chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old male patient. On 23-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
October 23, 2018: BEXSERO and Influenza vaccines both given in right deltoid. October 24, 2018: Redness, swelling and pain at injection site /Right deltoid. Nodule felt at injection site. October 25, 2018 swelling going down. October 26, 2018: Redness and warmth felt and nodule palpated by MD on exam. No swelling. No red appearance.
Vaccine DTAP on 02/09/04 was given on deltoid (right).  Raised, warm, indurated area 5-6 hours. Cellulitis with 2 hours.  Warm compress, antibiotics used to help cellulitis get better.
Itchy rash on arms, legs, back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on arms, legs, back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on arms, legs, back). At the time of the report, RASH PRURITIC (Itchy rash on arms, legs, back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were, sleep aide and blood pressure pill.  Treatment information was not provided.
Pt recvd 2 doses of Engerix-B & 21JUL92 following dose 2 exp general malaise;
04:30PM PT STATES "LIPS ARE TINGLING, HEAD ITCHES". DENIES SHORTNESS OF BREATH, TROUBLE BREATHING, SWELLING OF LIPS/TONGUE, OR DIFFICULTY SWALLOWING. ALERT, ORIENTED, PINK, W/D, RESP REGULAR WITH EASE. NO RASH OR HIVES NOTED. 05:00PM ALL SYMPTOMS HAVE RESOLVED.
Pt developed a hoarse voice and sore throat as well as b/l redness of the sclera about 4 hours after being vaccinated.
This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; Lot number: ER8727) via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis, depression and anxiety. The concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) 300 mg daily for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 13:45, patient experienced headache, dizziness, muscle weakness, joint pain throughout entire right side of her body and had very early menstruation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the events headache, dizziness, muscle weakness, joint pain throughout entire right side of body and very early menstruation were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
anaphylactic reaction tongue, eyes, face swelled with hives over her body; Initial information regarding an unsolicited valid serious case was received from a consumer (patient) via Medical Information (MI) (Reference number- 00397309) and transmitted to Sanofi on 17-Dec-2020.  This case involved Elderly female patient who experienced anaphylactic reaction tongue, eyes, face swelled with hives over her body (anaphylactic reaction), while she received vaccine DIPHTHERIA AND TETANUS TOXOIDS.   The patient's past medical treatment included EPINEPHRINE, 60 years ago from dental work where they used an anesthetic with epinephrine in it.  The patient's medical history, vaccinations, concomitant medications and family history were not provided.  On an unknown date, Patient stated that 6 or 7 year ago (now 80 years old)  got a DIPHTHERIA AND TETANUS TOXOIDS booster dose(produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination had a severe anaphylactic reaction tongue, eyes, face swelled with hives over her body (anaphylactic reaction). It took a week to get back to normal. She got the shot in Joplin. She stated she did report to Sanofi and the number that was on the paper to report.   Patient would like to know what was in that vaccine, because she is concerned about getting the covid vaccination.  Patient stated she was temporarily living with her daughter. Patient stated that she doesn't know which vaccine she had but remembers calling Sanofi at the time of the adverse event because that was phone number they gave to her. She stated that she was in the home babysitting small children when she got the vaccine but when she told her physician about it the physician told her she had already had the booster so didn't need the one that caused her the issues. Mentions 1-2 days after the injection she woke up in the middle of the night with hives, lips and face swelling and received Benadryl then went to the urgent care and they gave her an injection but it took a week for the hives to go away. She has had a scratch test for allergies but had an anaphylactic reaction to that also and they had to stop the test.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for anaphylactic reaction.; Sender's Comments: This case involved Elderly female patient who had reported anaphylactic reaction with tongue, eyes, face swelled with hives over her body (anaphylactic reaction), with DIPHTHERIA AND TETANUS TOXOIDS booster dose (produced by unknown manufacturer). The time to onset is unknown. Further information regarding previous vaccination, tolerance and laboratory tests ruling out alternate etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Patient started to feel a little light headed and throat started to itch- gave 10ml of benadryl and monitored for 30 minutes and pt said she was feeling better.
I was sitting in observation at minute 10 or 11. All of the sudden I felt as though my heart was racing, I developed numbness and tingling of both my arms as well as my legs. I then develop tingling and numbness of my face. I felt dizzy and as though I was going to pass out. I then sought help
SORE ARM, SWOLLEN LYMPH NODES IN INJECTED ARM,FEVER, CHILLS, HEADACHE, MUSCLE ACHES, LOSS OF APPETITE, EXTREME TIREDNESS, FREQUENT AND URGENT URINATION ALL WHICH LASTED 2 DAYS.  ALSO DEVELOPED FEVER BLISTERS ON LIPS  ON 2ND DAY
Redness, swelling, warmth, tenderness to touch to injection site, measuringn 9 cm x 11 cm
patient received an Adacel Vaccine that had been frozen and thawed, no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non-health care professional.   This case is linked to cases 2019SA224143, 2019SA224076, 2019SA224136, 2019SA224137, 2019SA224138, 2019SA224140, 2019SA224141, 2019SA224142, 2019SA224145 and 2019SA224144 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Pt received MMR approximately x2 weeks prior to presenting on 08/27/04 with bruising on legs and arms without apparel trauma. Pt also fell on 08/26/04 and has a bruise in right forehead. Also has pruritic rash on buttocks x 1week.
no adverse effects; The patient was administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-MAR-2020, the patient received improperly stored vaccine doses. At 10:21, the patient received an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # S023219 (expiration date 03-MAR-2022), 0.5 mL intramuscularly (IM) on the left thigh (LT) and at 11:22, an improperly stored dose of Hepatitis A Vaccine (HEP A) (manufacturer unknown) lot # 747P5 (expiration date not reported), 0.5 mL IM on the LT. Both vaccines were administered for prophylaxis.   It was reported that Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) was stored above 9 Celsius degrees (at 15.5 Celsius degrees) for 4 hours and 6 minutes and a digital data logger was involved; for Hepatitis A Vaccine (HEP A) (manufacturer unknown), no information was provided. No adverse effects were reported.  This was one of several cases received from the same reporter.  Lot number 747P5 is an invalid lot number for Hepatitis A Vaccine, Inactivated.; Sender's Comments:  US-009507513-2003USA002275: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2008USA008876: US-009507513-2008USA008883: US-009507513-2008USA008875: US-009507513-2008USA008880: US-009507513-2008USA008877: US-009507513-2008USA008879: US-009507513-2008USA008881: US-009507513-2008USA008878: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
Head Hurt when Coughing; Inner Ear Hurt; Muscle aches; Fatigue; headache/when coughed her Head hurt; felt like she was Ran Over by a Truck; Mild Chills (After Second Vaccine).; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was Ran Over by a Truck), COUGH (Head Hurt when Coughing), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches) and CHILLS (Mild Chills (After Second Vaccine).) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Mild Chills (After Second Vaccine).). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (felt like she was Ran Over by a Truck), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches), FATIGUE (Fatigue) and HEADACHE (headache/when coughed her Head hurt). On 16-Apr-2021, the patient experienced COUGH (Head Hurt when Coughing). On 16-Apr-2021, FEELING ABNORMAL (felt like she was Ran Over by a Truck), EAR PAIN (Inner Ear Hurt), MYALGIA (Muscle aches) and FATIGUE (Fatigue) had resolved. On 17-Apr-2021, COUGH (Head Hurt when Coughing), CHILLS (Mild Chills (After Second Vaccine).) and HEADACHE (headache/when coughed her Head hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment for the events was taken with Tylenol.   This case was linked to MOD-2021-080312 (E2B Linked Report).; Sender's Comments:  MOD-2021-080312:First dose of vaccine case
WITHIN 4 HOURS I STARTED DEVELOPING AN EXTREMELY PAINFUL AND TIGHT LEFT NECK.  THE FOLLOWING DAY I FELT TINGLING IN THE LEFT FOOT THAT SPREAD TO MY ARM. ON DAY 2 LEFT SIDE OF MY FACE IS NUMB AND FEELS SWOLLEN.  THE LEGS AND ARMS ALTERNATE BETWEEN FEELING HOLLOW AND TINGLY.  DAY 4 I HAVE DEVELOPED HEADACHES THAT ARE HALF OF MY HEAD ON THE LEFT SIDE AND THE NECK PAIN CONTINUES.  ALL SYSTOMS ARE ON AND OFF AND MAKES ME FEEL WEIRD.
I developed multiple blood clots in both lungs.  Five in total.  DVT was ruled out and there are is no other explanation.   No travel, recent surgery, or family history.
developed inflammation on the right arm; Slight itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of inflammation localized in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 15th April 2021, 3 days after receiving Shingrix, the patient experienced inflammation localized and pruritus. On 21st April 2021, the outcome of the inflammation localized and pruritus were recovered/resolved.   It was unknown if the reporter considered the inflammation localized and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received second dose of Shingrix on the left arm and developed inflammation on the right arm at a similar level of location as the injection site arm and had slight itchiness. The reporter enquired whether the adverse events that the patient reported had been documented before. The reporter consented to follow up. Note- The reporter also mentioned that, since then inflammation had not diminished and there was slight itchiness but in the same source document outcome of both events was reported as recovered. Therefore the outcome captured as per event section.
I started to get headaches a few days around the vaccine but briefly got a bit worse after the vaccine. My arm only got sore five days in the area of the vaccine.
About a day and 1/2 after shot had intense pain radiating up the neck and down the arm. Has difficulty raising arm. Can't sleep because of pain. Took Aleve and will see a doctor if not better.
very bad pain in right side of the tummy and back pain; back pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (very bad pain in right side of the tummy and back pain) and BACK PAIN (back pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ABDOMINAL PAIN (very bad pain in right side of the tummy and back pain) and BACK PAIN (back pain). At the time of the report, ABDOMINAL PAIN (very bad pain in right side of the tummy and back pain) and BACK PAIN (back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Td vaccine given 4/15/05- right hip. Called clinic 3-4 times came in for package insert. Called nurse today 04/28/05 to say arm was sore and painful.
CLIENT BEING OBSERVED 15 POST VACCINATION BY EMS.  COMPLAINED OF NAUSEA, CHILLS, WEAKNESS, DIZZINESS AND QUESTIONABLE THROAT TIGHTNESS.   TRANSPORTED TO HOSPITAL FOR FURTHER OBSERVATION
Developed severe body chills, muscle aches, headache, vomiting, fever >102.  Severe symptoms lasted 13 hours.  Fever lasted until 48 hours after vaccination.
My son had a normal ECG at age 5 as well as normal physical exam. His last physical exam at age 9 was normal. He did not have an annual physical at age 10. On his 11 year annual exam he was noted to have a heart murmur and later that night noted to have an irregular heart rate. He had a cardiology appointment with a normal echo but incidental finding of Wolff Parkinson's White Syndrome on ECG. This will now require an ablation to correct.
dizzy; Itchy back of throat; tightness in chest; flush face; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient. A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; LAMICTAL; VYTORIN; TYLENOL. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: DIZZINESS (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "dizzy"; THROAT IRRITATION (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "Itchy back of throat"; CHEST DISCOMFORT (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "tightness in chest"; FLUSHING (medically significant) with onset 18Nov2021 18:30, outcome "recovering", described as "flush face". The events "dizzy", "itchy back of throat", "tightness in chest" and "flush face" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, throat irritation, chest discomfort, flushing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Death  5/30/2021 Causes of death listed on death certificate: 1) Hypertensive Heart disease with Heart Failure Diastolic  Other: Covid-19
Initial report received from a healthcare professional on 18 September 2013. On 9-Sep-2013 unknown age and gender patient received dose of FLUZONE ID (Lot: UT4725AA) intradermal. Patient had painful experience since 09-Sep-2013. Patient experienced hot and hard with pain and that spread to patient's armpit until yesterday (16-Sep-2013). On 17-Sep-2013, injection site was hard. Patient reported that this intradermal injection felt like a whole bunch of needles pricking me at one time instead of one needle and caused a welt that spread. Events were resolved at the time of report. Documents held by sender: none. Follow-up information received from a health care professional on 15-September-2014: The patient received FLUZONE ID in the left deltoid, at the clinic. The patient did not visit the clinic for assessment. No medical history and concomitant medications were mentioned on the records.
Constant cramps in right calf. I start taking aspirin and natural blood thinners suspecting it may be a blood clot.
PATIENT WAS SITTING AT STATION AND PASSED OUT AND BANGED LEFT SIDE OF FACE AND FAINTED ON TO THE FLOOR. 911 WAS CALLED, PATIENT ASKED "WHERE AM I?" AND COULD NOT RECOGNIZE MOM. AFTER ABOUT 30 SECONDS PATIENT RECOGNIZED MOM AND THEN SAID SHE REMEMBERED FEELING LIGHTHEADED BUT NOTHING ELSE FROM THE INCIDENT. EMS TOOK BLOOD PRESSURE AND GLUCOSE READING WHICH WERE NORMAL BUT THE PATIENT FELT NAUSEA SO SHE WAS PUT ON STRETCHER AND
I had COVID - breakthrough case with dry cough, headache, chest tightness, sore throat and general tiredness.
This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 27-AUG-2015 the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD, lot # reported as: L023111, expiration date: 24-DEC-2016) (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptom was reported. This is one of several reports received from the same reporter. Additional information has been requested.
PAtient had already received the covid vaccine and the facility re added him to  the list were he received a 2nd dose of covid that was not needed.