chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 19 year old female patient who in January 2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). The patient was HPV positive and had an abnormal PAP since receiving GARDASIL vaccine (yeast). In May 2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). The patient's HPV positive and abnormal PAP were persisted. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previosly submitted on 7/15/2008. Initial and follow-up information has been received from a licensed practical nurse and a physician concerning a 19 year old female patient, also reported as 20 years old, with allergy to amoxicillin and no relevant medical history who on 28-JUL-2007 was vaccinated with a first dose of GARDASIL (lot number 658490/0802U) intramuscularly into her right upper arm. On 28-SEP-2007 the patient was vaccinated with a second dose of GARDASIL (lot number 658560/1062U) intramuscularly into her left upper arm. On 01-JAN-2008 the patient was vaccinated with a third dose of GARDASIL (lot number 659439/1267U) intramuscularly into her upper arm. The patient was tested HPV after completion of all three doses, and the result was positive. The patient had an abnormal PAP. The patient's outcome was unknown. Additional information is not expected.
About three weeks after getting the J & J vaccine, I began getting headaches, mostly on the top of my head. They have lasted a month. Within a week I went to the ER and had a battery of tests; The only thing that showed up is that I was dehydrated after several hours of not drinking water. Normally, I drink about 64 oz. of water a day. The pain sometimes radiated to my neck. An x-ray showed arthritis. I have had occasional nausea.
5 days after the first shot, had numbness over the left knee, then over the subsequent month, numbness spread to involve most of the thigh and leg. Following 4 wks after that, the numbness gradually receded but not resolved completely.
Approximately 8 minutes after patient received his Vaccine we were waiting to check out at the office desk when he said he was feeling dizzy, I turned towards him and reached for him but his eyes were rolling upwards and he fell straight backwards before I could catch him striking his head on the floor, patient went into a full body including arms, legs and head seizure that lasted about 8-10 seconds.  He was unconscious and would not respond to voice or touch.  He became completely soaked in sweat and his skin was hot to the touch. He was unresponsive for approximately 4 to 5 minutes, not responding to smelling salts, sternal rubs, voice prompts.  When he was moved to a treatment room in the office he began to come around but instantly stated he could not see anything.  His eyes were opened but he was rapidly scanning the entire room saying he could not see, he could hear myself and the doctor but could not see us in the room.  His vision problem stayed the same until after the EMS crew had arrived, began treatment and loaded him in the Ambulance which was probably around 10 minutes or more.  At the emergency room he had a CT scan where they determined patient had a concussion from striking his head.
patient received fluzone HD at our clinic today. insurance rejected stating that patient received fluzone HD at pharmacy on 9/11/23. patient did not report any adverse events at this time
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patient experienced redness at injection site, hot to touch, feeling of ball under skin and swelling at injection site. The action taken with the therapy with ZOSTAAVAX was unknown. The outcome of feeling of ball under skin, redness at injection site, swelling at injection site and hot to touch was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
rash; itchy; This is a spontaneous report from a contactable consumer.  A 69-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient experienced rash on chest and back that was itchy and consulted his doctor in which they stated to put hydrocortisone cream on it. Patient stated that his doctor said to go ahead and get the second dose, but to let the vaccination provider know about the reaction and let them make the decision there.  The reported events were rash (non-serious) on Feb2021 with outcome of not recovered , itchy (non-serious) on Feb2021 with outcome of unknown.  Therapeutic measures were taken as a result of rash and  itchy.   No follow-up attempts are possible. Information about lot/batch cannot be obtained.
tingling face, throat thickness, swelling.  This has been ongoing since 45 minutes after shot.  Pharmacist suggested taking 50 mg of Benedriyl.  Symptoms continued.  Went to primary care doctor on 4/7/21 who pricribed a stronger antihistimine, hydroxyzine.  Symptoms are still continuing. This was my second shot.  No reaction on 1st shot.
Felt kind of funny; Knot at the injection site/knot was not going away; Felt like being stung by a bee; Arm was sore/ killed her if she raised the arm/could not lay on the left arm; Knot was hard; Area itched; If the area was touched would go through the ceiling / the area could not be touched; Feel queasy in her stomach; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt kind of funny), VACCINATION SITE SWELLING (Knot at the injection site/knot was not going away), PAIN (Felt like being stung by a bee), PAIN IN EXTREMITY (Arm was sore/ killed her if she raised the arm/could not lay on the left arm) and VACCINATION SITE INDURATION (Knot was hard) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and INSULIN GLARGINE (TOUJEO MAX SOLOSTAR) for Diabetes, LOSARTAN, MELOXICAM, GABAPENTIN, CLONIDINE, METOPROLOL, OXYBUTYNIN, TRAZODONE and VITAMIN D NOS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING ABNORMAL (Felt kind of funny), VACCINATION SITE SWELLING (Knot at the injection site/knot was not going away), PAIN (Felt like being stung by a bee), PAIN IN EXTREMITY (Arm was sore/ killed her if she raised the arm/could not lay on the left arm), VACCINATION SITE INDURATION (Knot was hard), VACCINATION SITE PRURITUS (Area itched), VACCINATION SITE PAIN (If the area was touched would go through the ceiling / the area could not be touched) and NAUSEA (Feel queasy in her stomach). At the time of the report, FEELING ABNORMAL (Felt kind of funny), VACCINATION SITE SWELLING (Knot at the injection site/knot was not going away), PAIN (Felt like being stung by a bee), PAIN IN EXTREMITY (Arm was sore/ killed her if she raised the arm/could not lay on the left arm), VACCINATION SITE INDURATION (Knot was hard), VACCINATION SITE PRURITUS (Area itched), VACCINATION SITE PAIN (If the area was touched would go through the ceiling / the area could not be touched) and NAUSEA (Feel queasy in her stomach) had resolved. Not Provided          Relevant concomitant medications also included victo (verified). The patient did not take any treatment medication.  Action taken with mRNA-1273 in response to the events was not applicable.  Since the knot was not going away, she called the ER last night, 09 May 2021, to get advice and the healthcare professional referred her to Moderna medical information. The healthcare professional said that it could possibly a reaction to the Moderna COVID-19 Vaccine.   This case was linked to MOD-2021-116629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up was received on 10-Jun-2021 added outcome of the events was resolved.
One of five pt's, immunized from same vial of DTP, who devel high fever (103-104) & irritability w/in 12 hrs p/immun; Also recvd HIB-TITER/OPV; Tx included APAP & tepid bath;
patient is 26 years old.  She presented for bivalent COVID vaccine but was given Pfizer 5-11 year old vaccine in error.  She did also get the correct Pfizer bivalent vaccine on this day, as the error was discovered before the patient left the clinic.
blood clots found on his arm and lung; blood clots found on his arm and lung; valve blockage; This is a spontaneous report from a contactable consumer (patient's friend) via Medical Information team. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Relevant medical history included COVID-19 infection from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The reporter stated that the patient was due to receive his second dose the day prior reporting on 02Mar2021, and wanted to know if the patient should receive the second dose of the vaccine if he stayed longer than 3 weeks in the hospital. The patient was currently hospitalized; he received medical attention 2 weeks prior reporting on an unspecified date in Feb2021 due to some blood clots found on his arm and lung. The patient went into the hospital because he had a valve blockage on an unspecified date in Feb2021 and that the patient still had to go to rehab and might miss that 3 week window. The reporter wanted to know if a patient should restart the vaccination series if he could not receive the second dose 42 days after the first one. The patient was hospitalized for the events "blood clots found on his arm and lung and valve blockage" from an unspecified date in 2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Morning after DTP administration, pt c/o arm pain, made office visit. On my exam, pt afebrile, no distress, w/ 12cm x 12cm area of warmth/redness/induration.
11/1/04 called on 10/26/04 vaccine developed hive on lower arms, wrists, hands on both extremities and on buttocks. Advised Benadryl 10/30/04. Recalls one previous episode of hives on one cheek not related vaccines or illness. Symptoms resolving. 11/2/04 PC: F/U rash, 911 call tongue swelling at 10PM. Rx Prednisone Rc'd Snadapril, 11/8/04 PC will see HCP, no BP noted: one welt on wrist today, might be from old wrist watch (itching) or adornment. Suggest could be stress related: mother in law moving. Lab work ER.
Harder to breathe; Heaviness on Chest; Hot Feeling in back of throat behind nose and down throat; Hot Feeling in back of throat behind nose and down throat; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 23Dec2020 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Dec2020 at 15:00, the patient experienced a hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe. The patient was treated for the hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe with 50 mg of oral diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the hot feeling in the back of the throat behind the nose and down the throat and then heaviness on the chest and it was harder to breathe were resolved on Dec2020.   Information on the lot/batch number has been requested.
After the vaccine, patient had fever, irritability, and pain at the site of injection for 3 days. The fever resolved but the irritability has persisted (today is 6 days out from the vaccine). Mother reports that she is "not the same baby" and does not want to play as much and is less interested in eating (urine output at baseline). Her exam was unremarkable - no evidence of AOM or respiratory symptoms. No erythema, edema, or tenderness at the site of injection. Normal gait. She cried during the exam but was otherwise playful, eating snacks, smiling, and interactive. I was reassured by her exam but offered to report.
Today, March 3, 2021, Day 10, I woke with a red, raised rash surrounding the injection site.
This case was reported by a pharmacist and described the occurrence of hearing loss in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL at 0.5 ml. At an unspecified time after vaccination with FLULAVAL, the subject experienced hearing loss. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Seizure activity, (shaking, eyes rolled back, drooling) patient "out cold" as reported by parent.
1/2/05 had knot, redness, itching, warm to touch 7AM. 1/3/05 7:00AM itching, red, hot to touch, larger than 1/2/05. 1/4/05 hot to touch, red, itching, knot redness about size of softball.
Soreness and swelling, red raised area around where shot was administered, heat from shot site, weakness, paleness.
Tonic seizure about noon. Eyes rolled back and jerked in sockets with unresponsiveness for about 3 minutes.
Developed inability to swallow solid food 10/28/05 which worsened by 10/27/05 and is now having trouble swallowing liquids. Went to hospital walk in 10/27/05. Given prednisone 20 mg TID for 3 days and Pepcid. Not started as of this writing.
pt recv vax 19JUL96 & 25JUL pt devel a rash around inj site,which progressed to a gen maculopapular rash over entire body by 26JUL96;dx w/scalded skin synd, caused by staphylococcus & hosp 29JUL96;3AUG96 pt d/c;reporter concerned about lot;
Pt recvd 3 doses of Engerix-B vax on 21MAR91 & 20APR91, & 24SEP91 & 29OCT91 titers were checked & a value of 0.7 was obtained; pt was a non-responder;
I send you three paper sheet related with adverse symptoms; you can receive information related with my symptoms (clinic hospital).
Dizziness; Leg tremor; Arm pain; Huge rash that comes and goes; Nausea; Headache; Subcutaneous administration; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), RASH (Huge rash that comes and goes) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 10-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous administration). On an unknown date, the patient experienced DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), RASH (Huge rash that comes and goes), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), TREMOR (Leg tremor), PAIN IN EXTREMITY (Arm pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown, RASH (Huge rash that comes and goes) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       The patient stated that she experienced a huge rash two to three days post-vaccination, which went away then came back. She also experienced nausea, dizziness, headache, tremors in her leg, pain on her arm. The patient stated that her entire arm was in pain the day before the call.  No concomitant product use was provided by the reporter.   No treatment medications were reported.   Reporter did not allow further contact
Information has been received from a registered nurse referring to an unspecified number of patients with unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #L016427, expiration date 13-APR-2017; dose and route were not reported). The vaccine was improperly stored at 1 Celsius (C) for 7 hours and 9 C for 5 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client reported feeling dizzy to RN. Client ambulated and sat down in the anti-gravity chair. RN adjusted the anti-gravity chair to a low fowler's position. RN responded. The following was obtained with RN translating between Spanish and English. RN  noted pallor of the client's face and diaphoresis on the client's face. The client reported seeing white spots and dizziness. Vitals obtained at 02:56PM were as follows: automatic BP 97/46, HR 68, O2 97%. The client state she last ate at 2:00 PM. The client denied any chronic conditions or known allergies. The client reported a history of fainting twice before once when she exercised too hard and another after seeing blood. The client stated she experienced vision changes with the two previous episodes of syncope. The client received the first dose of COVID vaccine Janssen on 06/22/21 and denied any adverse reaction. Vitals obtained at 02:59PM were as follows: manual BP 94/50, HR 71, O2 99%. The client denied any other s/s of anaphylaxis. The anti-gravity chair was adjusted to a high-fowler's position. The client reported mild persistent dizziness. RN noted decrease in pallor on the client's face. Vitals obtained at 03:04PM were as follows: manual BP 102/56, HR 87, O2 99%. The client denied any current symptoms. The client began drinking a juice and eating animal crackers. Vitals obtained at 03:09PM were as follows: manual BP 102/58, HR 72, O2 99%. The client denied any current symptoms. The client's boyfriend joined the client next to the anti-gravity chair. Vitals obtained at 03:19PM were as follows: manual BP 114/68, HR 68, O2 98%. The client reported itchiness on the left side of her neck and on the right side of her scalp. RN  noted a red spot about one inch in diameter on the left side of the client's neck. The client stated she had scratched the spot. RN noted no visible redness on the client's scalp where the client pointed the itchiness was located. RN  noted no redness around the vaccination site or the client's right arm. Mild pink discoloration was located on the client's forearm. The client denied any itching on her arm. RN  offered the client Benadryl and educated on the possible adverse effects. The client declined the Benadryl stating that she was riding a motorcycle home. The client then stated the itching resolved. RN  noted a decrease in size and discoloration of the redness of the spot on the client's neck. RN provided education regarding possible adverse events and when to seek care. The client voiced understanding of this education. Repeat vitals obtained at 3:27PM were as follows: BP 110/62, HR 98%, O2 98%. The client denied any current symptoms. The client ambulated unassisted with a steady gait out of the vaccination site at 3:34PM.
Received the Pfizer COVID-2019 vaccine and within 5 minutes developed tingling and felt like pins and needles in the ring finger and hand of the arm injected (right arm). Started to improve about half an hour later, completely resolved within 2 hours. I was evaluated by our employee health services NP and my HR was slightly elevated but no other concerning symptoms noted.
Systemic: Body Aches Generalized-Severe, Systemic: Patient states her entire arm aches and she finds it hard to move/ use her arm-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: dose number in series- 1st bivalent vaccine - recieved at least 2 monovalents doses- with us (but i believe she got 3 pfizer monovalent before this)
Wrong dosage given to patient. Patient received Pfizer age 5-11 dosage, when he should have received Pfizer age 6 month-4 year dosage.
Upon second medical examination of the case during internal review, a significant correction was performed on 19 November 2015 to add the updated company comment and to add the related case ids in the company narrative and related cases field. Initial unsolicited report received from the literature on 12 November 2015. This case is linked to 2015SA184911, 2015SA188405, 2015SA188406, 2015SA188407 and 2015SA188408 (same literature). This case involves one of the six male patients (age group between 18-64 years) who was vaccinated with a dose of Quadrivalent meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Medical history included Homosexuality (Men Who Have Sex with Men) and concomitant medication were not reported. The HIV status of the patient was not reported. On an unspecified date following the vaccination, the patient developed serogroup C meningococcal disease. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, company assessed the event of serogroup C meningococcal disease as serious and important medical event. List of documents held by sender: none. Addendum on 19 November 2015: Upon second medical examination of the case during internal review, a significant correction was performed on 19 November 2015 to add the updated company comment and to add the related case ids in the company narrative and related cases field.
A Non-Serious Spontaneous report of HEADACHE has been received from a consumer concerning a four-year old male patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 02Sep-2008. The patient's parents reported that approximately six hours after FLUMIST administration, the patient experienced headache that lasted 10-12 hours into the night. The patient was given pain relievers with no relief. The outcome of the adverse event is resolved. The event resolved in the early morning hours.
Pt. received varicella vaccine on Friday and began breaking out in blisters on Saturday. Pt brought into clinic 5/6/13 and varicella and aerobic culture done. Varicella isolated.