chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion/Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient stated daughter got an infection from an air bubble she saw in the syringe upon injection. Security cameras in pharmacy reviewed. Technician followed protocol of removing bubble. Patient given antibiotics by daughter and going to follow-up with primary. Patient and daughter told that an air bubble would not cause an infection.
On 2/12/21 I noticed Petechiae type marks on my hands and right side of my neck. The lefthand spot  was larger than the right hand spot.  Sunday 2/14 when I woke up the spot on my right hand had gotten larger but I also had it on my left collarbone area, my stomach, my left breast and the injection site looked like a bite mark with a red circle all around it. There was no pain or swelling.
Seen at the Medical Clinic on 6/5/07 with c/o HA, vomiting, sore throat and mental status change. Elevated temp of 102.6. Sent to ER for full work up and was admitted due to continue Febrile status. IV fluids given. D/C'd to home on 6/7/07 and followed up with the Medical Clinic on 6/8/07 with c/o vertigo and nausea. Patient reported at that time that he had a spike in his temperature the previous night. Patient had received smallpox vaccination on 5/27/07. Given quarters x 48 hours, ordered Ibuprofen and Meclizine prn and Azithromycin was started.  06/14/2007 Additional records received from reporter for 3 OV of June 5,8,& 11 2007.  Initial visit of 6/5/07 for c/o fever, vomiting, dizziness, feeling of passing out, h/a and sore throat as well as pain at smallpox injection site.  Appeared lethargic and and had difficulty answering questions upon PE.  Disoriented.  Not well hydrated.  Tenderness noted on lateral aspect of neck.  Coordination and cerrebellum abnormalities noted.  Assessment:  Mental Status Change.  Refered to ER. 2nd visit 6/8/07 in F/U of ER visit with DX of Febrile Viral Illness vs Smallpox Reaction.  Still c/o fever, vertigo, and nausea.  Still appearing lethargic but now oriented x3.  A/P Infectious Disease-Viral.   F/u 6/11/2007 reports no better with cont H/A, nausea, vomiting, fevers, and pain. A/P Headache Syndromes with ? etiology-new onset migraines vs viral./pc 06/18/2007 MR received for admission 6/5-7/2007 for fever, chills, vertigo and vomiting.  Pt had headache and sore throat x 3 days. (+) fatigue, lethargy and malaise. PE (+) for temp of 104.1'F (40.1'C).  Pulse 105. Otherwise WNL.  Remained weak during admission, and C/o mild SOB with ambulation.  Throat pain remained. Discharge DX:  Fevers and lethargy, viral syndrome vs. reaction to small pox vaccine.  02/01/2010 Combined with headaches one month post vaccination and reported palpitatiosn and SOB at noc x 3.5 mm that started 19 June 07 fast reset to our TMC 21 hre 07.
Information has been received from a nurse practitioner regarding her husband who is over 60 years old who on 8/30/06 was vaccinated SC in the arm with a dose of varicella zoster virus vaccine live (lot 652965/0622F). Within a week after vaccination, in approx 9/06, pt developed about a 3cm circular area injection site rash on his arm that was red and sore for about a week after vaccination. Subsequently, the pt recovered. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is follow-up to report(s) previously submitted on 10/10/2006.  Information has been received from a nurse practitioner regarding her husband who is "over 60 years old" and a physician who on 30-AUG-2006 was vaccinated SC (also reported as IM) in the deltoid with one dose of ZOSTAVAX (Merck) (Lot # 652965/0622F).  Within a week after vaccination, in approximately September 2006, the patient developed about a 3 cm circular area injection site rash on his arm that was red and sore for about a week after vaccination.  Subsequently, the patient recovered.  No medical attention was sought.  A product quality complaint was not involved.  Additional information indicated that on 10-AUG-2006 the patient's injection site was red.  This lasted for one week and resolved on its own.  No further information is available.
Sharp pain in left ear, coming in waves, with severity waxing and waning,.  Second episode following 20 minutes after first, then becoming more frequent, until  about 4 minutes apart.  Then becoming less frequent.  Pain subsided by 6 PM.  Also, mild redness and swelling of left arm.
Patient was receiving the Moderna shot. Our technician gave her the immunization and let her sit in the chair a few seconds until she was feeling okay. Tech told her to exit the booth and wait in the post vaccination chair and began to usher the patients mother in the room for her shot. The patient fainted before making it to her seat and hit her head. Tech rushed over as well as the mother and cradled her head and called me over. The patient was unconscious, but breathing for about 15 seconds. When I approached her hands were drawn up into a fist and weren't releasing. THere were no jerky movement, just the clenched fists while she was unconscious. I informed staff to call emergency number since I was worried she was having a seizure. When she became alert again she was unaware of the fact that she passed out and was dizzy and nauseous. Tech got her some water and the patient was very pale. She sat up slowly but stayed on the ground. I pulled the IMZ shield out to try and surround her so she could have some privacy. EMS showed up and we went over what happened and what I saw.
Aproximately 10 min after receiving IPV and Hep A and B #1 for an indication of travel, pt could not see, was aware of surrondings, pupils were fully dilated, bradycardic. Event time 60-90 seconds. Patient recovered spontaneously without residual. Was observed for 45 min.
Received pneumovax 3/9/04. Later that night had swelling + redness in left upper arm. Came for urgent care appt 3/10/04- left arm early cellulitis- received ceftriaxone 1g IM, Keflex 500 mg, TIDX 7 d, + tylenol #3 for pain
FEVER ; CHILLS ; HEADACHE FOR ABOUT  18 HOURS THIS HAPPENED AFTER EACH OF THE  VACCINATIONS AND THE BOOSTER.  SAME SYMPTONS AND LASTING AROUND 18-24 HOURS.
5 October 2015 12 months old female received her 1-year-old vaccines to include MMR, varicella, and PREVNAR 13. Patient did well until approximately 5 days later on 10 October 15m pt developed a rash. Mother provided photos which were consistent with erythema multiforme. Also ED physician note and dermatologist both whom visualized the lesions concur with EM. Rash resolved without treatment after 5 days.
The patient received the vaccine on 7/14/21 and called on 7/26/21 stating that she breakout in rashes the day following her shot. She reports that she has been taken  Benadryl initially (not taking any longer0 and have been using hydrocortisone cream ever since with no significant relieve.
Pregnant pt received FLUARIX; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 1st January 2022. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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 case was reported by the patient.  A pregnant female who received the FLUARIX 2021-2022 vaccine.  The estimated delivery date is in January 2022.  The last menstrual period date was unknown but the gestational age at exposure was 23 weeks. Patient could not provide information on the lot and expiration of FLUARIX. The reporter consented to follow up.
8APR92, erythema, pain w/any movement; area 5-6 cm around inject site; temp 100.4 x 3 days; tx Kelfex; resolved 13APR92;
RIGHT ARM PAIN STIFFNESS SWELLING HOT REDNESS OCCASSIONAL SHORTNESS OF BREATH
Shot given 12/31/20. Pain in arm and chills lasting two days. Was fine until noticed red raised area around injection that itched on  1/7/21. Since this date redness and swelling with itching has progressed down arm from injection site in the deltoid muscle  to the bend of the elbow, and today?s date is 1/13/21.
It was until May I went and I had respiratory issues, went to the doctor and got diagnosed with Pneumonia. They gave me antibiotics.
Ongoing dull pain in right upper arm; sharp pain with elevation. 2.5 cm swelling and firmness. Difficulty lifting arm.
Day 1 after #1 Moderna injection had vaginal bleeding Day 8 after #1 Moderna had onset of Chronic Urticaria. Chronic Urticaria Continued from January 2021-September 2021.
persistent bilateral tinnitus, interferes with hearing - began 4 hours after 2nd dose of Moderna vaccine on 1-21-21. Stopped for 6 hours after PCP initiated treatment with prednisone (on 5-17-21)  but returned and has persisted since.  No prior history of tinnitus or hearing problems.
Sounded very congested at 9 PM. Started Alb nebs. No fever noted. (Evening shot was given). Next day saw pediatrician-started on antiviral.
PATIENT HAD SYNCOPAL EPISODE IMMEDIATELY FOLLOWING THE ADMINISTRATION OF 4 INJECTIONS. PATIENT OPENED EYES AND WAS ABLE TO TALK WITHIN SECONDS FOLLOWING THE EPISODE. (PASSED OUT AND WOKE UP IMMEDIATELY).
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. Information regarding the patient's medical history or concurrent conditions was not provided. On an unspecified date in July 2013, the patient was vaccinated with the first dose of GARDASIL (indication, dose, route of administration and lot number were not provided). Concomitant therapy was not reported. In March 2015, the patient was vaccinated with the second dose of GARDASIL (indication, dose, route of administration and lot number not provided) outside of the recommended dosing schedule; no adverse events were reported. Additional information has been requested.
Booster   dose of Moderna given 2  months after she had first booster of Pfizer in Feb 2022 that she insisted she never received.    She had lost her card.   She moved to  a new assisted living facility the end of March. Her primary doctor office said she was due for a covid vaccine booster.  I realized when making her a replacement card that she had a booster in mid Feb.   She had no side effects and no problems after receiving the vaccine.
Chills, neck stiffness, sore throat, fever (101), lethargy, headache,
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves Child of unknown gender patient and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Redness, hard lump, and heat around vaccine site 10-12 hours after vaccine. Then 10 days after vaccine dark redness appeared around site and extreme itching.  Approximately 18  days after first vaccine, a milder reaction occurred ? site turned pink and milder itching than the second  reaction.
PATIENT RECEIVED PFIZER VACCINE AND THEN STATED HE WAS LIGHT HEADED AFTERWARDS. WHEN HE TRIED TO STAND UP HE PASSED OUT AND HIT HIS HEAD ON THE FLOOR. NURSE TOOK BLOOD PRESSURE (88/47) AND HR (43). NURSE ADVISED PATIENT TO SLOWLY GET UP AND SIT DOWN. NURSE SUGGESTED CALLING 911 BUT PATIENT REFUSED TO PAY FOR AMBULANCE FEE. PATIENT CALLED PCP AND WAS ADVISED TO WAIT FOR 15 MIN FOR OBSERVATION AND THEN GO TO ER. NURSE TOOK READINGS AGAIN AND GOT BP 92/54 AND HR 53. PATIENT SAT DOWN AND WAITED IN WAITING ROOM FOR AWHILE LONGER. NURSE TOOK READING AGAIN AND GOT 119/73. PATIENT GOING TO ER AND WILL CONTACT US WITH ANY UPDATES.
Systemic reaction. Hives, puffy eyes, itching, left foot and hand swelling with (L) foot pain. BENADRYL & prednisone.
Left upper arm swelling 10.5X9.5 to, red, warm to touch, itchy, small blisters. Denies any fever, SOB or rash to other parts of the body.
Approximately 10 min after vaccination pt started to sneeze and c/o runny nose. 3-5 min later she started to cough. Approximately 10 min after initial symptoms. pt c/o chest tightness, itching ears and isolated raised area to right side of face that itched. Pt's mother gave pt an Albuterol Nebulizer treatment. (Pt is not asthmatic but her sister is) Pt relates symptoms improved after treatment. She did call her doctor who told her to contact the health department. When mom brought pt to health dept at approx 5:15PM she was playful with no apparent respiratory distress.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator: 14Jan2022. Dates of administration of vaccine reported as 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.
Pt in usual state of health reports getting oral typhoid vaccine (Vivotif-Live attenuated vaccine) on 7Aug2013 from his BAS despite his immune-compromised state. Pt has taken 3 of the 4 pills given. Four days ago (8Aug2013), pt noted unusual generalized fatigue, nausea, anxiety, and alternating subjective fever/chills.
Injection site is red, swollen, warm to touch, and sore.  More muscle soreness than previous days since injection three days ago.
After receiving the shot 15 minutes later I felt tingling in my toes, my breathing was labored and A fluttering sensation was in my chest, my pulse was 94 beats per minute. About a half an hour later my head started hurting on the left side Which lasted throughout the day and Hot flashes would occur a couple of times throughout the day. The following day September 14th I felt very sleepy and the headache still remained on the left side of my head I was continuously out of breath while walking and my chest would hurt while walking as well. September 15 headache still remains slightly on the left side of my head nose felt very weird as if something was stuck in there, I did not show up to work in order to get some rest at home. I rested all day and still a slight headache remain on the left side of my head.
Pericardial effusion on 6/19 s/p percardiocentesis. Ongoing hospitalization, associated complications including pleural effusion and new pericardial effusion on 7/16.   Initial rpesentation also with somnolence, decreased respiratory drive thought to be due to Onfi overdose. Was intubated now on room air.
On 07-15-21 we had a nurse vaccinating for Pfizer at one table and a nurse vaccinating for Janssen at another table. Each table keeps their vaccines in color coordinated boxes that is assigned for each vaccine being administered. At approximately 12:20PM the nurse who was vaccinating Janssen closed her pink box labeled J&J and stepped away 6 feet from her table to speak to the service representative that was checking in our patients. Unbeknownst to us, the nurse vaccinating Pfizer walked to the other table and grabbed vaccines from the pink box labeled J&J and took them back to her station and put them into her clear box. There were a total of 2 vaccines taken from the Janssen box. At approximately 12:45PM the nurse vaccinating Janssen returned to her table and noticed that two vaccines were missing from her box. The other nurse then proceed to give her one back. The nurse vaccinating Janssen immediately brought the syringes to a supervisor for disposal. Based on the timeline we have compiled a list of patients that were vaccinated by the nurse who took the Janssen vaccines. Patient was to receive his second dose of Pfizer but now based on the above instance we are unsure if he was given Janssen.
patient fainted after vaccine administration. Patient was given the vaccine and slumped in the chair ten seconds later. We were able to revive her after 20 seconds. We had her lay on her back and lift her feet. after 15 minutes she said she was feeling fine and left with her father.
She has cough and reports green sputum production that she feels started after the Pneumovax. She developed a sore, red, swollen area over most of right upper arm by 2 days after vaccination. Patient reports development of right upper extremity pain and swelling, fevers, chills, and headache after receiving her Pneumovax. Site of injection with warm, erythematous, and exquisitely tender demarcated region. She also developed sore throat, back pain, neck pain, light sensitivity, bilateral shoulder pain and bilateral hip pain. She states that she hurts all over.
Pt. dev. "softball" sized pink/red, warm slightly tender, localized swelling of (L) lateral thigh. Temp elevation to 100 for approximately 2 days.
48hours ofter booster,  left side lost all feeling.  congnitive thinkin blurred.  not energy as before.. lost all mind and physical of what i was as of wed. morning.  had the booster on monday.  wed. afternoon. everything gone.  felt like i have had a mini stroke on the left side.  i am at present got some  eneergy back, but nonothing of what i had wed. morning.  within 48 hours.  lost myself.
pain; joint stiffness; Heat rash; rash on chest; On and off chills; aches; fever; Pain at injection site; Skin feeling warm; Bottom of his feet started feeling bruised; slept most of the day and through the night; lethargic; No energy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), PAIN (pain) and JOINT STIFFNESS (joint stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), LETHARGY (lethargic), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site). On 23-Jul-2021, the patient experienced PYREXIA (fever) and MYALGIA (aches). On 24-Jul-2021, the patient experienced PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), RASH (rash on chest) and CHILLS (On and off chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Jul-2021, SOMNOLENCE (slept most of the day and through the night) had resolved. On 10-Aug-2021, PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), LETHARGY (lethargic), RASH (rash on chest), PYREXIA (fever), CHILLS (On and off chills) and MYALGIA (aches) had resolved. At the time of the report, SKIN WARM (Skin feeling warm), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site) had not resolved and CONTUSION (Bottom of his feet started feeling bruised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Follow up received on 21-AUG-2021 contains Patient Demographic details, Vaccine Facility Information and Added events and Events outcome.
SWEATING; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, headache, and fever on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210428358 and 20210430032.