chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The diluent provided for the vaccine was not used and instead sterile water was used to reconstitute the vaccine. No treatment was required and patient did not have any adverse events.
On the right upper arm it became very swollen and hot. I work at a doctor's office and so I got vitals at the end of my shift with a BP of 174/112, HR 113, temp 99.1 that climbed to 99.5  by the time I got home. I was hot, feverish, dizzy, nauseous (without vomiting), fatigued. The swelling and extreme heat at site persisted through four days. I got the vaccine Sunday morning and it is Friday morning. My arm is markedly swollen (won't entirely fit in my uniform sleeve) with collateral swelling through shoulder, right side of neck, right breast, right underarm, right scapula area. Flushed cheeks and inflamed facial skin spreading down to neck and upper chest, more towards right side. Persistent through day five. Elevating extremity provided no relief. Tylenol and Ibuprofen taken to not much effect other than bringing down the fever a bit, did not reduce pain, redness, or swelling. Ice packs helped to reduce heat but at no point did the site become cold under persistent icing. Would melt solid ice packs in less than 45 minutes with little relief. Right sinus began bleeding with blood clots after persistent right sinus headache and eye socket pain for 2 hours. Resolved in 20 minutes after starting. Over the course of the week experienced general myalgia.
Diagnosis Guillian - Barre 02/19/2022 - Weakness/Numbness all 4 extremities. Rx: IVIG. Plasmaphoreses. Prednisone. Hospitalized 02/19/2-21 - 04/25/2021 Currently home health care with PT 2x/week.
This spontaneous report as received from a pharmacist refers to a 75 years old male patient. On 23-JAN-2013, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. The pharmacist reported that on the evening of 27-JAN-2013, the patient began to experience pain in his arm at the injection site. The patient sought medical attention (the patient came to the pharmacy on 28-jan-2013). No treatment was given. The pharmacist reported that the patient might wish to take some acetaminophen or ibuprofen but has not taken either of them. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected.
Pfizer COVID-19 Vaccine EUA  Pt received the 2nd dose of the Pfizer COVID vaccine on 2/8/2021. She discharged to home without issue, but about 48 hours after receiving the vaccine pt developed a red, warm, itchy rash over her torso, abdomen, and back. Rash progressively spread across pt's chest, became itchier and slightly raised. Pt denied SOB or difficulty breathing. Pt did endorse headache and fatigue following the second dose. Pt states she had no reaction to first dose.  On 2/10/21, pt contacted their PCP via phone to discuss the issue. PCP prescribed a Medrol Dose Pak, as well as diphenhydramine 25-50 mg PO PRN for itching and famotidine 20 mg PO BID for the next few days. Pt reports her rash significantly improved within hours of the first dose of methylprednisolone and within 4 days the rash had resolved.
On 8/15/01, pt developed redness, swelling and a itchy rash at site of injection of vaccines that were given on 8/14/01 on right anterior-lateral thigh. Seen in office on 8/16/01 and advised to apply ice to site and use ibuprofen for pain and inflammation.
At first I was fine, later that night my arm was hurting, then the next thing I know everything was hurting in my body. I had to take off work Tuesday and Wednesday. I think I also had a little fever. Today I am feeling better, the arm is just a little sore.
10:15/AM Flu nasal, Hep A administered Lt arm. 10:18/AM syncopal episode with very brief loss of conscious. 10:20/AM BP 89/71. Pt recovered fully. Observed 20 min.
Some of the vaccine leaked out of the arm, like 2 drop; A spontaneous report was received from a non-health professional concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the vaccine leaked out of the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, during vaccine administration, some of the vaccine leaked out of the patient's arm. She estimates leakage of approximately 2 drops. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, some of the vaccine leaked out of the arm, was considered resolved on 30 DEC 2020.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Incorrect dose administered without any associated adverse events.
All of suddenly, my face was turning red like burn, then my hands. I was holding my hand and my hand was burning, swollen, like a lobster. Similar reaction to a flu shot that I had before. I called the doctor and they told me if impact my breath go to the emergency room. I decided not to go since it wasn't that severe. Eventually it passed after 24 hours. At the end of May, I got COVID, I got a home test and it was positive. I was extremely exhausted, very thirsty, a lot of pressure on the ears and Sinus, lack of infection. The worst was my head congestion, loss of hearing because the pressure on the ears and I still have some caught periodically. Suddenly, my hands were shaking, my legs were shaking too and I collapsed over the floor. I had a nurse that comes to check me out but she said it was not a stroke, I had some sugar, some food, drink water and it took a while but by the next day I was okay.
I had  rash all over body including face.  Legs arms Dr gave me a shot of benadryl, and an anti inflammatory shot one in each arm.
Received Pneumovax vaccine 12/14/04 at 09:30AM Left deltoid, chills x one hour. Noticed reaction while trying on clothes today. Red area with swelling noted left deltoid region to forearm.
Patient complained of sore throat and "allergy symptoms" upon arrival.  Temperature taken (97.7). About 9pm that evening, patient had taken one tab CLARITIN.  Temperature risen to 99.8, about 8:15 am next day, temperature 102, went to see private physician for routine physical exam.  Received antibiotic amoxicillin. Patient recovered by June 20TH.
Swelling and soreness entire length of arm. Sometimes lump under armpit and fold of arm.
PATIENT CAME IN TO RECIEVE A FLU VACCINE AND A RSV VACCINE. TECHNICIAN PREPPED THE VACCINES. PHARMACIST CHECKED THE SYRINGE WITH THE FLU VACCINE AND THE SYRINGE WITH THE VACCINE MIXTURE FOR RSV. AFTER PATIENT RECEIVED THE VACCINES AND LEFT, PHARMACIST NOTICED THE BOTTLES USED FOR THE RSV MIXTURE AT THE VACCINE PREP LOCATION WAS FOR SHINGRIX INSTEAD OF RSV. CALLED PATIENTS AND THEY ARE BOTH AWARE AND UNDERSTAND. PHARMACIST WAS EXTREMELY APOLOGETIC AND OFFERED FOR THE PATIENTS TO COME IN AT THEIR CONVENIENCE TO ADMINISTER THE CORRECT VACCINE. PHARMACIST REASSURED THEM THERE WILL BE NO HARM FROM RECIEVING AN EXTRA DOSE OF SHINGRIX AND PHARMACIST OFFERED TO MIX THE VACCINES IN FRONT OF THEM AND ADMINISTER THE VACCINES HERSELF. PATIENTS WERE NOT UPSET. PATIENT NOT EXPERIENCING ANY ADVERSE REACTIONS AT THIS TIME.
INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE  NEXT TO IT; COULD HARDLY  SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included viral meningitis, nausea, and headache, and concurrent conditions included clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.
Arm pain started on 9/21/10 and still continue to 10/11/10....
Pt recvd measles vax 12JUL91 then discovered was pregnant w/3rd child; LMP 13JUL91; On 16SEP91 spontaneously aborted;
Information has been received from a registered nurse concerning a female (age not specified) who on approx 10/26/05, the past 48 hours was vaccinated with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). On approx 10/26/05, the past 48 hours, the pt developed significant injection site reaction, fever, chills, swelling and redness from elbow to deltoid at injection site. it was also reported that symptoms started within 12 to 24 hours of receiving the vaccine. The pt sought unspecified medical attention. There were no lab diag studies performed. The pt had been taking acetaminophen Tylenol every four hours for the events. At the time of this report, the pt had no recovered from the events. Additional information has been requested.
Upon getting the vaccine I sat waiting in a chair just like everyone else; out of no where I became increasingly hot. I started fanning myself and my lips and hands started tingling. I became so hot it became noticeable to the nurses where I felt very alot of nausea. After theh rushed me an ice pack, water and fan to blow on me I slowly regained my normal  senses. I left on my own and drove home; was later ultra fatigued all weekend. Further swelling of secondary pimples intensified but under control. .. one of the worst vaccines I've ever gotten and I've never had such reaction. Shot was given just under the skin on my inner left forearm.
droopy; drugged; nausea; possible fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (droopy), FEELING ABNORMAL (drugged), NAUSEA (nausea) and PYREXIA (possible fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (droopy), FEELING ABNORMAL (drugged), NAUSEA (nausea) and PYREXIA (possible fever). At the time of the report, ASTHENIA (droopy), FEELING ABNORMAL (drugged), NAUSEA (nausea) and PYREXIA (possible fever) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-296450, MOD-2021-298769 (Patient Link).
Mother called the day after vaccines were administered stating that patient had a swollen right knee and was unable to bear weight. He was treated conservatively at first without improvement and was eventually admitted to hospital with IgA Vasculitis.
Three days after my Janssen vaccine for Covid-19 I awoke to a large lump on my labia. I asked for an urgent visit with my OBGYN and saw them that afternoon,  May 17, 2021.
Case number PHEH2015US025346 is an initial spontaneous report received from a nurse on 02 Dec 2015. This report refers to a 9 year old female patient. Past medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number: 1516401) via intradermal route by mistake at a dose of 0.5 ml on 30 Nov 2015. She experienced redness, swelling and itching at the vaccination site on an unknown date. She was given lidocaine/hydrocortisone cream. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
A 59 year old patient was inadvertently administered a Menveo 2 vial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 29-JUN-2023, the patient received Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: A 59 year old patient was inadvertently administered a Menveo 2 vial dose ). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-JUL-2023 The reporter wanted to know how to proceed. The reporter asked as the patient need to be revaccinated with another age appropriate product. The reporter unable to provide full vaccine and patient details. The reporter did not consent to follow up. The patient received Menveo vaccine who was older than the indicated age which led to inappropriate age at vaccine administration.
At this time, the Mother of the Child has not reported any adverse events, symptoms to PCP Dr. Reporting this as the patient was not intended to get these vaccines. Vaccines given by LPN were intended for patient's sibling, 11 year old. LPN noticed that she gave the wrong immunizations to the wrong patient, and self-reported to PCP, Mother, Office Manager, Nurse Manager, and agency. Per Dr.: "I called and spoke with staff at agency. This patient inadvertently received Tdap, MENVEO, and HPV vaccines at 2 mos. visit this morning (also received Rotavirus, appropriately). Per the CDC, there is no documented harm with giving the MENVEO and HPV vaccines, they were given off label at this age. Pt will still need to receive recommended PEDIARIX, HIB, and PNU vaccines (Tdap received does not count for DTaP)".
Patient was due for 3rd dose of COVID-19 vaccine. On 12/1/2022 Pfizer COVID 19 Monovalent vaccine was ordered and administered instead of Pfizer COVID 19 Bivalent vaccine. Also, vial had expired on 11/30/2022.
Patient presented to the ED with SOB and substernal chest pain. He was tachypneic with use of accessory muscles. He was seen by nephrology and had HD. Pt felt better after HD with no further pain and improved breathing. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Rt arm started hurting Sat AM; 11JAN92 was unable to move arm w/o pain; arm felt hot to touch & had goose egg according to pt; pt exp stiff neck & pain in back, t102 was unable to get out of bed 12JAN92 painful to move all, joints hurt;
First Dose: 28Nov2021; Second Dose: 12Dec2021; Her ear is blocked; Constantly tired; Has no energy what so ever; Has been feeling lousy and feels like everything is being drained out of her; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Dec2021 10:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hyperthyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Dosage text: First Dose; right arm, Time the Vaccination Was Given: 10:00am, both doses), administration date: 28Nov2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Ear has been blocked and cannot hear anything", "Constantly tired", "Having no energy what so ever". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Dec2021 10:00, outcome "unknown", described as "First Dose: 28Nov2021; Second Dose: 12Dec2021"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Her ear is blocked"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Constantly tired"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Has no energy what so ever"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Has been feeling lousy and feels like everything is being drained out of her". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ear discomfort, fatigue, asthenia, feeling abnormal.  Additional information: Patient received Vitamins and Armour Thyroid as concomitant product.Caller states Armour is a form of Synthroid that she takes, over the counter. She has never had issues with this and has been on it for years. Patient was using Advil as treatment.Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient gpt flu shot on 10/8/14 and patient came back to pharmacy at a later date (undetermined) to report arm pain.
NO AE REPORTED, HOWEVER, VACCINE WAS ADMINISTERED IM INSTEAD OF SQ, PER BAVARIAN NORDIC, NO REPEAT DOSE IS REQUIRED
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of bursitis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown details). At an unspecified time after vaccination with FLUARIX, the subject experienced bursitis, injection site reaction and joint inflammation. The subject developed "bursitis at the vaccination site and inflammation spread to joints". At the time of reporting the outcome of the events was unspecified. The healthcare professional reported eight patients, all of which received the same lot number of FLUARIX (unspecified lot number), developed bursitis at the vaccination site and inflammation spread to joints. This is seven of eight. See A0956566A, A0956567A, A0956568A, A0956569A, A0956570A, A0956571A and A0956573A and regarding the additional cases.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Swollen Lymph Glands, Large Lump at injection site, Clicking in Ears. All continuing at 6 weeks post vax
Blood pressure dropped quickly to 89/59 and oxygen level dropped. Felt dizzy like I was going to pass out. Family said I looked pale and yellow in face. Nurses were great but I have never had a reaction to a vaccine before.  I don?t think I will get 2nd dose. I will call my family doctor to inform him of what happened. Arm location of shot is red, swollen and tender still today. I have now been feeling ill like flu like symptoms but I was told that is normal.
Patient received Varicella vaccine 9/17/07 at H.C.  Pt c/o pain in the left upper quadrant of left arm, at the injection site before going to bed.  On 9/18/07 next morning the pt noticed swelling and redness at the injection site.  Pt returned to the clinic at 4:00pm 8/18/07.  The patient's left arm was examined and redness, swelling and warmth were noted at the injection site the area of redness and swelling measured 50mm.  b/p 122/90, P 82, R 20.  No other adverse SxS noted.
On 04 year old male child pt with no reported medical history and was in good condition at the time of the vaccination experienced bilateral leg pain in entire limbs with subsequent loss of reflexes on 02Oct05, i.e 5 days following influenza vaccine (Fluzone SV 20052006), lot no: U1804AA, administration. The pt was admitted overnight at an unspecified time in an hospital for observation. Neurological diagnosis was neuralgia. Reflexes returned to normal, pt was recovering but the outcome was unk at the time of the report.
fatigue extreme extreme headache  flu like symptoms fever 100 stiffness in neck nausea body aches
On the second day after the vaccination, my left arm and hand was very itchy in different areas.  I read about the allergic reaction that some were getting. I tried anti-ich cream hydrocortisone 1, and  "Benadryl". After several days, I still have the sever itching and started to use pharmacy Itch Spray (Diphenhydramine HCI 2%, Zink Acetate .1%) and the Cortisone Gel (USP 1%) intermittently.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a 14-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Awakened with severe wheezing and trouble breathing.  I couldn't wake up all the way or open my eyes.  I do sleep with oxygen, but wasn't helping.  When i awakened the next day my lungs hurt and i had plurious like symptoms on my right shoulder blade.  The wheezing had lessened.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have the name of the flu vaccine or manufacturer and had limited information regarding the events related to the flu vaccine.
Fatigue/was in bed basically for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/was in bed basically for a day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue/was in bed basically for a day). At the time of the report, FATIGUE (Fatigue/was in bed basically for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-579941 (Patient Link).