chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 25-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R021055 with expiration date in 01-APR-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Numbness in left hand and left leg below the knee; Cramps in left leg; Slight pain in left leg; Tingling in left hand and left leg below the knee; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 10Sep2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), gastrooesophageal reflux disease (GERD) and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), esomeprazole sodium (NEXIUM) and vilazodone hydrochloride (VIIBRYD); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 12Sep2021 at 00:00, the patient experienced numbness and tingling in left hand and left leg below the knee, slight pain and cramps in left leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 25Sep2021, 28Sep2021 and 02Oct2021, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events numbness and tingling in left hand and left leg below the knee, cramps in left leg and slight pain in left leg was not resolved at the time of this report.
See below: Persistent shoulder pain x 25 days after flu vaccine. This 42 yo female received her annual influenza vaccine FLUCELVAX (SEQ Lot#195231) to her left deltoid on 9/18/2017. She reports as vaccine given she felt an electrical jolt from her shoulder to all fingertips for 1-2 seconds that resolved when needle pulled out and a band-aid was applied (recalls was placed mid upper deltoid @ 3FB down from shoulder). Approximately 2 hours later her left shoulder hurt and felt like it wanted to pop with gradually worsening joint pain. She was unable to lift the left arm to undress that night due to pain and limited ROM/lifting-pulling. This discomfort persisted over the next 4 days and has remained as of 10/13/2017. She reports she saw her HCP on 10/9/2017 reporting limited ROM with certain positions: i.e. If elbow bent 90deg angle, she cannot raise arm above shoulder due to pain, and if arm extended she can extend arm overhead but feels the shoulder pop at shoulder level both raising and dropping arm which causes pain. She lists the pain as a constant 3-4 ache but gives a 4-7/10 with movements that cause shoulder to pop. Her HCP diagnosed her with nerve impingement and has started her on medrol dose pack and ordered physical therapy. She denies any injury, trauma, site inflammation (redness, swelling, TTP or other systemic reactions), denies exercising or carrying any heavy/bulky objects while at work or prior to vaccination (IE yard work over weekend). No other vaccines given with flu vaccine. Supplemental HPI [use for free text].
5 minutes after receiving the vaccine, patient felt dizzy and lightheaded. pt came to observation area in wheelchair with staff and her mother. pt had some water and crackers, no nausea, no dizziness. VS  AT 12:33 BP 91/59 P 67 RR 18 VS AT 12:38 PB 94/53 P 72, 02 99 VS AT 12:43 BP 86/56 P 75 02 100
Left arm (deltoid muscle)  red, swollen, and hot to the touch, onset 1 day after receiving the vaccine.   Patient was evaluated at clinic by CRNP.  Treatment- ice 20 minutes on 20 minutes off 3-5 times a day. Benadryl 25 mg 3 times a day and Tylenol as needed.  Outcome-if no improvement, patient to follow up in the office in 3-5 days.
This spontaneous report as received from a nurse refers to a 78 year old patient. Medical history and concurrent conditions were not reported. On 13-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm ) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Nurse reported about other patients who were vaccinated with improperly stored ROTATEQ (captured into MARRS #1403USA014557). Additional information has been requested.
I started to have a scratchy irritated throat with a dry cough. I then got a headache, fatigue and muscle aches. My cough got worse but it was still dry. I got a fever of 102 and my skin was prickly and sore. I had nausea vomiting and diarrhea for two and a half days. The worst symptoms lasted for about seven days. I was very fatigued and I did not do much but sleep. My husband also had Covid-19 at the same time as me. I went to Urgent Care about ten days after it started because my husband was having trouble breathing. We both tested positive for Covid-19I on 07/25/2021. I had symptoms for 14 days but the fatigue and headaches for longer than that. I still feel a little fatigued after eight weeks.
G62.9 PERIPHERAL NEUROPATHY 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE I21.4 ACUTE NON ST ELEVATION MI 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE I95.9 HYPOTENSION 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE J96.00 ACUTE RESPIRATORY FAILURE 11/8/2021 DM 2 W PERIPHERAL VASCULAR DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE R09.02 HYPOXIA 10/28/2021 DM 2 W PERIPHERAL VASCULAR DISEASE R57.1 HYPOVOLEMIC SHOCK 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE R57.9 SHOCK, UNSPECIFIED 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE G62.9 PERIPHERAL NEUROPATHY 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE I21.4 ACUTE NON ST ELEVATION MI 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE I95.9 HYPOTENSION 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE J96.00 ACUTE RESPIRATORY FAILURE 11/8/2021 DM 2 W PERIPHERAL VASCULAR DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE R09.02 HYPOXIA 10/28/2021 DM 2 W PERIPHERAL VASCULAR DISEASE R57.1 HYPOVOLEMIC SHOCK 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE R57.9 SHOCK, UNSPECIFIED 1/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE G62.9 PERIPHERAL NEUROPATHY 1/3/2022 ANEMIA OF CHRONIC DISEASE I21.4 ACUTE NON ST ELEVATION MI 1/3/2022 ANEMIA OF CHRONIC DISEASE I95.9 HYPOTENSION 1/3/2022 ANEMIA OF CHRONIC DISEASE J96.00 ACUTE RESPIRATORY FAILURE 11/8/2021 ANEMIA OF CHRONIC DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 ANEMIA OF CHRONIC DISEASE R09.02 HYPOXIA 10/28/2021 ANEMIA OF CHRONIC DISEASE R57.1 HYPOVOLEMIC SHOCK 1/3/2022 ANEMIA OF CHRONIC DISEASE R57.9 SHOCK, UNSPECIFIED 1/3/2022 ANEMIA OF CHRONIC DISEASE G62.9 PERIPHERAL NEUROPATHY 1/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE I21.4 ACUTE NON ST ELEVATION MI 1/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE I95.9 HYPOTENSION 1/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE J96.00 ACUTE RESPIRATORY FAILURE 11/8/2021 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE R09.02 HYPOXIA 10/28/2021 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE R57.1 HYPOVOLEMIC SHOCK 1/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE R57.9 SHOCK, UNSPECIFIED 1/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE G62.9 PERIPHERAL NEUROPATHY 1/3/2022 HYPOTHYROIDISM I21.4 ACUTE NON ST ELEVATION MI 1/3/2022 HYPOTHYROIDISM I95.9 HYPOTENSION 1/3/2022 HYPOTHYROIDISM J96.00 ACUTE RESPIRATORY FAILURE 11/8/2021 HYPOTHYROIDISM J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2022 HYPOTHYROIDISM R09.02 HYPOXIA 10/28/2021 HYPOTHYROIDISM R57.1 HYPOVOLEMIC SHOCK 1/3/2022 HYPOTHYROIDISM R57.9 SHOCK, UNSPECIFIED 1/3/2022 HYPOTHYROIDISM
This spontaneous report was received from a pharmacist via company representative regarding two patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. The pharmacist reported that on 14-OCT-2016, two patients received the PNEUMOVAX 23 (dose, strength, indication, route and lot# not reported). On the same day, both the patients developed similar kind of side effects on the same day of the vaccination. It was reported that both of the patients developed fever, it was not specified how high the fever was or how long it lasted and extreme pain (location of the pain was not specified). The patients sought medical attention by speaking to a pharmacist. Outcome of the events were unknown at the time of this report. No product quality complaint involved. Causality assessment was not provided. This case is linked to case 1611USA003592 (same reported link). Additional information has been requested.
Information has been received from a 62 year old female patient who in February 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included "calcium channel blocker" and "thyroid medication". The patient reported that on 25-FEB-2011 she came down with "shingles". The patient never went to her physician for a "diagnosis". The patient stated that she had had shingles every year for the 5 years before she received ZOSTAVAX (Merck) so she "knew what it looked like". The patient stated that the rash was between buttocks on the left side. She reported it as a "small patch". The patient reported 3 weeks of pain (unspecified nature) leading up to the onset of the rash. The patient said rash resolved on its own with no treatment. No further information is available.
Patient was injected IM with SHINGRIX 50mcg in his left arm at approximately 12:03pm. While walking away from the pharmacy with a shopping cart, he slowly fell to the ground, fainted. He did not hit his head, or lose consciousness. 911 was called and took care of the patient.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
pt recv vax 6FEB97 & devel fever to 103.7 on the evening 6FEB97 & had gen sz which was very brief when fever rose from 101+ to 103.7;
6/12- reports swelling redness with rash imediately after vaccine injections, fever 101 4 days later. Now with persistent redness, ttp, rash for 8 days now.
Saw burst of colors, everything went black, then returned to normal...she became frightened and confused and scared and felt strange, not just of the situation..but of just about everything...it continues....daily now....she cries and cries.
Extreme muscle pain on L side arm, up into neck, jaw & shoulder blade.  Ran a fever of 101.  Severe HA, sensitive to light.  Upset stomach lasted through Monday 8-31-09.  L arm is itching.
Fever/chills less than 12 hrs after receiving shot (approximately 8pm day of).  Fever/chills persisted Friday night, all of Saturday & some of Sunday.  By Sunday evening, fever was intermittent.  Highest temp recorded was 100.8.  Fatigue was noticed on Saturday, approximately 24 hours after the shot.  Got ~8 hours of sleep Friday night, took a 5 hour nap Saturday afternoon (not normal for me), got ~8 hours of sleep Saturday night (interrupted due to fever/chills), took another nap on Sunday.  Excessive fatigue persisted approximately 9 days. 3 weeks out and I am still very tired after a normal day of work; several times I fell asleep 2-3 hours before my normal bed time.  Approximately 3 days after receiving the shot (on Sunday), I noticed I was having trouble walking; my feet wouldn't lift up enough and I would "trip on nothing" (shoes would catch on the ground).  this progressed to my knees giving out on a daily basis, often for the entire day. This has been an episodic reoccurrence for me, but usually only lasts between a few minutes to 1 day.  3 weeks after the shot, my knees still give out on a daily basis.  I have not (yet) fallen due to this, but have had several close calls.  On day 10, I saw my PCP as I was very concerned about my energy levels (fatigue), and my knees giving out.  At the time of the appointment, my knees were not working properly at all (a nurse was concerned for my safety) and holding an arm was extremely tiring.  If I dropped my arm, it would fall unhindered until it hit my leg/whatever was underneath it.  July 27th, I started taking B vitamins and have noticed my energy levels have increased, but are still not where they should be.  Mostly days, after working approximately 8 hours with a 30 min 1-way commute, I am exhausted and only want to go to bed.  This is very atypical for me.  I noticed, also, my urine has smelled sweet most days since I have received the shot; I plan on contacting my PCP in the near future to discuss this.
Localized redness at injection site of about 1 inch wide and 2 inches long across upper arm area with localized itching.  Lasted for about a week.  Used warm compresses at site twice a day for 2 days which increased the size of the redness.
From initial information received on 08Apr05 from a health care professional regarding an adverse event occurring, it was reported that a female pt (no specific identification provided) received a dose of Tet tox ADS USP, lot unk, admin in her gluteal muscle on 06Apr05. One day later, on 07Apr05, the pt complained of generalized fatigue with local reaction. She also experienced a headache. The pt has not recovered from these events.
Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Pt recvd 3 doses of Engerix-B & on 3OCT91 titers were checked & the vax was found to exhibit seroconversion but no seroprotection, a weakly positive result was observed; pt considered a non-responder & will be revaxed;
Patient began experiencing chest tightness between 10-15 minutes after vaccination, followed by throat tightness and tongue thickness. Banophen (diphenhydramine) 50 mg administered PO. Shortness of breath began about 10 minutes after initial complaint, at which time epinephrine 0.3 mg was administered IM R thigh. Patient reported increasing shortness of breath and tightness of chest and throat, 0.3 mg epinephrine administered again IM left thigh about 6 minutes after previous dose. Patient requested additional diphenhydramine, so 50 mg Banophen administered PO. Continued increasing severity of symptoms, another epinephrine 0.3 mg IM right thigh 7-9 minutes after previous dose. Patient care was then transferred to EMS services.
Headache; Sore throat; Runny nose; Nausea; Muscle pain; Injection site pain; Chills; Feeling unwell; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 19:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Drug allergy", notes: Known allergies: Azithromyicin. The following information was reported: HEADACHE (non-serious) with onset 14May2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 14May2021, outcome "not recovered", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 14May2021, outcome "not recovered", described as "Runny nose"; NAUSEA (non-serious) with onset 14May2021, outcome "not recovered", described as "Nausea"; MYALGIA (non-serious) with onset 14May2021, outcome "not recovered", described as "Muscle pain"; VACCINATION SITE PAIN (non-serious) with onset 14May2021, outcome "not recovered", described as "Injection site pain"; CHILLS (non-serious) with onset 14May2021, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 14May2021, outcome "not recovered", described as "Feeling unwell"; FATIGUE (non-serious) with onset 14May2021, outcome "not recovered", described as "Tiredness". The events "headache", "sore throat", "runny nose", "nausea", "muscle pain", "injection site pain", "chills", "feeling unwell" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of headache, oropharyngeal pain, rhinorrhoea, nausea, myalgia, vaccination site pain, chills, malaise, fatigue.  Additional information: The patient previously took azithromycin on an unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.