chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exposed to someone who might have been re-infected with virus; 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 SUSPECTED COVID-19 (Exposed to someone who might have been re-infected with virus) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Exposed to someone who might have been re-infected with virus). At the time of the report, SUSPECTED COVID-19 (Exposed to someone who might have been re-infected with virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
Extreme fatigue Sore muscles Sore joints (never had them) that did not go away Increased tinnitus that has not gone away loss of hearing in right ear that has not gone away
On Tuesday April 6th at around 4pm patient came in for her second vaccine dose with her co-worker. I asked them the questions surrounding the protocol for the vaccination and proceeded to take temperatures. One thing that did stand out before the injection was she mentioned that she was out of work for about 3 days after getting the shot because she fell ill. I asked her how long it lasted and she replied about 3 days. I then asked her if she wanted me to proceed with her second injection. that day and she said yes, and added it's one of those things that  unfortunately happen. Some people have a reaction and I happen to be one of them:end quote. I gave her co-worker their injection first, then I gave her injection. About 5 mins in she started saying she was hot. I offered her some water and she said she was getting hot. About 10 mins in she started saying that she feels nauseous and hot still. We put a wet paper towel  on the back of her neck. By that Time I has  staff were up front assisting me with patient. That is when I asked someone to grab the Epinephrine injection for stand by and proceeded to call 911. I gave them all the information about the patient, but noticed that she was telling the ladies that her throat was tightening up and it was becoming hard to breathe. Her breathing was becoming deep and fast as I watched her from the phone. That is  when I told one of them to give her the injections, because the patient was becoming unresponsive to our questions except for nodding of the head when asked can we inject her with the pen. After the injection was given, EMT was right at the door and started to triage the patient.  I informed them that the patient had just received the epinephrine shot not even 5 mins before they walked through the door and she was given the wet paper towels to keep her cool because she was saying she was hot. After that  another  vehicle arrived and asked  if she wanted to go to the Hospital and she said yes. They got her on the gurney and I gave them the information about what happened before they arrived along with her Injection card.
Flu vaccine given in left deltoid. Later that PM, left deltoid swollen to "golf ball" size per mother. Examined by Dr 11/6/03 at 10:50 AM area left deltoid about 0.6cm erythema, slightly warm to touch.
1445: Shortly after receiving vaccine - member reported hot flashes, tingling in hands and wrist, nausea, and generally not feeling well. 1450: Began monitoring vitals, administered 50mg oral Benadryl. Member's symptoms fluctuated between feeling better and returning.  1510: Member with mouth dryness, appeared anxious. 12L o2 via NRB 1515: ambulance called 1517: tingling feeling both legs and chest tightness.  1537: symptoms began to fluctuate between better and worse. Epi administered at 1537. EMS crew assumed care of the patient. Patient transported via ambulance to Deaconess Hospital.   Per patient report, was placed on an Epi drip, later titrated and discharged on oral steroids.
Patient received her second MODERNA vaccine on 3/24.  She reports she developed a red, itchy rash to the injection site on 3/28.  She states it is warm to the touch and feels slightly numb. She denies swelling or fever, denies issues with moving the arm above shoulder level. She was advised that this seems to be a commonly reported side effect, and may go away on its own within 24-36 hours.  She was advised to ice, use Tylenol, and call if symptoms did not resolve in 24-36 hours.
Pfizer-BioNTech Covid 19 Vaccine EUA Started getting light headed and dizzy on early morning Sat.  Have been having off and on since then.  Have not been able to shower, drive for fear of having it happen again.  I did have a B12 injection on 2/15/2021 after checking with my physician to see if would be a problem with getting vaccine.
Pain and swelling in the injection site. 12 hours later a feeling of being hit by a mac truck plus headache and fatigue
Dx vestibular neuritis in right ear. Vertigo is constant and going on 7 days now.
Patient received dose of Pfizer Monovalent after 4/18 when the FDA stopped use of this vaccine.    Patient has returned on 5/11/23 for BIVALENT Dose
Dtap ordered; Tdap given - child scheduled to return ASAP to receive Dtap per CDC instructions.
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot #: M033209 with expiration date: 09-JAN-2018, lot #: M031942 with expiration date: 27-DEC-2017, lot #: M015698 with expiration date: 26-SEP-2017 and lot #: M002053 with expiration date: 11-JUL-2017 (all of them invalid lot numbers for varicella virus vaccine live (oka/merck)) (doses and routes of administration were not reported) for prophylaxis. There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of maximum 15.2 Fahrenheit for 2 hours and 8 minutes. Data logger was involved and there was no previous temperature excursion reported. There was no Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014218.
17AUG92 pt seen for contusion lt hand given Td; 19AUG92 pt seen for rxn to Td c/o erythema, pain, warmth @ inject site, lg area; tx Tavist, cool compresses & cont Naprosyn;
Patient had genital herpes and after 1 year of the vaccine had not any more breakout; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Herpes genital.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout).    No concomitant information was reported. It was reported that information can be useful for the people experiencing the same illness as patient. No treatment information was provided.
Swelling; Redness; Warmth; Tenderness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 38-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   On 3rd October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site tenderness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The nurse reported that, the patient received vaccine from different vial of same batch number. The reporter did not link this case with product complaint. The reporter did not consent to follow up. This case was 1 of 5 linked cases reported by same reporter.
Patient had various small red dots/marks on face, neck and collarbone area. Were not inflamed or swollen. Slightly bumpy and not itchy. Symptoms increased following day and moved throughout the body to include the torso, groin/butt area, legs and back as well as back of neck and scalp. redness decreased gradually on the face but still prevalent elsewhere. Dr. visit was made that day with no treatment necessary as it was thought this was a belated reaction to the MMR vaccine. No other symptoms were found common after vaccinations. Follow up with Dr. in a couple of days to confirm decrease of blotches/red marks.
I am not sure that this was an adverse event as a result  of the flu but felt I should report it just in case it is.  I suffer from episodic migraines and one trigger can be long runs, and I did go for a long run on the morning of Oct 24th.  What was unusual was that I had three migraines in a row over three days after getting the flu shot (migraines on Sat, Sun and Mon night).
Nausea Vomiting Vaccine site red and warm X 24 hours Narrative:
Extreme nerve and joint pain throughout entire body. Temporary loss of vision in 1/2 of left eye. Headaches.
Rash/ reaction on upper arm.  Itchy, red, and lasting 5 days now.
SWELLING; BODY ACHES/PAIN; ARMPIT WAS VERY PAINFUL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced swelling, body aches/pain, and armpit was very painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling, and body aches/pain, and the outcome of armpit was very painful was not reported. This report was non-serious.
Rash all over body that started approximately 1 hour after shot.  I called a advice nurse and she said to take a claritin.  She is going to have the doctor call me, but haven't had a call from the doctor yet.
This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown. The reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's arm was very red and sore for a couple days.  Nurse thought it was related to vaccine. The reporter was agree to follow up from GlaxoSmithKline. This case was linked with the case US2018GSK177931, reported by the same reporter.
Received An Expired Dose; Initial Report Received on 17-Mar-2023  This spontaneous report was received from a Medical Assistant who reported that a 42-year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 17-Mar-2023, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023 and NDC # 43528-003-05) intramuscularly in the left deltoid (inferior region). The patient also received a Hepatitis A vaccine in the left deltoid (superior region) for which no other details were specified.   On 17-Mar-2023, the patient was receiving an physical and received 2 vaccines (HEPLISAV-B and a Hepatitis A vaccine).  The HEPLISAV-B vaccine administered was 6 days past the expiry date.      It was reported that the patient did not report any adverse reaction.    No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
DTaP & Varicella given along with VIS, Mom called 8/2/12 at 0830 to tell me that pt has round, red lesions on thighs that itch. Size of tip of pinky finger, clear centers. Applied Calamine took BENADRYL, no better or worse at 1700. Resolved Sat, August 11, 2012.
Nausea felt warm Temp 99.9 b/p  110/70   Pt layers down rested cool cloths  sips of water  then felt better and went back to work.
I got the vaccine around 3:30PM, by 9pm I was fatigue and extremely tired. About midnight I woke up in cold sweats, I had a fever (101-102) over the course of two days I got up to 104. I took Tylenol and drank fluids. I didn't take Ibuprofen because it effects your kidneys. After the two days I felt terrible, after the second day my urine was dark color and a few days you could tell there was blood in my urine. I contacted my Dr. we did lab work. My GFR originally was 97 (prior to vaccine) and post vaccine was 74.  About day 10 I started to feel better. About two weeks after I re-did lab work and my GFR went back to normal and urine went back to normal as well.
Nausea, Stomach Pains, Chills, Fever, Light headedness, Body Aches and Pains.
KINRIX given to pt. This formulation indicated for 4 yrs or older. No adverse effect noted 2 vaccines where indicated by type.
Swelling of tongue; swelling of tonsils; swelling of back of his throat; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain), SWOLLEN TONGUE (Swelling of tongue), TONSILLAR HYPERTROPHY (swelling of tonsils) and PHARYNGEAL SWELLING (swelling of back of his throat) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U(or 0)25520-2A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (mold, cats and dust mites).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 13-Jan-2021, the patient experienced SWOLLEN TONGUE (Swelling of tongue), TONSILLAR HYPERTROPHY (swelling of tonsils) and PHARYNGEAL SWELLING (swelling of back of his throat). At the time of the report, ARTHRALGIA (Shoulder pain), SWOLLEN TONGUE (Swelling of tongue), TONSILLAR HYPERTROPHY (swelling of tonsils) and PHARYNGEAL SWELLING (swelling of back of his throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include  Benadryl and Allegra.
DEEP VEIN THROMBOSIS; CHRONIC EMBOLISM; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient was trying to get in contact for blood clots after receiving Janssen vaccine. The patient had very bad pain and swelling in leg and foot from 23-APR-2021 and was sent to the hospital on 26-AUG-2021. The patient had to be in hospital for a week from 26-AUG-2021 to 02-SEP-2021 for chronic embolism and thrombosis of vein in left lower extremity, Deep vein thrombosis. The patient's leg started turning black and had very bad shoot pains. The patient's leg was still not well and hurt whole lower leg and foot turned black and it went all the way to knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis, and chronic embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220257075-COVID-19 VACCINE AD26.COV2.S-chronic embolism and Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Lingering tinnitus; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced lingering tinnitus. Consumer stated that the patient mentioned that almost 2000 people who had a similar reaction from the Moderna COVID-19 vaccine and Pfizer. The outcome of the event was unknown.  Follow-up attempts are needed. Information on Lot/Batch number can be requested.
Patient was given a 2nd Moderna vaccine 3 weeks after her 1st dose, instead of 4 weeks. As of 6/8/21 no adverse events reported.
Subsequent to receiving one dose of varicella virus vaccine live on 4/22/96, the pt was exposed to his mother with shingles. In April, 1999, the pt developed a very mild case of chickenpox with approximately 10 spots. He sought unspecified medical attention and recovered.
Muscle soreness to upper arm.  Painful to raise arm above head.  Pain continued until now.  Arm is not getting bigger.
swelling from rt shoulder to below the elbow;red, hot w/inc pain;could hardly move arm rt hand dominant;applied ice & took APAP;
Parent reports pt c/o R arm pain, swelling of R arm and R axilla, over to R chest to bottom rib, chills present and achy on 4/14/06. Went to ER on 4/15/06 with symptoms. ER doctor prescribed cephalexin 500mg qid. Today4/18/06, c/o achy R side, stiff neck, lump under R axilla, swelling of arms and chest diminishing pain in school.
Patient administered the Pfizer Covid19 vaccine at age 11 years 6 months.  Physician from contacted for guidance Dr., she advised that this patient receive his second dose after his 12th birthday and this will complete his series.
J96.00 ACUTE RESPIRATORY FAILURE 11/18/2022 DM 2 W RENAL MANIFESTATION
On Saturday 6/25/2022 noticed slight sore throat when I woke up and didn't think much of it. 6/26/2022 woke up and it worse and had a runny nose. So I took an at home COVID-19 test and it was negative. On 6/27/2022, I woke up and felt even worse and also very fatigued; so I took another home COVID-19 test and it was positive. I didn't want to believe I was positive so I too 2 more and they were both positive. Once, I realized I was positive I called my PCP, they prescribed PAXLOVID and told me to quarantine for 5 days. I quarantined for 6 days testing everyday and I tested negative on the 7/2/2022. The medication helped tremendously and I did not feel any symptoms after I began it. No one who was around me after 7/2/2022 has been positive.
I developed a large mass on my arm. I went to an the Urgent Care Clinic. I was asked to go and get an Ultrasound of my arm. I had just had my final shot of my HPV vaccine, so they weren't sure if it could be an effect of that. I was told that if it didn't start going down on it's own, to let them know and they may need to take a biopsy. It started receding and going down on it's own within 1 month, so I let it be and didn't get anymore medical care. It seemed like my body absorbed it.
Information has been received from a physician concerning a 14 year old male who on 19-NOV-1998 was vaccinated with the first dose of MMR II, and the second dose on 15-NOV-2000.  On 12-NOV-2009 the patient developed mumps.  She was diagnosed with mumps on 30-DEC-2009.  The patient did not have a fever.  The patient had left parotitis and the parotitis count was 56.  Blood works were performed on 30-DEC-2009.  The serum immunoglobulin M test result was <1:10.  The serum immunoglobulin G was 1.91 and the serum amylase was 65.  At the time of the report, the patient's outcome was unknown.  Follow up information was received which reported that on 03-JAN-2010 the patient developed mumps.  She was diagnosed with mumps on 05-JAN-2010.  The patient had right parotitis.  Blood works were performed on 05-JAN-2010.  The serum immunoglobulin M test result was < 1:10.  The serum immunoglobulin G was 4.13 and the serum amylase was 129.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Client complained of fast heart rate post vaccination while waiting in the observation room. Vital signs initiated. Water, ice pack, candies provided and other care.
still have shingles/suspected vaccination failure; Shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: still have shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 The case was received from the consumer interactive digital media. The patient had vaccines and still had shingles and it was very very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.