chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Saturday 06Mar started getting a few red bumps on butt.  Woke up on Sunday 07Mar had many more bumps on butt, stomach area, a few on the chest area, a few on each leg and about 30 on each side; Hives; This is a spontaneous report from a contactable Other HCP (Patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Latex: allergies. The patient's concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) and ibuprofen. The patient previously took Sulfonamide/sulfa antibiotics and Erythromycin and experienced known allergies. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. On Saturday 06Mar2021 (12:00 PM) started getting a few red bumps on butt. Woke up on Sunday 07Mar2021, the patient had many more bumps on butt, stomach area, a few on the chest area, a few on each leg end about 30 on each side of my torso. Looks like mosquito bites but most likely hives (on 06Mar2021). Size of red bumps are 1 to 5mm in diameter and raised with some looking to have a white center. As a result of event patient required Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for events. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Information has been received from a 48 year old male consumer with arthritis, lazy eye, Hepatitis C, and allergies to methadone, codeine, and anti-depressants, who in July 2004 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot and administration site not reported) and in October 2005 was vaccinated with a dose of PNEUMOVAX 23 (lot and administration site not reported).  Concomitant therapy included influenza virus vaccine (unspecified) one week before the PNEUMOVAX 23 vaccine, and interferon (unspecified) treatments for Hepatitis C.  On an unspecified date in October 2005 the patient was in bed for a month, had an arthritis flare up in all joints, experienced neuro-optic pain, interfered with his interferon treatment, developed incontinence, porus and thinning bones, aggravated his lazy eye, had a local reaction at the injection site, his legs and feet swelled twice the normal size, developed a fever, complete loss of libido, sometimes paralyzed upon waking up, nausea, vomiting, and paresthesia in his legs and fingers.  The patient sought unspecified medical attention.  Laboratory diagnostic tests included a bone density test and blood tests - no results for either were reported.  At the time of reporting the patient had not recovered.  Upon internal review paralysis was determined to be an other important medical event.  Additional information has been requested.
Flecks of blood in stool 7 days after ROTATEQ. No irritability, lethargy, emesis. Will observe. No treatment recommended.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-month-old male patient who received HAV (Havrix pediatric) (batch number Zj3g3, expiry date 12th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Aug-2022:  Reporter's comments: Medical assistant reported that the patient was administered with an expired dose Havrix.  The reporter did not consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix pediatric, which led to expired vaccine used.
Patient presented to the pharmacy today, approximately 24 hours after receiving second dose of Shingrix with red rashes on both arms from about armpits to the palms of his hands and around the injection site.  I advised the patient to go to urgent care or primary doctor which he did.  Dr. (urgent care physician) said it was an allergic reaction to the Shingrix and prescribed the patient Prednisone 20mg tablets to take two tablets daily for five days.
Approx: 4:00PM- Received phone call client's mother-reporting that they had to rush adolescent to ER due to reaction from vaccines given. Mom reported that on way home, client compliant of scratchy throat, chest tightness, itching, rash developing around neck. Parent immediately return to town to take to nearest hospital stopping at local Fire Department to have child assessed due to developing reaction. On assessment, increase resperation, chest tightness,  O2 sat at 96%, family headed on the ER approx. 9 miles away. Child's condition deteriorating with increacing difficulty breathing. Child in distress on arrival- O2 sat down to 84%. Breathing treatments started, child given Benadryl, was placed on steroids and release after stable. Mom reports, child returned to ER the following day with respiratory distress. Was given breathing treatments, steroid injection and oral steroids to take. Follow up on 3-07-13-mom reported that lower arms developed bilateral redness and swelling approx 4 inches in width (area MMR and Varicella were give). Teen was slowing improving. On 03-12-13, spoke with mom and child was back to normal.
Sore arm, chronic fatigue.   Costochondritis. This came on about a week or two after second injection and lasted about 3 months. Pain ranging from mild to chronic. In the beginning would be most of the day, felt particularly when putting weight on arms (pushing up from prone position) or lifting things in ways that caused movement/strain in my ribs. For first few weeks, pain was felt with deep breathes as well as the chest wall expanded, then eventually being more occasional and when ribs were directly used with movement. No injuries, causes, or related events happened in the months before this began, so I did relate it entirely to the vaccination.
sore right shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right shoulder deltoid muscle) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Nervous system disorder NOS (Patient has a long history of nerve problems prior to vaccination).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore right shoulder deltoid muscle) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
Approx 1-2 weeks after 2nd vaccine Moderna 024c21a 5/11/21 began to experience numbness tingling in left leg. June 10th eye exam noted vision problem with referral to ophthalmologist as original optometrist could not treat.  On 7/21/21 was DX with Papilledema and CT scan ordered.  CT scan negative, 2nd opinion agreed with Papilledema tumor of brain ruled out with CT scan.  Have follow up to monitor for changes in Dec 2021, still have numbness of left leg, also right leg and left arm but mostly left leg.
Red warm area (R) upper arm approx 4 cm circular. Observed at O.V 8/13/18 for an illness.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who experienced uneven skin and injection site pain, redness and itching, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2018, the patient received 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unspecified date, the patient developed a non-serious uneven skin, unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unspecified date, the patient developed a non-serious injection site pain, redness and itching unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab test.) Final diagnosis was injection site pain, redness and itching and uneven skin. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site pain, redness and itching and as Unknown for uneven skin. List of documents held by sender: none.
Headaches, joint aches, cough, vaginal bleeding, memory loss, constipation, frequency of urination, blurry vision, hair loss, weight gain, seizures, muscle spasms/twitching shortness of breath, anxiety, extremely fatigue, nausea, varicose veins/clotting/bruises, rashes, cysts, fishy odor, excessive sweating. Follow up on 9/22/04 via phone: Patient reports that she is still having many of the same symptoms I had right after I got the anthrax shot, as well as several new ones. She is currently quite concerned about intermittent muscle twitching of her hands and legs...sometimes her whole body, joint aches, continued hair loss, irregular periods with heavy bleeding and clotting, chronic headaches and fatigue, insomnia, periodic episodes of SOB, urgency and frequency, constipation and diarrhea, memory loss and blurry vision. She has undergo evaluations by Dermatology, Neurology (for her headaches), Gynecology, Endocrinology, Neuropsychological evaluations as well as Head MRI, X-rays of C- and T-spine, Thyroid US and Sleeps study done in an effort to diagnose and/or treat these symptoms. The patient's medical problems are complex, although some may be potentially treatable (dysfunctional vaginal bleeding, panic attacks, and insomnia). To what degree treatment of these problems will resolve her chronic fatigue, myalgias, arthralgias (pain), chronic headaches and cognitive dysfunction remains to be determined with time improved therapy and close monitoring. Athralgias are among the most common systemic side effects associated with anthrax vaccine and is a common complaint of some individuals seen.
Extreme swelling and pain in the right thigh and knee resulting in inability to walk without extreme difficulty.
Chills - eventually ceased after one day Nausea - ceased after one day Headaches - ceased after two days Body aches
Patient presented for 2nd dose, Vax team of LPN and staff administered Pfizer vaccine, Lot # EW0196 exp 09/2021. Further review of patient medical records show patient received his first dose, MODERNA on 2 Jun 2021. The LPN who documented encounter on today?s date recognized her mistake and will be inputting report for event. Patient was monitored for 15 minutes for reaction, I consulted supervisor for further guidance, patient instructed not to receive any additional COVID Vaccine at this time. Patient contact information was collected should follow up be needed.
Suspected Vaccination failure; got the shingles; got post herpetic neuralgia/Suffered in excruciating pain for almost two years; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, it did not work at all for him/her. The patient also got post herpetic neuralgia.  He/she suffered in excruciating pain for almost two years until doctor finally put him/her on Lyrica for it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Chest pain, started the same day as the vaccine. Seen in ER 4 days later since symptoms had not alleviated.
Information has been received through the manufacturer pregnancy registry from a 29 year old Caucasian female pt with no allergies and no past medical history, who on 09/19/02 and 10/25/02 was vaccinated with a first and second dose of varicella virus vaccine live, respectively. There was no concomitant medication. The pt reported that she was "14 weeks" pregnant with a LMP of 08/17/02 and had conceived between receiving doses of varicella virus vaccine live.  Unspecified medical attention was sought.  Follow-up information was received from a physician. It was reported that the pt had one previous pregnancy, no full-term births, no pre-term births, no stillbirths or miscarriages and no birth defects with previous pregnancies. The pt was not tested for varicella antibodies prior to vaccination with varicella virus vaccine live. There was no local reaction at the vaccination site.  There were no varicella or herpes zoster symptoms post vaccination.   On 02/11/03, an ultrasound for a fetal anatomic survey and cervical length was normal. Two other ultrasounds were also normal. In Jan 2003, MSAPP was normal (part of a study).  On 06/07/03, a "biophysical" for decreased fetal movement was normal (8/8). During the third trimester in 2003, the pt experienced excessive weight gain. There were no concurrent conditions, no infections or illnesses during pregnancy and no complications during labor or delivery.  On 06/16/03, the pt gave birth to a normal, male infant weighing 6lbs, 11 oz.  The reporter indicated that the birth was "36+1" weeks from the LMP. There were no features of congenital varicella zoster syndrome.
The patient experienced diaphoresis; Pallor to the extremities; a cold sweat; He almost fainted; This spontaneous report was received from a nurse practitioner concerning an 11-year-old male patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). On the same date, the patient received diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA).  On the same unspecified date, when the patient began to walk out of the nurse practitioner's clinic, he almost fainted (presyncope). Additionally, the patient experienced diaphoresis (hyperhydrosis), pallor to the extremities (pallor) and a cold sweat. On the same date, the patient recovered from the abovementioned adverse events and about half hour later the patient could leave the clinic.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the abovementioned adverse events was not provided.
Patient received COVID Pfizer vaccine series on 7/6/22, 8/2/22 and 9/6/22. The third does was given to  early,  before 8 weeks after the second dose. Family notified. No adverse reaction noted by family.
Day of vaccination 6-8 redness, a little soreness and warm to touch, day 4 (6-12) following symptoms: red rash, pain going up across the neck and as each day followed continue until the pain was from left shoulder to neck and back down the right shoulder, continued with muscle pain, seemed to affect her thinking process. Went to MD on 6-22-2018 placed on prednisone 20mg bid x5 days, Patient came in to pharmacy on 6-22 spoke on Monday 6-25-2018 and feeling much better after the prednisone. Patient's main concern is that this reaction to the 2 series shot be reported.
Initially within a hour slight headache, slight nausea. Lasted 2 days after injection.  Two days after injection, only at night when laying down, severe localized pain near shoulder blade and spine.  Deep throbbing and sharp pain.  Very difficult to sleep.   Lasted 3.5 days, started at night. During day, moving around, working with horses was not noticed.  Still have that localized pain going on 7 days.  As of 2/12/21. But not to the extent stated earlier.   When pain first started, took 800 milligrams ibuprofen each night and 400 milligrams for two nights.  Medicine took about 2.5 hours to actually work enough to be able to sleep.  Have not taken any meds for 2 nights now.  Occasional throbbing but staying away from meds.
pt recv vax 18NOV96 & that evening had 2 major sz adm to hosp 1 day;EEG revealed sz;pt cont to have occasional sz since then;
Patient received Novavax in her left deltoid Patient states the injection site swelled and got hot and she had shooting pain on her right side for greater than 24 hours.  She went to the physician office ~4 days post shot
tender arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (tender arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for an unknown indication.    Concomitant products included NIFEDIPINE, AVENA SATIVA FLUID EXTRACT (AVEENO), VITAMINS NOS, COLECALCIFEROL, FISH OIL, TROSPIUM CHLORIDE, SIMVASTATIN, ALENDRONATE SODIUM, HYDROXYZINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE, ASPIRIN [ACETYLSALICYLIC ACID], METHYLPREDNISOLONE and CITALOPRAM for an unknown indication.   In May 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every other day. On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE PAIN (tender arm). At the time of the report, VACCINATION SITE PAIN (tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant medical history was reported. Patient administered aveeno clear complexion bar and citalopram. Dupixent therapy administered via pre-filled syringe. Approximately 4 months following the first dose intake of dupilumab and unknown latency with moderna covid-19 vaccine. No treatment drug was reported.   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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Patient initial, age, gender, concomitant medication, Suspect and co-suspect start date were added. Narrative updated.
Initial reaction was noted on 8:00 PM 3/17.  Jitteriness and fatigue on 3/17. Around 9:00 felt neck pain and it was hard to move her neck. The neck pain was severe 10/10.   Still has problems with the neck. Her neck pain has improved but the pain is worse than it was before she had the vaccine.
Nonresponder; Titer < 10; Initial Report Received on 24-Jun-2022, 18-Jul-2022 (non-significant from QA confirmed no action at this time).   A registered nurse reported that a patient  (age, race, and ethnicity unknown), who received Heplisav-B had a titer <10 following vaccination with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On unspecified dates, the patient received a full series of HEPLISAV-B injections (no details provided). It was reported that she was not given titers thereafter because HEPLISAV-B has >90% seroconversion.   On an unspecified date, months after having received HEPLISAV-B, the patient (employee) had an exposure (unspecified) and titers were checked. Titers were reported as <10.   The reporter was unable to be reached for follow-up; therefore no additional information was available.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
RESIDENT, TESTED + FOR COVID 11-4-21 AND LATER HAD LEFT FEMORAL NECK FRACTURE TRANSFERRED To HOSP 11/09/2021.   DECEASED 12-19-2021
I had the anticipated sore upper arm for a week or so.  1-2 weeks after getting the injection, I had severe, burning pain in my upper arm that was almost paralyzing. I continued to have the burning sensation off and on for several days. I could not lift or use my arm, or sleep on it, without severe pain. The issue mostly subsided after 4 weeks, but occasionally occurred when I reached for something.
First started out as what felt like a sore throat but over the course of the next few days it was obvious the left side of my neck in the lymph node area was swollen which was causing the sore throat. It felt like I had a giant lump in my throat but only on the left side of my throat. It made it very painful to swallow anything, even my own saliva. The right side of my neck and throat were completely fine, which luckily allowed me to eat and drink because the left side felt almost completely closed at one point during the worst of it. Over the next few days it was kind of going away, not so swollen or painful but still there and hard to swallow. During this time it was hard to sleep on my left side as well because the pressure of the pillow on my neck made it uncomfortable. Pressing on the area in general was painful because it was so tender. It lasted overall for about a week and a half to 2 weeks, which went beyond the initial first two weeks after getting the second dose of the covid 19 vaccine. If it had lasted longer I would've gone to the doctor since most side effects shouldn't last more than 2 weeks after getting vaccinated. There wasn't much I could do to help with the swelling, sometimes I took ibuprofen for the pain and it would help a little temporarily. I had heard of people getting swollen lymph nodes on the side they got the shot, but I only found reports of it being in the armpit/breast area, so I thought it was strange yet maybe made sense that I had experienced it in my neck on the left side where I got my shot. Although searching I couldn't find anywhere that people were experiencing it in their neck. Overall this was the worst sore throat I've ever had and I hope to never experience the severity of it again.