chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on both legs (lower; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on both legs (lower) and PRURITUS (itchy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (pistachios). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on both legs (lower) and PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on both legs (lower) and PRURITUS (itchy) outcome was unknown. Not Provided      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.   Patient has taken Benadryl day before vaccination due to pistachio allergy.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded
Pt states she received the flu vaccine and 2 hrs after getting the vaccine she had bilateral leg weakness while ambulating, right mid torso numbness radiating into right shoulder down the right arm. Pt states she went to sleep and the symptoms and resolved when she woke up from her nap. At the time of her appointment the  following day she had mild pain at the site of injection and mild pain in the right wrist and right hand.
Extreme fatigue; Persistent nausea.; Immediate lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical and concomitant medications were not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced penicillin allergy. 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 the vaccination. On 07Apr2021 at 11:30, the patient experienced immediate light-headedness and immediate dizziness, both persisting all day and into the night. Three hours after the vaccination (at 14:30), the patient experienced extreme fatigue and persistent nausea. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events immediate light-headedness, immediate dizziness, extreme fatigue and persistent nausea was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt mother states that he had a fever of 100.5 with some vomiting.
Due to my MS I have numbness, and a ?pins and needles? feeling in my lower legs, bilaterally, below the knee. About 30 minutes following the 3rd shot I began to have a feeling of numbness (new) in both legs extending up to my mid-thighs - not completely numb, I can still feel everything, the feeling is just diminished. More on the left than the right. It has made walking more challenging than usual. If not improved in the am then I was going to go to the doctor.
Numb feet and hands, proceed to prickle, pins, hurt above both knees, then thighs, buttocks, pain, now all the way to waist line. Latest scalp sore to touch and had sore throat yesterday. No temp.  11/23/09 Medical records received for DOS 11/16/09 and 11/24/09.   Final DX: severe reaction to H1N1 flu shot (10/22/09). Hypertension benign C/O swollen painful joints, heart palpitations, tingling and pinprick/discomfort  in thighs, ascending to buttocks/waist.  Patient had stress r/to CA tx and job. Hypertension.   ICD9 Codes: 782.0, E948.8, 401.1
Dizziness, nausea, fainting spells initially. Dizziness and headaches daily since.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 17-JUN-2014 patients were vaccinated with PROQUAD (dose, route and lot number were not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received PROQUAD (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 17-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient hospitalized with severe anemia March 14. Received 2 units of blood. Patient hospitalized April 24-26 severe anemia ,revived 3 units of blood . Both events occurred shortly after end of menstrual cycle. Blood transfusions and severe anemia were not part of patients history.
Patient was fully vaccinated. Patient has now been hospitalized  on 8/16 with C19+ diagnosis. Presented with upper respiratory symptoms of distress.
Red itchy  rash with swollen cyst a few inches below the injection site appeared a week later
COVID; EYE INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and EYE INFECTION (EYE INFECTION) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID) and EYE INFECTION (EYE INFECTION). At the time of the report, COVID-19 (COVID) and EYE INFECTION (EYE INFECTION) was resolving.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  Reportedly, the patient had COVID and eye infection, off for 15 days.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COVID and EYE INFECTION with RINVOQ(UPADACITINIB) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Swelling lymph node in one of  breasts with the size as Lima bean; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. 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, the patient experienced swelling lymph node in one of the breasts with the size as lima bean. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling lymph node in one of the breasts with the size as lima bean was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
ON 10/12 PATIENT REPORTED SHE WOKE UP WITH HER NECK HURTING, SHOULDERS FELT LIKE THEY WERE ON FIRE, SCALP HURTING, LYMPH NODES SWOLLEN IN NECK, AND HAD HEADACHES. SHE TOOK CELEBREX AND 30 MINS LATER SHE FELT NO RELIEF. ON 10/13 PATIENT SAID SHE STILL FELT AWFUL SO SHE STAYED IN BED ALL DAY AND IT HURT T0 MOVE HER HEAD. ON 10/14 PATIENT WENT TO THE URGENT CARE TO BE TESTED FOR THE FLU. RESULTS WERE NEGATIVE BUT FELT IT WAS A VIRAL INFECTION NOT CAUSED BY THE SHOT ON 10/17 A RASH DEVELPED ON THE LEFT SIDE OF PATIENT'S FACE AND HER SCALP HURT ON 10/18 PATIENT SAW A DERMATOLOGIST WHO TOLD HER IT WAS PROBABLY CELLULITIS AND NOT CAUSED BY THE SHINGLES SHOT. PATIENT GIVEN HYDROCORTISON CREAM ON 10/19 THE RASH IS EXTENDING TO THE LOWER PORTION OF HER LEFT FACE AND LYMPH NODES ARE STILL SWOLLEN UNDER THE JAW ON 10/20 THE RASH COVERED THE ENTIRE LEFT SIDE OF HER FACE. DEMATOLOGIST GAVE PATIENT ANTIBIOTIC AND EVENTUALLY RASH WAS MUCH BETTER BY 10/22.  PATIENT SAYS THE ONLY THING DIFFERENT IN HER ROUTINE WAS THE SHINGLES VACCINATION
Patient was given his 2nd dose of covid vaccine only 16 days after his initial dose.
Next day - chills, sweaty palms and feet. Tingling in hands. No symptoms at injection site. Symptoms subsiding on day 2.
Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.
1215 patient received Pfizer vaccine 1230 patient reported scratchy throat. assessed: airway clear. pulse ox 98 HR 80s 1235 given po Benadryl 50 mg 1240 worsened symptoms: throat scratchy, throat clearing and grunting.  administered epi pen 3mg IM.  Called 911 1245 no improvement in patient symptoms.  BP 130s/80s, HR 190s, sat 94% 1250 ambulance arrived, they called for staff. Patient left in care of ambulance staff, pt transported to hospital
febrile sz x 2-treated in ER pm, p/receiving immun earlier that day
Firm lump in arm about 1" in diameter at injection site. Lump/upper arm was tender to touch. Slight throbbing pain in arm at lump/injection site. Itching and broken skin on upper arm about 4 inches in diameter.  "Covid Arm"
Information has been received from a 71 year old female consumer, with a thyroid disorder, who on 17-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included SYNTHROID and CRESTOR. On 17-SEp-2007, following the vaccination, she experienced flu like symptoms, including pain over her entire body, and developed redness and soreness at injection site in a 3 inch diameter "blotch." The patient visited her physician, though no treatment was administered. On 20-SEP-2007, the consumer had recovered from flu like symptoms, redness at injection site and soreness at injection site, though the general body pain continued. No further information is available.
Got Shingles despite the 2 Doses of Shingrex/ Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 doses of Shinglrix and got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
I  received the second dose on 4/9/21 Lot 037A21B and the same symptoms occurred and increased in severity.  Fever 102 for 3 days, fatique for 5 days, terrible migraine headache 5 days, lumbar back pain with sciatica nerve pain down right leg which began approx 4 hours after first injection and second injection.  I had to take Sumatripton every 8 hours for 5 days to manage Mirgraine to tolerable level otherwise my head felt like it was going to explode.  I called primary care doctor, Doctor who prescribed Robaxin muscle relaxer for lumbar pain and nerve pain which alleviates pain.  Once I stop taking it since March 16th, I have sciatica pain or neuropathy type pain radiating down right leg to foot from buttock area.  Difficult to walk.  Very tired.  Ulcerative Collitis came out of remission- Left lower quadrant abdominal pain.
Patient develop a raised red rash at the injection site. Approximately 1 to 1 and 1/2 inch in circumference.
Swelling, redness, tenderness to right deltoid where Tdap injection was given and low grade fever.
The patient presents with abdominal pain. 77 year old male presents to ED complaining of abdominal pain. He states he has a chronic ventral hernia located in his central abdomen. He notes he had a cough last week that aggravated the hernia, along with an episode of vomiting 3 days ago. He currently complains of soreness to the area of the hernia and nausea.
14 year old male pt presented with syncope episode upon walking from vaccination room to the observation area, LOC for 2-4 seconds, pt placed in supine position with elevated feet, woke up immediately. Pt did not hit head and was assisted to into wheelchair and place on cot. 2:25pm vitals: BP 66/48 P 92 SpO2 98 on RA. Pt history obtained from father, no history of allergies but does have needle related anxiety. Pt supine with feet elevated, ate bag of chips, juice box and water. VS at 2:33 BP 98/65 P 65 when sitting. Pt ambulated, alert and oriented x3, and final VS at 2:38 at BP 94/62 P 76.
This literature report (initial receipt 04-Sep-2012) concerns an 11-year-old female patient who had a medical history of von Willebrand disease and family history of atopic dermatitis and hay fever. 6 months after influenza vaccination (manufacturer and batch no. not specified) and 14 months after DTaP vaccination (manufacturer and batch no. not specified) the patient presented for evaluation of delayed-type hypersensitivity reaction. Symptoms included swelling, erythema and pruritus at the injection site and concurrent pruritic, erythematous eruption of arms and legs. The pruritic eruptions were partially relieved by oral antihistamines. A patch test was positive for aluminum chloride hexahydrate (2+).
Muscle and joint pain began post 3rd shot. Persisted x 1-2mins despite Tylenol seen by family physician and given Naprolen which gave some relief. Muscle and joint pain persists.
The morning after the vaccination, I woke up and felt slightly nauseous. When I got out of bed, and went to the bathroom, everything went white and I fell. I was able to get up on my own but had to lay back down. I thought I would be unable to go to work but after resting for about 15 minutes, I was able to get up, finish getting ready for work but continued to get lightheaded if I stood in one spot for too long. I was very tired and out of it the rest of the day, and having chills throughout the day. All of this in addition to my arm being very sore and my back hurt from my fall. I also had a very bad headache, and later in the day, around 430pm, my temp was 100.2.  I took tylenol and went to bed around 630.
Information has been received from a physician concerning a 6 month old male with no medical history and no allergies who on 19-JUN-2007 received his first dose and on 19-OCT-2007, received his third 2.0 ml oral dose of Rotateq (lot# 656385/0030U) (date of second dose was not reported). There was no concomitant medication. it was reported that on 19-OCT-2007, he developed diarrhea with trace amounts of blood two hours after he had received the vaccine. He was seen by his physician and it was reported that the diarrhea lasted for a few days then resolved on its own. A stool culture was reported as negative. It was reported that as of this report the patient had recovered. No product quality complaint was reported. Further information was not available. Upon internal review it was determined that diarrhea with trace amounts of blood was an other important medical event. Additional information has been requested.
pt recvd vax 2NOV94 p/laceration to digit states 3NOV94 arm felt like had been stung by a bee; today entire deltoid is edematous, hot to touch & has 2" x 2" reddened area @ site of inject;
SUSPECTED CLINICAL VACCINATION FAILURE; VIRUS HAD EFFECTED THE WALLS OF HER HEART; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer who reported hearing a radio news (social media) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient was a cardiologist. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient got covid-19 (coded as suspected covid-19 infection and suspected clinical vaccination failure). The patient was very sick and there was a diagnosis that the virus had affected the walls of her heart, which made difficult to breath long term (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, virus had effected the walls of her heart and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000217755.; Sender's Comments: V0: 20220237050-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
SOME PATIENTS GOT ARM BIT PAIN; SOME VIALS DID NOT HAVE ENOUGH FOR 5 DOSES/ NOT ENOUGH VOLUME IN VIALS; USED 9 VIALS TO GET 40 SHOTS/ USED THE LEFT OVER QUANTITY FROM ONE VIAL WHICH WAS 0.2 OR 0.3 ML AND COMPLETE THE DOSE FROM THE NEXT VIAL; This spontaneous report received from a pharmacist concerned multiple patients (ages from 35 to 70 years). The patient's height, and weight were not reported. The patient's concurrent conditions included some patients have cancer and recover from cancer, diabetes type 1, diabetes type 2, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced some subjects got arm bit pain. On 06-MAR-2021, the subject experienced some vials did not have enough for 5 doses/ not enough volume in vials. On 06-MAR-2021, the subject experienced used 9 vials to get 40 shots/ used the left over quantity from one vial which was 0.2 or 0.3 ml and complete the dose from the next vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some patients got arm bit pain on 07-MAR-2021, and the outcome of some vials did not have enough for 5 doses/ not enough volume in vials and used 9 vials to get 40 shots/ used the left over quantity from one vial which was 0.2 or 0.3 ml and complete the dose from the next vial was not reported. This report was associated with product quality complaint: 90000172234 This report was non-serious.; Reporter's Comments: This report contains multiple patients
Patient presents to ED with COVID symptoms and positive test. Chest pain as well. Fully vaccinated May 2021.
About 24 hours after receiving VARIVAX in her left arm, patient noticed a large swollen itchy red area at the injection site on her left arm. She took BENADRYL 25mg, but it did not have much effect on symptoms. On exam 12-4-08, there is an 8cmx7cm red,indurate, swollen area on left upper arm.
My alopecia areata had been under control for several years prior to my COVID vaccination.  Within a few weeks of receiving the second dose, my hair started falling out very quickly.  I've now lost 50% of the hair on my head and I have painful sores all over my scalp.  There is no way to know if my hair will ever come back.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 25-MAR-2014 at 14:15, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 20/20; Mar 20 26/40. This is one of several reports received from the same source. Additional information is not expected.
Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up with a fever and scratchy throat and headache. Since then the symptoms have lingered. Jan 2- 3 he developed more fatigue. Jan 4 - fever to 101 and headache. He also feels weak and has intermittent scratchy throat. Also had injection site soreness. He has Rheumatoid Arthritis for which he's taking actimira, and methotrexate (immunesupressants). Will test him today (1/4) for COVID-19. 1/5 - COVID-19 test is negative. Employee reports resolution of all symptoms.
Pulsatile tinnitus prior to vaccination was tolerable; got real bad 10 days after vaccination.  No longer tolerable