chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A reaction / generalized hives / reaction all over (from head to toe); A reaction / generalized / rash reaction all over (from head to toe); A reaction / That is itchy; This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 49-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 13th December 2022) for prophylaxis.   Concomitant products included HAV (Havrix) and HBV (Engerix B).   On 12th January 2021, the patient received the 2nd dose of Engerix B (intramuscular). On 12th January 2021, 4 hrs after receiving Engerix B and an unknown time after receiving Havrix, the patient experienced generalized urticaria, generalized rash and pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized urticaria, generalized rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the generalized urticaria, generalized rash and pruritus to be related to Engerix B.  Additional details were provided as follows: The nurse reported that patient herself administered the 1st dose of the Havrix vaccine herself on 19th November 2020. The patient received first dose of Engerix B on 10th December 2020. After 4 hours of second dose patient developed generalized rash, generalized hives and reaction all over from head to toe. Batch number was available as P4BJ5 and updated as P4DJ5 according to sales data sheet. Nurse consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021057745:Same reporter
This spontaneous reprot was received from a 75 year old male patient who reported for himself. The patient's current conditions were not reported. Pertinent medical history and history of drug allergies or reactions was none. Approximately in 2013 (July or August, 2 years ago), the patient was vaccinated with ZOSTAVAX (unknown strength) subcutaneous injection. Concomitant medications were none. On 05-JUN-2015, the patient started to experience pain and swelling in his stomach. The pain proceeded to his hip, legs and buttocks. He then started noticing blisters on his body. No lab diagnostic procedures were done. The patient sought medical attention and was seen by the physician on an unspecified date and the physician prescribed 800 mg acyclovir taken 5 times daily. The outcome of the events reported as not recovered. There was no product quality complaint involved. Causality assessment was not provided. Additional information has been requested.
pt recv vax 16MAR95 in AM; had persistent crying for 10 hr nothing would stop; high pitch cry; pt recv DT for #3 dose w/o any problems;
Information has been received from a physician concerning a female who on 06-NOV-2009 was vaccinated IM with the third 0.5 ml dose of GARDASIL. On 060-NOV-2009 the patient developed swelling and numbness at the injection site after receiving her GARDASIL. The numbness extended to the patient's elbow and she experienced tingling on her fingers on her left hand. It was reported to the representative that the patient had "recently" received FLUMIST. The patient had sought medical attention, office visit. At the time of report the patient's status was unknown. Additional information has been requested.
started crying 2hr p/vax;cried for 10hr;slept 2hr & cried 3hr when took to ER;told probable shot rxn;took very little formula;
Hives, urticaria, Tender Indurated Nodules of B/L lower extremities Treatment with Benadryl PRN
leakage from syringe of Fluarix; received only 2/3 to 3/4 of dose; due to leakage from the top of the syringe of Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 38-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 4L97X, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe issue and pharmaceutical product complaint were 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 stated that, the patient received only two third to three fourth of the Fluarix Quadrivalent dose due to leakage from the top of the syringe of Fluarix, which led to incomplete dose administered, syringe issue and product complaint. A technician reported to her that the needle was on very tight.  There was no option for this vaccine in AE form drop-down menu.  The pharmacy was very busy during the call, so the caller was not able to be transferred to determine whether there was a product quality issue. The reporter consented to follow up via email.
This spontaneous report has been received from a registered nurse, who reported that unspecified number of patient has been vaccinated with MMR II (lot #, rHA/HAS status not reported), which underwent an unsupported excursion in December 2013. No adverse effects reported. The nurse reported also that unspecified number of patients was also administered GARDASIL, RECOMBIVAX, Oral ROTATEQ and PEDVAXHIB which underwent supported excursion in December 2013. Additional information has been requested.
20 minutes after injection began to itch within an hours the itching intensified  from head to mid thigh front and back. Itching level about an 3 to 8
rash that developed  on his face, trunk, and butt. Mother reports him feeling warm 3-4 days  ago and he was given tylenol. He did not eat in the beginning, however ate two  bananas today.  Received vaccines 13 days ago. Rash self resolved in approx. 2 days
Prolonged fatigue, nausea, constipation, dysequilibrium, and dark urine
erythema @ site w/induration;fever of 104 p/4 hr;later devel sore throat;seen on 14AUG95 w/dx of sinusitis or poss vaccine reaction;18AUG95 fever down & inj site inflammation resolving;
Rash on stomach that looked like pimply bumps. Had worn new shirt the same day but no rash anywhere else on my body besides the stomach. Not identified as hives.
Patient was inadvertently administered a Proquad (MMRV) when he was only due for a Varicella. Prior to this visit he had received an MMRV on 11/12/19 and an MMR on 3/5./19.  Despite reviewing their record and having an alert in my EHR system, I missed that he already had two doses of the MMR and administered an MMRV.  Therefore, he received and extra dose of MMR.
swelling went down however the pain in breast continued/pain is still occurring and seems to get worse around menstrual cycle; nerve damage in right breast; swelling went down however the pain in her breast continued; experienced a knot in right breast; This spontaneous case was reported by a nurse and describes the occurrence of BREAST PAIN (swelling went down however the pain in breast continued/pain is still occurring and seems to get worse around menstrual cycle), NERVE INJURY (nerve damage in right breast), BREAST MASS (experienced a knot in right breast) and BREAST SWELLING (swelling went down however the pain in her breast continued) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J217 and 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BREAST MASS (experienced a knot in right breast). On an unknown date, the patient experienced BREAST PAIN (swelling went down however the pain in breast continued/pain is still occurring and seems to get worse around menstrual cycle), NERVE INJURY (nerve damage in right breast) and BREAST SWELLING (swelling went down however the pain in her breast continued). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PREDNISONE at a dose of Prednisone taper. At the time of the report, BREAST PAIN (swelling went down however the pain in breast continued/pain is still occurring and seems to get worse around menstrual cycle) had not resolved, NERVE INJURY (nerve damage in right breast) and BREAST MASS (experienced a knot in right breast) outcome was unknown and BREAST SWELLING (swelling went down however the pain in her breast continued) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Mammogram: Mammogram to rule out a swollen Lymph Node.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NERVE INJURY (nerve damage in right breast) to be related. No further causality assessments were provided for BREAST PAIN (swelling went down however the pain in breast continued/pain is still occurring and seems to get worse around menstrual cycle), BREAST MASS (experienced a knot in right breast) and BREAST SWELLING (swelling went down however the pain in her breast continued).    Concomitant drugs were not reported. It was reported that patient had no adverse reactions or side effects after first dose. It was also reported that patient had to wait 6 weeks to get a Mammogram and had a CT Scan. Treatment included icing the area and a short course of Prednisone taper which helped for a period of time however the pain in right breast was recurring.
Contracted varicella after exposure from classmates.  Sibling (who was also vaccinated after 1 year of age) has also contracted varicella 2 weeks after exposure to sib.
numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/numb all over her spine; loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; paresthesia; having trouble with dexterity; This is a spontaneous report from a contactable physician (neurologist) via a Pfizer-sponsored program. A 51-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in left arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced allergy. The physician reported that the patient received the first dose of the vaccine and has been experiencing numbness for 10 day from an unspecified date. This patient received the injection in the left arm and she started experiencing numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine, she's still experiencing ongoing numbness the numbness in her 4th and 5th digit. The patient experienced loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; and felt numb all over her spine, all on unspecified dates. The patient was having trouble with dexterity. The physician ordered an MRI for the patient but does not have the results back yet. The physician asked if it is safe for the patient to get the second dose. The second dose will be on 15Jan2021. The outcome of the event numbness was not recovered, and the outcome of the remaining events was unknown.  Information on the lot/ batch number has been requested.
Shortly after receiving the vaccine, the patient reported feeling nauseous (he was sitting in the waiting area). I asked if he felt dizzy and he said no. He asked for a bag in case he threw up so I walked back into the pharmacy to get one. When I left he was leaning against the wall and when I came back he was on the ground with his eyes very dilated and a blank stare. He appeared to have slouched down the wall (didn't fall over or hit his head). I started tapping his shoulders and loudly saying his name to try to arouse him. He then began mildly convulsing. I yelled for my technician to call ED and to get the store manager. I tried to move him into a recovery position but was unable to. I kept an eye on his breathing and pulse and after about 1 minute he came to. After the initial shock wore off of me telling him he had a seizure, he said he felt better. We waited for the paramedics to arrive, at which point they took his vitals and did a work up. They determined he did not need to go to the hospital but they were going to go wait in the ambulance with him until someone could come pick him up from the store. At that point the patient and the paramedics departed the pharmacy. As far as I know, he did not go to the doctor or hospital to be evaluated further.
Patient complained of itching at the site of injection immediately after receiving the vaccine. She got swelling and redness at the site of injection. She placed an ice pack on the site for 20 minutes, said she was feeling better and left. 10 minutes later she returned complaining of itching on her chest and other arm. Upon inspection the patient was found to have hives on her neck, face, chest and redness on her chest, both arms and legs. School nurse administered 25mg of Benadryl and another 25mg of Benadryl 15 minutes later. The redness and hives completely resolved and the patient returned back to work.
I felt chills and body aches with coughing. I had a fever as well low grade never above one hundred degrees. I had a virtual conference with a physicians assistant and was offered Pacxlovid but did not take it. As of Friday of that same week I was still Positive for COVID-19 and the following week, day seven a test still showed a very faint line, during this time I was not working.
c/o dizziness, lightheadedness-started day p/vax persisted x 4 hrs; also had "knot" inflammation & lt arm inject site; 23OCT93 sx are gone;
1 day after the vaccine (4/28) - low energy level, achy, tired, shortness of breath 2 days after vaccine (4/29) - shortness of breath after physical activity, irregular pulse 3 days after vaccine (4/30) - back to normal - no symptoms
fever at 12h and 28h after vaccine, profound body aches (muscle, joint, headaches) that were debilitating and could not go to work
soreness in the arm from both shots that lasted about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm from both shots that lasted about a week) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    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 PAIN IN EXTREMITY (soreness in the arm from both shots that lasted about a week). At the time of the report, PAIN IN EXTREMITY (soreness in the arm from both shots that lasted about a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported.   This case was linked to MOD-2021-092360 (Patient Link).
15min p/vax red blotchy rash over body-very fussy pulling @ ears went to MD office gave Pred & PDH;kept in office 20-30 min then home on Pediapred, DPH;noted no wheezing;
My legs and feet are very weak and my feet start tingling. I can barely walk.  I have no strength and I get  wobbly and I also fall. I can hardly get out of the bath. I can't stand on my tip toes or I can't run at all, I also  have slurred speech. I have to work an by the end of the day I can't walk much.
I contracted Covid. I had congested and I had this from the 11th of July to present day 2 weeks later. It's congestion in my head that got a bit better. I had a sore throat that lasted for 7 days. I had a fever, night sweats, fatigue, muscle aches, vomiting, and diarrhea. I thought I had a regular cold and 2 days later, on the 13th of July, I started having chest pains. I went into the ER because of these chest pains and they told me that I was positive for Covid. They treated me with some antibodies, and magnesium, and I was in there for approximately for 5 hours. I have been home and isolating. I am still on oxygen because my oxygen had dropped on the 3rd day, and without the oxygen it drops below mid 80s.
Aplastic anemia; Covid; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Aplastic anemia) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced APLASTIC ANAEMIA (Aplastic anemia) (seriousness criterion medically significant) and COVID-19 (Covid). At the time of the report, APLASTIC ANAEMIA (Aplastic anemia) and COVID-19 (Covid) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product information was not reported.  Patient stated that she has seen reports about aplastic anemia, specifically, 18 instances studies, Where the vaccine is linked to aplastic anemia and COVID. patient stated that it is rare but has seen it in the studies.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Aplastic anaemia and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient has seen reports about aplastic anemia, specifically, 18 instances studies, Where the vaccine is linked to aplastic anemia and COVID. patient stated that it is rare but has seen it in the studies. The current pandemic situation of COVID-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Aplastic anaemia and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient has seen reports about aplastic anemia, specifically, 18 instances studies, Where the vaccine is linked to aplastic anemia and COVID. patient stated that it is rare but has seen it in the studies. The current pandemic situation of COVID-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Redness and swelling on Lt thigh from injection given on 8/24/06. Went to ER for lt leg swelling, redness and pain on 8/26/06.
A rash on the middle of my neck. It happened to me on my first dose as well but I did not report it. It did not happen for my second dose. I just got my booster and the rash happened again. It's itchy and red.
Fever; chills; body aches; This is a spontaneous report from a non-contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient experienced fever, chills, body aches. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Has a history of left upper extremity, elbow, neuropathy. Was well controlled until 5th vaccination, then had significant worsening of symptoms.
Tingling and swollen lips an hour after vaccination. Went away after 30 minutes or so. Did not think much of it until she came for her booster dose today. Cancelled her booster dose of the Pfizer COVID-19 vaccine.
2 areas, 4cmX5cm amdm 3cmX4cm.  Both areas red, raised and warm.  Painful.  afebrile
Swollen foot (right) for over a week, discomfort/tightness in calf(right) a few days, painful achiness in knees (Primarily left) over a week-still persisting
No adverse event; HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date).    Concomitant medication details not reported by the reporter. The vials were stored in the fridge since 12-MAR-2023. Patients were administered on 19-APR-2023 and 21-APR-2023. HCP did not knowthat patients experienced any AEs and did not have any patient's demographics but she knew they were both adults. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721681 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721681:2ND PATIENT CASE