chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving her shots, my daughter cried, and then became listless. I placed her in her car seat, and was told to wait in the lobby for a few minutes. Once in the lobby, I took her out of her seat and tried to nurse her. At this time, she was completely unresponsive. She was breathing fine, but would not wake up or nurse or make any noise. I returned to the front desk and asked for assistance. Two nurses came to the door and took my daughter and I back to the exam room. They took her out of her car seat, and looked her over. They asked if she cried very hard after her shots, which she had, and that it was normal for them to be "sleepy" after their shots. This was not "sleepy", however, this was near catatonic.
headache aggravated; hot flashes aggravated; random pain throughout her body aggravated; blurring of vision aggravated; joint pain aggravated; fatigue aggravated; brain fog aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), FEELING ABNORMAL (brain fog aggravated), HEADACHE (headache aggravated) and HOT FLUSH (hot flashes aggravated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Metastatic breast cancer. Concomitant products included LETROZOLE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (brain fog aggravated). On 20-Feb-2021, the patient experienced ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), HEADACHE (headache aggravated), HOT FLUSH (hot flashes aggravated), PAIN (random pain throughout her body aggravated) and VISION BLURRED (blurring of vision aggravated). At the time of the report, ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), FEELING ABNORMAL (brain fog aggravated), HEADACHE (headache aggravated), HOT FLUSH (hot flashes aggravated), PAIN (random pain throughout her body aggravated) and VISION BLURRED (blurring of vision aggravated) outcome was unknown.            Reporter did not allow further contact
Headache, Myalgia injection site pain/swelling Narrative:  Employee received second dose of Pfizer vaccine from an outside facility ("Pharmacy") on 07/28/2021 at approximately 17:00. Reported injection site pain and swelling, along with chills, headache, body aches and general fatigue which all began around 09:00 the following day (07/29/2021). Reports use of Motrin (ibuprofen; unknown dose/duration/frequency) for symptoms.
Td given in ER on Sunday 3/10/13 to Health Dept today arm is red, swollen, hot to touch, hard - area where shot is given is toward back of arm. Pt states could barely move/raise arm has been using TYLENOL the entire time.
Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right arm where she got the vaccine shot that is painful; Cold chills; Body aches; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: SJ1865), via an unspecified route of administration on 06Jan2021 10:00 at SINGLE DOSE at right arm for COVID-19 immunization.  Medical history included ongoing Diabetic- Started 4-5 years ago. Concomitant medication included ongoing metformin for diabetic. The patient clarified the side effects she experienced were cold chills, body aches, and stiffness on the right arm where she got the vaccine shot and there was pain. The cold chills started late afternoon on 06Jan2021 around 1:00 PM or 1:30PM. She confirmed these have gone away and she has recovered completely. The body aches started around this same time as well. The stiffness on the right arm where she got the vaccine shot is painful. She noticed the stiffness and pain about 30 minutes after she got the vaccine, it was like 10:30 AM when she noticed this. She is no longer hurting and the stiffness has gone away.  It went away on Saturday late in the evening like 7:00PM or 8:00 PM. The outcome of the events was recovered on 09Jan2021.
hives; itching; 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 URTICARIA (hives) and PRURITUS (itching) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and PRURITUS (itching). At the time of the report, URTICARIA (hives) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment drug was reported.   Reporter did not allow further contact
Pt started w/red spots over body then turned white then purple; had white hives; swelling of body-general; took to MD given DPH;
1 of 5 pts who exp an inject site react w/in 24 hrs p/vax; reaction was the size of a quarter, hard, raised & warm to touch; afebrile; no tx initiated;
Reduced kidney function went from 2 to level 5.  Creatinine went from 1.2 to 9.3
4 cm red papule distal to injection site. One injection site with 1/2 red macule around it both on (R) arm.
Breakthrough COVID case confirmed by PCR; Breakthrough COVID case confirmed by PCR; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Dec2021 (Lot number: FD7218) as dose 3 (booster), single, administration date 12Apr2021 (Lot number: EL3247) as dose 2, single and administration date 22Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 18Feb2022, outcome "recovering" and all described as "Breakthrough COVID case confirmed by PCR". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Child received vaccination and appeared to be in good health. After vaccination, child stood up. When nurse looked back at the child she was on the ground. The fall resulted in a minor injury, including an abrasion and small cut on the bottom lip. Child was responsive immediately after fall. Able to follow commands, sit and stand. BP 110/60 5 minutes after fall.
Presuming patient came back early for 2nd dose. Patient was scheduled for 1st dose on 3-12 and simultaneously scheduled for 2nd dose on 4-2. Patient presented on 3-26 and appears that he was scheduled in the moment (again) for 2nd dose and the dose was administered. Dose was administered at day 14. Minimum interval is 21 days however there is a 4 day grace period.
I started having severe headaches approximately 24 hours after the vaccination. Initially  I was prescribed Methylprednisolone ,Amox/Clav 875-125 tab, Sumatriptan Succinate and Tylenol 500 mg. After not getting much relief, was next prescribed Nortriptyline Hydrochloride, Nurtec, and Ibuprofen 800 mg.
Arm pain. Fatigue. Later, right hand broke out with small clear blisters. Within days extreme fatigue like my mono from high school had returned. Lasted 3 days. Meanwhile, long dormant herpes simplex V2 issues began and have continued. Treating with hydrogen peroxide and abreva to keep in check.
SWOLLEN LYMPH NODES IN THE BACK OF NECK; STIFF KNEES; JOINT PAIN/KNEE WAS SORE; This spontaneous report received from a patient via (other manufacturer- Abbvie ) concerned a 64 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for moderate to severe chronic plaque psoriasis, and moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate for drug used for unknown indication.  On 2021, the subject experienced stiff knees. On 2021, the subject experienced joint pain/knee was sore. On 16-MAR-2021, the subject experienced swollen lymph nodes in the back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in the back of neck on 2021, was recovering from joint pain/knee was sore, and the outcome of stiff knees was not reported. This report was non-serious.
Initial report received from a healthcare professional on 17 October 2008.  Cluster of six unidentified patients experienced itchy and swollen throats after receiving FLUZONE SV 2008-2009 (lot number U2740AA).  The six patients arrived together at a flu clinic on 15 October 2008.  One hour after receiving their FLUZONE vaccines, the patients drove back to the clinic, all six complaining of itchy and swollen throats.  A nurse at the clinic sent one of the patients to the emergency room.  Outcome was unknown for the six patients.  Documents held by sender: None.
April 7 I got the worst case of eczema ever. Only get it occasionally, say every couple of years. This was face, neck, arms, stomach, thigh and butt. Then  May 15v got Shingles. Still dealing with severe pain.
Pt received Varivax 12/08/06 pt broke out with chicken pox lesions 12/15/06 with high fever 102-103 Mom was in contact with office several times reports on 12/23/06 pt still with lesions 50+ fever finally broke concerned due to amount of lesions.
I woke up in the middle of the night after getting the vaccine in my right upper arm with pain from my shoulder to just below the elbow, on the outside of the arm. Bending the elbow was excruciating (9 out of 10). Not moving the elbow circa 4-5 out of 10. Pain resolved in upper arm, but elbow is still painful to bend a month later.  Treating with a tennis elbow arm wrap & tylenol help.  I also experienced a deep cough, coughing up thick phlegm, for about 3 weeks post vaccine.
ALMOST KILLED AND CAUSED LOT OF MEDICAL ISSUES; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced almost killed and caused lot of medical issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost killed and caused lot of medical issues was not reported. This report was non-serious.
Initial unsolicited report received from a consumer (patient herself) on 13-Nov-2017. This case involves a 28-year-old female patient who was vaccinated with a 0.5 ml single dose of TYPHIM VI (batch number: PE0653-1, expiration date, dose in series and site of administration were not reported) intramuscularly on 23-Aug-2010 prior to traveling. The patient's medical history and concomitant medications were not reported. It was also reported that the patient denied that she took oral tablets with the vaccine. On an unknown date, within a few days following the vaccination, the patient developed fever, diarrhea and gastrointestinal (GI) upset. Later, she had medical problems and on an unknown date, after the vaccination, she was diagnosed with an elevated aluminum level and she was wondering if it's related to this incident. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient recovered from fever, diarrhea and GI upset and the outcome of elevated aluminum level was not reported. Documents held by sender: none.
Then about a week later, pt had vesicles and sores in the armpit lasted 3 weeks. Evening of 2nd moderna, he had fatigue and had hallucinations during his sleep, and chills that lasted 3 days.  About a week after he became fatigue again. Now he is getting waves of feeling "down" in his health. These events are preceded with  lump in throat, starts clearing his throat and then will get this down wave of his health. Constant swallowing.
Client stated that she had swelling of her face and lips and her lips peeled, she stated she couldn't move her R arm. She said it started a couple days after her flu shot. She also stated that her chest was itchy and that it lasted a couple of days. She denied any breathing issues. Client stated that she did not go in but waited for her son to get home
weakness; sleepiness; tiredness; fever of 101°F/elevated temperature of 102 for a few days; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, SOMNOLENCE, FATIGUE, PYREXIA, and HEADACHE in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 003A21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy and Bone marrow disorder. Concurrent medical conditions included Blood pressure. Concomitant products included MULTIVITAMIN and VITAMIN D for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA, SOMNOLENCE, FATIGUE, PYREXIA, and HEADACHE. The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA, SOMNOLENCE, FATIGUE, and HEADACHE outcome was unknown, and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High). On an unknown date, Body temperature: 102 (High).         Concomitant Included Blood pressure medication.   This case was linked to MOD-2021-047276.   Most recent FOLLOW-UP information incorporated above on 06-Jul-2021, Follow-up information received on 06-jul-2021 contains significant information patient lab data updated result, event pyrexia outcome updated to recovered resolved.
Information has been received from a physician and a nurse in the physician's office concerning a 14 year old female who on 12-FEB-2007 was vaccinated with the first 0.5ml dose of Gardasil. within two minutes of receiving the shot, the patient passed out. it was reported that as she was falling to the ground, it was observed that she was having a seizure. The seizure was described as a "drawing of the right arm". The patient did not have full body tremors. The seizure lasted approximately one minute. The patient was sent to the emergency room, however, was reported as being "Fine" when she left the office. The patient was not admitted to the hospital. The nurse did not know of any treatment given in the ER and believed that the patient was just observed and released. The physician reported that the patient was fine after being released from the emergency room. On 12-FEB-2007, the patient has recovered from the events. It was reported that the patient had no history of seizures and the nurse stated that the patient will continue with the Gardasil series. Upon internal reviews, seizure was considered to be an other important medical event. Additional information has been requested.
Site: Swelling at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
'Covid-arm' developed overnight on the 7th day. Swelling, itching, redness, warm to touch, tenderness
No adverse effects reported; a patient was given an improperly stored dose of MMR II; This spontaneous report as received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.   On 23-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R030808 and expiration date 24-OCT-2020 (strength, dose, frequency and anatomical location were unknown) for prophylaxis (product storage error). The administered dose of the vaccine was stored with the temperature of 10.3 degrees centigrades, for 39 hours and 33 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Within 5 min after administration, 6cm area of erythema and intense itching developed.  BENADRYL + XYZAL given.
fluzone qiv administered to a pregnant with no reported adverse event; Initial information received on 06-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 25-year-old female pregnant patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]  with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported fluzone qiv administered to a pregnant with no reported adverse event occurred at 37 weeks of pregnancy.  The date of last menstrual period was reported as 15-Dec-2022. The estimated due date is 22-Sep-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On 06-Sep-2023, the pregnant patient received a dose 1 of suspect Influenza Quadrival A-B Vaccine Suspension for injection with unknown strength, batch number & expiry date via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  Additionally, at time of reporting, the pregnancy is still ongoing.
Pt called clinic with questions about localized swelling to R arm and fever upon waking the day after immunizations were given. Pt was seen in clinic today because symptoms were not better. Pt also developed malaise and runny nose. Has been taking ibuprofen and Tylenol for fever, mother states initial fever was 101.4, has not let it go with out medication since, pt came to clinic with fever of 99.2 after receiving Tylenol 1.5 hours before visit. Ice packs have been applied consistently to arm. Reddened welted area approx. 10 cm in diameter to R deltoid (Menactra injection site), L deltoid with light red patch around injection site apporx. 4 cm in diameter (Tdap injection site).
Seizure, developed fever 11/09/2004. Medical Record received on 1/12/2005 states dizziness, nausea, and lethargy.
Patient reported feeling nauseous and light-headed post-vaccination. EMS evaluated and gave him water and snacks. Patient's girlfriend drove him home.  6/1/21: 11:42am - TC to client. No answer. Left message to call back. 6/4/21: 2:20pm - TC to client. No answer. Left message to call back. 6/7/21: no call back from client. Record closed.
Developed high fever with chills, sweating, "racing" heart rate, diarrhea, extreme skin flushing "looked like I had body sunburn"-weakness, sick all night, better today but very weak.
This spontaneous report was received from a nurse practitioner and refers to a 21-year-old non-pregnant female patient. Her concurrent conditions included hypothyroidism. Concomitant medications included an unspecified thyroid medication and unspecified birth control pills. She did not have any drug reactions or allergies. On 24-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose was not reported, lot # reported as M026306, expiration date: 30-APR-2018, intramuscularly). The nurse practitioner reported that within 2 minutes after receiving the GARDASIL 9, the patient fainted. Within 30 seconds after she fainted, she recovered, but she felt weak for the rest of the day. No medical treatment was provided, except observation after the patient fainted (it was also reported that there was a treatment given for thr adverse events). No laboratory tests were performed. The patient recovered the following day, on 25-OCT-2016. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
69 year old patient was supposed to receive fluzone hd qiv but received fluzone qiv instead with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old female patient who was supposed to receive Influenza quadrival A-B high dose hv vaccine [fluzone high-dose quadrivalent] but received fluzone qiv (influenza quadrival A-B multidose vaccine preserved) instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a 0.5 ml dose of suspect influenza quadrival A-B multidose vaccine preserved Suspension for injection (lot U8049BA, Expiry: 30-Jun-2024) via intramuscular route in the deltoid nos (not otherwise specified) as immunization instead of Influenza quadrival A-B high dose hv vaccine with no reported adverse event (wrong product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Started with watery eyes after never having allergy before.  Watery eyes turned to itching, itching turned to pain, eye drops did not offer relief, both eyes suffered from high eye pressure, left eye developed corneal erosion, both eyes developed cataracts upon healing 6 months later.