chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Covid arm" 7 inches down and 3 0r 4 inches across redness; itchiness at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA ("Covid arm" 7 inches down and 3 0r 4 inches across redness), INJECTION SITE PRURITUS (itchiness at the injection site) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Hypertension.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA ("Covid arm" 7 inches down and 3 0r 4 inches across redness), INJECTION SITE PRURITUS (itchiness at the injection site) and CHILLS (Chills). At the time of the report, INJECTION SITE ERYTHEMA ("Covid arm" 7 inches down and 3 0r 4 inches across redness), INJECTION SITE PRURITUS (itchiness at the injection site) and CHILLS (Chills) outcome was unknown.            Patient put ice on the area where the injection site
Next day arm hurts. On Saturday I felt congestive, Monday I had bad sore throat, I tested Positive Monday. Now I have COVID.
On post-vaccine day #11, developed diffuse whole-body urticaria that has persisted for at least 5 days (through the day of this reporting, 11/13/21).
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 10-month-old female patient who experienced rash. The patient received a dose on 12-Aug-2010. The patient also received a dose of ACT-HIB (Aventis) on 12-Aug-2010. The patient experienced rash on 13-Aug-2010. Treatment and outcome were not provided. No additional information was available at the time of this report.
Information has been received from a 76 year old female consumer who was vaccinated in 1978 with a 1/2 dose of pneumococcal vaccine 14 polyvalent. Post vax, the pt "felt faint and had partial shock". She reported that the physician came to her home and gave her "something". The pt "thought it was epinephrine". She also stated that she has pneumonia "on and off". The outcome of the pt's experience was unknown. Upon internal review, the pt's faintness and partial shock were determined to be "Other Medical Events". Additional information has been requested.  Follow up on 03/28/2001: "adverse event onset date/time, lot # for vaccine 1 and vaccine administration date/time is not provided."
Patient reports:"lips feel puffy" Vitals:  4:55pm 190/92  76  18  O2 97%;   5:10pm  178/88  69  18 O2 96% 5:25pm  172/88  72  18  O2 96%;   4:55pm Patient given Oral diphenhydramine 25mg. po. Disposition: Stable upon leaving.
Information has been received from a consumer concerning her 23 year old daughter with no pertinent medical history and no known drug allergies or reactions who in August 2008, was vaccinated with the first dose of GARDASIL (lot # not provided). There was no concomitant medication. In August 2008, the patient experienced nauseous constantly. No lab diagnostics studies were performed. The patient had not gotten the second dose of GARDASIL and did not plan on receiving it. At the time of reporting, the patient's nausea persisted. The patient did not seek medical attention. No further information is available.
COAGULOPATHY, UNSPECIFIED TYPE ACUTE PULMONARY EMBOLISM
3 1/2 x 7 cm area of erythema with induration.  Treatment: warm compresses and MOTRIN.
Patient received dose of Jannsen vaccine as 17 years old, when agency indication was 18 years old. Event reported to state authorities as well. Patient did not experience any side effects and is now considered vaccinated by the state.
Chills, headache, muscle aches, sore throat, fatigue, L sided numbness. Started the morning after the injection.
flu like symptoms; The swelled area was warm to the touch; redness was about 3 inches in diameter; swelling; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE WARMTH (The swelled area was warm to the touch), VACCINATION SITE ERYTHEMA (redness was about 3 inches in diameter), VACCINATION SITE SWELLING (swelling) and FATIGUE (Very fatigued) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-Jun-1982, High cholesterol since 01-Jan-2017, Depression since 01-Jan-1996 and Allergy to antibiotic (ZPack). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 01-Jan-1996 to an unknown date for Depression, ATORVASTATIN CALCIUM (LIPITOR) from 01-Jan-2018 to an unknown date and EZETIMIBE (ZETIA) from 01-Jan-2020 to an unknown date for High cholesterol, LEVOTHYROXINE from 01-Jun-1982 to an unknown date for Hypothyroidism.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE WARMTH (The swelled area was warm to the touch), VACCINATION SITE ERYTHEMA (redness was about 3 inches in diameter), VACCINATION SITE SWELLING (swelling) and FATIGUE (Very fatigued). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE SWELLING (swelling) and FATIGUE (Very fatigued) outcome was unknown and INJECTION SITE WARMTH (The swelled area was warm to the touch) and VACCINATION SITE ERYTHEMA (redness was about 3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use include censoroid. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-JUN-2021. Reporter details was reported. Patient details was reported. Medical history was reported. Concomitant product was reported. Adverse event was reported. Event outcome was updated.
Within 5 min headache took ibuprofen.  7 hours after vaccine SOB, scratchy throat, cough and voice changes took 125mg Benadryl over a 2.5 hours time frame.  Felt ok the next 2 days.  Third day after vaccine nauseated but manageable. Fourth day horrible nause that requires multiple medications. Fatigue and chills. Took zofran, reglan, phenergan and ibuprofen. Unable to do anything. Fifth day still nauseated but improved.
Information has been received from a physician concerning a 6 month old female who on 31-JAN-2007 was vaccinated with her last dose of Rotateq (lot #654970/0777F) (the dated of the other two doses were not reported). The patient had no medical history or concomitant therapy. On 27-FEB-2007, the patient was examined by the physician and had developed intussusception. The patient's symptoms at the time of the exam were reported as unknown. On 01-MAR-2007, the patient was hospitalized for intussusception. An enema reduction was attempted unsuccessfully. The patient had bowel resection surgery. On an unspecified date, the patient recovered from intussusception. Her release date from the hospital was not known. The physician considered intussusception to be immediately life-threatening, and disabling, and an other important medical event. There was no product quality complaint involved. Additional information has been requested.  4/13/07 Received medical records & vax records from PCP which reveal child was in good health on day of vax 1/31/07.  Growth & development were as expected for age.  Lot # for 3rd dose of Rotateq incorrect on VAERS report & corrected in database. 4/27/07 Received medical records from hospital which reveal patient experienced bilious vomiting, lethargy, fever & dehydration x 2 days prior to admit on 3/1/07-3/5/07. Exam revealed tachycardia, decreased bowel sounds & guarding.  Rad attempts at reducing IS were unsuccessful & taken to OR for exp lap, reduction of IS & small bowel resection w/primary anastomosis.  Developed post op ileus which resolved.  Slowed advanced diet & had maroon stools initially.  D/c to home. FINAL DX: ileoileal intussusception, surgically reduced & small bowel resection.
1845 PATIENT REPORTS HEART PALPITATIONS, FLUSHED FACE, FEELING WARM, ICE PACK TO NECK, FEELING NAUSEATED. 1848 BP 161/114  HR 112. 1852 BP 148/91 HR 92 PATIENT RESTING. 1900-1910 PATIENT FEELS LIKE SHES "HAVING A DRY THROAT, "A LITTLE SHORT OF BREATH,  AND TIGHT IN CHEST." BP 144/95 HR 84 SAO2 99%. ICE PACK TO NECK. PT OFFERED H20 AND JUICE. RELAXING WITH EYES CLOSED.1920-1928 BP156/97 100% PATIENT FEELING ANXIOUS. DEEP BREATHING. 1938-1949 PATIENT MOVED TO QUIET AREA UNDER OBSERVATION. BP 138/93 HR 81 SAO2 99%, FEELING BETTER, NO NAUSEA, SCRATCHY THROAT IMPROVING, DENIES SEVERE ANXIETY. 1959 PATIENT FEELING BETTER, NO RASH, THROAT TIGHTNESS OR ANXIETY, VSS, CHEST TIGHT BUT BETTER, PATIENT REPORTS SIMILIAR TO BASELINE. PATIENT STABLE WANTING TO GO HOME. AWARE OF NEEDING TO SEEK MEDICAL CARE THROUGH ER OR HER PROVIDER IF SYMPTOMS WORSEN.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a male patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right upper deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
Metallic taste; This is a spontaneous report from a non-contactable consumer or report from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine,Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose Number Unknown.Single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported.The patient experienced metallic taste.The patient asked What if the second dose cannot be provided at 3 weeks (21 days)? When do I receive my second dose of the Pfizer-BioNTech COVID-19 Vaccine? The outcome for the events was Unknown.                          . No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Fever (temp 104.5) for 4-5 days after HIB.  Then developed pink rash that closed within 24 hours.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/05/2021. PATIENT FULLY VACCINATED ON 02/11/2021.
3 days after I had the shot, a fairly mobile lump developed in my left armpit.  I thought is was perhaps a swollen lymph node but I haven't noticed this before with flu shots that I take regularly.  After a couple of days the lump became painful and inflamed but generally I felt fine.  I mentioned this irritant when I was seeing a rheumatologist (first time about my painful hands) early in the morning 7 days after the vaccination .  He looked at the armpit area and said it looked like a cyst that had not come to a head yet but to monitor it.   That night it started to drain onto the armpit skin with a clear fluid that was not smelly.  Now two weeks after the  original flu shot it has almost totally disappeared.  I have no idea if this is typical for a swollen lymph node or if this is just coincidental with the shot but I am not aware of having a cyst in either armpit previously
25JAN93 mom 1st called @ this date; however did call fam phys @ the time (2 days p/11JAN?) red, swollen @ site, elevated temp;
J&J Dose 1 3/7/21 lot 1805018. Pfizer Dose 2 10/25/21 (lot not listed). COVID Positive 1/5/22. 1/5/22: The patient presents with Patient with a history of heart transplant 2008 on chronic immunosuppressants presents with an acute illness starting the morning of 01/05/2022 with body aches, malaise, cough, fever, chills, headache. Around 2 pm she became very nauseated and started vomiting. She is currently on Bactrim DS for apparent colitis, seen as colon wall thickening on a CT of the abdomen and pelvis from 12/28/2021. This was done for abdominal pain and diarrhea, which she has had from time to time in the past. She is scheduled for a colonoscopy on January 10th. In the ED she was noted to have periods of hypoxemia (down to 84% saturation on room air) and she was Covid positive. Chest x-ray appears generally unremarkable. 1/7/22: 62-year-old white female recently diagnosed with colitis by history, physical examination and radiographic analysis and was on antibiotics for the same. She continued to have nausea, vomiting, abdominal pain weakness. She was seen in the ER on 6 January and was diagnosed with COVID with transient hypoxia down to 84%. She was put on supplemental oxygen. She was given dexamethasone and remdesivir. She was on Levaquin. She is a at this time room air sat 91-94%. Her cough is dramatically improved. She has no nausea, vomiting at this time no abdominal pain at this time she is in no respiratory distress and she is requesting to go home. She lives with her husband, she feels strong enough to go home and her headache which should bother her when she 1st came in is also resolved. So she does have COVID but she is not hypoxic weakness stop the remdesivir continue the Decadron for now. She has improved colitis symptoms.
Itchy; Fever; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy), PYREXIA (Fever) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchy), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions included autoimmune disorder and immunocompromise. No information was provided regarding the patient's medical history, drug reactions or allergies and concomitant medication. On an unknown date, the patient who was not on dialysis was administered a dose of RECOMBIVAX HB 40 mcg (dialysis formulation), followed by a second dose of RECOMBIVAX HB 40 mcg (dialysis formulation) one month later for an unspecified autoimmune disorder for which he was being treated with HUMIRA and for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-DEC-2017, the patient was inadvertently administered an expired dose of VARIVAX lot # L043622 03-NOV-2017, for prophylaxis (strength, dose, route and frequency were not reported).  Other suspect therapies included sterile diluent (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). No adverse effects reported.
Fever 100.4 (12/31/2020) Fever 101.2 (01/06/2021)
the sxs pt exp lasted 2 days;pt had terrible h/a, was achy all over; had the sweats & was extremely tired;had to rest for several hrs to have enough energy for about 30mins a/was exhausted again
Approximately  2 months after receiving my 2nd dose, I developed a raised, red, itching rash at both temples of my head, on my chest and stomach, predominately the left side of the torso. Rash stayed for a bout a week. Since developing rash, I get skin "tingling spells" mainly on my chest, back and neck when I experience a raise in surrounding temperatures. The intensity of the tingling varies in size, duration, and  degree each time. Some short and minor going to 5-6 minute intense duration
Missed period; abnormally high amounts of clear, non-stretchydischarge; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ZR8730) via an unspecified route of administration on 26Mar2021 at 18:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient had missed period with abnormally high amounts of clear, non-stretchy discharge. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent for pregnancy test on an unknown date and the results were found to be negative. The clinical outcome of the events missed period with abnormally high amounts of clear, non-stretchy discharge were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
PAIN IN ALL BODY, CHILLS, AFTER RECEIVING BY ORAL ROUTE MUSCLE RELAXANT IN 20 MINUTES SYMPTOMS WERE COMPLETELY GONE
PATIENT BEGAN HAVING SYMPTOMS ON 1/30/21 AND DX WITH COVID ON 2/1/2021
Large urticaria all over body x hrs after flu shot. Taken to ER - RX steroids and BENADRYL.
She received the 1st dose on 28Dec2020. She taShe received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021ested positive to COVID-19 on 06Jan2020.; She received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: )Mar2021 , via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021. She was still currently in isolation and symptomatic. Her second dose was scheduled on 18Jan2020. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive to COVID-19  based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Patient came in for a visit, 8 days post vaccine administration, with a chief complaint of a rash. No rash noted but right lower leg swelling noted. Out of abundance of caution, patient advised to go to emergency room to rule out DVT.
Dose #1 administered on 1/11/21 with terrible arm/back pain and achiness x19 days.  Finally subsided 2 days before vaccine #2.  Morning after does #2 I woke with awful arm pain, swelling.  Hand/finger tingling and numbness has continued to worsen since .  Ibuprofen and Tylenol taken x 3 days with no relief.  Ice and heat also done with no relief.  Pain is unbearable today.  PCP contacted, waiting to hear back.
Approx 10 hours post-vaccination patient began to have a fever (102.4 F), chills, severe pain at injxn site, headache, joint pain especially in her hands, swollen lymph glands esp. sub-mandibular, nausea, increased heart-rate of 104 beats per minute at rest.  This lasted approx 36 hours and after significant resolution patient still was fatigued and had some hand pain.
Day 6 after vaccine I developed three raised and hard spots in the from of a smiley face, one with two below.  They sore, itched and were red to look at.  Its now day 9 and they are still the same.
red hives with central clearing at injection; swelling at the injection site; redness at the injection site; slight itching at the injection site; pain at the injection site; This spontaneous report was received from a medical assistant, referring to a 4-year-old male patient. Drug reactions/allergies included amoxicillin: mild rash. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 30-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (0.5 ml, lot # U039254, expiration date: 09-JUN-2023, vaccination site: left upper thigh, strength was not provided) subcutaneous for prophylaxis (reported as vaccination).   On 31-MAR-2022, the patient had swelling, redness, slight itching, and pain at the injection site. The patient was seen in the office on 01-APR-2022 and the medical assistant read the office notes from that visit "left upper thigh, non tender, red hives with central clearing at injection". The patient sought medical attention. The swelling had progressed when the patient was seen in the office. The outcome of the events was unknown.  The causality assessment between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was not provided.  Additional information had been requested.; Sender's Comments:  US-009507513-2204USA004513:
Mom claims that child had wheezing after the 3/24/03 DTaP, IPV, Hib, Hep B at age 5 1/2 months.
Sore arm, onset 13 hours after injection. Severe enough to wake me up. Took Arnica 200, improved gradually over 12 hours. Flu-like body aches. Onset 15 hours after injection. Mild intensity. Improved gradually over next 15 hours. Intense fatigue. Onset 15 hours. Slept approx 6 hours day following vaccine, plus slept 6 hours next night.  Improved gradually over next 15 hours. Red, blotchy rash on chest and red rash back (waist to neck) 2 days after vaccine. Plainly visible. Improved but still present today (day 3)