chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient immunocompromised had Shingrix first dose 3 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient received first dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The patient was immunocompromised and the pharmacist inquired if she needs to restart the series. The patient was taking steroids medication. The reporter consented to follow up by fax.
chills, lightheaded, body aches & h/a 7NOV96 approx 1030AM to 8NOV96 took ASA & rest;
Patient presented to the clinic, 8/16/22 to receive outstanding immunizations, but mainly MMR for school. Patient's chart flagging as patient also needing Hepatitis B, and HPV. RN checked patient's immunization record, confirmed there was no record of patient previously receiving Hepatitis vaccine, and did not notice any titers. Patient due for final dose of HPV series, and only received one dose of MMR previously. RN administered Hepatitis and HPV to left deltoid; MMR subcutaneously to left arm. Patient tolerated immunizations well. RN printed the patient's immunization record, then noticed a Hepatitis B titer that stated patient was immune to Hepatitis B, therefore immunization was not necessary. RN explained error to patient, informed patient there is no danger to receiving additional dose, but encouraged call back to clinic if any symptoms develop. Patient expressed understanding, had no further questions or concerns.
5 hours after vaccination began to have chills, shaking, pale "out of it" appearance, headache worse. ? unusual vocalizations, incoherent. Taken to local ED. Observation only. - sent home. Seen in PCP office this morning. Symptoms resolved.
Pt recv vax on 2/2/99; on 2/3/99 pt exp dizziness, unable to walk, nausea, fatigue; tx=Meclizine; The vaccinee has no known drug allergies. Patient's medical history included positive PPD, genital warts, and unspecified allergies. Patient denied a history of lupus, Crohn's disease, and rheumatoid arthritis. There was no illness at the time of vaccination. Concomitant medications included cetirizine (Zyrtec). On February 2, 1999 12:00, the patient received the first "standard adult" IM-left deltoid done of LYMERIX for prophylaxis of Lyme disease. Approximately 8 hours later, February 2, 1999 the patient developed "extreme" dizziness, the inability to walk, nausea, vomiting, and fatigue. The physician reported that the dizzziness was treated with meclozine (Meclizine) but persisted. The patient was seen by a primary care provider, two HNT physicians and a neurologist who all told the patient  that the symptoms were a coincidence and they were not casually related to the vaccine (LYMErix). As of March 26, 2001 the vaccinee reported bilateral knee joint pain, which patient states was diagnosed as arthritis (NOS) by an orthopedist. The most recent information received on March 26, 2001 reported the outcome of the events as ongoing. The patient's symptoms have lessened, but "still has problems and is not the same since the vaccine." The adverse evens of 'dizziness' and 'arthritis (NOS)' do not meet ICN serious criteria, but are being submitted as an expedited report by FDA request per the June 28, 2000 letter.
Initial misuse report received from a healthcare professional on 11 November 2013. A 03-year-old patient (gender was not reported) had received a dose of 0.25 ml of FLUZONE. No adverse event was reported. Documents held by sender: none.
Diarrhea (7 days), fever (1 day), fussiness (7 days).
At 8:58 patient drinking water during obs report when swallowing she feels a lump in her throat.  VS 165/85;  78; 99%.  CAT call made.  9:07 pt reports no increase enclosure of throat. 100% o2  hr 84, ER nurse arrived assessment made, patient to ER for further observation.
Vaccine administered on 1/19/21 at Health Center Covid Clinic. itad some soreness over immediate week "but not bad"; increased soreness on 1/26, 1/27 swollen puffy & warm, last night red from shoulder to above elbow took 2 Benadryl little effect, today remains red, hot, swollen; now rash.
Pink rash on left arm, about two inches by three inches.  Pink rash on nose and both cheeks, brighter on left side of face than on right side of face.  Rash on left arm disappeared by April 14, 2021.  Rash on face has faded, but is still visible today, May 9, 2021.   The rash looks similar to a mild sunburn, and does not itch or hurt.
3/2 - Felt nausated a few hours after, but it passed 3/3 - Right arm (injection arm) itched, but hydrocortizone application relieved it 3/4 - Began feeling hot and flushed towards the early afternoon, no fever. That evening I slept under multiple blankets because I could not seem to get warm but I was sweating 3/5 - The skin on both arms was red and hot all day. I felt like I was sun burnt; no itching and no fever. By the end of the day, I was red and hot all over. No other symptoms except feeling like I was sunburnt all over. I began, at the suggestion of an urgent care doctor, taking a regime of Benadryl and Tylonel. I stopped taking the multivitamin that contained niacin.  3/6 - The same and the day before; no fever, no itching, no respiratory complicatons.  3/7 - Some redness, but I stopped taking Benadryl  3/8 - Some redness, resumed multi vitamin 3/9 - No change, still some redness.
Patient scheduled to be seen at medical center, presenting with c/o rash from recent vaccine administered at local store on 9/11, 3 days prior to presentation. Patient states that the rash started the day that the flu vaccine was administered. The rash is on the patient's upper right arm and is described per treatment room note as being red, swollen, warm to touch and itchy. Rash is described as being 4 cm x 7 cm. Pt denies pain and denies fever. Symptoms: 1. Skin Rash, 2. Rash, 3. Urticaria Pruritus. Treatment Drugs Used: 1-Acetaminophen Dose: 650 Units: MG Freq: TID Route: PO, 2- Hydroxyzine Dose: 10 Units: MG Freq: BID Route: PO
On Jan. 4th at 7am I had no immediate reaction. At 2pm that day got extremely nauseated, local injection site red and warm, muscle aches through out body experienced. No other symptoms at that time.  Arm redness started to fade and go away over the next three days. On January 11 at 9pm, Injection site became red, itchy and  warm to touch, Heart rate fluctuated in the 102 to 120 range intermittently. Normal heartrate is 85. Notified Employee Health and supervisor and made appointment with primary doctor for Wednesday Jan. 13th at 2pm. Applied cool compress to site all throughout the reactions.
Nausea 18 hours after; Fatigue and headache within an hour of vaccine; Fatigue and headache within an hour of vaccine; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and anxiety. The patient had known allergy (unspecified). It was not reported if the patient received any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fatigue and headache within an hour of vaccine on 02May2021. The patient experienced nausea 18 hours after on 03May2021 at 07:00. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fatigue and headache within an hour of vaccine and nausea 18 hours after was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2cm circular indention w/a superiorlyu dissected atrophy on the inner aspect of lt thigh;looked like this since OCT96;no tx;
Left upper arm from elbow up was hot and red except for approx 1 inch strip.  Resolved without medical intervention. Mom administered Tylenol. Mom reported reaction on 1-22-03.
Patient received first dose of Moderna mRNA Covid-19 vaccine on 2/3/21 at 11 AM. Approximately 3-4 days after receiving the vaccine, the patient developed a maculopapular rash on the trunk and arms that later spread to involve most of the trunk and proximal extremities. Patient had no immediate reaction to the vaccine, reporting only mild muscular discomfort starting about 24 hours after administration. Patient had no respiratory symptoms, no swelling, no fever or chills. Patient has not had a similar drug eruption in the past, and has had no reaction to prior vaccines.  Treated rash with oral diphenhydramine, and the rash slowly improved.
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 15-month-old female patient who received INFANRIX (batch number Y5475, expiry date unknown). This case was associated with a product complaint. On 19th April 2018, the patient received INFANRIX. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint. On an unknown date, the outcome of the injection site rash, injection site erythema, generalized rash and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema and generalized rash to be related to INFANRIX. Additional details were provided as follows: The nurse reported that the patient experienced a red rash at injection site that was larger than usual and a systemic rash (rash over body). In total 13 patients received INFANRIX with the same lot number but only 3 patients including this patient experienced reactions. The vaccine was administered at the 15 to 18 month visit. According to the treating physician the adverse events reported were not due to the INFANRIX but thought it was a normal reaction to DTap. The nurse reported that they had 40 more doses from this lot number and she was not sure if they should use so she had sat them aside in the refrigerator until she hears from GlaxoSmithKline (GSK). The nurse was informed that there had not been a recall on this lot but that investigation would be carried out. The reporter had return the one vial from the lot for investigation. The reported agreed to contact on follow up. This case has been linked with cases US2018GSK080169 and US2018GSK080194, reported by the same reporter.
Kinrix/Proquad given 6/7/2022 . Patient began with Rash/redness  Left thigh 6/8; Patient was seen 6/9/2022 in office.
Information has been received from a registered nurse concerning an 11-18 year old female who was vaccinated with her first dose of GARDASIL (lot number, route and site not reported). Subsequently the patient experienced headache. The patient did not receive anymore GARDASIL. This is one of several reports received from the same source. Additional information has been requested.
Problems since they got the second dose; Difficult to sleep; Interfering with daily activities; Muscle pain got worse and past few weeks it has stayed the same; Sharp pain through the vaccine site going down the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Problems since they got the second dose), INSOMNIA (Difficult to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with daily activities), MYALGIA (Muscle pain got worse and past few weeks it has stayed the same) and VACCINATION SITE PAIN (Sharp pain through the vaccine site going down the arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Problems since they got the second dose). In October 2021, the patient experienced INSOMNIA (Difficult to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with daily activities) and MYALGIA (Muscle pain got worse and past few weeks it has stayed the same). October 2021, the patient experienced VACCINATION SITE PAIN (Sharp pain through the vaccine site going down the arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 for Muscle pain, at an unspecified dose and frequency; Manual therapy (Heat on arm) for Myalgia and Manual therapy (Heat on arm) for Vaccination site pain. At the time of the report, VACCINATION COMPLICATION (Problems since they got the second dose), INSOMNIA (Difficult to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with daily activities) and VACCINATION SITE PAIN (Sharp pain through the vaccine site going down the arm) outcome was unknown and MYALGIA (Muscle pain got worse and past few weeks it has stayed the same) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient stated he did not take regular medications and tried the treatments for a week.
Rash, fatigue, vertigo, nausea for approximately a day and a half.
bright red hives all over her body; itching; burning; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bright red hives all over her body, itching, burning.  The patient's medical history was eczema. She has applying a cream it seems to be helpful.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) bright red hives all over her body. itching, burning.  Treatment details included She has been applying a cream and it seems to be helping..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), bright red hives all over her body, itching,burning was unknown.
1 week after dose 2 of the COVID-19 vaccine, the patient experienced swelling, burning, itching, and redness over the injection site in the left upper arm.  Then over a few days, experienced a burning, itching, and tingling sensation over the left face, left arm, and left leg.  The left side of her face became mildly swollen and itchy.  She has since noticed swelling over the palms and soles.   No shortness of breath or difficulty swallowing.  No fever/chills.  No pre-syncope/syncope.
hives; shingles; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HERPES ZOSTER (shingles) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN, METOPROLOL, TRAZODONE, BUPROPION HCL, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced URTICARIA (hives) and HERPES ZOSTER (shingles). At the time of the report, URTICARIA (hives) and HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Adverse effect fever 100.8, myalgias, redness @ injection site after administered.  6x8 cm area.
PATIENT'S RIGHT LIP AND FACE SWOLLEN TO THE NASAL AREA.  ADVERSE EFFECT STARTED THE MORNING OF 3/16/2021. PATIENT NEVER HAD BEFORE. HAD EATEN OATMEAL AAND COFFEE THAT MORNING, PATIENT DID NOT FEEL ANY PAIN, PECULIAR TASTE SENSATIONS, SENSITIVITY TO SOUND, OR DIFFICULTY CHEWING. PATIENT USED BENADRYL AND ICE PACKS . SWELLING SUBSIDED BY BEDTIME.
Pt is a 59 YOF who received her first COVID-19 Pfizer vaccination on 4/16/21. She has PMH significant for diabetes mellitus type II, hypertension, COPD. Almost immediately post vaccine, patient started exhibiting signs of slurred speech and right side weakness. Patient started improving when being moved to triage  however after a few minutes, slurred speech and confusion returned. 911 called and patient transported to ED. On admission neurology consulted and initial CT head negative. Patient received IV tPA and MRI brain was obtained which showed left medial pontine infarct. Diagnosis: Left pontine stroke. NIH 4 on admission and discharge. No history of TIA nor stroke. Unclear if stroke is related to vaccine...
Extreme bone and joint pain, muscle weakness. Could not stand or walk. Debilitating migraine behind left eye. Vision changes (could only see red). Nausea. GI pain. Swollen lymph nodes in armpits and throughout chest cavity. Shortness of breath. Aforementioned symptoms persisted 24 hours. I am still getting headaches daily and experiencing brain fog 13 days later.
Caregiver of pt called to say pt had low-grade fever, chills, nausea and dizziness about 8 hrs after receiving flu vaccine. Pt took ibuprofen which resolved some symptoms.
pt recvd vax; flaccidity; unresponsiveness; pt sxs lasted 10-15 min; to er;
Extreme soarness of muscles in both thighs, lasting 3 days (this has recently recurred for 3 days).  Parathesia in hands, face and head and feet, still continuing. Headaches, dizziness, feeling off-balance and stumbling. Heaviness and weakness in legs. These symptoms still persist.
pt was admitted to 7/25-8/2; came back for ER visit on 8/4; double pneumonia; difficulty breathing
On May 11th Patient started receiving nausea and Headaches. Patient went to ER they  thought she was having Vertigo. Primary care stated that she was fine before the vaccination. Patient can not walk. Patient now has a immune disorder. Patient also has ANA. The blood in her body is having inflammation.  On her left side part of her body is numb and the other half is in pain.
9/13/19 varicella titer result 0.6 (negative)      9/20/19 Varicella #1 administered     11/1/19 Varicella #2 administered (42 days after varicella #1)     11/4/19 Patient noticed arm where varicella was administered was a little red and very itchy.     11/5/19 In the evening the patient noticed a few lesions - stated had about 15 total lesions that she described as red with tiny vesicular spots (clear liquid) in center. They occurred on her abdomen, chest, thighs, and arm (opposite of one where vaccine given).     11/6/19 Employee was sent home from work after seeing nurse practioner. According to the nurse practioner she did not notice any vesicles, just a few red maculopapular lesions. Also on this day her 9 year old son who had previously received 2 doses of varicella vaccine had an outbreak of lesions similar to hers. His lesions totaled approximately 30 and were on his trunk, legs, arms and one lesion was on his face. Employee stayed home until 11/12 after rash resolved/crusted and not having new lesions for 24 hours  Employee does not know if family was exposed to wild-type varicella. Husband and 3 other children did not get rashes.
Patients received expired Moderna COVID-19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2022 and was forwarded to Moderna on 28-Apr-2022.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna COVID-19 vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone temperature excursion.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022.
This spontaneous report as received from a Certified Medical Assistant refers to an infant of unknown gender of 10 days old at the time of the report. Concurrent conditions and medical history was not reported. On an unknown date, the patient was administer4ed a dose of (Oka/Merck) VARIVAX (subcutaneous injection)(dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is related to MARR#1505USA009906, MARR#1505USA013645,MARR#1505USA013646. Additional information has been requested.
I tested positive forCOVID-19 on Tuesday December thirteen. My Doctor prescribed medication the same day. I was tired and had fever the first couplie of days. I do not think I had a fever by the fifth day.
22JAN91 temp 104 taken to ER temp down to 102.4; 23JAN91 temp to 103 MD notified MD;admitted to hospital fever of unknown origin- cultures for blood, urine , throat were all negative. MD stated that rxn to DPT could not be ruled out.
This spontaneous report as received from a medical assistant refers to a 20 year old male patient. On 23-JUL-2013 the patient was vaccinated with a fourth dose of GARDASIL (0.5 ml, intramuscular, in the left arm, lot number was not reported). The reporter stated that this error occurred when they were converting paper charts to electronic records. Vaccinations dates of the previous vaccinations with GARDASIL were not reported. The reporter stated that the patient did not experience any adverse effect due to the extra dose of GARDASIL. This is one of several reports from the same reporter. Additional information is not expected because the reported doesn't want to be contacted.