chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 72-year-old male patient. The patient received unspecified concomitant medications. No information regarding the patient's medical history and concurrent conditions was provided. The patient had no drug reactions or allergies. On 31-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564, expiration date: 22-OCT-2018, 1 dose, intramuscularly to prevent pneumonia. On 01-SEP-2017, the patient experienced adverse effects of pain in the back and spine, causing the feeling of paralysis. The patient also felt tingling in the face and could not move. The patient was given an unspecified treatment for the events but did not have any laboratory test performed. The patient sought medical attention at the pharmacy, however the pharmacist told him to go to a hospital. It was unknown if the patient went to the hospital or which hospital the patient went to. The reporter requested a time sensitive lot check for PNEUMOVAX 23. The outcome of the events was reported as not recovered. The casual relationship between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of feeling of paralysis was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000941.
Received DTaP in (L) arm 3/23/2010. Onset of (L) arm swelling (L) axillary swelling and pain started that evening and continued to worsen x 36 hours. On exam 3/26/2010 - (L) shoulder noticeably swollen and hot (no red) axilla swollen with enlarging lymph nodes. Pain described as troubling and keeping him from sleeping/moving arm.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 vaccine had two temperature excursions; one on 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and the other one of 1128 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-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 10:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.71.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
MULTIPLE SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection and route of admin were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced multiple side effects. The action taken with covid-19 vaccine  was not applicable. The outcome of multiple side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210354511.
Lips feeling like tingly and swollen and eyes feel like swollen; Lips feeling like tingly and swollen and eyes feel like swollen; Lips feeling like tingly and swollen and eyes feel like swollen; This is a spontaneous report from a contactable consumer (neighbor). A female patient of an unspecified age received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Her lips are feeling like tingly and swollen and she says her eyes feel like swollen on 18Jan2021. The reporter asked if it is okay to give her Benadryl for that. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Patient, age 16 female had just received a third dose (first booster shot) of Pfizer vaccine at 17:37 on May 18th, 2022 at a facility. Patient sitting in observation area with her mother started to look panicky and stated "I need some air". Before any healthcare staff could intervene and strongly advise patient to remain seated, the patient ran out of the vaccination/observation room, outside, stumbled and fell onto the ground at 17:40. The nurses immediately ran out to help, sat her in a chair outside, obtained a set of vitals (O2 sat 99% on Room Air, Hr 97, B/P 98/62. Patient given a sport drink and crackers to eat while the nurses cleaned and applied Bacitracin antibiotic ointment to the patients cuts that she had sustained from her fall as well as a ice pack to her left knee. Five minutes later, patients disposition improved, color had returned to her face, her eyes looked more responsive and patient stated "I feel better". Patient's mother was at her side the whole time. Patient and mother educated on the importance of informing any healthcare staff of any fears of needles/shots and the potential of syncope for any future events.
156/106-b/p; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; skin pink; skin warm; skin dry; This is a spontaneous report from a contactable other health care professional. This Other HCP reported for a 61-year-old female patient that: A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via intramuscular route of administration on 06Mar2021 at 11:30 (at the age of 61-year-old) as dose 1, single for COVID-19 immunisation. Medical history included epstein-barr virus infection, bradycardia, tachycardia, nephropathy; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient allergies to medications, food, or other products were unknown. The treatment received for the adverse events was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient experienced dizziness approximately 15 minutes post vaccine. The patient stood up dizziness increased, and skin became pink, warm, and dry. EMS (emergency medical services) and physician on duty at bedside assessing patient. The patient advised to be evaluated in ED (emergency department). The patient was refused ambulance transport. Symptoms subsided, minimal at the time of departure approximately equal to 12:10. The patient taken to care via wheelchair. Daughter to transport to ED (emergency department) by patient's own vehicle. The adverse events were resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure: 154/104 on 03Jun2021 (1141 VS: 154/104), blood pressure: 146/98 on 03Jun2021 (Repeat 146/98), blood pressure: 156/106 on 03Jun2021 (VS:1127:156/106-b/p), EKG (electrocardiogram): unknown result on 03Jun2021, heart rate: 58 on 03Jun2021 (1141 VS: 58- HR), heart rate: 60 on 03Jun2021 (VS:1127 60-hr), oxygen saturation: 98 on 03Jun2021 (1141 VS: SaO2 98% on RA) , oxygen saturation: 96 on 03Jun2021 (VS:1127:SaO2 96% on RA), vital signs: normal on 03Jun2021 (Patient A and O x4  PERRLA approximately equal to 3mm, Speech clear and appropriate. The outcome of the events was reported as resolved on an unknown date.  Information on the lot/batch number cannot be obtained.
Patient called clinic 12/21/2004. Received Hep A vaccine 1.0cc IM right deltoid lot AHAVA039AA Exp 10/28/2006.  Patient has hives on 12/21/2004.
At about 6:30 AM the following morning after the injection, patient came down from his bedroom in tears.  He said in the middle of night, he started feeling like his head hurt, and his arm was very sore.  He said he stomach also didn't feel good.  He said he "just felt bad."  Patient was given Tylenol and was kept home from school.  He had no appetite.  3 hours later, he reported mainly a headache and sore arm.
pt recvd vax & p/ 12 hrs, exp facial swelling; redness & itching; exp chills also;
improperly stored vaccine administered; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021925, expiry date : 15-JUL-2021) for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). It was unknown if diluent used to reconstitute was stored at proper temperature.    It was reported that the vaccine experienced a temperature excursion total time in the range of 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to - 10 degrees C) for 30 minutes, 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) for 7 hours and 47 degrees F to 77 degrees F (9 degrees C to 25 degrees C) for 9 hours (product storage error). There was no previous temperature excursion and it was reported that this call was due to a digital data logger. The patient had no adverse events. There was no product quality compliant involved.   This is one of the several reports received from the same reporter. Sender's Comments:  US-009507513-2001USA005586:Original Case : 2001USA005586
Received first dose of Pfizer at about 27 weeks pregnant (due date 7/5/2021).  Had extreme pain in arm for first 24 hours after dose. Made a sling to keep arm from moving/extending which caused pain.  A few days later on 4/13, I started having sharp, stabbing pains in my lower abdomen in the late afternoon. Over the course of the night pain got worse. Pain came and went every 30-40 minutes and would last from 1-10min.  On morning of 4/14 had diarrhea for about five hours in the morning. Stabbing pain in lower abdomen continued  throughout the day.  Did not eat throughout the day until around 6:00PM at dinner time. At around 9:00PM went to the ER and was redirected to labor and delivery unit.  Was examined for signs of early labor and there were none.  UTI, STI tests were run and came back negative.  Was given Tylenol and some sort of thick, white liquid containing lidocaine.  About 40 minutes after taking meds pain was almost gone. Was sent home with instructions to take Tylenol if pain returned. So far has not as of 4/10/2021.
Pt stated she had difficutly breathing and racing heart rate. Symptoms resolved by the next day.
pt recv vax 2NOV95 & 9JAN96 pt devel hives;pt recovered;
This spontaneous report was received from a company representative refers to a 11 year old male patient. On an unknown date the patient was vaccinated with GARDASIL lot # K008621, expiry date: 04-MAR-2017 (also reported as 20-MAR-2017). It was reported that this product was exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range was not established. No allergic reaction was observed. No medical attention was needed. Outcome of the event was not reported. Causality assessment was not provided. This is one of several reports from the same source (MARRS # 1412USA009297). Additional information has been requested.
High Fever consistantly for weeks from March thru April 2007.  Weight loss, eyes are not as bright since vaccine, eneryg level not the same since vaccination
Information has been received from a registered nurse concerning a 23-year-old female with no known drug allergies, who on 14-DEC-2006 was vaccinated with a subcutaneous dose of MMR II. There was no concomitant medication. A pregnancy test revealed the patient was 2 weeks pregnant (LMP= 29-NOV-2007, EDD=05-SEP-2007) at the time of vaccination. The patient sought unspecified medical attention. No other information was provided. Follow up information received indicated that there were no diagnostic tests, infections or illnesses during the pregnancy, and that no prescription drugs were taken. On 24-Aug-2007, at 39 weeks of pregnancy, a live, normal, female infant was born that weighed 8 pounds 9 ounces. There were no complications during the pregnancy, labor or delivery. However, it was also reported that the baby had unspecified congenital anomalies. The congenital anomalies were the only known complications for the infant. Additional information has been requested.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with Hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings and has not has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. the subject received injections of Engerix-B on 03 Feb 1998 (lot ENG2368A2) and 19 Nov 1998 (lot ENG2795A2). He also received combination Haemophilus influenza type B conjugate/hepatitis B vaccine (Comax, Merck: 03 March 1998): diphtheria and tetanus toxoids and acellular pertussis vaccine (Acel-Imune, Lederle Labs: 03 March 1998 and Tripedia:08 May 1998, 23 July 1998, and 06 april 1999): Haemophilus Influenza type b conjugate vaccine (Hib Titer, Lederle Labs: 08 May 1998 and 23 July 1998 and Act Hib, Aventis Pasteur: 06 April 1999): inactivated poliomyelitis virus vaccine (IPOL: 03 March 1998 and 08 May 1998) : oral poliomyelitis virus vaccine (Orimune, Lederle Labs: 06 July 1998):MMR II 06 April 1999: and varicella virus vaccine (Varivax 05Jan. 1999). He also received an injection of tubeculin purified derivative (TB Mantoux 05 Jan 1999). The subject's attorney alleged that as a result of the vaccines administered, the subject "suffers from the effects of mercury poisoning". The mercury poisoning in this report is considered GSK medically serious.
-Pt had her 2nd COVID vaccine on 2/5/21, and during the night at 2 am on Saturday, 2/6/21, she woke up to go to the bathroom; she noticed numbness around the left side of her mouth affecting her lips; she also noted drooping of the left side of her mouth at this time -She did not have a headache -She did not think she was having a stroke as she had no numbness or tingling or weakness in her extremities, so she didn't go to the ER -She is having trouble closing her left eyelids -She feels like she had novocaine injected into the left upper/lower lip -When she tries to drink, liquid dribbles out of the side of her mouth -She can still taste, but her mouth tastes like salt -On Saturday, she had a fever of 100.6 -No trouble walking-No confusion -No h/o stroke or TIA -No weakness, numbness or tingling in extremities -No vision changes -No slurring of speech -No recent infections -No ear pain or tinnitus -She is allergic to iodinated contrast, but has never had gadolinium
pt recv vax 18MAR97 rt deltoid & next day arm hurt, sore (could barely move);swelling the size of a baseball & red area around inj site (bullseye);has had prev tetanus shots w/o rxn arm sore x 1 1/2wk
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient came in on 07/25/2001 for a follow-up visit. On exam, the patient was found to have numerous varicella scars on the back of his neck, back and legs.
Information has been received from a registered nurse concerning a 59 year old female who on 22-OCT-2007 was vaccinated with a possible first dose of PNEUMOVAX 23 (lot# 658075/0962U) 0.5mL subcutaneously. On 25-OCT-2007 the patient was seen in the office with a large area of swelling and redness at the injection site. The patient's large area of swelling at injection site and large area of redness at injection site persisted. There was no additional information at this time. Additional information has been requested.
Unusual bruising in the shoulders of both arms. It was more so in the arm that had most recently gotten the vaccine and less so in the arm that had gotten the first dose. Bruising didn't show up until day 6 after the second shot. No swelling, itching or pain. Went to the Dr. and all blood work came back normal so there is no explanation for the bruising.
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up,  nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 16-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
The first one on 3/16/21 only causes soreness for about 2 days.  The second one started swelling into a very hard bump and redness and has remained that way.  Also, about 30 hrs. after I received it, I walked to the store (across the street and up 2 buildings) and found myself staggering and struggling to walk straight.  I am feeling better today, but not well enough to resume normal activities. I felt "loopy" yesterday, required a couple of 3 hr. naps yesterday and today.
After severe reactions from the last two shots patient will never get a flu shot again; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who had severe reactions from the last two shots patient will never get a flu shot again (vaccination complication), while patient was treated with influenza vaccine.  Vaccination(s) included influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, it was reported that after severe reactions from the last two shots patient will never get a flu shot again (vaccination complication) and that certainly goes for a new, relatively untested vaccine for covid.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Right upper arm (DTaP) 20cm circumference compared to left arm 17cm. Erythematous diam 10cm x 7cm, warm to touch. No fever uses arm freely.