chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Mar-2021 at 12:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.38  Concomitant product use was not provided by the reporter.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 and 37 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 09-Mar-2021, beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Lethargic; Not himself; Nauseous; sleeping a lot for 2 days  .; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot for 2 days  .), LETHARGY (Lethargic), MALAISE (Not himself) and NAUSEA (Nauseous) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included Brain operation (affected memory).    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleeping a lot for 2 days  .), LETHARGY (Lethargic), MALAISE (Not himself) and NAUSEA (Nauseous). At the time of the report, HYPERSOMNIA (sleeping a lot for 2 days  .) had resolved and LETHARGY (Lethargic), MALAISE (Not himself) and NAUSEA (Nauseous) outcome was unknown.            No concomitant medication were reported.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-321082, MOD-2021-321453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received contain patient's postal address, procedure as brain surgery . On 21-Sep-2021: Follow up received contain no new information.
Pain, which initiated within few days after vaccination and still present a few weeks out after vaccines received/were administered (pain/soreness on arm which they were given). (Left and right).
administered only the liquid portion of the pentacel to a patient with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who administered only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation.  On 25-Oct-2022, the patient received a 0.4 ml dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: Once) (Strength: Standard) (lot number: U7238AA) (Expiration: 04/May/2023) (formulation unknown) via intramuscular route in the left thigh as Immunization.  On 25-OCT-2022 the patient administered only the liquid portion of the pentacel to a patient with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a other health professional which refers to a male patient of unknown age. On 08-APR-2014 the patient was vaccinated with ZOSTAVAX dose 1, subcutaneous. No relevant medical history was reported. No concomitant medication was reported. On 17-APR-2014 the patient experienced numbness in his fingers, thumb, index and radial aspect of the middle finger. Patient was seen by a neurologist on 22-APR-2014 and was diagnosed with brachial plexus neuropathy. Patient received treatment with Prednisone. On 22-APR-2014, 15 days after onset of therapy the patient experienced brachial plexus neuropathy (medically significant). The outcome of brachial plexus neuropathy and numbness in his fingers, thumb, index and radial aspect of the middle finger is unknown. No further information was provided.
Arm pain, states hurts so bad he can't lift his arm. Denied redness or swelling. Recommended to take 800mg ibuprofen every 8 hours as needed for pain. Pain was resolved by 3/16/18.
First Night, High Fever had to take PJs off to get cool, Next day, Cold,very Cold.Arm ached, had red colot going from injection towards elbow on outside for 6 inches. about 1-12 inch wide. Tired and slept except to get up for bathroom, eat a little, go to bathroom. Kidneys hurt, could feel pulse in Kidneys. Was weak. Back and legs ached. Legs felt almost numb. Hard time walking from back pain and had to sit ina chair for about 30 minutes to get relief from kidney pain. This continued until the 9th @ noon. Arm stopped aching then. Kidneys still hurt. Back strain started getting better. Bak and kidneys still hurt hen I first get out of bed. Have to sit in chair till it goe away. If the Kidney pain continues, I will se
Information has been received from a physician concerning a female in her 30's with an undefined illness who was initially vaccinated (date not provided) with a dose of Pneumococcal 23v polysaccharide vaccine(lot 651318/1006). Subsequently the pt developed pain, redness and swelling at the site of injection. No treatment was ordered. The pts outcome was not reported. There was no product quality complaint involved. The physician also provided information regarding another pts experiences with Pneumococcal 23v polysaccharide vaccine (WAES0510USA07275, WAES0510USA08240. Additional information has been requested.
Patient bleed a lot immediately after the vaccination. Pressure was applied to stop the bleeding and patient was bandaged. Patient was instructed to stay at the pharmacy for 15 minutes for observance. Within 10 minutes, patient start to experience diarrhea sensation, sweating, low blood pressure, dizziness, nausea and vomiting, and almost fainting sensation. Vitamin water was given to patient, and blood pressure was checked which was low according to the patient. This sensation lasted about 5 minutes, and patient recovered, but still felt weak.  She was comfortable to leave after 30 minutes of rest at the pharmacy.
Per mother: mild rash on body, lump in R leg where vaccine was administered the size of a golf ball and entire upper leg rediculously swollen.
10/16/13 Temperature (101) per patient with c/o body aches x3 days.
erythema, swelling, hive like appearance to lt thigh;bruise @ site;T99.6 on 11/3/99;taken to ER same day given Rocephin IM & started on oral  ATB;;
Information has been reported in a published literature article, concerning a 59 year old male who had undergone thymectomy and received a total radiation of 62 Gy (Gray) over six weeks following surgery. The patient later developed and sought treatment for generalized urticaria. Initial evaluation revealed a low absolute lymphocyte count (615 cells/microliter), prompting further analysis. The patient's immune globulin levels, CD4 and CD8 counts and antigen response to a polysaccharide pneumococcal vaccine were monitored for several months. To prevent opportunistic infections, the patient was placed on BACTRIM prophylaxis. Although the patient's IgG, IgA, and IgM levels were unremarkable, the patient failed to respond to 11 of 12 serotypes of the PNEUMOVAX 23 (strength, dose, dose #, lot #, route and application site were not reported). The patient's low CD4 lymphocyte count and failed response to pneumococcal vaccination were consistent with immunodeficiency. After radiation alone, a recovery of T lymphocytes were usually observed after about three weeks. Even a year later, the patient still had not made a full recovery of T-lymphocytes suggesting a possible role of the adult thymus in immune recovery. To prevent serious complications, the authors reported that it was necessary for patient's who underwent radiation to be closely monitored for immunodeficiency, especially if they had undergone thymectomy as well. Follow up information has been received on 19-MAY-2015 from Sanofi Pasteur MSD. Follow-up information was received in published literature. It describe the longitudinal progress of the male with a thymectomy for a microinvasive thymoma involving the capsule. The patient tested negative for human immunodeficiency virus. His lymphocyte counts 87 months after thymectomy and 85 months after radiation therapy were as follows: absolute lymphocyte count 956 cells/mel, absolute CD3+/CD4+ 164/mm3 (16%) and absolute CD3+/CD8+ 257/mm3 (25%). The patient was able to discontinue BACTRIM prophylaxis after 9 years of treatment. Over the course of 8 years, the patient had still not made a full recovery according to laboratory markers, which seemed to have stabilized at chronically low levels. Additional information is not expected. Reporter's information, lab data, product information, AE and narrative were updated.
Child complained of a stomach ache. Diarrhea and vomiting several times throughout the night. Headache followed by the morning.
Inflammation and rash (raised) about 2-3 inches below injection site. Tx: prednisone 50mg tablets qd x2 days.
01/20/22 patient was given a 2.5 mL instead of a second dose 0.5mL.  Dr. was notified at 5:11, was directed to notify patient of reduced dose administered, inform patient to come to clinic to receive a 2nd dose of 2.5mL for a completed dose.  Attempted to notify patient, message left.  Will continue to call patient to inform.
Allergy reaction, redness, swelling from shoulder to elbow, pain and hot along tricep.
Extreme lightheadedness for entire day after vaccination.  Tapering severity of lightheadedness and duration over following two weeks. Some mild persistence of lightheadedness.
Patient developed tongue tingling 30 minutes after receiving first dose of Pfizer covid vaccine. Patient also reports that she experienced tongue swelling, lip swelling, difficulty swallowing and rash on her back that developed 1 hour after vaccine.   Patient did not seek immediate medical treatment and  will receive treatment at Occupational Health.
I woke up with swelling in right hip, my right hip was swollen and aching. The swelling progressed and my hip was swollen the size of a softball. It went on for 2-3 weeks, I was doing telehealth doctor appointments where I was told to take ibuprofen and anti-inflammatory medicines. I was not getting better from the virtual appointments; I went to my PCP he prescribed Tramadol for pain management I only take once a day as needed. I was referred to ortho. I had an X-ray done and now waiting to start physical therapy.
fatigue; pain at injection site; lower abdominal pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN LOWER (lower abdominal pain), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal pain) and VACCINATION SITE PAIN (pain at injection site). On 03-Feb-2021, the patient experienced FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 05-Feb-2021, ABDOMINAL PAIN LOWER (lower abdominal pain) had resolved. On 06-Feb-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Reporter did not allow further contact
She got her vaccine,  she didn't feel the needle, did not have any symptoms including soreness.  The next day her arms feel clogged or that the blood supply is not falling properly, like they are falling asleep.  From her shoulders down to her fingers.  Her arms kind of feel cold.  It doesn't matter which position they are in, propped up, hanging down, the feeling does not go away and also feels it when she is in bed.  He saw her PCP and she felt that Pfizer is the least amount of side effects and if she got the 2nd one it would happen again and perhaps to a more degree.  She ordered the antibody test to see if she had ever had COVID.  She said that they could try a steroid to see if it was swelling related.  Then if that did not work then they could send her to a neurologist to do a nerve test.   She prescribed steroid pills for her to take, this was this morning.
Pt. states lethargy, aching, and swelling of left arm, Tuesday, night of vaccination. Wednesday and Thursday fever, sweating, and itching began. Symptoms subsided on Friday. Patient contacted pharmacy on Friday to report adverse reactions. Pt. stated she is hypersensitive and MD told her to inform anyone whom may give her injections and she did not inform pharmacy at time of her vaccination. Patient took TYLENOL and rested. Patient is symptom free and feeling better. Pharmacist followed up with patient on Monday 01/21/19 to complete report and retrieve necessary info to complete form.
Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm and following morning significant brain fog and loss of energy. Noted after second injection on 1/27/2021, not much in the way of symptoms until about 3:15 a.m. on 1/28/2021 when was awakened from a sounds sleep with tremendous body aches, chills, fever, fatigue and headache.  Took about 7 full days to completely recover.  During weekly healthcare PCR testing, tested positive for COVID 19 on 2/10/2021. Two weeks later to the day.  Week prior test was negative.
At approx. 10:30 pm after having the shot. I began to have chills to the point where my teeth were chattering.  I crawled in to bed to try to cover up to get warm at which time I realized both of my hands were ice cold.  Shortly after that my left side of my nose swelled and would not allow me to breath through that side.  I then checked my pulse and oxygen levels since my heart felt like I was having a tachacardia episode.  My oxygen was between 92 and 93 with my pulse between 100-110. This continued until around 6 am at which time my pulse was staying steady at 85-90 and my oxygen was 95-96. I also noticed on the evening of August 20 I had 2 red patches on the same arm I had the shot on about 2 inches beneath the shot area.  This is Saturday and I still have the red area but the two have blended in to each other and are one area.  It is not itchy or sore and only slightly raised area.
A coordinator in an Infectious Disease dept reported that a child rec'd her 3rd dose of Prevnar, along with IPV(manufacturer unknown), Hib (manufacturer unknown), DTaP (manufacturer unknown) and Hepatitis B (manufacturer unknown) vaccines. Six hrs post immunization, the infant developed a fever < than 38 degrees C and a high-pitched cry which lasted for 3 days. The infant's pediatrician later reported, that in a follow-up visit, the infant's temperature was subnormal (95.1degrees F). Additional information was rec'd from the child's current pediatrician on 11/26/01 and 11/28/01. It provided the infant's date of birth and stated that the child was first seen by this pediatrician when the child was 7 months old  for an upper respiratory infection. The child's mother relayed to the physician the adverse event experienced by her child 3 months earlier.
On 4/29 (the day after receiving the vaccine) the patient returned to the provider's office with-3 spots of maculopapular rash on
Dizziness/ vertigo starting 3/12 and off and on since. I?ve never had this prior to vaccine
Patient was given expired booster; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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 details were provided as follows: The age at vaccination was not reported. The reporter asked for information about a patient who was administered expired booster Bexsero vaccine.
This report was received from a health professional on 13 February 2008. An 11-year-old female patient, with a history of asthma (until age 6) and poison ivy, received an injection of Adacel (lot number not reported) in August 2007. Approximately one week prior to receiving Adacel, the patient had been diagnosed with poison ivy/contact dermatitis on the face and arms. She was treated with cortisone cream, and the event was reported to be recovering. After receiving Adacel, the rash worsened, with the same distribution. The patient was evaluated by a dermatologist "who did not feel this was vaccine related". Outcome was not reported.
Appearance of maculopapular rashes on face, trunk, thighs, 11 days after MMR vaccination. No fever.
Patient received flu vaccine (R) deltoid. Red area at injection site noted, size of quarter. (Screened negative for allergy). I sat w/ patient x 30 min, redness subsided at 15 min. At 30 min, she developed 1 itching hive under chin, lips "tingly". Patient took BENADRYL 25 mg P.O. and I contacted Dr. for orders. "BENADRYL 25mg po now and additional 50mg in 4 hrs. Go to ER for SOB, tongue swelling." I advised patient not to drive/operate machines if drowsy. Agreed. Follow-up call to patient revealed no further systemic allergic symptoms or signs.
June 15, 2015 I went to clinic for annual physical. I was given the PCV 13 vaccine. Within a week of that date I woke up one morning unable to lift both of my arms and with numbness, and tingling in my hands and fingers. I did not have this problem before. July 8, 2015 I returned to the clinic because the pain in my arms, numbness, tingling in my hand and fingers had not stopped. I was told not to lift anything or exercise. The doctor gave me a prescription for Naproxen 375mg 1 tab twice per day. July 18, 2015 With no change in my condition I went to a local hospital clinic. I saw a doctor who increased the prescription of Naproxen to 500mg twice per day. The doctor said there could be a possibility of carpal tunnel problem. I was given wrist braces. August 4, 2015 Went to see a private primary doctor. I discussed my problems with him. He suggested a blood test to check for other illnesses which could be the cause my problems. All tests came back normal. He suggested to go to a Neurologist. Returned to my second home. October 21, 2015 Met with my primary doctor who referred me to a Neurologist. October 30, 2015 I met with the neurologist and set up nerve test. November 10, 2015 I had a full nerve test of both arms and hands. His report did not rule out the PCV 13 vaccine. He referred me to a hand surgeon. November 19, 2015 I saw the hand surgeon. We discussed carpal tunnel surgery. I decided to have the surgery in hope that it would bring some relief to my problems. The first surgery was December 17, 2015 and the second on April 21, 2016. After of all of this I have little or no relief.
The patient is experiencing pain when he lift his arm, went to emergency room on 12/02/2018 and the doctor prescribed meloxicam tablet. He did not start the medication yet.
Patient reports intense pain left shoulder, left arm. Edema present. Fever started 4/3/2021, 1 day after injection. The shoulder swelling started 4/8/21
Patient received vaccine @ 0745 on 2/27/08.  Approximately 1030, she developed pain behind the eyes with blurred vision, severe head ache, numbness in the hands, and nausea which worsened through the day and then began to alleviate at 0500 this morning.
Generally feeling unwell initially. Visit with Dr. on the 28th. Ascending paralysis by the 31st. Admitted to Hospital on January 2nd. 2012