chrisvoncsefalvay/vaers-outcomes huggingface dataset:
motor tic in foot; lethargy; oxygen saturation varied between 88 to 98; low grade fever; blood pressure both increased and decreased; increased heart rate; vomiting; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 19th August 2020, less than a day after receiving Menveo, the patient experienced lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased and vomiting. On an unknown date, the patient experienced motor tic. On an unknown date, the outcome of the lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased and vomiting were recovered/resolved and the outcome of the motor tic was not recovered/not resolved.   It was unknown if the reporter considered the lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased, vomiting and motor tic to be related to Menveo.  Additional details were provided as follows: The reporter was the mother of the patient.  The patient had received the Menveo vaccine and within 24 hours he had lethargy, vomiting, increased heart rate, blood pressure both increased and decreased, low grade fever, oxygen saturation varied between 88 to 98.  These symptoms lasted for approximately 4 days then resolved.  She took her son to a pediatric cardiologist on the 5th day and he had no symptoms.  Three to six months later the patient had developed a motor tic in his foot, he had not been to the doctor about the motor tic, it was not resolved. The reporter consented to follow up.
- fever - fatigue - muscle/bone pain - moderate chest pain during exercise - moderate difficulty breathing during exercise - random chest pains
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 (also reported as "l003188" and an expiration date of 20-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 168 and 24 hours and the highest recorded temperature reported was 49 and 47 Fahrenheit (F) (9.44444444 and 8.333333333 Celsius (C)) respectively. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
First Shingrix 2/15/2019. Second Shringrix 4/19/2019. Before first of May, 2019 I experienced intermittent buzzing and itching of inner left ear. On 6/13/2019 Internal Med MD said my left ear was clear/normal and prescribed acetic acid drops (did not help). By first of August 2019, I started having continuous left occipital soreness of my scalp and skull, which by mid-September, had spread to the entire back of my skull. This unrelenting headache, continued for over 2.5 months, until today, the fourth day that I have taken valacyclorvir 1000 mg every 12 hours. My scalp also seems flat against my skull bones for the first time in 2 months; there remains left ear-to-chin tingling present x 3 weeks.
injections site, red and swollen 1 inch diameter, also itchy.  same arm of the injection site has swollen sore armpit.
injection site was reddish and itchy; injection site was reddish and itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site was reddish and itchy) and INJECTION SITE PRURITUS (injection site was reddish and itchy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and Supplements for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site was reddish and itchy). On an unknown date, the patient experienced INJECTION SITE PRURITUS (injection site was reddish and itchy). At the time of the report, INJECTION SITE ERYTHEMA (injection site was reddish and itchy) and INJECTION SITE PRURITUS (injection site was reddish and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Distress and pain for 2 days, then rash appeared and shingles diagnosed.
Tested positive for COVID 5/17/2022, died 5/27/2022. Symptoms included muscle aches and cough.
Initial misuse report received from a healthcare professional on 26 November 2013. The cases were received on 21 March 2014. A female patient (No other information was provided regarding the patient), received FLUZONE on unspecified date. It was reported that the pregnant patient received 2012 dose of vaccine. No adverse event was reported. List of documents held by sender: none.
Pt recv vax on 1/25/99; 15 min post vax pt exp paleness, vomiting 3x, lethargic, headache, nausea, tachycardia, drowsy; tx=sleep for 30 min, supine -feet up
Red swollen from shoulder to elbow, hot to touch, blisters on bottom half, blotchy. Dr. Dx with chicken pox gave atb. doing BENADRYL and MOTRIN.
Second dose administered at 2:30pm 3/15 Began running a 99.8 fever at 1:30pm 3/16 headache begins Spiked to 103.4  at 3:00 While napping heart rate was averaging 120. It continued at that average while resting on the couch until my fever broke at 7:30. my heart rate remained above 100 until I went to bed.  Woke up at 8:30 and still have a headache as of 4:05. Heart rate is now 89
(L) injection (MMR & DTaP) 8/3/09 24 hrs later parent noted redness 48 later child c/o pain at injection site w/noted spreading erythema no assoc fevers.
Patient has not received 2nd dose due to side effect experienced, 1st dose given 18May2021; red welts all over body head to toe; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (red welts all over body head to toe) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose due to side effect experienced, 1st dose given 18May2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (red welts all over body head to toe) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose due to side effect experienced, 1st dose given 18May2021). At the time of the report, URTICARIA (red welts all over body head to toe) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose due to side effect experienced, 1st dose given 18May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was supplements but was unsure of which. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received on 6-JUL-2021 and contains non significant information.
There were no signs of adverse events at the clinic. Infant was found dead in the morning on or around 8/14. Infant was well evening before. Mother had slept in same bed with her infant daughter.
Stiff Neck, Sore Throat, Feeling feverish, Left Arm Pain
1.  Dry red rash over both legs, torso, chest and back.  2.  Elevated liver enzyme values for ALP (289.00), AST (115.00), and ALT (168.0).
I felt generally ill. About 3 weeks later I got tightening in my chest which caused left arm to go numb. I was short of breath. Provider did a full work up and provided medication. It was worked up as cardiac event. The symptoms eased up and I had to do cardiac follow up with a different specialist (MD). I still have recurring migraines more often than prior to this event.
This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. On 10-MAY-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021581 with an expiration date 09-AUG-2019 for prophylaxis (dose, route of administration anatomical location were not reported). Concomitant therapies included properly stored sterile diluent (MERCK). Administered dose of VARIVAX experienced the temperature excursion form -9 degrees Celsius to 8 degrees Celsius for 192 hours. There was no previous temperature excursion. A digital data logger was not involved. Product quality complaint (PQC) was not reported.
On 6/21/2021 I developed a itching blistery rash 3"×3" in diameter in the exact location where both vacine were administered, putting the reaction almost exactly 2 months after my second dose of the v; On 6/21/2021 I developed a itching blistery rash 3"×3" in diameter in the exact location where both vacine were administered, putting the reaction almost exactly 2 months after my second dose of the v; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0172 and expiration date were not reported), via an unspecified route of administration, administered in left arm on 25Apr2021 (Age at vaccination was 38 years) as dose 2, single for covid-19 immunisation. facility type where vaccine was administered was School or Student Health Clinic. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8737 and expiration date was not reported), via an unspecified route of administration, administered in left arm, on 25Apr2021 at 10:00 AM as dose 1, single for COVID-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the covid vaccine. Patient did not received any other medications within 2 weeks of administration of vaccine. Patient did not have allergies. On 21Jun2021 the patient developed a itching blistery rash 3 by 3 inches in diameter in the exact location where both vaccine were administered. Patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination patient was not tested for COVID-19. Patient reported that "putting the reaction almost exactly 2 months after my second dose of the vaccine". No treatment was received for the events. The outcome of events was not recovered.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
When I left Pharmacy and got in my car after the first vaccine, the left side of my face went numb for 3 hrs. The second shot it went numb for one hr. The first booster it went numb and has stayed numb.
Typical soreness at injection site immediately after.  Next morning extreme pain in shoulder joint.  Applied ice pack.  No relief.  Three days later, still in pain.  Have flu shot annually, never had any problem.
Immediate hives. BENADRYL 25mg PO. 11-18-09 f/u call to mother who reports hives gone, but developed fever last night. Child dx with bilat ear infection by their MD.
right arm pain; Pain in his 2 fingers; he can't grip things with that hand; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "right arm pain"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in his 2 fingers"; GRIP STRENGTH DECREASED (non-serious), outcome "unknown", described as "he can't grip things with that hand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: Patient received both doses. 2nd dose the patient had right arm pain, took ibuprofen for it. Still has continuing pain in those two fingers his Index and middle fingers. The pain was worse in the morning, but he can't grip things with that hand. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This error may have occured but (physician) was not certain; a lot of crying for 5 to 7 days; Child was also fussy; Had night terrors; Possible low grade fever; Physician stated a 1 year old female was inadvertently administered GARDASIL 9; Receive Hep A vaccine but instead may have received HPV in error; This spontaneous report was received from a physician and refers to a 1-year-old female patient. The patient had no concomitant medications and or pre-existing allergies, birth defects and medical conditions. She had no illnesses at the time of the vaccination. The patient was the only child and her bith weight was 7 ibs and 14 oz.  On 02-AUG-2019 the patient was inadvertently vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  The patient was supposed to receive an unspecified hepatitis a virus vaccine (reported as Hep A vaccine), but instead she might had received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (also reported as HPV) in error. The administration physician was not certain if that error had occurred.  On that same day, the patient was also administered with a fourth dose of hib conj vaccine (intramuscularly, lot # UJ077AA (formulation, strength, expiration date were not reported) and with a fourth dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) intramuscularly, lot # AF5647 (formulation, strength, expiration date were not reported).  On 02-AUG-2019, the patient's parents observed a lot of crying (also reported as cried more than usual) and for the next week (also reported as 5 to 7 days), the patient was fussy, had night terrors and a possible low grade fever.  Additionally, it was reported, that the patient's mother subsequently changed practices.  The patient recovered from the events on 09-AUG-2019 (reported as for 5 to 7 days). The causality assessment was not provided.
headache that evolved into a serious migraine.; woke up with a headache that evolved into aserious migraine; felt nauseous from the pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW9150) via an unspecified route of administration in the left arm on 31Mar2021 at 13:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, polycystic ovarian syndrome(PCOS), depression and allergy to red dye #40. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), escitalopram oxalate (LEXAPRO), deogestrel, ethinyl estradiol (VIORELE), lansoprazole (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D), all from unknown dates and for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccination. On 01Apr2021 at 13:00, the patient experienced headache that evolved into a serious migraine, which kept the patient in bed for half the day and also felt nauseous from the pain. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events headache, migraine and felt nauseous were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
A week before, I received Tetanus, Shingles diphtheria vaccines. Within 2 days of the COVID vaccine I became very dehydrated and had a fever. For the dehydration I drank milk, water, took Vitamin E and fish oil. I also started to have severe pressure in my ears. I do have a history of ear pressure, but it would get worse with the COVID vaccines. The pressure would build, rupture and drain out of my ears. I went to see a  doctor on 04/19/2022 to discuss my symptoms. She checked my ears and throat and ordered bloodwork. I did get a referral for an ENT but have not made my appointment yet.
pt recv vax instead of depoprovera & exp flu like sx which resolved the next day;2MAY97 pt exp ha/ which resolved p/2-4 days;
It was a rash/hives on arms, back and inner thighs. Severe itching. Now is currently present on lips.
Ataxic event lasting 30 minutes 10 days following vaccine. Developed fever and rash. Now (11/23/2001) doing well.
Vaccination failure; COVID 19 Treatment; 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 66-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 19May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "supraventricular tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Sep2022, outcome "not recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset Sep2022, outcome "not recovered". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received paxlovid from 19Sep2022 (Lot number: GE4606) to 24Sep2022 for covid-19 treatment. Patient did not had any known allergies.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 06-AUG-2013 was vaccinated with VARIVAX (Merck), (lot # H020672, expiry date 14-NOV-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009867, 1312USA009868, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875, 1312USA009869 (Same reporter link). Additional information has been requested.
High blood pressure starting on March 28 (day 7 of vaccination).  Blood pressure continues high despite conservative measures of rest, alternating rest and activity for three days, low sodium, turning the news off, etc.  Started on Atenolol on Monday, March 31 at 7 p.m.Blood pressure varied from 172-110-139/96, p 85-100
This spontaneous report as received from a nurse refers to a 18 year old male patient. In approximately September 2013 ("about 1 year ago"), the patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscualr in the left deltoid. On 12-SEP-2014 ("today") the patient was vaccinated with second dose of GARDASIL 0.5 ml, intramuscular in the left deltoid. No adverse effects reported. Additional information has been requested.
Received FLUMIST vaccine. Had this also last year. Within 5-10 minutes after administration, noted red blotches on face, then tiny hives on arms - very mild case. No other complaints.
She noticed swelling, redness and itching at the site of injection. Erythema about 8X8cm in size.
1st Dose - Headaches - Nausea - Dizziness - Faint  started on 5/29-5/31 recovered and then on 6/4 symptoms returned progressively worse.  Went to Urgent Care on 6/6  2nd Dose - Arm stiffness (6/18) - Bruising in the injection site - Swollen armpit on the injection arm (6/19 -present
I have bled for 20 days and it is still ongoing; menstrual cycle was delayed a week; high blood pressure; I had a fever; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 11:00 (Batch/Lot Number: EW0153) as DOSE 2, SINGLE for Covid-19 immunisation. Medical history included Temperature intolerance, Vertigo, Heat stroke, Food allergy and Shellfish allergy from an unknown date and unknown if ongoing and included Historical Vaccine BNT162B2 for COVID-19 immunisation as Dose 1 on arm left at 2:30 Pm with Lot number ER2613. The patient's concomitant medications were not reported. The patient experienced I have bled for 20 days and it is still ongoing, Menstrual cycle was delayed a week, High blood pressure and I had a fever on 05Jul2021 12:00. No other vaccine was given in four weeks. There was no treatment received for any of the events. Patient did not have Covid prior vaccination and patient was not tested for Covid 19. The outcome for all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Patient's arm is red, swollen, and warm to touch. Patient's upper arm was measured: 4.5 inches in length, 5 inches width. Patient advised to visit a medical doctor. When patient received vaccines the parent was advised to place cool wash cloths for the redness and swelling and give Tylenol if patient developed a fever.
2 days after 1st Pfizer shot left ear felt like a vacuum trying to suck into left side of skull, then muffled sound, then high pitched ringing that is still currently present 24/7
She got her first ever flu vaccine, and by Friday her elbow felt funny and she looked in the mirror and it was swollen, felt like a water balloon.  Looked on line and said about deltoid swelling, put an elbow wrap on it to compress it and took  Bayer aspirin which it swelled and then relieved.  On her way to getting a mammogram on 12/9/22 she then had a burning sensation at the site of the vaccine shot itself.  It is a pain that goes towards the bicep but is swollen from the front of her forearm to the back of her arm.  It is swollen like a water balloon but it is painful.   The area has stayed at the elbow, but the entire elbow.