chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt and pt's mother noticed swelling and tenderness to left deltoid area starting on 9/15/01. She was seen in the MD's office on 9/19/01.
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID complications.  Provider d/c note:  "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented with dyspnea found to be hypoxic and covid positive. CTA did not show pulmonary embolism nor pneumonitis. Started on decadron, remdesivir and given a few doses of diuretic with interval improvement. His o2 sat was great at rest but close to needing o2 on discharge. He states he has nocturnal oxygen he can use but doesn't plan to use it. Discharged with remainder course of 10 days decadron after only getting 3 doses remdesivir."
The child woke from nap with swollen right arm, which was hot, painful to the touch. The child also experienced difficulty in standing in walking and the next day his right foot was drawing backwards. The pt was taken to PMD and was advised not to have any more DTAP's Child is doing somewhat better.
reported reactions at the site; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients on behalf of Physician. This is the first of two reports. An adult patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date single dose for immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that a patient reported reactions at the site. She did the reassuring thing, like to take Advil, and put ice on it, and told them to call back if it didn't improve. Outcome of the event was unknown.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019164502 same reporter, same product, same events, different patients
Migraine for 4 days..diarrhea nausea  feel weak stomache pain
A spontaneous report has been received from a consumer. The report concerns a female patient (age 13 years, height 59 in, weight 76 lbs). No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown. Concomitant medication included sertraline for anxiety (since 2017). The patient received FLUMIST QUADRIVALENT (live, attenuated) 0.2 ml once/single administration, via nasal route, for prevention of influenza during 2007. On 27-FEB-2019, the patient experienced flu (preferred term: Influenza). At the time of reporting, the event was ongoing. The event was considered non-serious.
More pain than expected from tetanus vaccine.  Pain did not resolve for many weeks.  After a couple of months, I started to have pain beyond the injection area with some shoulder motions.  In February, 2016, PCP recommended PT which did not help.  In May, 2016, an orthopedist made the diagnosis of adhesive capsulitis of the left shoulder.
SOFTBALL SIZE RED AREA ABOUT INJECTION SITE, WARM TO TOUCH AND SIGNIFICANT SHOULDER PAIN
Received 1 dose of Moderna COVID-19 vaccine; State Immunization registry indicates patient received a dose of Pfzier vaccine on 04/21/21.
PATIENT COMPLAINED OF FEELING OFF. PATIENT DIAPHORETIC. OBSERVED AND DRANK WATER
This case was reported by a physician and described the occurrence of arm soreness in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included high blood pressure. Concurrent medications included unspecified blood pressure medication. On 26 October 2010 the subject received 1st dose of FLUARIX in the right deltoid. On 27 October 2010, 1 day after vaccination with FLUARIX, the subject experienced arm soreness (subject complained of injection site soreness) and swelling at the injection site. The subject was advised to treat with ADVIL and compression to injection site. The next day, on 28 October 2010, the subject complained of sustained tooth-achy type sensation (toothache intermittently). As of 11 November 2010, more than two weeks following onset of events, the patient continued to complain of sustained tooth-achy type of sensation; upper arm to nape of neck. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with FLUARIX. No further details were available at the time of reporting.
Chest tightness and chest pain. Pain with deep inspiration. Nausea and diarrhea. Tactile temperature elevated, no true fever. Symptoms lasted for 3 days before improving. Muscle pain and fatigue
2nd dose given too early. 1st dose administered on 1/5/21 and 2nd dose administered on 1/20/21
Pt presented to ED w/erythema and pain of injection site of pneumonia vaccine, received 3 days ago. Received BENADRYL, PEPCID, DECADRON, and PERCOCET discharged scripts.
Patient fully vaccinated with Pfizer vaccine x doses. Tested positive for COVID 19 on 8/6/2021 and died at home on 8/20/2021.
p/vax pt eyes started burning then nose, ears, mouth;went to hosp ER 4PM IV w/DPH, pred & rx for hydroxyzine HCl, difficulty swallowing;
Patient received vaccine at pharmacy, comes in different pharmacy reporting redness about 3-4 radius in size, a bit warm, a bit swollen.
Within 12 hours of receiving the vaccine I had horrible side effects. My joints have swollen to 3 times the normal size and it has gotten to the point I can barely walk and I am In excruciating pain. My right knee looks like it is dislocated it?s so swollen and I can barely walk. The only option is to get a cortisone shot which is extremely damaging to the body. I am In perfect health otherwise and have never had any health issues prior to getting the vaccine. It is getting so painful I can not workout, go up or down stairs and feel like my leg is going to give out when I walk
Patient was administered an expired vaccine/ no AE; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Agency (Reference number- 00697308) and transmitted to Sanofi on 26-Jul-2021.  This case involves a two-year-old female patient reported that the patient was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (VAQTA) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  On 26-Jul-2021, the patient received 0.5 mL (once) fourth dose of suspect HIB (PRP/T) VACCINE [lot UJ356AAB and expiry date 25-Jul-2021] via intramuscular route in right thigh for prophylactic vaccination.  It was reported that, "Clinical Supervisor called to report that ACTHIB was administered to a patient on 26JUL2021, but it expired on 25JUL2021. Caller would like to know if this dose is considered valid and whether the dose should be repeated? Product used: Used".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse 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 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.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ANGINA, UNSPECIFIED 11/15/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Woke up on 1/26/21 with aches which lasted until 1/27/21. After I got up I had loose bowel movements approx. 15-20 mins apart for approx 2 hours.  Felt nausea upon waking and for 2-3 hours.  Became dizzy about 1 1/2 hour to 2 hours after waking. Duration of dizziness approx 1 hours. Tired all day.   1/27/21 woke up with all symptoms gone. New symptom was swollen lymph gland under right arm and very sore.  Duration 3 hours so far.  Will call primary doctor.
Swelling of face, hands, eyes, redness, rash on hands (B), (B) arms, chest area, light rash and burning on thighs and legs, BENADRYL, hydrocortisone cream, CLARITIN.
Pt received FLUVIRIN to L deltoid on 9/18/09. Stated she started having pain to her L upper arm on that evening and has continued with pain to that arm. Pt reported the incident on 10/8/09.
Information has been received from a physician concerning a 12 month old female with no known drug or food allergies who on 30-NOV-2004 was vaccinated in the right thigh with a 0.5 mL dose of Varivax (lot # 649268/0647F). There was no concomitant therapy. In June 2005, the patient experienced vesicular lesions/chicken pox. On 27-JAN-2007 the patient developed shingles/herpes zoster described as 6-7 vesicular lesions on her back only. The patient felt itchy with a pain level of 1 out of 10. There was no recent exposure to chicken pox. Her maximum temperature was 97.6 degrees Fahrenheit. There was no fluorescent antibody testing or PCR performed. The patient recovered. No further information is available. It was reported that two older siblings developed chicken pox after Varivax (WAES0703USA02158).
EMS called to pt's house due to fever, generalized weakness, cough, myalgias; O2 saturation 88% on RA; O2 supplement; found to be positive for COVID; admitted; AHRF secondary to COVID pneumonia; Decadron; US showed DVT left peroneal; started on Eliquis; placed on BiPAP; developed left pneumothorax, Chest tube placed; pt changed status to DNR/DNI, comfort measures only; pt expired in the hospital
? Fatigue ? Cough     Stracthy throat x 1 week, now it's getting worse. producitve ? Shortness of Breath ? Nasal Congestion ? Dry Mouth ? Diarrhea     2 nights ago ? Headache ? Poor Appetite ? Chills ? Generalized Body Aches  Flonase nasal spray  Tylenol
Recipient was seen for homebound COVID-19 vaccine booster.  Prior history of J&J for primary series 6/28/2021 and Moderna booster 2/3/2022 both of which recipient reported as tolerated well.  Due to history of allergy to medications a 30 minute observation period was in place.  Per PHN who administered vaccine, recipient was alert and oriented sitting in a chair after vaccine administered, soft spoken, approximately 10 minutes after vaccine administered the recipient complained of feeling dizzy, had not eaten that day, was able to drink a small amount of orange juice, became increasingly lethargic,
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Patient reported itchiness after the shot. Was monitored for anaphylaxis - yet no signs so she went home. Three days later she called pharmacy to report still feeling  itchy all over
Neck pain - moderate to severe Left arm pain - severe Headache - moderate Chest pain, left side -  moderate
Patient received GARDASIL-9, BEXSERO, VAQTA, and MENACTRA. Pt and mother were instructed to wait 10-15 minutes in waiting room following vaccine. Pt exited to waiting room to wait and was seated next to her mother. Pt reported at that time she felt "fine". A few minutes later mother came to door yelling for assistance. Pt was found slumped over on chair and appeared unconscious. Pt was lowered to the floor by staff. At that time, pt became conscious and was stating she could not hear. Pt was allowed to rest lying on the floor with ice pack. Pt reported she was feeling better and sat up to drink a cup of water. Pt was alert and oriented x3 at that time. Pt then stood and rested in the chair for additional five minutes. Pt reported she was feeling fine and mother wanted to take her to get something to eat. Nurse walked pt and mother to the car. Pt appeared to have recovered from episode at that time.
7 days post vaccination, developed tenderness, warmth and swelling at injection site, size of  her palm.  Did not seek treatment, resolved within 4 days.
Was diagnosed with shingles and treated with antiviral with good results First vaccine was 1/6/21 and second vaccine was 1/27/21.  Developed shingles approx 9.5 weeks later.
Vaccine administered at 3:00pm 3-21-21 Fever (99+), Chills, Aches, Headache start at 2:00am 3-22-21 Started Tylenol 500mg doses at 7:00am 3-22-21 and repeated every 6 hours. Symptoms ended 9:00pm 3-22-21 after 3rd Tylenol dosage.
12/6/07 Patient observed with right deltoid having 5 x 8 cm. area with significant swelling, redness, nontender, warm to touch. Following injection in the AM 12/05/07 patient went swimming that evening. 12/7/07 patient rechecked and area with less redness but increased swelling.  Benadryl given in office 12/6/07 and instructions to continue every 4-6 hours in additon to applications of cold/ice to area.  To follow-up if worsens.
SORE ARM WITH FIRST TWO COVID VACCINE SHOT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM WITH FIRST TWO COVID VACCINE SHOT) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM WITH FIRST TWO COVID VACCINE SHOT). In 2021, VACCINATION SITE PAIN (SORE ARM WITH FIRST TWO COVID VACCINE SHOT) had resolved.            No concomitant medication was reported. In 2021, the patient experienced OFF LABEL USE, RIGHT HAND SWOLLEN LIKE A BALLOON/RIGHT HAND COULD NOT CLOSE AND HURTING and SORE ARM WITH FIRST TWO COVID VACCINE SHOT.  On 04 Dec 2021, the patient experienced STOMACH UPSET, SLEPT MOST OF THE DAY AWAY and WAS LOOKING REALLY PALE. In 2021, the SORE ARM WITH FIRST TWO COVID VACCINE SHOT resolved. In December 2021, the STOMACH UPSET, SLEPT MOST OF THE DAY AWAY and WAS LOOKING REALLY PALE resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was not available.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-628605 (Patient Link).
I got the shot around 12:45 PM. By 8 PM, I started with a fever. I took tylenol and went to sleep. By 11 PM, my fever was at a 104.7 and I was vomiting uncontrollably for the whole night. My fever did not go below a 102 until two days later. I was unable to keep water down. I was also extremely fatigued. My fatigue has not gone away since. Basic chores completely wind me and knock me out. The fatigue is so bad that I had to nap for hours each day. I have also had numbness and tingling in my fingers and toes. I tried to ignore it, but it became painful so I started making doctors appointments because I felt like maybe something was really wrong. I also have had extreme joint and muscle pain to the point I can't move some days. The right side of my body keeps going numb. This has been going on since last April and I haven't been the same since. I have gone to so many doctors and nobody knows how to help me.
wife was injected by the needle in the right arm, but "screamed out" because the needle was put in a bad spot; keeps her awake at night; Right arm is still hurting her and is getting Worse; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9263), via an unspecified route on 29Jan2021 (at the age of 76-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient experienced was injected by the needle in the right arm, but "screamed out" because the needle was put in a bad spot. The vaccine provider then administered dose in left arm. Reporter says his wife is still having right arm pain. Reporter was unsure if wife had vaccine dose injected into right arm or just needle insertion. Reporter says 2nd dose was given in left arm because right arm was still hurting at the time of 2nd dose. She had 2 of them, the first was on 29Jan2021 and the second was on 26Feb2021. Reporter asking what he and his wife should do about the arm pain. Reporter stated that his wife had severe pain in the right arm from the first shot and it keeps her awake at night. What his wife said was at the site, for the first dose they initially put the shot in the right arm and then the person administering the shot said they had a problem, and so then they put the shot on the left arm. Reporter stated that he thinks the needle broke in the arm. He again confirms that they made an attempt to administer the vaccine on the right arm, but because they had a problem administered the vaccine in the left arm. After his wife was done he saw that the patch was placed on her left arm. Her Right arm is still hurting her at the moment. He asks is this normal and how to deal with it. He confirms it was her right arm still hurting her and getting Worse. The outcome of the event keeps her awake at night was unknown and other events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested  Follow-up attempts are completed. No further information is expected.
I missed my period for the following 4 months after receiving my 1st covid vaccine.  (I have always been regular)
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: stiff/frozen in position hand-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: pt can not hold/grasp items such as a pen. started with arm pain/swelling - now hand is "locked" in a position where thumb meets pointer and middle finger - went to urgent care who told them they could not help. iI referred to ER/neurologist for consultation.
Information has been received from a pharmacist concerning an 80 year old female with no pertinent medical history who on 29-JUL-2008 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #658859/0411X). Concomitant therapy included unspecified cholesterol and blood pressure medication. On 01-AUG-2008 the patient experienced an injection site reaction which was golf ball size. The area was red, itchy and warm to touch. On 04-AUG-2008 the patient went to see the pharmacy. No laboratory diagnostics studies were performed. At the time of this report, the events persisted. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a pharmacist concerning an 87 year old female with no known drug allergy and a history of breast cancer (not treated currently) and lumpectomy who on 29-JUL-2008 was vaccinated subcutaneously in left arm with the 0.65 ml first dose of with ZOSTAVAX (Oka/Merck) (lot #658859/0411X). Concomitant therapy included unspecified cholesterol and blood pressure medication. There was no illness at time of vaccination. On 01-AUG-2008 10:00 AM, the patient developed a large lump at the site of injection (golf ball size). The area was red, itchy, warm to touch and sore. Patient treated with warm compresses. On 04-AUG-2008 the patient went to see the pharmacist. Subsequently, the patient recovered from the symptoms. Additional information is not expected.
PATIENT REFERS DIFICULTY IN BREATHING AND SWALLOWING AND NECK PAIN.
No additional AE reported; four year old patient was accidently administered GARDASIL 9 today, Apr 18, 2022; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On 18-APR-2022, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, frequency reported as once, lot #T028583, expiration date: 04-MAR-2023, (dose, site and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event was reported.
Patient received FLUVIRIN and PNEUMOVAX-23 in left arm 12/7/2013. Called back 12/9/13 and 12/11/13 to complain of pain and limited movement, (no swelling, redness numbness).
Pfizer vaccine caused the death; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter claimed that Pfizer vaccine caused the death of the doctor (patient). No further details reported.  No follow-up attempts are possible. Information about lot and batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer vaccine caused the death
Patient developed a rash several days after receiving her first dose of the moderna vaccine. Rash is present across her body - mostly legs, but also arms.