chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reporting DAPTACEL, ADACEL, PENTACEL , IPOL, and FLUZONE QUADRIVALENT PREFILLED SYRINGES at a low of 0C for 17 hours, with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported daptacel, adacel, pentacel , ipol, and fluzone quadrivalent prefilled syringes at a low of 0c for 17 hours, with no reported adverse event while receiving vaccines IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and with the use of medical device FLUZONE QUADRIVALENT PRE-FILLED SYRINGE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started using FLUZONE QUADRIVALENT PRE-FILLED SYRINGE Unknown dosage unknown (lot - U7093AA, 30-Jun-2022). On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5743AA in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7093AA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ582AAA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect IPV (VERO) lot T1E872M in unknown administration site.  On an unknown date the patient developed an event of a non-serious reporting daptacel, adacel, pentacel , ipol, and fluzone quadrivalent prefilled syringes at a low of 0c for 17 hours, with no reported adverse event (product storage error) (unknown latency) after starting use of FLUZONE QUADRIVALENT PRE-FILLED SYRINGE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (reporting DAPTACEL, ADACEL, PENTACEL , IPOL, and FLUZONE QUADRIVALENT PREFILLED SYRINGES at a low of 0C for 17 hours, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event reporting daptacel, adacel, pentacel , ipol, and fluzone quadrivalent prefilled syringes at a low of 0c for 17 hours, with no reported adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Dose 1 Moderna and dose 2 Pfizer 3 days apart.
Patient said that immediately after given the vaccination, her arm started hurting.  Pain would not go away so after 2 weeks she went to her doctor and via XRay and MRI patient now has arthritis, tendonitis, and 2 muscle tears in her rotator cuff.
Patient received vaccinations on 8/5/13. On 8/6 she woke up with a 102.5 degree fever, diarrhea, stomach and congestion. On 8/9 she woke up with a red blotchy rash that was itchy all over her upper body. No fever on 8/9.
Onset of acute cerebellar ataxia AM of 2/8/06. Could not walk. CBC, CRP NE Chems with CO218 Cl113 (101-111). CT of head NR. Neurologist evaluation confirms diagnosis.  Symptoms persist as of report.
This spontaneous report as received from a male consumer unknown age. No information provided regarding concurrent condition and medical history. On November-2012, reported as about one and half year ago the patient was vaccinated with ZOSTAVAX (route, lot#, dose not reported). No concomitant medications reported. On an unknown date he patient experienced shingles. The reporter wanted to know if he should get the vaccination again. It was unspecified whether the patient sought medical attention. The outcome of shingles was unknown. Product quality complaint was not involved. Additional information has been requested.
Patient completed COVID-19 Moderna vaccine series on 4/30/21. Patient was admitted to reporting hospital on 10/12/21 with shortness of breath needing high flow 30L of 02. Patient originally tested positive on 10/7/21 after attending a funeral where lots of other people tested positive. Chest xray shows patchy opacities favoring COVID pneumonia. Patient is still admitted at this time.
This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of GARDASIL 9 with a lot # L011846 and expiration date of 16-JUN-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports redness at site of injection immediately following vaccine. Redness and warmth continue to worsen.
Moderate to severe rash developed around waistline which spread to both breasts, back, buttocks, back of thighs, inner thighs, ankles and underarms. Saw Dr. on 07/10/19 and decided to wait until filling RX he prescribed to see if symptoms would subside.  Used oatmeal cream and Gold Bond powder and symptoms are finally started to subside somewhat and I think are no longer spreading.
Information has been received from a physician assistant (P.A.) and medical assistant concerning a 19 year old female with no medical history or drug allergies who on 20-FEB-2009 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot # 659655/0940X). Concomitant therapy included DEPO-PROVERA. The patient experienced back pain in May 2009. She went to the emergency room and was diagnosed with sciatica. An unspecified person at the emergency room told the patient that the sciatica was caused by GARDASIL given back in February 2009. Doses 1 and 2 were administered at a different facility and the physician assistant and medical assistant did not have the dates of administration or lot numbers. The patient returned to the office of the physician assistant and medical assistant in June 2009 and informed them of the AE. At that time, the patient still had back pain (not recovered) and was having physical therapy. Additional information has been requested.
Chills, fever, body aches, headache, fatigue, night sweats. Lasted approx 24 hours after second dose.
pt recvd vax 12 & 12 days later had t 104; was seen by MD who said pt had some type of infect & tx w/ atb; had rash started on torso disappeared then started in extremities & face;3aug94 still febrile; MD feels it's MMR related;
Within hours of vaccine he developed pain at site, swelling at site, erythema at site and chest pain. Dyspnea. His symptoms worsened 24 hours post vaccination required antibiotics and steroids. L arm swelling.
Reddness at injection site from shoulder and down to elbow.; Itchy; Periodically painful; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 13Mar2021, (at the age of 92-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer and lumpectomy. The patient was allergic to codeine and penicillin. Concomitant medications included levothyroxine (SYNTHROID), calcium carbonate (CALTRATE), biotin (MANUFACTURER UNKNOWN), vit D (MANUFACTURER UNKNOWN), fibre (MANUFACTURERE UNKNOWN), docusate (COLASA) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced redness at injection site from shoulder and down to elbow, itchy and periodically painful. A polysporin ointment on arm was taken as therapeutic measure for event redness at injection site from shoulder and down to elbow, itchy and periodically painful. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of redness at injection site from shoulder and down to elbow, itchy and period painful were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shingles; other zoster related injuries; Information has been received from a lawyer and a currently 70-year-old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was related.
interchange of vaccine products; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Spiked temp > 103 degrees F @ 2A 6/21/09 post experiencing fever rigors.  Temp did not decrease with TYLENOL.  High temp X 36 hrs.  Fever rigors X 3 Extremely restless.  C/o severe body aches - including severe pain in feet Unable to raise head from bed - c/o "arms heavy"  Pulse up to 114 bpm
After both vaccines same reactions. Approx. 3/4 hours after injections, increased hyperactivity, like I get when given prednisone. My pulse rate is normally 50/55. It increased to various rates 75/85 .Tachycardia, feeling as my heart was/is coming out of my chest. Trouble falling asleep, Restless sleep, lack of focus. 1st vaccine reactions last 3 days. I just had the 2nd vaccine 3 days ago, but the reactions are not slowing down at all. The 1st vaccine I could feel by morning of day 3 the hyperactivity slowing down and pulse going back down. I'm a work in massage therapist so this is way to hyper for me to be at all times of the day.
Beginning on 11/26/00, patient noted to have urticaria, swelling, nausea and joint pain. She was treated with prednisone and Claritin.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 24-FEB-2015 and 24-APR-2015, the patient was respectively vaccinated with improperly stored GARDASIL (lot #K003520 with expiration date of 20-NOV-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt presented with fever, pain, swelling and redness in the area where she had the injection. Rx'd with ibuprofen and Benadryl.
Scattered erythemous papular vescular rash thinly on trunk, few on face and scalp.
The day after receiving GARDASIL patient had 12 hour episode of lightheadedness and vertigo & was unable to walk, normally due to vertigo. Same symptoms occurred after 2nd dose GARDASIL.
1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic  , was sent via ambulance to ER .   Admitted with diagnosis of pneumonia, fluid retention /edema .  Spent 6 days in the hospital. Was told by hospital staff to report to VAERS.   Covid test was negative.   4.  Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute.  Saw Dr.  - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2.   Home bound.   This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.
Covid arm...  8cm circular red Rash at injection site  Delayed hypersensitivity reaction
5/16/2022 case went for his routine dialysis treatment. The next day, 05/17 he began feeling extremely week, fatigued and congested. Case went to hospital on 05/18 and was admitted for 2 days. Case was given monoclonal antibody treatment and is beginning to feel better.
At clinic, patient complained of nausea to RN at Obs station #1. She was walking him to bathroom outside Obs station #2. Pt complained of lightheadedness. Supervisor, grabbed chair out of Obs #2 and asked us for help. I came on seen found pt diaphoretic, pale, shaking. Said he was nausea. given trashcan. Asked his history.Said he had a similar rx after having a flu vaccine in the past and Gallium Injections for cardiac condition. Asked meds. Told me he takes Propanlol for Afib and SVT. Has a low heart rate normally. Heart was very week. HR52. Asked supervisor to call 911. BP tried by one nurse and unsuccessful. I tried and got a 90/52. Pt then stated he was SOB and felt difficultly breathing. Attempted pulse ox. Unable to get reading. Place him on o2 at 10l fase mask. Ask to prep benedryl. Pt said he had benedryl in past and it made symptoms worse. He said breathing was improving. Still very cold with chills. BP rechecked 102/60 Hr 68. Wife was standing by. Patient was slowing improving. Color in face improving, reported nausea was gone. Still unable to get a pulse ox. Heart rate at wrist very hard to palpate.Increased O2 to 15L with face mask. No medication was given, only O2. EMS on seen, reported & assisted him to gurney. Gave his wife his apple watch.
12/31/20 & 01/01/21- Right side axillary lymph node swelling and tenderness 01/01/20 - Right side cervical lymph node swelling 01/01/20 - injection site swelling, warmth, and redness 01/02/20 - extreme fatigue 01/03/20 - fatigue 01/04/20 - fatigue
5 minutes following vax while driving, the pt felt a hot burning sensation go up her arm ant hen throughout her whole body. The pt complained of a loss of peripheral vision. When getting out of her car she became dizzy and nauseated and began stumbling. The pt went to the ER by ambulance. The pt was diagnosed with an adverse flu shot reaction. No further problems as of this date.
5/10/21 @ 1:59 Patient c/o tingling of the lips. 50mg of Benadryl tab where administered by mouth.  5/10/21 @ 2:35 Patient c/o of chest pain, EMS was Called.
Post vaccination, the patient experienced dizziness, nausea, weakness, headache, body aches and a stiff neck.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L044707, expiration date 06-OCT-2018, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ fatigue Narrative;
VasoVagal response after last injection, within 2 minutes. Feeling faint, increased respiration, sweating, cold palms, chills later. Patient was given ice packs on back of neck, forehead, and chest. Placed in Trendelenburg, BP monitored, respiration monitored. Some loss of conscientiousness but revived quickly. 911 was called. BP was stable. Patient given a snack and drink after he was sufficiently recovered and remained at the clinic until he was able to move on his own. Parents declined transportation to ED.
Developed a sore and swollen left deltoid about 4-5 days after the injection. About a 3 x 3" area at least..  The injection site was sore the first 2 days and went away.  Came back on day 4-5. I also had bumped up against the corner of the wall while walking but I do that often.  Never got this reaction.  I was worried it could be a blot clot so on the 9th day I went to urgent care.  The PA said it was inflammation from the vaccine.  Post-injection inflammatory reaction.  Put heat on it .  Treat as normal. No massaging.  She said it could go away in a couple of weeks.  If it got red to call doctor for ultrasound orders.  This is day 17 and the arm is still sore.  The swelling is going down slowly. Usually I have a sore arm for days after injections but this time it was  one or two days and then it quit but came back. It is sore  to stretch my arm across my chest.  Used to be sore when I would stretch the arm straight out.  That has subsided. Still tender to lay on it.  I try not too. It doesn't hurt just sitting and doing normal activity.
Information has been received from a medical assistant concerning a 16 month old female with no past medical history and no known allergies who on 11/6/01 was inadvertently vaccinated with a fourth dose of haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot #638136/1589K), IM in the right thigh. There was no illness at the time of vaccination. It was reported that on 11/6/01 at 2:00PM the patient developed a bruise at the injection site. The mother described the bruise as the size of her hand. The patient sought unspecified medical attention. No further information is expected.
Patient tested Positive for Covid-19; Lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested Positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergic to Banana), Dust allergy, Scleroderma since 15-Jan-2004, Palpitations since 15-Jan-2004 and Intermediate coronary syndrome (Intermed coronary syndrome) since 15-Jan-2004.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milligram. On 06-Jan-2022, the patient experienced COVID-19 (Patient tested Positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Patient tested Positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.  Company Comment: This is a Spontaneous case concerning a 54-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was reported. The event occurred approximately 1 year, 1 month and 4 days after the administration of a dose of the mRNA-1273 vaccine of a proper schedule of vaccination, the patient has received 2 doses of mRNA-1273 vaccine (with an interval of 28 days between two doses). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.   This case was linked to MOD-2022-472088, MOD-2022-460301 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 54-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was reported. The event occurred approximately 1 year, 1 month and 4 days after the administration of a dose of the mRNA-1273 vaccine of a proper schedule of vaccination, the patient has received 2 doses of mRNA-1273 vaccine (with an interval of 28 days between two doses). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
Information has been received from a nurse practitioner concerning a female who on 17-APR-2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included MOBIC and antifugal (unspecified). On 18-APR-2008 the patient experienced rash on face. Unknown medical attention was sought with the nurse practitioner. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient admitted with pneumonia, given Pneumovax on day #2 of admission and developed severe swelling and hardening of upper extremity at site of injection on day #3 and 4. Doppler ordered to that ruled out DVT. Over time symptoms improved.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In or about May 2016, the patient was treated at a medical center and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to ER. Diagnosis with multiple acute CVA and Rt sided hemiplegia
Fever 103 (12 hrs post vaccination) dizziness, nausea. Pt received PNEUMOVAX-23 (9/16/15).