chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4-month-old patient received a dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included MMR (Priorix) for prophylaxis.   Concomitant products included AMBIGUOUS MEDICATION NOS (VARIVAX).   On 14-JUN-2023, the patient received Havrix and Priorix. On 14-JUN-2023, an unknown time after receiving Havrix and Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4-month-old patient received a dose). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-JUN-2023 A sales representative called on behalf of a healthcare professional to inform that, a 4-month-old patient received a dose of Havrix and Priorix. The vaccine administration facility is the same as primary reporter. Call was done originally by a sales representative who did not provide many details for the adverse event (AE). Also sales representative stated that on that same visit Varivax was also administered to the patient. The reporter consented to follow up.  A 4 month old patient received a dose of Havrix and Priorix, which led to inappropriate age at vaccine administration.
(L) arm pain at first- 12/23/14. Then red streaks down arm towards hand. Hard to touch/warm to touch. Very painful. 12/24/14 ER-IV antibiotics/steroid allergic reaction vs cellulitis.
Itchy pink lump arm; Itchy pink lump on arm; Itchy pink lump arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Itchy pink lump arm), VACCINATION SITE PRURITUS (Itchy pink lump on arm) and VACCINATION SITE ERYTHEMA (Itchy pink lump arm) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Itchy pink lump arm), VACCINATION SITE PRURITUS (Itchy pink lump on arm) and VACCINATION SITE ERYTHEMA (Itchy pink lump arm). At the time of the report, VACCINATION SITE MASS (Itchy pink lump arm), VACCINATION SITE PRURITUS (Itchy pink lump on arm) and VACCINATION SITE ERYTHEMA (Itchy pink lump arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that it was a bit of delayed reaction.  No concomitant medications were reported.  No treatment information was provided.
1st dose over 4 years ago, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had 1st dose of shingles vaccine over 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: This case was received from the consumer via interactive digital media. The reporter wanted to know if a second shot of shingles vaccine gave us protection or would we need to start over again. Additional Supportive Information: Till the time of reporting, the patients did not receive the 2nd shot of shingles vaccine, which led to incomplete course of vaccination. The case had been linked to US2022AMR144728, reported by the same reporter, for different patient. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR144728:Same reporter
1/26/21 @ 3:40PM - CHEST PRESSURE AT A 2 ON 0-10 SCALE.  DENIES SOB, DIZZINESS, CHEST PAIN OR RADIATION. A/O X3, SKIN PINK, W/D, RESP WITHOUT DISTRESS, LUNGS CLEAR TO AUSCULTATION. 1/26/21 @ 4PM - ALL SYMPTOMS RESOLVED. 1/27/21 @ 9:20AM DENOES SOB, FEELS "A LITTLE TIRED AND ACHEY TODAY".
24 y/o male, presents with multiple erythemic papules 3cm in diameter across trunk. Pt had H/A and malaise. Site was robust with enlarged lesion.
Developing a skin rash; it spread all over my body; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 11Jul2021 12:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 20Jun2021 as dose 1, single for covid-19 immunisation. The patient received the second dose of the vaccine on Sunday afternoon and developed a skin rash (on Jul2021). The patient was not sure if it was from the vaccine or not, but it spread all over the body and patient was little bit concerned. The patient does not know if that vaccine was good, it does give an allergic reaction or something in the vaccine (Further clarification was unknown) that was not sure of. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
After Dose #2, I had no side effects until the morning of the 5th day after. At 3 a.m. I woke suddenly to a very severe itching in the front of my left forearm about an inch  below the crook of my elbow. I went in the bathroom to examine it and had a slightly red rash that was about an inch in diameter. As I looked at it, it appeared to be spreading. At that point I applied topical Benedryl gel and the itching and redness went away almost immediately! I was able to go back to sleep and so far have had no further reactions.
Developed high fever ~104, lasted 7 days treated using Motrin / Tylenol. Transient upper trunk and facial rash on 3/08/2015. Swollen parotid glands and petechiae noticed on 3/11/2015, brought to Dr's. office who diagnosed strep infection, which was negative.  Started azithromycin evening of 3/11/2015. Partial SEIZURE* (actual adverse event) observed on 3/12/2015, lasting 60-90 seconds:  lip smacking, inappropriate giggling, staring off, not responding appropriately, then immediately and abruptly fell asleep, had no remembrance of the episode. Got second opinion who diagnosed vaccine reaction.
tenderness to the touch at the injection site; golf ball size lump in her arm/the lump has slowly gone away; she has developed some side effects after receiving the 1st shot of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (she has developed some side effects after receiving the 1st shot of the Moderna COVID-19 vaccine), VACCINATION SITE PAIN (tenderness to the touch at the injection site) and VACCINATION SITE MASS (golf ball size lump in her arm/the lump has slowly gone away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, the patient experienced VACCINATION SITE PAIN (tenderness to the touch at the injection site). In January 2022, the patient experienced VACCINATION COMPLICATION (she has developed some side effects after receiving the 1st shot of the Moderna COVID-19 vaccine) and VACCINATION SITE MASS (golf ball size lump in her arm/the lump has slowly gone away). In January 2022, VACCINATION SITE MASS (golf ball size lump in her arm/the lump has slowly gone away) had resolved. At the time of the report, VACCINATION COMPLICATION (she has developed some side effects after receiving the 1st shot of the Moderna COVID-19 vaccine) and VACCINATION SITE PAIN (tenderness to the touch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided Patient should get the second dose which was scheduled on 09-feb-2022. Patient was retired nurse has never seen anything like this before so Patient is having doubts about getting the 2nd dose.   Reporter did not allow further contact
Swelling redness, pain and warmth at injection site. Diagnosed with cellulitis. Pt prescribed Levaquin.
(L) arm swelling and redness within a day of receiving pneumococcal vaccine and the swelling & redness extended as far forearm in 3 days.
Pt states that within 15min of receiving her flu shot on 10/31/21, she noticed itching at the injection site. Pt states within a few hours her injection site was red, swollen, hot, and tender with continued itching. Pt present at clinic on 11/1 and are is noted to be red, edematous with 1+ non-pitting edema, warm, tender, and approximately 5cm X 7cm.
Slept a lot; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot) and CHILLS (chills) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept a lot) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Slept a lot) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Company comment:This is a spontaneous case concerning a 102-year-old female patient with no medical history reported, who experienced the non serious unexpected events of Hypersomnia and the expected event for Chills. Both events occurred on an unknown date, with the patient receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 27-Feb-2021. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to MOD-2021-417655, MOD-2021-417678 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 102-year-old female patient with no medical history reported, who experienced the non serious unexpected events of Hypersomnia and the expected event for Chills. Both events occurred on an unknown date, with the patient receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 27-Feb-2021. The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Information has been received from a physician concerning a 93 year old female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported) at a local store and then showed up at her physician's office 3 days later with the shingles. The patient was treated with steroidal therapy. At the time of the report, the patient was recovering. No further information is available.
Extreme rash, starting at the back of the neck and moved down my entire back and then out to arms, stomach and legs.  Went to urgent care, they didn't even look at it and said it's normal "covid arm" and I asked, "to my entire body??" and the PA said "yes".  However, I don't see anything online, showing my reaction as normal.   Because I have autoimmune issues, I question if this is why my reaction is so severe? I wanted this type of reaction noted by someone because this isn't a simple rash at the injection site.  I never have rashes and I'm 51 so this reaction is not normal for me. This did not happen with the two Pfizer shots, only the booster of Moderna.
inj site tender immed p/inj;erythema, edema & pain grew steadily worse-saw MD approx 2wk p/inj treated w/cortisone cream-arm became worse;returned to MD tx unsuccessfully w/oral ATB;13MAY97 drained abscess & packed;
pt reports that didn't feel well & had a small knot in lt arm @ inject site; 17JUL knot was size of ping pong ball, red, warm to touch & dull pain when touched; enlarged glands under lt arm, hard to put arm down; enlarged gland in lt neck;
Client received vaccines on 9/4/12 and states that 2 hours after receiving vaccines, her lower lip became swollen and her tongue became numb. Client called on 9/5/12 to report symptoms and states she has been taking Benadryl and that her lip is only mildly swollen and tongue is not as numb as previous day.
Wife had pain in her arm after receiving the vaccine 75 years old; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN,SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced wife had pain in her arm after receiving the vaccine 75 years old on an unspecified date. The outcome of the events was reported as unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of MMR II. The medical assistant reported that a male patient had negative antibody titers to measles (date unspecified). The patient did not have access to vaccination records, but was thought to have received one or two doses of MMR II on unspecified dates in the past. The patient sought medical attention via office visit. Additional information has been requested.
seven days after the first shot I experienced a rash size was 9 inches around my arm and  13 inches long from the injection site.  It was red, swollen and itching!! the itching was the worse!  it was from the injection site to almost my elbow.  it went away within about 4 days.  but the injection site was still sore.  I was told from my doctor to take the second shot but get it in my other arm which will be my right arm.  not looking  forward to it.
Can barely move her arm / Difficult to raise her arm; Cannot sleep at night because of the pain; quite painful /  aches at night/SORENESS IN THE LEFT ARM/Soreness in the left arm / "it puts me over the floor"; Swollen in the arm muscle halfway between the elbow and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the patient experienced injected limb mobility decreased and sleeplessness. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, swelling arm and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, swelling arm and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose pretty high in her left arm. The patient stated that the lot number and expiration date of vaccine were not available. The patient experienced soreness in the left arm and difficult to raise her arm.  The patient still had swelling, aches at night and could barely move her arm (moving her arm would cause it to ache more). The patient reported, she could not sleep at night because of the pain and it puts her over the floor. The patient described that the pain was not at the injection site and it was swollen in the arm muscle halfway between the elbow and shoulder of the left arm. The patient reported a pain medication was prescribed but it did not help at all and the pain has not resolved.  The patient gave permission to follow up with her doctor. This case had been linked with US2020231854, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231854:same reporter US-GLAXOSMITHKLINE-US2020239794:Same reporter. From FU1 deleted
Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (also reported as Pneumococcal (PCV13)) with lot number M003027 (strength, dose, expiration date and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
I had a horrible taste in my throat 2 days after the booster shot, which tasted like poison. Went to Dr. the next day. She didn't think it was from the vaccine and said it could be bile. She told me to take Omeprazole for 14 days. That helped a little bit, but I still get acid reflux from almost everything I eat and drink. A pharmacist told me that another person that got the booster where I got mine told her that she had the same reaction as I did after getting the vaccine. While I was waiting for the vaccine, a lady with a box full of what I assume were needles, asked the pharmacist who was giving the shots a question and the pharmacist told her it was ok to mix them.That lady disappeared in the pharmacy and came back out with the box and she took over for the pharmacist that was giving shots and that lady gave me my booster shot. I hope that vaccine wasn't mixed with something else!
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild
Needle was missing from syringe. Not sure if it retracted back into syringe or in patients arm
PATIENT STATED ABOUT 20 MINUTES POST VACCINATION HER TONGUE WAS TINGLE AND FELT LIKE IT WAS SWELLING. THERE WAS NO CHANGES IN HER BREATHING OR THROAT SWELLING.
08/30/04 13:45 PC from clients parent stating child received immunizations and now has blotching red rash on face progressing to neck and chest. No Tylenol given and temp was not taken. Instructed parent to give Tylenol ASAP and present to PCP and/or ER.
Information has been received from a registered pharmacist concerning a 1 day old patient whose mother might have received MMR II (lot# unknown, dose unspecified) on an unspecified date during pregnancy (WAES# 1109USA01746). Pharmacist reported that the pregnant patient gave birth to a newborn, and the newborn was born with a cleft palate. It was unknown if the patient sought any medical attention. At the time of reporting, outcome was unknown. Pharmacist was not sure that the patient received MMR II. Pharmacist might call back with more information, once she was able to confirm which vaccine that the pregnant patient received. Upon internal review, cleft palate was considered as congenital anomaly. Additional information has been requested.
Numb mouth, lips, and tongue until the next morning. Mouth went numb/tingly and then began having shortness of breath. Breathing got better/slowed down within 15 mins after taking Benadryl. Luckily, I had my Epi-Pen just in case - I I had not had an Epi-Pen I definitely would have immediately gone to the emergency room. It was very scary. I woke up this morning with an extremely sore throat.
Redness, pain and swelling at injection site about 1.5 inches in diameter.
Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vomiting, mind splitting headsche
Full body hives; This is a spontaneous report from a contactable healthcare professional. A 29-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899; expiration date: unknown), via an unspecified route of administration on 18Dec2020 08:15 at single dose (on the left arm) for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient has no known allergies. The patient was no pregnant at the time of vaccination. The patient had no other medications the patient received within 2 weeks of vaccination. The patient experienced full body hives on 23Dec2020 06:45 AM. The patient received treatment of Benadryl. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not yet been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Initial case report received from a health care professional on 20 OCT 2009. A 38-year-old female patient, was vaccinated with FLUVIRIN 2009 (batch no. 1008131P) i.m. on an unknown date. During administration of H1N1 from a pre-filled syringe, part of the vaccine ran down the patient's arm. No adverse effect was reported. Reference no. NA09-006656.
Received vaccine at 1:30 pm on Friday. Around midnight started fever and chills. At 8:00 am Saturday morning I felt fine upon waking and went downstairs to kitchen at which point I felt myself go dizzy and faint. Profuse sweating and vomiting followed. Did not go to urgent care but slept off and on all day and night. Woke up Sunday and felt fine.
#1 jan 20 2021           #2 2/17/21 pfizer #1 el 3248           #2 en 9581 pain in side near ribs , started on 2/24 comes and goes caller did yard work last Saturday thinks maybe he tweaked something?adv f/u with pcp if pain continues
Patient was doing well until the evening of 6/14/21 when she suddenly stopped breathing while laying on side on father's chest. CPR attempted and was taken to hospital by EMS but unable to regain spontaneous circulation despite ACLS measures. Patient expired.