chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of hepatitis A antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On 21 October 2011, 21 November 2011 and 26 April 2012 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). On 26 April 2012, 47 days after vaccination with 3rd dose of TWINRIX, 7 months after vaccination with 2nd dose of TWINRIX, 8 months after vaccination with 1st dose of TWINRIX, the subject experienced hepatitis A antibody negative. The subject had a titer performed on 12 June 2012 Hepatitis A was non reactive and Hepatitis B was reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases 0994236A, A0994238A- A0994244A, A0994246A.
Fever 101.3, headache for 3 day, diarrhea 3 days, nausea/dizziness, location of Tdap shot became very hot then spread to fever.
pt recv vax 29JUL93 & reporter stated MD may have improperly given inj-sciatic and/or perineal nerves were damaged which resulted in neuro injury to rt leg & foot;pt refused to walk p/vax, guarded leg & stopped walking;abn gait, pain;
Rash; Fever; Body aches; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, fever and general body pain. On an unknown date, the outcome of the rash, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the rash, fever and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a lot of adverse reactions after vaccination with Shingrix. She had rash that lasted for 1 to 1.5 weeks. She also had fever and body aches that lasted over a day.  The reporter consented to follow up.
received /Kinrix/ before her 4th birthday.; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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 details provided were as follows: Health care professional reported that, the patient received a dose of Kinrix one day before her 4th birthday, which led to Inappropriate age at vaccine administration.  The reporter consented to follow-up.
Information has been received from a registered nurse concerning a 4 year old white female with no allergies or medical conditions who on 24AMAY2000 was vaccinated with a 0.5ml second dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. The reporter noted that the patient was immunized at a health department before she became their patient. On 24MAY2003 the patient's mother noticed two small fluid filled spots on the abdomen and by 25MAY2003 it "spread to about a dozen vesicles," was "itchy on trunk and extremities" and the patient was "uncomfortable from itching." The patient was diagnosed with "chickenpox post vaccine" and it was also noted that she had been exposed to varicella about three weeks prior to breakout. Prescription drug treatment was not required and the patient was "treated only symtomatically for varicella." The symptom was still being treated and she was expected to recover. The outcome was reported as uknown. There were no diagnostic tests or laboratory results. Follow up information received from the registered nurse indicated that on 24MAY2003 the patient started with two "vesicle looking spots" on the belly and within 24 hours had spread to "about a dozen vesicles on a red base (belly and extremities)." The patient's mother was instructed to treat symtomatically for varicella. On 06JUN2003 the patient recovered without complication. No further information is expected.
Severe chills, shaking Fever of 101F  Knee partially paralyzed for 3 days in a row (difficulty walking) Severe headache
Headache, extreme body and join pain, nausea, fever, flye-like symptoms, sinus congestion
Nausea x3 days. (5/27-5/29/21). "Moderna rash" x5 days (5/27-5/31/21).
Shingles; Starting to dry up; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 51-year-old male patient (reporter's son) that who received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Medical history included the patient had covid-19 in early Jan2021 to an unknown date. The patient's concomitant medications were not reported. Two weeks later in 2021, the patient had shingles and now starting to dry up. Responded that you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Referred to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller was wondering if her son should get the second dose of the vaccine. Caller waned to know if he should skip his second dose or what he should do. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 69 years old male patient who developed an itchy rash on both arms and fingers on both hands and pruritus in the groin area, his left arm became red, warm and aches and pain, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing FLUZONE HD. Concomitant medication was not reported. On 17-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot LUI994AA via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious developed an itchy rash on both arms and fingers on both hands and  pruritus in the groin area (rash generalized) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious his left arm became red, warm (vaccination site inflammation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious aches and pain (pain) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was aches and pain, his left arm became red, warm and developed an itchy rash on both arms and fingers on both hands and pruritus in the groin area. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for his left arm became red, warm, as Unknown for developed an itchy rash on both arms and fingers on both hands/ pruritus in the groin area and as Unknown for aches and pain.
Constant chest pains, difficulty breathing, wheezing, shortness of breath and fatigue over several months (into 2022).
shots given 23SEp sx started 3OCT93 in PM; t104 ax & vomiting excessively; rash only on legs; specks & blotchy only on legs; no trunk or face;
Moments after receiving her HPV #3 and Flu vaccines patient felt Light headed and passed out. She was sitting on the exam table with the MA present to help Lower her to the table. She stiffened and developed pallor. VS were taken and she was observed for ~ 20 minutes pt reports that the same response occurred w/the same vaccines 11/18/17 when she was 18 year.
Fever, nausea, fatigue, pain at injection site, swelling at injection site, generalized pains
-mild arm soreness progressing to moderate pain (began around 1pm, got worse for approximately 24 hours, then began subsiding) -mild nausea about 12 hours after vaccination, followed by lightheadedness and cold sweats, which only lasted 20-30 minutes
The wrong booster given.  Received Pfizer.  Should have received Moderna booster.  Pt came into our Pfizer booster clinic.  Could not find her card.  Stated she was here for her Pfizer booster.  Was asked, "You are here for your Pfizer booster?"  Yes.  "How did you do with your last 2 Pfizer doses?"  Fine.  "Do you have any questions about the Pfizer booster before I give it to you?" no.  Proceeded to give Pfizer a booster.  While sitting in the waiting room she found her card.  Her previous 2 doses were Moderna.  I told her that she should have received a Moderna booster, not Pfizer.  She replied "oh".
My left arm hurts when I move it in certain positions.  It is around the injection site.  There is no visible signs around the site.  My range of motion is limited in the left arm.  I had an injection in my back March 17, 2021 and the pain when away.  It started hurting again in about two weeks.  It is not as bad now but I do not have full range of movement.  I have been applying different pain lotions and exercising it on a regular basis but I still am having trouble with it.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient had no known drug allergies.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient did not take any concomitant drugs.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of COVID-19 with Humira (adalimumab) was no reasonable possibility. The reporter assessed events of COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
ITCHY THROAT,  EYE SWOLLEN SHUT, INSIDE MOUTH SWOLLEN, COVERED IN HIVES
VOMITING; DRY HEAVES; BAD HEADACHE; NAUSEOUS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma, raynaud's disease, osteoporosis, arthritis, and end-stage kidney failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09/JUN/2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced vomiting. On 29-MAR-2021, the subject experienced dry heaves. On 29-MAR-2021, the subject experienced bad headache. On 29-MAR-2021, the subject experienced nauseous. Laboratory data (dates unspecified) included: Dialysis (NR: not provided) Not reported. Treatment medications (dates unspecified) included: calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 01-APR-2021, and had not recovered from bad headache, nauseous, and dry heaves. This report was non-serious.
Breakthrough Case of Covid: My stepdad had a positive test on Friday, May 13th. I got my Covid shot on noon the following day on the 14th. I felt fine on the morning of the 15th, but I noticed when I took a walk I didn't have the normal energy. Otherwise, I had the normal amount of tenderness you would have from any other injection. By Sunday night, the 15th, I started to feel very achy. I couldn't sleep all night which is very unusual for me. I woke up feeling very hot. I took my temperature and it was 101.9. I checked the pulse ox and it was 94 which is low for me and heart rate was 124 which is double my normal. I was extremely nauseous. I made myself take Tylenol. Every bone and muscle hurt. My head felt like it was going to explode. My neck glands were extremely sore and swollen. My ears hurt. I took a Covid test but my nose was very dry. It came back negative. Once I was got out of bed, my nose started running so I retested. It was immediately positive. I contacted my doctor about starting an antiviral. I still didn't really have an appetite. Today is the first day I ate. I had a smoothie yesterday. I feel about 65-75% better after starting the Paxlovid. I also had a weird rib pain. It felt like someone had broken all my ribs.
Neck pain which has persisted and gotten worse.  Pain from injection site, running down into my thumb.  Swollen glands causing light bruising on the right side of my neck.  I also had 4-5 days of both kidney pain and testicular pain.  On top of that, a bad case of covid followed
local rxn below inj site 5x8cm;redness, heat, swelling, & pain; cellulitis @ inj site;
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: Approximately 10 minutes after vaccination patient reported feeling shortness of breath and lightheadedness. Blood pressure was checked and was 172/100. After 5 minutes blood pressure was checked again and it was 145/95. Patient reported symptoms were dissapating. Blood pressure continued to go down over the next 30 minutes. Patient stated this has happened one other time and she has been working with a doctor in relation to it. She had no other symptoms. I encouraged her to continue to monitor.
right arm swollen; hard knot; red; second dose on Day 43; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (right arm swollen), VACCINATION SITE MASS (hard knot), VACCINATION SITE ERYTHEMA (red) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on Day 43) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE for GERD, ATORVASTATIN for Hyperlipidemia, GABAPENTIN, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LAMOTRIGINE, CITALOPRAM and LUBIPROSTONE for an unknown indication.   On 09-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on Day 43). On 10-Jun-2021, the patient experienced VACCINATION SITE SWELLING (right arm swollen), VACCINATION SITE MASS (hard knot) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SWELLING (right arm swollen), VACCINATION SITE MASS (hard knot), VACCINATION SITE ERYTHEMA (red) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on Day 43) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She stated that there is no pain unless it is pressed upon. It looks like a mosquito bite. Her daughter has put a circle around the knot so that they can watch if the knot changes shape or color.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication information were reported
Initial report received on 22 July 2010 from a consumer, who is the patient's parent. An 8 week old female patient, with no medical history, received a first dose of ACTHIB (lot number UF813AA, which corresponds to sanofi pasteur SA lot number D0259-1) and a dose of DAPTACEL (lot number C3192AA) on 25 February 2010. Two to three hours post-vaccination, the patient began crying a high-pitched continuous cry for 2.5 hours. Afterward, the patient slept for six to seven hours and when she woke, she was dazed and cranky for the remainder of the day. That evening, the patient also had projectile vomiting twice. The patient recovered. This case is linked to case 2010-03965, in which this patient also experienced high-pitched crying, sleeping for six to seven hours and waking up dazed and cranky after receiving a second dose of ACTHIB on 03 May 2010.
Chills (24 hours), fever (24 hours), headache (over 24 hours), injection site pain (over 24 hours), nausea (after 24 hours)
Shortly after my vaccination, I began to feel a hot pain in my spine that ran from between my shoulder blades up into my skull. That pain subsided after a couple days, but I could not shake the headaches and agitation. for the next month, I had increasing  mental health issues, sleep problems, and became manic.   On May 4, I had a psychotic break and lost my grip on reality. It was so severe that the police were called, and I was taken via ambulance to the hospital. After a six day inpatient stay, I was diagnosed with bipolar disorder and released from the hospital even though I was still struggling with symptoms.  It's now been over four months, and I am still fighting a constant battle for my mental health. It is affecting my livelihood and relationships with loved ones. I had been in an Executive position at a software company responsible for a large budget and many people. Although I've tried to return to work, I haven't been able to do so since May. It feels like my brain is working in slow motion, and I can no longer cope with stress.  As for treatment, I've been seeing a psychiatrist to help with medication management; I'm on 1500mg of lithium daily and Olanzapine as needed for manic/psychotic symptoms. I see a therapist biweekly for talk therapy. I am making forward progress on my mental health, but it is slow and feels like I'm always "taking one step forward, two steps back".
About 1 week after 2nd vaccine, I experienced heart palpitations and soreness in chest and was extremely tired. It seemed to mimic a bout of pericarditis that I experienced in my mid 30's.  Then this past week, I started to have stomach problems. I was fine in the morning but by the evening I had severe stomach cramps if I ate anything.  Again, this seemed to mimic the colitis that I had in my late 20's. Although I don't have any bloody discharge with my bowel movements. I do have cramps and a sudden urgency to go to the bathroom. Sometimes it is diarrhea but not always.  I have lost 4 pounds in the past week or so. I had put off getting the vaccine because I was afraid that it would reawaken my Lupus which has been in remission for many years.  I have not been to the doctor. I am hoping that my immune system will calm down my itself. If not, I will probably have to go back on medications to subdue it.
This spontaneous report was received from a registered nurse concerning a currently 1-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (DILUENT MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14 °C to -10 °C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (DILUENT MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Vaccine leaked out after administration. Unable to estimate proportion of dose received.  Informed patient. Patient agreed to receiving repeat dose in opposite arm. Repeat dose COVID-19 Moderna Lot 038B21A 0.5 mL given intramuscularly on R arm at 4:34 PM.
A few days after second Covid 19 vaccine, woke unable to get out of bed. Swelling in hands, pain in knees/shoulders. Stiff all day. Since diagnosed with reactive HLA B27 + arthritis, treated with prednisone and sulfasalazine. Still active, but patient found (in work-up of arthritis) to have metastatic lung cancer and awaiting treatment of this.
Fussiness on First Day, runny nose, crankiness & diarrhea during 2nd day (12/29). Fever started 12/29 in evening (101.5) very uncomfortable, screaming when trying to lay down, decreased appetite. Unable to sleep well.
Poison ivy flare 2 days after stopping Prednisone taper and 3 days after second Pfizer COVID vaccination.    2/10/21 Walk-in clinic doctor prescribed round 2 of Prednisone taper and Hydroxyzine HCL
Cold and burning sensations; prickly cold/burning type pins and needles; in hands, arms, abdomen, eyes, face, ears, back of thighs, and calves. Muscle spasms in calves, abdomen, and side/kidney area.  Dilated pupils, photo sensitivity/eyes. Very cold painful hands.  Some brain fogginess.  Very uncomfortable and scary. Sounds like some type of neuropathy - small fiber, perhaps?
The night after receiving the vaccine my symptoms included cold sweat, shaking,  dizziness, fatigue, unable to sleep and had an extremely high heart rate when standing. The symptoms such a dizziness, numbness, syncope, memory loss, severe fatigue, feeling faint, brain fog and high heart rate when standing persisted constantly. Then i was diagnosed with postural orthostatic tachycardia syndrome and Dysautonomia by a cardiac NP and a neurologist. i keep getting sinus infections over and over again.
Presented with sore throat and nasal congestion. Diagnosed with acute upper respiratory infection. Advised to treat at home with rest and fluids.
On  07/27/2022 I had mild flu symptoms with fever.  i had mild Headaches, weakness, and  sinus congestion.  I tested positive  on the same day. I called my doctor who  prescribed me Paxlovid for 5 days.   Since I had COVID-19  i am experiencing Sinus congestions  all the time ongoing. I also have lack of energy mild.