chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, Sore arm, fatigue, joint pain, headache, unable to sleep,
Patient came in to show the arm that she had gotten ZOSTAVAX injection in. It was swollen, red and hot at injection site - Also slightly painful to touch.
3 days after receiving vaccines - developed fever 102 degrees F. Fell to the floor, fingers curled up, turned purple. Recovered without assistance under one minute. Continued with fever intermittently x one week. No further color changes or spastic reactions.
Received Covid vaccine on 4/2 and then starting 4/3 starting experiencing  nocturnal chest pain. Found to have bilateral pulmonary embolism on evening of 4/5.
Hives starting 72-96 hours after administering vaccines. Persisted 4-5 days with hive at site of injection on right deltoid; Treatment with benadryl. This is in follow-up to report (s) submitted on 11/14/2007; 2/7/2008. Information has been received from a pharmacist concerning a 14 year old female with a history of asthma, allergic rhinitis, GERD, psoriasis, eczema, and multiple allergies (dust mites, pollen, grass, ragweed, pine needles, and oak) who on 14-OCT-2007 was vaccinated intramuscularly in the right deltoid with HPV (LOt # 658558/1061U). On 17-OCT-2007 the patient experienced a minor rash. On 18-OCT-2007 the rash increased to go all over the patient's body and she was given BENADRYL. The hives were reappearing on and off by day 3. On 19-OCT-2007 the patient was ok, however later that evening the patient got hives and took BENADRYL again. The patient was taken to the pediatrician on 20-Oct-2007 and was told to take BENADRYL "around the cklock". On 22-OCT-2007 the patient got hives again, and one big hive, "the size of a pencil eraser" appeared at the injection site. After an additional dose of BENADRYL, the hives resolved. MEANCTRA and flu vaccines were administered in the other deltoid at the same visiit. The patient had not been tested for any yeast allergies.
Pain in arm of injection. Swelling, redness, fever of 103.4 F. Later orange colored urine. 103 fever for two days, 102 for 1 day. Pain in arm for two weeks, hard bump at point of injection still.
Pain down left side entire left side for months now. Ear pain constantly. Tightness in chests and sharp pain.
Tested positive for virus 5 days after receiving vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route in left arm on 22Feb2021 at 12:00 (age at vaccination 61 years) at single dose for covid-19 immunization. Medical history included diabetes. Patient have known allergies with Augmentin. Other medications taken by patient in two weeks were Metformin, Atorvastatin (Lipitor), Hydrochlorothiazide, Lisinopril (Lisinopril HCTZ). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 26Feb2021 at 12:00, the patient tested positive for virus 5 days after receiving vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown if the treatment was taken for adverse event. COVID was tested post vaccination. Test type for COVID was nasal swab done on 27Feb2021 with positive results. Reporter assessed case as non-serious. The outcome of the events was not recovered.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, RECOMBIVAX HB was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown. Product quality complaint was not reported. No further information provided. This is one of several reports received from the same reproter. Additional information has been requested.
Information has been received from a registered nurse concerning a 20 weeks old female who on 15-MAR-2011, was vaccinated with the first dose of ROTATEQ, oral (lot number not reported). No adverse effects were reported. Additional information has been requested.
Diverticulitis; The initial case was missing the following minimum criteria: Adverse Effect. Upon receipt of follow-up information on 09Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 07Apr2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included shellfish allergy. The patient's concomitant medications were not reported.  The patient received tetanus vaccine on 30Dec2020 for immunization. The patient took the Pfizer covid vaccine shot on 07apr2021, but her doctors gave her augmentin because she has diverticulitis. Outcome of the event was unknown.  Information about lot/batch number has been requested.
This spontaneous report was received from a pharmacist concerning an unknown number of unspecified patients who on unknown dates were vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). The registered pharmacist stated that the patients had developed swelling at the injection site after vaccination with ZOSTAVAX. At the time of the report, the patient outcomes were unknown. It was unknown if the patients sought medical attention. Additional information has been requested.
Patient checked in on 10/14/2022 requesting bivalent Pfizer vaccine. Medical Assistant took out the monovalent Pfizer vaccine from the fridge and doctor did not visually inspect the vial and administered the vaccine. No adverse side effects reported.
exp violent shaking, chills, feels feverish & achy, 8hrs p/vax 15NOV95;
This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at newborn (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 23 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
Covid Vaccine box was received and marked with an expiration date of 09/17/2022 (10 weeks post receipt of shipment, per protocol)  This was first breakdown of patient safety barrier.  Second, when scanned into system, was given a false expiration of 2069, and no hard stop placed, provider not alerted, second safety barrier broken.  Vaccine was given on 09/02/2022- and based on CURRENT website, vaccine would have expired on 08/31/2022- 3 days prior.
severe muscle pain in my arms, shoulders and my thighs; a golf ball size blood clot; I can not lift my arms over my head; my right hand has went numb due to it getting ahold of my ulnar nerve; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 30Apr2021 (Batch/Lot Number: ER8737) as dose 2, single for COVID-19 immunisation. Medical history included no spleen, asthma, arthritis, many broken bones, and allergies to penicillin, all from an unknown date and unknown if ongoing. Patient was not diagnosed with COVID prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 09Apr2021 (Batch/Lot Number: EP6955) as dose 1, single for COVID-19 immunization and experienced severe muscle pain in my shoulders, arms and back of thighs, hand is completely numb, and have no strength. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol xinafoate (ADVAIR); and naproxen sodium (ALEVE), all taken for unspecified indications, start and stop dates were not reported. The patient received the Pfizer vaccine (second dose) 30Apr2021. Patient stated "since then I have been put on disability, because I have severe muscle pain in my arms, shoulders and my thighs. I cannot lift my arms over my head, along with a golf ball size blood clot on an unspecified date. Now for the past month, my right hand has went numb due to it getting ahold of my ulnar nerve. I have seen 4 doctors no one knows what to do with it. My labs are good. I need help." Outcome of the events was unknown. SARS CoV-2 Antibody blood test on 29Jun2021 was positive.  Follow-up attempts are completed. No further information is expected.
No adverse event but accidentally administered Fluad when patient is 63 years old at a vaccine clinic.  Pt was the only resident under 65 years old.
The patient was administered a second dose of  0.3ml of Pfizer undiluted vaccine on the left arm intramuscularly on 10/27/21. The patient was notified and instructed to watch for symptoms (i.e fatigue, chills, sore arm) and seek medical attention if necessary.
10 hours after injection, severe chills began.  About 15 hours after, extreme fever. I received the injection at about 2 pm on a Tuesday, went to bed about midnight that night. I slept through all of Wednesday, and wasn't able to get up until Thursday morning at 9am.  I attempted to get up once Wednesday night, and was extremely dizzy and disoriented. I was able to get up a few times to use the bathroom. While I was sleeping I  felt like I was having sleep paralysis. I was having a massive fever (grade unknown), and I was unable to respond to my fiance when she came into the room. I wanted to ask for tylenol, or a doctor, but even though I could hear her, I wasn't able to  say anything.  This feeling lasted for about 10 hours, which was almost 24 hours after the injection. On 9/5/19, I went back to work. I still felt miserable, but was able to move about. I felt like I had the flu however. From 9/5-9/9/9 I experienced memory issues. I had a hard time recalling peoples names, including close family members. My speech and memory were not working well. My fiance was showing me a photo with something red and something yellow on it, and I couldn't recall the names for the colors. The memory issues were the worst until the 9th, and at this point, have improved, but are not completely back to normal.
Chronic Migraine, Persistent Diarrhea, Allergies (Nasal), Eczema on face and neck, swollen eyelids.
Information has been received from a healthcare worker concerning a 39 year old female medical assistant with no medical history and no drug allergies who on 21-MAR-2011 splashed in the eye with MMR II. The medical assistant was reporting eye irritations, and the medical assistant flushed eye with water. No lab diagnostics studies performed. It was unspecified whether the medical assistant sought medical attention, although it happened in physician's office. At the time of the report, the medical assistant was not recovered. Additional information has been requested.
ACUTE ASTHMA, DYSPNEA, ORTHOPNEA, WHEEZING
Asthenia / Fatigue, - Information has been received from a male consumer concerning his male grandson who in approximately January 2001.  was vaccinated with measles virus vaccine live mumps virus vaccine live rubella virus vaccine live second generation.  Immediately after the child's vaccination he became lethargic, very inactive and sleepy. subsequently the patient recovered.  Additional information has been requested.
Body aches after first shot; Tired after first shot/Fatigue after first shot; Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches after first shot), FATIGUE (Tired after first shot/Fatigue after first shot) and CHILLS (Chills after first shot) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced PAIN (Body aches after first shot), FATIGUE (Tiered after first shot/Fatigue after first shot) and CHILLS (Chills after first shot). At the time of the report, PAIN (Body aches after first shot), FATIGUE (Tiered after first shot/Fatigue after first shot) and CHILLS (Chills after first shot) outcome was unknown.    The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Concomitant mediation was not reported. Treatment information was not reported. Patient reported that 1 to 2 hours after vaccination, she felt tired, body aches, fatigue and chills.
Patient received Moderna as their first covid dose. The patient scheduled their second dose online and selected Pfizer incorrectly. Pfizer was administered at the pharmacy.
FLUBLOK being administered to pediatric patient with no reported adverse event.; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who stated that influenza quadrivalent recombinant vaccine [Flublok] being administered to pediatric patient with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient received suspect standard influenza quadrivalent recombinant vaccine at a dose of 0.5 ml once (lot QFAA223, expiry date - 30-Jun-2023) (formulation unknown) via intramuscular route in the left deltoid for influenza and was being administered to pediatric patient with no reported adverse event. (product use issue) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event flublok being administered to pediatric patient with no reported adverse event..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
fully vaccinated (moderna: 3/20/21, 4/18/21); onset of symptoms 7/23/21
Initial information received on 13 October 2011 from a company representative who provided a link to an online news article (lay press). Information in this article was provided by county health officials. A seven-year-old who was up-to-date with immunizations was diagnosed with pertussis. No specific product information or laboratory confirmation of the diagnosis was provided. No additional information available. List of documents held by sender: none.
began having periodic flu like dx 3 days p/vax & cont on & off until pt died; from viral endocarditis;
exposed at the gym to COVID and sx 18Feb and positive AG test 20Feb2023; exposed at the gym to COVID and sx 18Feb and positive AG test 20Feb2023; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Feb2023, outcome "unknown" and all described as "exposed at the gym to COVID and sx 18Feb and positive AG test 20Feb2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Whatever the efficacy of a product, lack of effect can occur and it is an expected finding. Based on the information provided by the reporter, the reported events most likely were due to the pandemic.,Linked Report(s) : US-PFIZER INC-202300078340 Same patient/vaccine, different event and dose;US-PFIZER INC-202200511012 Same patient/vaccine, different event and dose;
Patient received his 3rd booster fo the Moderna Covid-19 vaccine on 11/16/2021. On 11/18/2021, the patient woke up with perioral edema, presumably secondary to an immunological reaction to Klybella lip injections received in June of 2021.
Feeling sore on that day of my vaccination the 13th of February 2021. I thought I was developing flu or like symptoms. That was on the evening of 13th of February 2021. The 15th my husband saw a weird rash on my back. The pain was an 8 out 10 on the rash site It was wrapping around the left side of my body and moving to the front of my body. On the 26th February 2021. I went to Urgent Care, and I was diagnosed with Shingles.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/5/2022  HYPOXIA 3/6/2022
exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 7-year-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 3-AUG-2023 Nurse reported Havrix vaccines from lot number PB5JA exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. This is 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023105928:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105927:same reporter
leg was burning all the time; red patches on my right leg; body was aching all over like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (leg was burning all the time), ERYTHEMA (red patches on my right leg) and MYALGIA (body was aching all over like I had the flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced BURNING SENSATION (leg was burning all the time), ERYTHEMA (red patches on my right leg) and MYALGIA (body was aching all over like I had the flu). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (leg was burning all the time), ERYTHEMA (red patches on my right leg) and MYALGIA (body was aching all over like I had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR : email obtained
Pentacel was ordered, pt was aministered only the DTaP-IPV components of the vaccine. It was not reconstituted with the Hib portion of the vaccine. Patient's mother advised to return for hib vaccine.
Fever, cough, stiff neck, headache, red eyes, swollen throat, BENADRYL, ZANTAC.
Severe pancreatitis with no specific cause identified followed by complications of peritonitis, fluid in lungs of 80%, deep leg vein thrombosis, and multiple episodes of coronary arrest and systemic inflammation.
~ 7 minutes post injection, patient reports ?warmness in throat?. ~10 minutes post injection patient reports to being asymptomatic, V/S BP-130/75, HR-78, O2-98%, Resp. 20. ~30 minutes post complaint patient continues reporting asymptomatic. Education provided to seek medical attention if symptoms worsen. Patient expresses understanding.
2 hours, post vax, pt's left arm was swollen and circled around injection site. Fever of 103F on 9/18/00 through 9/19/00 when it was 101F. Today no fever. Vomiting started at 14:00 on 9/18/00 and continued until 9/19/00 AM. Had diarrhea from 9/18/00 to 9/19/00. Seen by PMD on 9/19/00 and states "allergic reaction".
pt recv two dose; p/ exp unusually fussy, total body rash(flat,macular,erythematous,blotchy); sx resolved by next morning; test determine allergic reaction to preservative thimerosal
The vaccination with Prevnar 13 was administered by the Pharmacist.  I do not know her name.  The vaccination was painful at the site of injection immediately.  The deltoid muscles was inflamed at the site of the injection.  Waking up the next day I stated to my wife that my entire left shoulder hurt.  Movement of the left glenohumeral joint and left rotator cuff elicited sharp arthritic-type pains deep in the shoulder joint.  As time progressed over the few days and then weeks the I was unable to move my left arm with experiencing sharp pains radiating from the joint down my arm along the radius and ulna muscle mass.  Any movement of my left shoulder continues to be quite painful.  Pain also remains at the site of injection and has never lessened.  I have taken non-steroidal anti-inflammatory drugs to combat the shoulder pain and stiffness.  They have not lessened the pain or stiffness.
This case was reported  by a healthcare professional and described the occurrence of erythema in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ACTONEL, Baby aspirin, Omega 3, Prednisone, Vitamin D, Glucosamine and Multivitamins. It was reported that  the patient has a history of cystolic heart failure and giant cell arthritis. There was no history of reactions following previous flu shots. On 14 September 2010 at 09:33 the subject received 1st dose of FLULAVAL at 0.5 ml in the left arm. On 15 September 2010, 1 day after vaccination with FLULAVAL, the subject experienced erythema and swelling. At the time of reporting redness was improved and the outcome of swelling was unspecified. Redness was reported to be unrelated to treatment with FLULAVAL. Swelling attribution was not known.