 04-DEC-2012 the patient experienced redness, itching and swelling to baseball size at the injection site. About 2 days later (on approximately 06-DEC-2012), the redness and size resolved and itching resolved after five days later (on approximately 09-DEC-2012). On 09-DEC-2012 the patient started to have nerve sensation on his right clavicle that bothered him only when clothes touched the area. He saw his physician on an unknown date in December 2012 who stated that he nerve irritation and might or might not be related to ZOSTAVAX. No labs were performed. As of 17-DEC-2012 he did not plan to have any more ZOSTAVAX and he continued to nerve sensation on his clavicle that bothered him only when clothes touched the area. This is one of several reports received from the same reporter. Additional information has been requested.
Night of    severe pain right arm, not able to lift arm.  Next day, sore throat.       Did contact Doctor.
I have had a horrible taste in my mouth since 10:15 AM MT. There is no loss of taste, as I can taste all of the foods/snacks I have eaten since the onset of symptoms.  The horrible tastes comes back as soon as I swallow my food and has lingered since its onset
Patient states she experience peripheral neuropathy after receiving the vaccination.   Initially presenting in her left hand and moving to her right hand over a period of 2.5 weeks.  Neuropathy then moved to feet for additional week.
Post vax, the pt developed swelling and redness in left upper arm, 4 inches in diameter. Very uncomfortable. No relief from ice or Claritin. Pt seen in ER and treated with IV antibiotics and discharged with Augmentin for 14 days.
Information has been received from a registered nurse (R.N.) concerning a 23 year old female with abnormal cervical cell result and no drug allergies who on 06-OCT-2010 was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL, on 08-DEC-2010 was intramuscularly vaccinated with the second 0.5 ml dose of GARDASIL (lot # 666595/0992Z, exp date 14-OCT-2012). Concomitant therapy included birth control pills. The reporter stated that patient experienced local reaction around injection site after receiving second dose of GARDASIL on 08-DEC-2010. Patient called next day to complain of the tenderness around the injection side and little bump. Patient was prescribed TYLENOL and told to apply ice pack. Patient came in on 21-DEC-2010 for an office visit and bump around the injection was still present. Tenderness to touch was also noted. No lab diagnostics studies were performed. Additional information has been requested.
After receiving the Omicron variant booster on December 5, 2002 which was a Monday, on Thursday, December 8, I woke up with pan and aching in my left groin and upper thigh.  Previously, I had no problems with this.  Upon tracing back to when I had a previous booster (Pfizer), I also had the same pain and strong aching in my right leg and went through 6 months of physical therapy and had a shot for pain in the right groin.  The shot nor the PT helped the issue at all.  Now I have both groin areas affected and am having trouble walking, getting up from chairs and bending from the waist.  Have had a few sleepless nights with pain but mostly the symptoms are felt during the day.  Quite debilitating for me as I have always exercised and walked every day.  Now I cannot.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    On or about 24-JAN-2011 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. On or about 24-JAN-2011, the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.   On an unknown date, reported as subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event shingles to be serious due to hospitalization and life threatening.
Around three minutes after, pt had a tantrum and started rubbing his eyes and spots appeared on pt's forehead.
In 14 minutes facial cheeks,nose, lips tingling and num accompanied with dizziness-nurses evaluated with elevated blood pressure and very high heart rate-EMTS also evaluated & said I could go to hospital for observation but I refused. I remained for hour with unchanged symptoms-left took a Benadryl and it helped with tingling. For remaining 36 hours was short of breath and difficulty swallowing. Continued on Benydril for 2 days-olater symptoms were side effects fatigue headache, joint pain, chills, tenderness at injection but mild
I have all the not severe' side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient had all the not severe side effects. The patient enquired how long did the Shingrix side effects last. The permission to follow up was denied.
Migraine, nausea, dizziness, insomnia, none relieved by excedrin 500 mg dose
No adverse event .  Hep A exp. 08/09/2022.  Dose given  on 8/10/2022.  Client called and informed.  Will repeat dose.
Information has been received from a nurse concerning an 18 year old female who on 30-OCT-2006 was vaccinated with the first dose of GARDASIL. On 30-OCT-2006 the patient developed a "rash on the palm of her hand and also red, itchy eyes." The patient sought unspecified medical attention. The nurse reported that the patient had recently purchased new eye makeup. At the time of this report, the outcome of the events were unknown. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 11/14/2006. Initial and follow up information has been received from a nurse concerning an 18 year old female student with no pre-existing medical conditions and no known allergies reported. On 30-OCT-2006, at approximately 9:30 AM, the patient was vaccinated with the first dose of GARDASIL (Lot# 653650/0702F). There were no illnesses noted at the time of vaccination. On 30-OCT-2006, at 11:00 AM, the patient developed swollen eyes and rash to hands and feet (previously reported as a "rash on the palm of her hand" and also red, itchy eyes). The patient sought unspecified medical attention. The patient reported that she had a new makeup product applied several days around the injection. The patient went to the school clinic after the onset of symptoms. The patient was treated with ALLEGRA and the symptoms improved in approximately 24 hours. On 31-OCT-2006, the patient had recovered from the events. Additional information has been requested.
Difficulty sleeping.  General feeling of being unwell.  Morning 04/22/2019 5 am to 6 am drenched in sweat, nausea, vomiting and lightheadedness.
Initial misuse report received from a healthcare professional (nurse) on 17 September 2013 and the case was received on 21 March 2014 at agency. A patient (gender and date of birth was not reported) had administered only the ACTHIB portion of PENTACEL vaccine with sterile water and DTaP-IPV portion was not administered on 16 September 2013. No adverse event was reported. List of documents held by sender: none.
Violent shaking, 101 degree fever, severe headache and pain in upper cervical region, malaise, body aches, dry mouth and white tongue turned to red tongue and tongue paresthesia which worsened over 3 days and persisted for 2 weeks, hearing difficulty and sloughing of skin on palms of hands and feet.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: K011239, expiration date on 11-JUN-2016 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. No previous temperature excursion was reported. Other suspect therapies included a sterile diluent (lot #: K026419, expiration date: 19-OCT-2017; Lot #: L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
menstrual cycle early; rash on chest; rapid heart rate; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate), MENSTRUATION IRREGULAR (menstrual cycle early), RASH (rash on chest), FATIGUE (fatigue) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). On 11-Apr-2021, the patient experienced HEART RATE INCREASED (rapid heart rate). On 12-Apr-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual cycle early) and RASH (rash on chest). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, FATIGUE (fatigue) and HEADACHE (headache) had resolved. On 13-Apr-2021, RASH (rash on chest) had resolved. At the time of the report, HEART RATE INCREASED (rapid heart rate) and MENSTRUATION IRREGULAR (menstrual cycle early) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-FEB-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in arm 3 days after shot then two weeks later developed rotator cuff pain 2 weeks after injection. Then 2 days after rotator cuff pain developed shingles.
My sister and I and our husbands we all got the vaccine and had a little sore arm after; This is a spontaneous report from contactable consumer. This consumer reported similar events for 3 patients. This report is for 1st of 3 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced my sister and i and our husbands we all got the vaccine and had a little sore arm after. Reporter spoke with someone before being transferred to report the side effects. Reporter states "My sister and I and our husbands we all got the vaccine and had a little sore arm after. My sister noticed this morning her teeth are chattering and the chin is moving up and down." Reporter wants to know if these symptoms are reported with Pfizer COVid-19 vaccine mainly the one her sister had this morning. The outcome of the event was unknow.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111789 same reporter/drug/event, different patient
Red rash on left arm near injection site. Rash is a large red patch that is warm, and continues to grow in size. Rash did not appear until two days after the shot.
My friend (60 yrs old) had high blood pressure after the Pfizer Covid19 vaccine."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 60 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "My friend (60 yrs old) had high blood pressure after the Pfizer Covid19 vaccine."". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Left arm where injection was given is sore at the site of the injection.  If I sleep on my left side my arm will hurt for 4 to 6 hours after I awake.  If I lean against something my arm will ache where the injection was given.  I don't think this is normal.  I had the covid vaccination of 04/01/2021 -- 2 months ago and to have my arm hurt is not normal.  I have never had pain from an injection of a vaccination.  I did not have any pain from my first injection. only the second injection.
This case was reported by a nurse and described a 47 year old male patient who did not respond to the hep-B vaccine.    On 30 December 2003 and 02 FEB 2004, the patient received the first and second dose of Energix-B.  On 01 JUL 2004 the patient received the third dose.  Approximately two months after the third dose on an unspecified date in SEP 2004 a hep-B surface antibody titer was "negative".  The reporting nurse considered the event to probably be related to vaccination with Energix-B.
Pt woke up at 1:00 am with chills, this continued till aprox 4-5:00 am. Pt denies fever and chills at this time.Today pt is feeling unusually tired and reports aching legs
First noticed redness and itching at site of injection approximately one week after injection. Continue to have redness (large circle) and itching at injection site.
On Saturday, April 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT #EW0217 , EXP 7/15/2021) at approximately 2:20 pm. After vaccine was administered, client directed to observation area for 15 minutes. At 2:25pm, RN observed the client leaning forward in chair and noted that client was falling toward floor. Ae, RN responded at 2:25pm with  EMT. RN responded at 2:25 pm. RN found client on the floor in prone position. Client stating she needs to vomit. Client prompted to lay on one side with help of RN. Upon assessment, client alert and oriented to self, place, and situation. Client denied allergies. RN offered client Benadryl IM. Client denied stating "it makes me sick". RN gave direction to EMT to call 911. Client admits to history of "vasovagal reactions" after lab blood draw procedures. At  vitals were taken: BP: , HR: , RR:  O2 sat: %. Vitals at 2:25 pm: BP: 110/70, HR: 58, O2 sat: 98%.  Client denied shortness of breath, swelling of throat or tongue, chest pain, difficulty swallowing, palpitations, or dizziness. Nausea and vomiting resolved at 2:26 pm. Vitals at 2:31pm: BP: 114/70, HR: 59, O2 sat: 97%. At approximately 2:34pm, EMS arrived on seen. RN provided report and informed EMS that client denied benadryl. Client transported to ambulance vehicle at 2:42pm. Per EMS, client signed against medical advice and will be taken home by step mother. RN observed client until client was picked up in by step mother. Client was educated by Lead RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to follow up with PCP as soon as possible. Client was able to ambulate with Lead RN to her car unassisted with a steady gait at approximately pm. Client was driven by step mother.
Information has been received from a physician concerning a 24 year old female with no drug reaction/allergies who in November 2007, was vaccinated IN in the hip with the first 0.5 mL Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 28-DEC-2007, the patient was vaccinated IM in the hip with the second 0.5 mL Gardasil.  On unspecified date after each vaccination, the patient developed enlarged lymph nodes in the groin.  A complete blood count with results within normal limits was performed.  The patient's status was not reported.  There was no product quality complaint involved.  Additional information has been requested.
herpes lesion in cornea; arm swelled; red arm; painful arm; This case was reported by a consumer via call center representative and described the occurrence of corneal herpes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received Shingrix. On an unknown date, 28 days after receiving Shingrix, the patient experienced corneal herpes (serious criteria GSK medically significant), pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the corneal herpes, swelling arm and erythema of extremities were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the corneal herpes, pain in arm, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix, 4 weeks ago from the time of reporting. After that the patient experienced painful reaction for 8 days. The patient's arm swelled and became very red and painful. The patient had a herpes lesion in cornea.
On 9-22-10 infant received Hepatitis A (HAVRIX 0.5ml) immunization IM (L) thigh, per phone interview with mother 9-23-10 -> infant with decreased appetite, sleepiness, sl fussy.
Pt experienced swelling, redness, fever and hardening of left thigh. Pt was treated with antibiotic therapy.