chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got booster shot on November 5,2021 and I noticed on November 6, I noticed it was hot and started itching. It was swelling up and had a lump in my arm. I also experienced a headache that was the worse I've ever had and did take some Tylenol. I put cortisone cream on my arm and took some Claritin and it didn't go away. It took about 3-4 weeks, but it still itched. Then it went into my back and shoulder which had a knot on it. It was small now it's pretty big. I've been putting heat on it and I'm not sure what to do with that. The doctor took x-rays to see if it was something else, but she said that she didn't know what happened. It just popped up. I couldn't lift my left arm up very well for a long time either. Another symptom I experienced after the booster was a fast heart rate for about 3 months. I did experience some breathing problems like not being able to catch my breath and some weakness in my legs where I couldn't walk. I did experience light chills, but nothing else like that. Knot in the back is still there, put hot pads on it to try and relieve symptoms. Knot is not hard, just soft, unsure of what it could be.
Near syncopal episode approximately 15 minutes after vaccine administration.  Pt became cool, clammy and diaphoretic.  Complained of feeling dizziness.  Pt was ambulated to Urgent Care.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 02-DEC-2013, the two unspecified patients were vaccinated with PROQUAD, 0.5ml subcutaneously, lot # J006569, expiration date 30-NOV-2014. The patients received doses of PROQUAD (Merck) but were supposed to receive M-M-R II. The doses of PROQUAD (Merck0 that were administered were exposed to temperature outside of the proper storage range. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccine administered on Friday 8-17-18 at Pharmacy. Patient started having fever, arm tenderness, swelling and redness which expended around injection site and down arm several inches. Was seen in ER and diagnosed with Cellulitis on 8-18-18 and started on an antibiotic. On 08-21-2018 Patient came to pharmacy - area was marked with marker - to update me on her situation. On 08-23-18 patient called me, stated she seen her normal provider (Dr) on 08-22-2018. The area had worsened and continued further down her arm through 08-22-18. On 08-23-2018 it was starting to lessen and was half as big as it was per patient report.
The resident was found unresponsive in his bed at 11:15AM.  CPR was initiated but unsuccessful.  The resident was pronounced deceased after attempting CPR for an hour.
Fever and Rapid heart rate to 160, hospitalized and had cardioversion but rate only controlled for a few hours.
Very swollen gland above collar bone on left side.  It has been over 2 weeks since "I" received the second dose of the vaccine and my gland is still swollen; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 14Apr2021, the patient had very swollen gland above collar bone on the left side that had been over 2 weeks since the patient received second dose of vaccination and her gland was still swollen (when reported by the patient). The events did not result in doctor or other healthcare professional office/clinic visit, 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 very swollen gland above collar bone on the left side was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse referring to a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (Lot # K012457, expiration date 04-JUN-2017) and (Lot #M011116, expiration date 17-JUN-2017) doses and routes were not provided. There was no concomitant medication reported. This is one of three cases received from the same source. Additional information has been requested.
Arm hurts; Body aches; Tiredness/ sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches) and FATIGUE (Tiredness/ sleepiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches) and FATIGUE (Tiredness/ sleepiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches) and FATIGUE (Tiredness/ sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
When patient woke up the day after receiving the vaccine, patient stated the room was spinning.  Continued off and on for a week after receiving the vaccine.  Patient was able to perform activities of daily living.  Worse when the patient was laying down and tried to get up.  Tolerable when she was sitting.  Dizziness wasn't constant, but happened a few times throughout the day.
Information has been received from a health professional concerning an approximately 9 year old white male on 02-FEB-1998 was vaccinated with Varivax. Subsequently, the patient experienced a generalized rash with 50-200 lesions. The case was documented or evaluated by a physician. The child was not hospitalized. No additional information was provided. Additional information has been requested.
This spontaneous report as received from a consumer and the patient's daughter, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 12-MAY-2014, the patient was vaccinated with ZOSTAVAX 1 time vaccine. Lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The consumer reported that the patient received ZOSTAVAX and at the time of this report had shingles (on 13-MAY-2014). The outcome of shingles was unknown. Treatment was not specified. The patient sought medical attention. Additional information is not expected.
Received 3 vaccinations on 9/8/11. Flu vaccination in Rt arm. Received PNEUMOVAX and TDAP vaccinations left arm - presented with fever 101.2, erythematous area measuring 22cm x 17cm.
within seconds horrible headache and dizziness.  within 10 minutes sever burning over skin on feet, legs, chest and scalp that developed into hives..  Developed shakes over body for near 12 hours.  took Benadryl and Motrin to combat head ache and hives.
Headache; sore left arm and shoulder, on across the top of my back, and to the right shoulder; 100.8 F temperature, vertigo, couple of shock-like zingers going across my back from left to right, upset GI, loss of appetite
This spontaneous report was received from a physician referring to 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # N003536, expiration date 02-NOV-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 19-JUL-2017 till 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 34 degrees Fahrenheit (F) to 50 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012766:
Parents report temp "110 degrees" had generalized "shaking" was given one shot, Tylenol, and prescription for 1 dose qd for 5 days. Seen at facility.  4/13/07 Received medical records from hospital which reveal patient seen in ER on 12/10/06 for possible febrile seizure, nasal congestion & ear pain w/vomiting x 1.  Temp 102.6.  TM's distended, right greater than left.  Anterior lymphadenopathy present bilaterally.  Given antibiotics in ER & upon d/c. FINAL DX: Febrile seizure, right otitis media.
pain in right upper arm, patient states the pharmacist gave too far over on the deltoid since she was having a hard time getting her sleeve higher.
increased heart rate over 150 directly following injection. Shakiness/numbness in left hand.   Numbness/tingling and pain in left hand continues several months later
Patient was administered HPV vaccine without issues/complaints. Escorted to waiting room, ambulating without assistance. Patient later stood and walked to front desk with mother, at which point he felt dizzy/lightheaded and was guided to the floor with assistance of staff. Patient placed in semifowlers position, BP was checked, cool compresses applied to head/neck, and patient offered sips of juice until recovered to a sitting position. Patient monitored for 15 minutes and released with mother after symptoms resolved. During recovery mother informed staff that patient's father has had syncopal episodes following injections in the past, recommended to patient and mother that in the future staff being informed about possibility of syncopal events.
From initial information received on 26MAY2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt receiving first of of YF Vax, administered IM in the distal right posterior deltoid on an unspecified date. Several hours after receiving the vaccination, the pt noted numbness and paresthesias involving the right medial scapula and entire right arm. No systemic sxs were reported. The pat was seen in the ER on 24MAR2004 with weakness and numbness of her right hand. The pt's recovery status was reported as unknown. The pt also received a Hepatitis A vaccine on 17MAR2004, in the right posterior deltoid. It was not reported whether the Hepatitis A vaccine was administered post or prior to the YF VAX.
PT FELT BURING THROUGH, THEN STOPPED AND DEVELOPED HIVES AND VAS VERY ITCHY
Initial report received on 07 October 2011 from a healthcare professional. This case involves 1 of a cluster of 2 patients from the same reporter, where the same vaccine was administered with the same lot number. Information pertaining to the other patient is captured in case number 2011-09782. A female patient (date of birth not reported) had received an intramuscular injection of FLUZONE (lot number UH477AB) on 05 October 2011 and approximately 7 hours later developed petechiae on the back of her soft palate and throat that was dark red in color. She also experienced hoarseness and redness in her cheeks. No other information was provided. At the time of this report, the patient had not recovered. Follow-up information was received on 09 January 2012 from a health care professional. Based upon the new information provided, this case has been upgraded to serious. The patient was a 56-year-old female. The patient had received the vaccination in the left deltoid. The patient experienced the petechiae on the soft palate/uvula and also experienced swelling of the tongue and face (date of onset not reported). The patient had no illness at time of vaccination and no pre-existing medical conditions. No further information was available at the time of the report. The patient's outcome remained not recovered. Documents held by sender: None.
(L) lateral arm - 4.5 in x 5.5 in red, hot, itching. BENADRYL, ZYRTEC, KEFLEX.
Twenty four hours post vax, the patient developed redness, tenderness, and swelling in the right deltoid. These symptoms occurred immediately following exercise. The patient was treated with aspirin after the injection and following the exercise.
Half of my left hand went slightly numb 30 minutes after I received the first dose. Today, 01/16/21, my hand finally returned to normal
Hard time walking to the kitchen; Injection site began to hurt; Headache; Body aches; Weakness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, general body pain, weakness and nausea. On 28th January 2020, the patient experienced walking difficulty. On an unknown date, the outcome of the injection site pain, headache, general body pain, weakness, nausea and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, general body pain, weakness, nausea and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and that on same day around 6 pm, the injection site began to hurt. She started experiencing headache, body aches, weakness, and nausea. She took some medication and her symptoms are less, but she still has them. She said she had a hard time walking to the kitchen this on the morning of reporting date.  The reporter consented to follow up.
devel h//a day p/flu shot felt weak & nauseous & lightheaded; residual tiredness;
Pt had double vision, dizziness, for 5 months and still on and off. Occurs on her right now. She went to see family Dr and neurologist, but they did not find out any diagnosis for her.
First vaccine on 03/12/2021: Noted injection site pain and swelling, fatigue, foggy mentally on day 2. All slowly resolved by day 5. Day 8, 03/20/2021: Itching of head, arms, and chest. Felt general malaise, and lightheaded with movement or any activity.  Day 9, 03/21/2021: Injection site erythema and swelling greater than 15 cm.  Day 10, 03/22/2021: PETECHIAE of lower extremities from uper thighs to ankles.  Day 12, 03/24/2021: First sign of improvement. Itching less, slightly less erythema at infection site, less lightheadedness with some increase in number of PETECHIAE. Continued to feel physically restricted.  At no time was there a fever, chills, or typical headache. However, there was occasional mild nausea,  Continued from page 1: and one migraine aura. Day 13, 03/25/2021: Appointment with local Internist who agreed with findings during his physical exam. Dx : "CUTANEOUS SMALL VESSEL VASCULITIS". Tx: Rest, observation, Labs, Avoid 2nd vaccine dose,  go to the emergency department with worsening of any signs or symptoms.  Day 14, 03/26/2021: No increase in the number of PETECHIAE. Day 15 to Day 25, 03/27/2021 to 04/5/2021: All signs and symptoms slowly resolving. Labs performed on  on 03/31/2021 at Day 19 were reported to all  be within normal limits on 04/02/2021.
Patient received her vaccine on 01/25/2021.  Two days later, she presented with an acute right MCA stroke with aphasia.
January 26, 2021 Pt w/ adverse reaction after received vaccines Bexsero and Menactra to LD IM. Pt noted to be teary, after 1st vaccine, sitting in red chair. After ma administered 2nd vaccine, pt noted to sway slightly in chair, pt w/ head forwad/ head down, ma/rn//Dr. at side, pt w/ eyes noted to be turning up/ eyelids fluttering. Pt went limp, B wrist started turning inward. Mother at pt's side, per mother pt w/ no hx of sz or fainting w/ vaccines. Pt not responding for approximately10-15 seconds, when pt responsive, slow to respond to RN's verbal questions. After approximately 1 min, pt able to state her name, dob, and where she was at. Pt moved to exam table after about 2-3 min w/ Dr. assistance, pt able to stand and ambulate slowly, Mother cont @ bedside. Pt layed flat, VS taken, VS: bp:122/72, hr: 72, O2Sat: 96% on RA, rr: 18, temp 97.6. Pt laying flat, cool damp cloth applied to forehead, pt instructed to relax, take deep breaths. Pt continued, alert/awake, pt instructed to slowly stand after 15min, able to ambulated to chairs in IZZ waiting area w/ SBA, NAD noted, mother continued at her side. Per pt feeling better.  VS cont stable, bp:125/76, hr:70, rr18, o2Sat: 97%, temp 98.2. Per Dr. pt okay to go home w/ Mother. Mother w/ other appt here in clinic w/ Dr. Pt and mother walked over to Faculty side of clinic. Mother/pt instructed to advise staff if pt begins w/ abnormal sx. Mother/pt v/u....................................................................RN  January 26, 2021 10:22 AM
Suspected vaccination failure; Had after Covid; Had after Covid; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles after Covid. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
patient reporting "robust" reaction. severe rash on arm, nausea and vomiting. patient felt miserable for 3-4 days following vaccine
3/24/04 upset stomach for 1 1/2 days. 3/25/04 low grade fever. 3/26/04 started breaking out (vesicles). 3/30/04 started Acyclovir & Benadryl.
Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; lot number C3609AB received on 07 October 2010, lot number C33669AA received on 03 December 2010 and lot number C3334AA received on 28 April 2011 and a dose of TRIPEDIA lot number U3470DA on 09 February 2012 (routes and sites of administration not reported). The subject developed cough on 14 August 2012, approximately 6 months after the last dose. On an unspecified date, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. It was unknown if a PCR test was conducted. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 05 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had not eaten all day. She began to feel much better after drinking some apple juice approximately 10 minutes after the vaccine. EMT came to evaluate her, but she chose not to go to the hospital.
11/27/22 presents to ED for "shortness of breath". PMHx of "asthma, hypertension, left bundle branch block, cardiomyopathy, and gout"
mom states 8PM pt acted tired, eyes rolled back, pt was hyporesponsive; pt cont to act lethargic until fell asleep @ 10PM; ok in AM;
4 1/2 x 5 cm area of induration right thigh, mild redness.
Pt was vaccinated in 1996. In 1999,the pt developed chickenpox subsequent to receiving one dose of varicella virus vaccine live.
bad rash reaction to the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (bad rash reaction to the moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (bad rash reaction to the moderna vaccine). At the time of the report, VACCINATION SITE RASH (bad rash reaction to the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Vaccine administered on 11/17/2014. Pt started noticing yellowish cyst/blister start about 10 days ago.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "Allergy_Fentanyl", notes: known allergies Fentanyl. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Paxlovid was taken on 14Dec2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.