chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 28 September 2009 from a consumer, who is the patient's parent. A 7 year old male patient, with a history of asthma and seasonal allergies, received a left deltoid intramuscular injection of FLUZONE (lot number not reported) on 25 September 2009. He had no illness at the time of vaccination and concomitant medications included SINGULAIR and fluoride. Five minutes after vaccination, the patient began sneezing repeatedly, coughing, he felt nauseous, his face became flushed and facial swelling occurred. He had no difficulty breathing or swallowing. His temperature was 99.9 F (tympanic) and his chest became red and blotchy, but he had no actual hives. Corrective treatment was BENADRYL which was given every four hours. At the time of the report, the patient was much improved, but he had not completely recovered. Follow-up information received on 22 October 2009 from a physician. The vaccine administered on 25 September 2009 was FLUZONE (lot number U3195AA). Per the reporter, the patient recovered (date not provided). No further information is expected. Documents held by sender: None.
severe pain in my muscle of my left shoulder blade and it radiated down into my elbow joint; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (left arm) on 30Jan2021 as single dose for COVID-19 immunisation. Medical history included diabetes. No Covid prior vaccination. No known allergies. No concomitant medications. No other vaccine in four weeks. He received other medication (unspecified) in two weeks. After dose number one, the patient experienced severe pain in his muscle of his left shoulder blade and it radiated down into his elbow joint on an unspecified date. Not Covid tested post vaccination. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Was given the PREVNAR 13 and influenza vaccines at the same time. Four hours later, became very cold and started shaking violently. At six hours had a temperature of 102.3. Took additional 6 hours to get temperature down to normal range. In meantime was sweating profusely and went through 3 changes of clothes and bedding. Possibly adverse reaction to administering both vaccines at the same time. Had no problem when either were administered singly. I see that this is a known adverse reaction in children and wanted to report it so you know it happens in adults as well.
Pt presented to the hospital with SOB and fever. The pt was given remdesivir and steroids
(+) PCR covid test 1/9/2022; hospital admission, extreme fatigue, SOB
Had been sick for 3 days; Headache was tolerable; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Had been sick for 3 days) and HEADACHE (Headache was tolerable) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 042L20A and 004F211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergic to almost everything (did not specify)) and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, RIVAROXABAN (XARELTO) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Had been sick for 3 days) and HEADACHE (Headache was tolerable). At the time of the report, ILLNESS (Had been sick for 3 days) had resolved and HEADACHE (Headache was tolerable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included Supplements and cholesterol medication, for unknown indication.  Patient did not consult with MD yet. Patient was unsure of the last 3 digits of dose 3 LOT due to poor handwriting.   This case was linked to MOD-2021-317581, MOD-2021-317587 (Patient Link).
While conducting monthly vaccine clinics, pt was administered the following vaccines: TWINRIX and TDAP. Approximately 3 minutes after receiving the vaccines, pt. stated "I don't feel well". Within a few seconds after the pt. statement, his eyes became glassy, complexion became pale and diaphoretic. Pt. loss consciousness approximately 5 seconds later for a period of less than 20 seconds. His breathing was regular during period of unconsciousness, pulse was 60 and regular and BP was 80/40. Upon regaining consciousness, pt. was moved to the floor and placed in Trendelnburg position. Ongoing monitoring continued and a cool compress placed on pt. forehead. 3-5 minutes after loss of consciousness, pt. blood pressure was 100/60, breathing regular, pulse regular skin color returning and pt. repotted he felt much better. Nursing assessment: Pt. appeared to have a Vaso-vagal response following immunization administration. Pt. assisted to a seated position on the floor for a period of approximately 5 minutes and continued to report feeling well. During that period of time the pt. was given instructions to alert medical personnel in the future of a history of fainting following a vaccine administration. Pt then assisted to a standing position. Reported feeling fine and escorted back to his housing unit. A check was done on the pt. later in the day and he reported no complaints.
Severe headache and vomiting onset 8:30am the next day, resolving 3:00pm  No known effect to pregnancy due 6/14/2021
induration, swelling & erythema w/2 days measuring 5cm x 7cm of induration;
Information has been received from a medical assistant concerning a 72 year old female with allergies to PENICILLIN, SERTRALINE, ZOLOFT, LOVASTATIN and SENTANUL and no pertinent medical history who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot# 659615/0162X). Concomitant therapy included CRESTOR. The patient developed local injection site reaction after receiving ZOSTAVAX vaccine. The injection site was red and swollen. The redness spread into linear streaks above and below the injection point. The patient had terrible pain on her arm and wasn't able  to sleep. The patient eventually developed a 2 by 5 cm oval erythematous patch on the left posterior upper arm around the injection point. The entire area was tender and had an appearance of severe inflammation, but it didn't appear to be cellulitis. The patient was prescribed BETAMETHASONE CREAM, CLARITIN, and BENADRYL. The patient saw the physician. At the time of the report, the patient was recovering. Additional information has been requested.
On Saturday I developed red itchy bumps on my Stomach and underarms. The itching continued throughout the day.  I took two Benadryl at bedtime and when I woke up Sunday the bumps were still there but the itchiness had stopped. As of Monday they are slowly fading and not itchy.
One week after receiving the first dose of the Pfizer COVID-19 vaccine I broke out in canker sores on the gums all over in my mouth. Date of outbreak was Saturday, November 13 and I still have them as of today, November 17. Painful
FEELS LIKE A LUMP IN THROAT, FATIGUE, NAUSEA. BEGAN APPROXIMATELY 7/7/02 AND CONTINUES AS OF 7/13/02 PM
Extreme swelling of arm, patient said she got up in the night to take something for pain and passed out, swelling continued next day, suggested BENADRYL and contacting primary doctor.
Patient was seen in our office on 10/12/22 for covid-19 vaccination and received a dose of Pfizer COVID-19 vaccine for 6m to 4 year olds. However, on re-examination of her vaccination record after vaccination,  it was noticed that the patient already received two doses of Moderna  COVID-19 vaccine for 6m to 5 year olds, which she received at an outside pharmacy. Therefore, the patient received an additional dose of COVID-19 vaccination in error. Patient received an influenza vaccination today in addition to the Pfizer COVID-19 vaccine.  I called and spoke with the patient's mother and and disclosed the vaccination error on 10/12/22 at approximately 3:20 PM. I also after spoke with a representative from the CDC and provided mother with a list of common side effects to monitor/call for based on their recommendations. At the time of the phone call, mother did not disclose any side effects. I discussed with mother that I will call the family for an update and advised for family to call at any time if side effects are experienced and offered for family to return to office for further discussion and/or evaluation in the next week.
A third moderna booster was given unintentionally after the second booster. Patient waited 30 minutes post administration(s). Patient was immediately made aware of what happened and experienced no adverse reactions. Patient was called 2 afterwards for follow up.
Severe ring in the injection side; Shingles had it vaginally in the outer / Is ongoing / Has also re-activated; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes zoster.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and shingles. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the injection site reaction and shingles to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had a severe ring in the injection site for several days. The patient previously had a shingles she had it vaginally. The reporter stated that the patient shingles re activated.
Itching , throat swelling. Burning palms ,hot flashes,  chest discomfort
VARIVAX was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to an 8-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 16-DEC-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (lot # T002845, expiration date 23-JAN-2022; strength and route were not reported) for prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of -14 degree Celsius to -10 degree Celsius (-12 degree Celsius) for 2 hours and 30 minutes recorded by a data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA002097: US-009507513-2101USA004102: US-009507513-2101USA004159:
After getting the shot Friday morning, I felt sluggish all day,  I went to bed early and woke up at about 2 am Saturday with joint pain on every joint in my body from my neck to my ankles. I could hardly get out of bed because my knees were so stiff. My hands were stiff and I couldn?t open and close them without pain.   It has been like that every day since. I?ve been unable to sleep and trying to turn over in bed is excruciating . I have been taking  Xtra strength Tylenol and that helps for about 2-3 hours
Shingles on the Right side of Face, Right side of Neck, Right Ear and Right side of her back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on the Right side of Face, Right side of Neck, Right Ear and Right side of her back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Nov-2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HERPES ZOSTER (Shingles on the Right side of Face, Right side of Neck, Right Ear and Right side of her back). At the time of the report, HERPES ZOSTER (Shingles on the Right side of Face, Right side of Neck, Right Ear and Right side of her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
Body aches in particular joints ache, headache, fever (>100F for three days), nose hurt, rash on stomach, arm hurt, mouth ulcers, weak, and hard to move.  Symptoms lasted for four days.  Did not see a doctor.
Shaking, headaches, weakness, muscle aches, veins hurt, shortness of breath,
Patient states she had severely dry lips for 4 weeks and cold sores. Patient reports a history of cold sores.
(L) arm was hot and red. Mother stated no fever. Instructed to put cold compressions and TYLENOL if she likes to give to help for pain or any other brand she wants over the counter, instructed orders per doctor.
Intense Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Intense Migraines) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Coeliac disease, Graves' disease, Pernicious anemia and Anemia. Concomitant products included VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Anemia.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MIGRAINE (Intense Migraines). On 25-Feb-2021, MIGRAINE (Intense Migraines) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patient's physician did not recommend that the patient should get the second dose of the vaccine.  Treatment included Ice packs.
Lower Limb Paralysis, Demylination in lower extremeties, Intestinal Damage. 06/09/2008 MR received for 2 OVs 1/20/2007 and 6/20/2007. Pt seen 1/20/07 (prior to reported vaccine) with c/o not walking and not gaining weight.  Bilateral lower extremities with decreased tone on PE.  Assessment:  Hypotonia. Referral to neurologist. Seen for last time in this practice on 6/20/07 for 18mon WCC. Noted at 16 months was able to walk holding on. Gait is wide-based. Neuro eval noted Gross Motor Delay. DTaP given. Parent/reporter now believes sx r/t genetic/chromosomal origin.
Breakthrough case after Covid vaccination. Dose #1 4/28/2021, C/O muscle aches, runny nose, sore throat, headache, fatigue, and earache/onset 9/1/2021
Inside of mouth - cheeks were swollen hanging over his teeth. Bottom lips swelled up 3 times the size. Pain on tongue, and back of throat swollen. Neck glands were swollen, painful to the touch. Longenzer taken - medrol taken for 1 week. Last night lips are still swollen.
The pt was given an incorrect dose of FLUZONE 0.25 mL instead of FLUZONE 0.5 mL. Guardians notified and patient is scheduled to come in for corrected dose and then will need additional dose as this is the first time receiving the flu vaccine.
Had a Fever 101F daily around 1PM for 3- 4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a Fever 101F daily around 1PM for 3- 4 weeks) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 011J20A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Had a Fever 101F daily around 1PM for 3- 4 weeks). On 02-Mar-2021, PYREXIA (Had a Fever 101F daily around 1PM for 3- 4 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 101 (High) 101F daily around 1PM for 3- 4 weeks. In May 2021, SARS-CoV-2 antibody test: 0.04 (Negative) 0.04. On an unknown date, SARS-CoV-2 antibody test: 26.75 The booster shoot up his antibody levels sky high to 26.75.         No Concomitant product use was reported.  The reporter was calling on behalf of their husband who was the patient. The patient had 3 doses of Moderna COVID-19 vaccine and after the 2nd shot, had a Fever of 101F daily around 1PM for 3- 4 weeks. The patient did not take medicine for it. The reporter stated tat the patient with Leukemia tested negative for vaccine produced antibody on May-2021 and the antibody results were 0.04 but the booster shoot up their antibody levels sky high to 26.75.  No treatment information was provided.   This case was linked to MOD-2022-441925 (Patient Link).
Case PHEH2016US023383 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to a 51 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular on right arm on 30 Jan 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Info has been received from a physician concerning a 4 year old female who on 11/1/01 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/8/05, the pt presented to the office with a case of breakthrough characterized by greater than 50 lesions. The pt was noted to be afebrile. No medication was given to treat the breakthrough. At the time of this report, the outcome was unknown. Additional info has been requested.
Recently diagnosed with Motor Neuron Disease, ALS type limb onset. Symptoms began late August, early September.
Patient is fully vaccinated.  COVID + on 11/15/2021.  Hospitalized from 12/10/2021.  Admitted with COVID 19 infection. Presented to the hospital from  Nursing Home/Rehab.  Over there, the patient was tested for COVID-19 and recently patient reported that fatigue, weakness, cough, and she has started suffering from shortness of breath recently.  Active problems:  hypertension, acquired hypothyroidism, hyperlipidemia, kidney stone, AKI.  COVID-19, diagnosed more than 10 days ago.  The patient presented to thehospital with shortness of breath. Had a chest x-ray, which was multifocal bilateral pneumonia.   Continue with dexamethasone.  Shortness of breath/respiratory distress. Continue oxygen supplementation, breathing treatment if needed. Elevated Ddimer .The patient was started on heparin drip due to elevated D-dimer.   Need to do a CT to rule out PE. CT: no acute pulmonary embolism present.  Anemia - likely the Hb drop from 11 - 8. Acute kidney injury.. Avoid nephrotoxic medication.  Encourage the patient to use oral intake and follow up with the CBC and chem 7.  Hypertension.  Blood pressure stable and under control.  Discharged
shortness of breath with no relief from CPAP and oxygenation, tremors Sent to Emergency Department for further management
2/5/00, within 3 hours of vax pt experienced some blotching of cheeks and eye. Pt also experienced face, eye, and ear swelling.  2/6/00 pt experienced stomach ache, some blotching to left cheek, eye continued.  2/7/00 received call from school, pt still has swollen face with blotchiness. Pt vomited, was listless by PM, fever, right arm blotchy, left arm bruised. Mom gave Tylenol, child vomited when home, then felt better and fever decreased.   2/8/00 pt is back in school, face is bright red, but no blotching.  2/11/00 pt is better, brother is now sick.
pt recv vax & w/in a few hr pt devel an inj site rxn characterized by soreness & a nodule;
Upon waking up the morning after receiving the SHINGRIX vaccine, I had significant pressure in my left ear, somewhat degraded hearing in that ear, tinnitus, and a headache. This continued for several days. The headache went away after the 1st day, but the pressure in my ear remained, the tinnitus sounds varied, and my hearing in that ear remained degraded. On April 8, 2019, I was completely deaf in my left ear when I woke up. I contacted an Otolaryngologist by phone and he was able to see me that same morning. In his examination, he found no fluid in either ear, nor was there any wax buildup. He gave me a hearing test, and the only sounds my left ear were able to hear were a few high frequency tones. He prescribed an 11-day course of Methylprednisolone, 4 mg, a 7-day course of Cephalexin 500 mg, a baby aspirin, and 2 over-the-counter medicines to keep my nasal passages open. 48 hours after waking up with essentially no hearing in my left ear, I woke up and had some degraded hearing in my left ear. The pressure was gone but the tinnitus remained. Over the next 24 hours, my hearing improved substantially and no longer seemed degraded. The tinnitus diminished.
Sore arm went back and forth/sore shoulder; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm went back and forth/sore shoulder) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, 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 experienced MYALGIA (Sore arm went back and forth/sore shoulder) and HEADACHE (Headache). At the time of the report, MYALGIA (Sore arm went back and forth/sore shoulder) and HEADACHE (Headache) outcome was unknown.            No treatment medication details was provided. Concomitants includes Flu shot on 19Oct2021 , Heart medication   This case was linked to MOD-2021-373613 (Patient Link).
20 mins after vaccine had dry flush of face lasting 5 mins, then patchy hives on face/neck for 24 hrs. Treated with Zyrtec after 12 hrs