chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had not administered a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2021, received first dose.).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had not administered a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 08-MAY-2023 The reporter reported that the patient did not received the second dose of Shingrix vaccine. The exact date of vaccination and lot number was not provided as register is not available because it was happened at a different facility. The reporter did consent to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Per patient, she got headache and nausea for 4 days, and fever for 2 days following vaccination.
Tested positive exactly 5 months post 2nd vaccine dose; Tested positive exactly 5 months post 2nd vaccine dose; fever; chills; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Aug2021 (Lot number: FA7484) at the age of 49 years as dose 2, single and intramuscular, administered in arm left, administration date 21Jul2021 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "in remission for prior breast cancer treatment" (unspecified if ongoing), notes: in remission for prior breast cancer treatment; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; OLMESARTAN; AROMASIN; XOPENEX; CLARITIN [CLARITHROMYCIN]. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022 15:45, outcome "recovering" and all described as "Tested positive exactly 5 months post 2nd vaccine dose"; PYREXIA (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "fever"; CHILLS (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 11Jan2022 15:45, outcome "recovering", described as "cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, chills, nasopharyngitis.  Clinical course: Facility type was Pharmacy or Drug Store. If Covid prior vaccination was yes. If covid tested post vaccination was yes. The patient did not receive any other vaccines within four weeks prior to the vaccination.
Pregnant EDD is 7/20/2021 First pregnancy   Adverse reaction was bilateral hives starting in both hands and spreading to armpits. Treated with hydrocortisone and Benadryl x 3 days resolved.
Vaccine given at noon. At 2 am that night she was awakened by rigors lasting 2 hours. The 2 days following vaccine admin she had chills, sweats, nausea and mild headache. She has history of severe headaches after PREVNAR 13 administered 7/30/15 onset within 1 day and lasting one full day.
Fever for over 10 hours,,Covid-19 like symptons,blurred vision,extreme sweating,loss of appetite,brain fog
Pfizer 8/20/21 and 10/1/21. Positive on 1/21/22
Information has been received concerning a patient who was vaccinated PO with a dose of ROTATEQ.  Subsequently the patient experienced an adverse experience.  The patient sought unspecified medical attention.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Patient stated that he felt very diaphoretic once placed in observation area He received vaccine at 11:10 and felt symptoms at 11:23 Had patient lie down on Gurney and vs were monitored 11:23  120/74  77 pulse 100% room air 11:36  138/85  65  pulse 100% Still felt a little warm 11:47  134/83 58  100% Denies any allergies.  Medication Augmentin ( he saw ENT)  about 10 days ago.  Patient states he went because he felt like something in throat.  He had dosage series of steroids which finished a couple days ago and then placed on Augmentin.   He has a inguinal thyroid. 11:56 139/91 62 100%  denies feeling warm/diaphoretic 12:10  142/82 52  100% pulse ox 12:15 142/102   64 100% pulse ox 12:20  148/91 74  100%pulse ox 12:26   139/103 74 12:32  143/95   76  100% pulse ox  Wife stated that he take anti anxiety medication but did not take last evening.  He was feeling anxious Patient took liquids, some food while being observed Let feeling much better, BP stable.  Advised that he let PCP know what happened.  Also let him know that for his next dose we will have him on gurney to give shot and monitor.  Escorted by wife and daughter.
Local adverse reaction to right thigh from DTaP: area of 4x4 inches induration, erythema, tenderness.
Starting approx 7 hours after the vaccine : vomiting, nausea, abdominal pain and diarrhea Abdominal pain persisting after 2 days.
Flu vaccine administered on 10/1/09. Rash developed approximately  10/29/09, evolved into Henoch-Schonlein purpura with knee pain, arthralgia of wrists. Improved by 11/5/09. Remained resolved.
Severe fatigue, over-sleeping, muscle and joint pain, body aches, headache, baseball sized knot and itchy rash at the injection site. Fatigue and body aches lasted over 72 hours from time of shot.
11/08/2005 received flu shot and pneumo vaccine in left deltoid and PPD left forearm. Pain in left deltoid within 1/2 hour of recd shot. Swelling started by that evening and grew larger within 24 hours. Approx 4-5 inches from injection site dime size, non blanching erythema that was tender to palp started 24 hours later. By 48 hours erythema increased to about 4x3.
Information has been received from a nurse and a physician concerning an "occasional patient" who experienced redness at the site of injection after administration of PNEUMOVAX 23 (dose number and vaccination date not reported). It was noted that this usually occurred when it was the second dose for the patient. At the time of report, the status of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
Increased redness and pain to injection. Instructed pt to apply ice and to take Tylenol for pain.
Mom started with banging noise in her head night after getting vaccination (possible auditory hallucination?)  these have continued with different sounds - she has not had them every night but always around 3 am during a sleep cycle.  This has been discussed with her neurologist and her primary healthcare provider
This spontaneous report was received from a nurse, referring to a one year old patient of unknown gender. There was no information about the patient's drug reactions, allergies, pertinent medical history and concomitant therapies provided. On 25-JAN-2017, the patient was vaccinated with an expired dose of M-M-R II (lot # L001336 with expiry date of 13-JAN-2017; dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Information has been received from a pharmacy intern via Pfizer, Inc. (MFR#2016108904) referring to a 55 years old (also reported as not yet 55) female patient with asthma. She was having pneumonia infections and on an unknown date she had already received a dose of PNEUMOVAX 23 (dose, frequency and lot# were not reported). The patient seemed to be having pneumonia infection and abnormalities (unspecified date) and also had the PNEUMOVAX 23. The outcome of the events was unknown. Causality was not reported.
(L) thigh swollen and red. No pain swelling decreasing ~ cool compresses as needed.
This spontaneous report was received from a medical assistant, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The medical assistant informed that on 22-SEP-2015, the patient was vaccinated with a expired dose of ROTATEQ oral, lot # J011340, expiration date 14-MAY-2015. Concomitant therapy was not reported. There was not adverse events. Additional information has been requested.
(name) receive vaccine 05Mar2021. Tested positive.; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that, received vaccine on 05Mar2021 and tested positive 09Mar2021 or 10Mar2021 (reporter is not quite sure) and scheduled second dose on 26Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
This should probably be considered a vaccine failure since the child was fully immunized and was diagnosed with pertussis at age 6.
Administered second shingles shot on 7/17/19. Symptoms started evening of 7/17 with soreness, aching, and pain in shoulder blade and back pain then pain traveled down arm on 7/18/19.
nasty taste in mouth p/1st dose; 1JUN92 phone f/u; rec'd other 2 doses in series w/no addtl problem x/metallic taste after inject;
Patient came back to the pharmacy a couple of days later to report a "rash" on her arm where the injection took place.  She said it was red and hot.  It appeard to be an injection site reaction very common with a live vaccine.
1:32 Shivering and fatigue, chills; BP: 132/35, O2: 97%, HR: 70, Temp: 98.4, Med team alerted; Non-verbal at baseline, hands cold, wearing gloves; (Given warm compress for hands) 1:43: Back to baseline per family, BP: 131/54, MAP: 67, continued observation 1:50: Observation ended, left with 2 family members
tested positive herself on 27Mar2021; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored program.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 17Mar2021 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient experienced covid 19. She was exposed to a Covid patient on 23Mar2021, became symptomatic on 26Mar2021 which was the day she found out about her friend testing positive and tested positive herself on 27Mar2021. She was scheduled to receive her second dose of the vaccine on 09Apr2021. The patient wanted to know what the recommendations were for receiving the second vaccine if she has tested positive for Covid after receiving the first vaccine. She wanted to know the suggestions about waiting after being positive. She was feeling better today and that she read that on day 12 you may have built up immunity by 52 percent and that was good. She had no issues with the first vaccine. The outcome of the events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Mar2021.
Difficulty breathing, sick to stomach, swollen arm, pain.  By the time he reported all was well.  Still just a little pain at injection site.
Right arm started to swell; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm started to swell) and PAIN IN EXTREMITY (Arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right arm started to swell) and PAIN IN EXTREMITY (Arm pain). At the time of the report, PERIPHERAL SWELLING (Right arm started to swell) and PAIN IN EXTREMITY (Arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Approximately 12 hours post receiving the vaccine, the patient's right arm began to swell, and experienced arm pain. The patient reported that the events were still ongoing, and they didn't report it to their Health care physician.   Reportedly, the patient was taking a lot of medications but did not report them.   Concomitant medications reported included unknown medications.  No treatment information was provided.
EXTREME REDNESS AND SWELLING AND HEATED AREA ABOUT THE SIZE OF A SALAD PLATE ON THE UPPER ARM OF THE PATIENT.
my back is killing me; i can hardly walk; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (my back is killing me) and GAIT INABILITY (i can hardly walk) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (my back is killing me) and GAIT INABILITY (i can hardly walk). At the time of the report, BACK PAIN (my back is killing me) and GAIT INABILITY (i can hardly walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided. Treatment information were not provided.
5 days after vaccine, family reports > 12 hours hypertonic episode, then cried all night, inconsolably, fine the next am. and since. Follow up: pertussis omitted on next site of vaccination.  No treatment given.
Fever; Chills; Muscle Ache; Headache; Tiredness; Injection Arm Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle Ache), HEADACHE (Headache) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle Ache), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection Arm Hurting). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) had not resolved and MYALGIA (Muscle Ache), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection Arm Hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
16YR FEMALE GIVEN 1ST DOSE OF MODERNA. PATIENT/MOTHER REPORTS  PATIENT HAD  SORENESS IN ARM FOR FEW DAYS THAT RESOLVED WITH NO ADVERSE EFFECTS
Pt. received Covid Moderna Vaccine at unknown outside facility on 8/3/21 Received 2nd Covid Moderna Vaccine at unknown outside facility on 8/27/21 Pt. presents to hospital ER w/symptoms of facial droop & left sided weakness  Work up positive for Acute R MCA stroke w/R M3 Occlusion - etiology likely embolic
Patient says his left arm muscle up to shoulder and back muscle is in severe pain & getting worse and now he cannot lift anything.
pt recv vax 2MAY96 & pt exp soreness of the arm which recv inj, & had trouble lifting it;
Pt rec'd pneumo shot and lost hearing in both ears for 4 days and hears again now. Was concerned maybe about ear wax/infection? No S/S beyond hearing loss.
Fever 102.2; sweating, body aches, headache, lethargy; headache; body aches; sweating; lethargy; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) in the left arm on 25Mar2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included osteoporosis, arthritis and cholesterol. Concomitant medications of the patient included rosuvastatin (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), D3 (MANUFACTURER UNKNOWN), Magnesio (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and CENTRUM all used for unknown indications from unknown dates within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) in the left arm on 04Mar2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had a known history of allergy to penicillin. Prior to 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 4 weeks prior to the COVID vaccine. On 26Mar2021 at 23:00, the patient experienced fever 102.2 (unit unspecified), sweating, body aches, headache and lethargy. Therapeutic measures were not taken as a result of all events. On 26Mar2021, the patient underwent a fever test and the result was 102.2. The clinical outcome of the events fever, sweating, body aches, headache and lethargy was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Extreme burning nerve pain in both hands and fingers. 10/10 on a pain scale, especially at night. Extreme pain and trigger thumb in both thumbs. Given an NSAID, topical NSAID and referral to a neurologist. My neurology appointment is 3/10/22. All symptoms happened at once, within a week or 2 after my booster shot on 11/23/21. I had no reaction with my first 2 shots, which were Pfizer. My booster shot was Moderna. The burning nerve pain in my hands is starting to ease, but the trigger thumb/joint pain is getting worse.
Pt vaccinated at approx. 0830 4/22/09. Mother reports that pt. had increased temp starting at 1200 4/22/09. Mother reports to clinic 4/22/09 with child & c/o erythema, edema, and hardness in (L) & (R) D. C/o temp of 103.5, mother instructed to visit PCP for temp. TC 4/24/09 from mother. Pt has been admitted to the hospital 4/23/09 at approx 11:40 with temp of 103.8 F.   6/29/09 Hospital ER records received DOS 4/24/09 to 4/25/09. Assessment: Febrile illness. Patient presented with fever, runny nose, cough, fussy, decreased PO intake. Short of breath. Exanthum, 'masses' upper arms area of injection.   7/23/09 ICD-9 Codes: 780.60
Redness, soreness, lump and mild itching at injection site  - prevalent beyond one week post vaccination Low grade fever (99.7) beginning 24 hours post injection, lasting approx 12 hours Chills and fatigue beginning 12 hours post injection, lasting 24-48 hours (in total) - Tylenol treatment
This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Seasonal trivalent Influenza vaccine. On an unknown date, the patient received Seasonal trivalent Influenza vaccine (unknown). On an unknown date, unknown after receiving Seasonal trivalent Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal trivalent Influenza vaccine. Additional information received on 16 October 2014: The patient had a reaction after a Flu vaccine. The caller was not sure that it was FLULAVAL. The medical fellows thought it was due to Thimerosal.
Cough; Sore throat; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion). At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
Approx. 24 hours after receiving vaccines, child developed a red spot on (L) outer thigh that increased in size, was painful to touch. Symptoms child care to be evaluated 8/26/15. No tx needed.
Mother noted swelling and redness to left deltoid pt was taken to local emergency room and was told she had a reaction to the shot according to mother. Pt was given an antibiotic and pain medication. Today 09/14 swelling improved child in no apparent distress.
Painful, hot, swollen, red raised patch about the size of a fist roughly 3? below the injection side. Soreness in arm,  numbness in hand.  Primary concern is that the area in question is not at the injection site, but very markedly below it.
Received FLUZONE at my son's pediatrician office the morning of 10/6/2018. Twenty four hours later developed fever of 100.4; severe headache, lower back pain and lethargy. Injection site swelled and turned very red (area of swelling and redness close to 5 inches in diameter). Fever resolved by 10/7, headache was dulled but not resolved. Back pain has resolved.
Possible side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Possible side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Possible side effect). At the time of the report, VACCINATION COMPLICATION (Possible side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Information has been received from a health professional concerning a female who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 27-MAR-2008 the patient experienced back spasms within 6 hours of receiving the first dose. The patient sought unspecified medical attention. Subsequently, the patient recovered from her back spasms. Per the reporter, the patient may like to be contacted. No further information is available. Additional information has been requested.