chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site rash. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site rash were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site rash to be related to SHINGRIX. Additional details were provided as follows: Event reported on after hours voice mail. The age at vaccination was not reported. The symptoms lasted for approximately about 5 days. No further information was obtained due to limited contact with the reporter.
Started with pain and stiffness left side of neck, same side shot was given, became severe on 11/10/2011 spread to entire neck and head and had to go to after hour clinic and emergency room.
Pt reports arm was a little sore but nothing unusual. Pt repots yesterday noticed a small rash on her chest. red, flat, pin point. Denies itching, wheals, "not like hives". Pt reports woke this am and arm where given vaccines was hot, red, swollen and hard. Size of baseball. Pt reports putting ice 20 min that cooled and softened knot but still red and swollen. Pt denies any SOB, wheezing, fever, red streaking from site. Pt reports has never had allergic reaction to vaccines in past.
s/s edema, induration & heat-pain;tx advil, ice-sling-warm bath;
I had 2 shot series and I have shingles/ suspected vaccination failure; shingles in left eye; shingles in both hands and head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had twice, once as a child and once as an adult).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient's doctor told that patient would have the shingles.  The patient had the Shingrix vaccine, 2 shot series back in late 2022. The fast forward to now the patient had shingles affecting both hands, head, and left eye.  The doctor said that because of vaccine the patient should not had a full blown case.  The patient pray that doctor was right, this was no fun. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This is a spontaneous report from a noncontactable consumer (patient). A 66-year-old (non-pregnant) female patient received the first dose of BNT162b2 BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot#EP7534), at the age of 66, via an unspecified route of administration, left arm on Mar 17, 2021, at 19:45, single dose, for COVID-19 immunisation. Medical history included Factor V Leiden carrier and sulfonamide allergy. Concomitant medications included warfarin, diphenhydramine, calcium, Vitamin B and Vitamin C (ascorbic acid), for an unknown indication; from an unknown date. The patient previously took pseudoephedrine on unknown date, for unspecified indication; and experienced drug allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 18, 2021, at 02:00, patient experienced headaches, body aches and slight fever. The event lasted about 24 hours. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the headaches, body aches and slight fever recovered on Mar 19, 2021. No follow-up attempts needed. No further information expected.
hard to walk or write/type; Pains in hands/wrists and feet/ankles; Sharp pains; Numbness; Burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (COVID 19) via an unspecified route of administration in 09Apr2021 (Lot number: FA6780) as single dose for COVID-19 immunization. Medication history included migraines and kidney stones. Known allergies: erythromycin and morphine-based medications. COVID prior vaccination was none. COVID tested post vaccination was none. The patient didn't received other vaccine in four weeks. Concomitant medications include topiramate, clomifene citrate (CLOMID), ascorbic acid (VITAMINS C) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously received erythromycin and morphine, both experienced allergy. On 15Apr2021, the patient experienced pains in hands/wrists and feet/ankles,  sharp pains, numbness and burning. So bad some days it was hard to walk or write/type, was told by medical practitioners this was not side effects. The events resulted in emergency room/department or urgent care and hospitalization for 5 days. Treatment include pain medications. The outcome of difficulty in walking was unknown. The outcome of other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127635 same patient/drug, different dose/event
Patient had flu-like symptoms begin the day after vaccination (1-13-20).  On 1-14-2020, the patient woke up with a widespread itchy rash over most of her body.  Patient started taking Benadryl and topical hydrocortisone for 10 days.  The rash persisted and patient went to her prescriber on 1-29-20 and started oral prednisone and topical triamcinolone, and cetirizine.  The rash is still present every morning when the medications have worn off.  Her provider is recommending allergy testing at this point since she did not have a response to the first vaccination.
Congestion, headache, dizzy, whole body soreness, nose swelling, ears stuffed gave cough med with antihistamine and symptoms resolved by morning.
Pt recv vax on 7/28/98; post vax pt exp fatigue &nausea.
Soreness in arm/shoulder, some stiffness, progressively getting worse through the day and evening. Severe pain by morning with the slightest movement. Unable to move arm for 2 plus days. Doctor advised Advil. As of 05/26/2015 shoulder still sensitive with certain movements.
24 hrs status post injection, pt has erythema, edema and pain at site.  Pt also with fever of 101 &102, no CP, no SOB.
Headache; Chills; Poor sleep; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Poor sleep), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement. Concurrent medical conditions included Hypertension and Thyroid disorder.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced POOR QUALITY SLEEP (Poor sleep) and FATIGUE (Fatigue). On 28-Jan-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, POOR QUALITY SLEEP (Poor sleep), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment was reported.   Reporter did not allow further contact; Sender's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, fatigue and chills are consistent with the known safety profile of the vaccine
About 6 to 8 weeks after my vaccine shot, i started to experience numbness in my last 3 fingers on my left arm.   The fingers tingle  / numb through out the day and is most noticeable when i shower or when i sleep in a certain way and my fingers really tingle.  It has been about 6 weeks now and it hasn't gotten worse nor really better.   I feel like I got a mild case of guillain-barre.
Mom described waking to hear baby making noises in crib around midnight, eyes wide open, but making gasp like noise, ambulance called. Symptoms continued for 3 mins. Seen at medical center. Diagnosed for febrile seizure. Discharged to home.
Mother called service over the weekend that he has had soreness to his left arm since getting the FLU shot on 10/7. He is being admitted to 5T for IV Abx care for his cellulitis of the left arm. It is painful and warm to the touch since 10/11. It measures 7.5mm by 12mm. Marked with a pen. Received first dose of Clindamycin IV in clinic (12pm) and will continue inpt q8hrs. Sent a MRSA swab from clinic as that needs to be f/u. Dc'ed Mg today d/t Mg of 2. Continues on Siro taper as below. VSS, no fever, labs WNL. Soft tissue ultrasound showed cellulitis, no evidence of drainable fluid. When admitted, switch IV Abx to cefazolin due to known resistance with clindamycin.
Pt was given immunizations 11/8/00 and that same day, pt developed a fever 103F and developed seizures and was brought to the hospital ER. Seizure and sepsis work-up was done. Cultures were negative and pt was discharged after 3 days. Per F/U 4/10/02: At 11:30AM, pt began to have shaking of his upper extremities, eyes rolled into head, teeth clinched, saliva from mouth and he was unresponsive. This episode lasted about 15 minutes and mother states child felt warm to touch at this time. She called EMS and was brought to the ER. While in ER, he was witnessed to have another seizure for about 5 minutes and temperature was 104F. ER note states pt was "irritable". DX: Complex febrile seizures S/P immunization. R/O sepsis/meningitis.
hives all over her body; overwhelmingly itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body) and PRURITUS (overwhelmingly itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (hives all over her body) and PRURITUS (overwhelmingly itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over her body) and PRURITUS (overwhelmingly itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient use prescription cream as treatment as well.
pt recv vax & day p/vax pt exp a hive-like rash;from follow up 3NOV97 pt was reported to have recovered from this exp;
A couple of days after, my arm was extremely sore and hot and I couldn't lift my arm above the height of my shoulder.
Employee complain of itching on 11/20/08 in the evening big. 11/22/08 left arm was swollen, golf ball size, felt hot and red.
Fifty nine minutes after the vaccine I started to get hives. I was red everywhere also had a rash especially on my neck face and arms. My legs were more like lumps. I took some enzymes that usually help with my symptoms with food allergies. I do not like to take Benadryl. The rash got better but I felt very congested in my nose for a couple of hours. The following day my arm was swollen and I had a headache and I was tired. I fell down because I lost my balance. I have a service dog because of my condition. Orthostatic intolerance is part of my condition and it was much worse than usual. It came so much quicker. For the next three days those symptoms persisted. Five days after the vaccine I started to have problems two hours after I got up in the morning. My speech is difficult and I am stuttering which happens to me a few times a year. It became very bad and it sounds like Stroke like symptoms. It has been five hours and it seems to be improving right now. It normally lasts about six hours. My Headache is much worse today and my Orthostatic intolerance is still causing me problems.
21Aug90 pt vax;  26Sep90 devel h/a, dizziness, muscle pain, neck pain, & testicular pain dx as orchitis.
This spontaneous report was received from a pharmacist refers to a 66 years old female patient without drug reactions/allergies. The patient was vaccinated with MMR II (dose, route and lot# not reported) 2 weeks ago, about on 24-SEP-2012. It was reported that the patient who received MMR II at an unspecified hospital was on BACTRIM on 09-OCT-2012. The reason why the patient was on BACTRIM was unknown. The pharmacist stated the patient had been on BACTRIM before but not chronically. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Shortly after taking the vaccine, I started having some chest tightness, trouble breathing, and was nauseous but thought it was my asthma so I did not report it. It continued to happen and still have more breathing issues than before.
His reaction was swollen lymph nodes nearly blocking his airway; His reaction was swollen lymph nodes nearly blocking his airway; This is a spontaneous report from a contactable consumer (pharmacy intern) reported a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reaction was swollen lymph nodes nearly blocking his airway. He did not seek treatment and it did subside.  It was reported that a patient received the first dose of the Pfizer Covid vaccine and it seems like there was swelling of the lymph nodes in the neck to the point where it started to block the airway. Patient had no swelling of the tongue or shortness of breath, but there was swelling that was starting to block the airway due to that. Patient had no anaphylaxis reaction. They are wondering if he should get the second vaccine. Knows there is extensive guidance on the CDC and on Pfizer website about not to get the second dose if anaphylaxis occurs, but they don't consider this anaphylaxis reaction in this case. Should patient get it or not or if he can get it to go to a facility where he can be monitored and have Epipen on stand by if needed. They know normally it would be treated with steroids, but they tend to counter interact with the vaccine which can affect the immune system. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Developed a shingles like rash on neck, ear & head on left side.  Rash started approximately 4/9/10.  ER Dr. prescribed VALTREX one gram three times a day X 7 days & LYRICA 75 mg three times a day X 7 day.
expired vaccine administered. Pfizer consulted, advised to revaccinate immediately with no interval time.
Pt received vaccines in right arm (Typhoid, Flu) with no reaction, after the last of the 2 vaccines (Tdap, Hep A in that order) was given patient stated that she felt lightheaded and like she was going to pass out, stated she saw black spots as well, patient was transferred to exam room 4 where she laid down, b/p taken at 4:37 147/93, HR: 56, O2 99RA. Patient stated she had not eaten since breakfast so she was given Crackers and peanut butter as well as water, patient stated she was feeling better, vitals taken again at 4:51 b/p 137/88,  HR 61 O2 99RA. Patient's mother stated that she has had similar reactions when giving blood or having blood drawn. Patient was advised to eat a little closer to next vaccine time.
Stiff neck on the same side of the injection; A spontaneous report was received from a Healthcare Professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of stiff neck on the same side of the injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On unspecified date, the patient experienced stiff neck on the same side of the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 03 Feb 2021 the outcome of events stiff neck on the same side of the injection was reported not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
My daughter was administered multiple immunizations on 3/9/04. That night she became very, very, fussy.  Even with TYLENOL she had a temp of 99.  Before the vaccinations she was a Healthy, Happy, Friendly, Bright, Brilliant and Smart child.  Within a week my daughter went into what I call a FOG.  She would no longer respond to her name and would not even respond to most sounds.  She quickly and drastically began to lose her many skills.  She could no longer talk (she had been saying mama, dada, lala, bye bye). She began this constant deep wining, moaning sound that at times she would make all day and nothing would comfort her. She was friendly to family and strangers and then all of a sudden she would scream and cry if we were in a room with people or family members that would try to interact with her.  Her family gave her a nickname was because she could mimick anything that her mother did. She could wave, play patty cake, dance, jump, stick her tongue out, pose with smiles for pictures.  Anything I taught her she learned almost instantly.  Since 3/9/04 we cannot attend a family function longer than 5-10 minutes because my daughter becomes hysterical.  This extreme, traumatic fog lasted from March to Mid August when she began showing slow, small improvements. She no longer pushes her mommy away but will now let me hold her or kiss her.  Other family members still can't hold her but they can wave or talk to her.  She has slowly re-learned to clap but she still cannot speak or wave bye bye.  Her arlertness to sounds has improved but she still usually won't respond to her name.  She has every test imaginable done to determine what is wrong with my baby and all the results come back fine or negative.  Please, Please, Please help me to understand what happened to my daughter after she received those shots and what I can do to help her.  She is my whold world.  I cry myself to bed everynight because I don't have the answers needed to help her.  She and I are currently in speech therapy, occupational therapy but my daughter is still only 25% of the child she once was.  Please, Please, Please help me to help her.
Patient under 10 YO got Boostrix; This would have been dose 5 in the DTaP series; Patient under 10 YO got Boostrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Daptacel (received two doses of Daptacel), Daptacel (received two doses of Daptacel), Pentacel (received two doses of Pentacel) and Pentacel (received two doses of Pentacel).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and accidental underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and accidental underdose were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The physician reported that under 10 year old patient received a dose of Boostrix, which led to inappropriate age at vaccine administration and accidental underdose. The physician clarified the patient had previously received two doses of Daptacel and two doses of Pentacel, so this inadvertently administered dose of Boostrix would have been dose 5 in the DTaP series, which led to wrong vaccine administered. No further details were shared during the call. The reporter consented to follow up.
Stiffness in left arm; Stiffness in back of neck; Very, very slight headache; This is a spontaneous report from a contactable Consumer (patient)  An 89 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247) on 27Jan2021 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included blood pressure abnormal. The patient informed she received Flu vaccine either Oct2020 or Nov2020. Concomitant medications included ASPIRIN [ACETYLSALICYLIC ACID], ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), levothyroxine sodium (SYNTHROID) and unspecified blood pressure medicine. On 27Jan2021 the patient experienced stiffness in left arm for a few minutes. She also complained stiffness in back of neck 8described as not painful or debilitating) and very slight headache on the same day (27Jan2021). The patient recovered from reported events on 27Jan2021. It was informed that second dose of vaccine was scheduled for 17Feb2021.
Swollen and painful supraclavicular lymph node and left axilla lymph node days 2 - 13 Red, itchy rash and firmness on left deltoid muscle, anterior aspect of left axilla and left subclavicular region on chest pronounced starting day 9. Lingering still day 13 but much less pronounced.
Evening: chills fever Morning: fever, Nausea, fainted,  Resting comfortably now