chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was sore; Upper lip started tingling a little bit; Lips felt tight but they didn't look swollen; Tongue tingled just a tiny bit; Slight metallic taste; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PARAESTHESIA ORAL (Upper lip started tingling a little bit), ORAL DISCOMFORT (Lips felt tight but they didn't look swollen), PARAESTHESIA ORAL (Tongue tingled just a tiny bit) and DYSGEUSIA (Slight metallic taste) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Blood pressure under control) since 2007, Prediabetes (Under control no medicines) since 2015, Drug allergy (Cefzil), Drug allergy (Cipro) and Drug allergy (Sulfa). Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, VITAMIN D NOS for Bone disorder, ESCITALOPRAM OXALATE (LEXAPRO) for Stress, KRILL OIL for an unknown indication.    On 22-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PARAESTHESIA ORAL (Upper lip started tingling a little bit), ORAL DISCOMFORT (Lips felt tight but they didn't look swollen), PARAESTHESIA ORAL (Tongue tingled just a tiny bit), DYSGEUSIA (Slight metallic taste) and HEADACHE (headache). On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). The patient was treated with PARACETAMOL (TYLENOL) from 22-Jan-2021 to 23-Jan-2021 for Headache and Pain in arm, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 22-Jan-2021, PARAESTHESIA ORAL (Upper lip started tingling a little bit), ORAL DISCOMFORT (Lips felt tight but they didn't look swollen) and PARAESTHESIA ORAL (Tongue tingled just a tiny bit) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), DYSGEUSIA (Slight metallic taste) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced similar tingling feeling when she took Cipro several years ago.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received and contains patient demographic data, medical history, concomitant medication and Second dose vaccine details updated.
Patient developed a red, raised area-size of a quarter night of injection. Gradually became the size of a lg-grapefruit and was itchy, tingle, and painful. Ibuprofen 600mg x 8hrs. F/U on Monday 4/6/15.
As soon as I got the shot my left hand started to tingle and I was light headed. About 30 minutes later my throat started to it. 2 hours later my head started to hurt and my neck started to hurt.  Had trouble sleeping that night. The next day my throat hurt very bad 5 on the wong backer scale. All over body aches pain at about 5. My 3pm on april 15 I had 100.7 fever, body aches of about a 7. And developed a cold sore on my nose, Very tired: this lasted until April 16th had a phone call visit from the Covid clinic.  Throat hurt for 5 days, trouble sleeping continues cough started on day 4. Throat started to feel better. Thick mucus. I have not felt good since getting the vaccine.
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
I got the JNJ vaccine on Wed 4/7/21 (a wk before FDA paused that covid vaccine).  Initial response was Extreme Fatigue, but starting 11:45 pm on 4/18/21, I suffered headache, chest pain, short of breath. I could not sleep at all till 4/19/21 PM after asking my kids to pray for me. In case it's just heartburn, I took TUMS at 8:15 pm  on 4/19/21 . Headache, short of breath comes and goes, but the chest pain persists, and I develop a hot flash.  I never took birth control pills, but my OB/GYN prescribed daily Estrogen (to prevent osteoporosis) and every 3 month, Progesterone for 10 days (to prevent breast cancer). Estrogen & Progesterone happen to be the birth control pills' composition.  On 4/17/21, I finished my 10 days Progesterone regime. I discontinued the Estrogen supplement on 4/19/21 or 4/20/21, now (4/23/21 1:20 am) no more chest pain, but still feel fatigue, feverish with a hazy/foggy head (not really a headache).   I have a suggestion for JNJ, FDA, CDC on JNJ vaccine warning label.   If indeed those 6 women are all on birth control pills which are composed of synthetic estrogen and progesterone, then the warning label should also warn people who take these hormone supplements, instead of just an age range.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with GARDASIL 9dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses of GARDASIL that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
felt sick/feels horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 27Oct2023, outcome "unknown", described as "felt sick/feels horrible". Therapeutic measures were taken as a result of malaise.  Additional information: Patient was calling about the Pfizer COVID-19 shot that she just received this morning. Patient reported that as soon as she got home, she felt sick, and she wants to know what she could do about it. The patient also wanted to know how long the symptom may last. Additional Context: Had the Pfizer and was so upset. Clarified had the Pfizer Covid 19 shot this morning and as soon as came home she felt sick. Was 86 years old and stated should not give it to older people unless they know it was going to work. Got Pfizer because a couple of friends got sick from Moderna. Had Pfizer two years ago when first came out and did not get sick. Felt horrible. Took Tylenol. Was really scared. Asked if there is anything she can do and how long this last. She did not know what to do.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Post 10 minutes of 2nd Pfizer vaccine, patient developed a headache, seeing flashes light, & felt a lump in her throat. The symptoms lasted 15 minutes, & resolved on their own. A medical evaluation team was called and assessed the patient. Their recommendation was for extra observation time. Patient was observed for an extra 20 minutes and then left. Patient was given juice and crackers prior to leaving.
Low grade temp 99.9, pt c/o of soreness in right arm to elbow area with raised reddened area.  On 4-22-10 pt returned to practice & Dr. assessed pt. noted 5 cm reddened area and ordered Cephalexin 125/5ml - 1 QID for 10 days.  Mother noted improvement by April 28th. Pt denied any resp. s/s.
No adverse event. This was a vaccine error in which the VanishPoint needle was not retracted in the patient's arm and the patient did not receive the full dose of the vaccine.
Fainted for a few seconds within minutes of his vaccine administration. His sister had fainted after her vaccine just minutes before, which he also witnessed. Spontaneously recovered, no injuries sustained.
Day 11 post vaccine developed quarter size red rash. Continued to grow and become red, purple. Very sore. Second set of sores have occurred now 6 days after first rash appear.
2 hours after shot felt flushed, dizzy. Vomited by 3.5 hours later. Had ENT, neuro evaluation. Diagnosed as labyrinthritis associated with vaccine. Still with dizziness 6 weeks later. Administered 10/17/06. Per report from doctor: Patient received flu vaccine on 10/27/06 and suffered a vertigo type reaction within a few hours after the vaccine was administered. Dr. discussed with patient. Patient states she has taken the flu vaccine for many years with difficulty. She received shot at about 8am and by 10am felt flushed and dizzy. This worsened and by 11:30 am she was vomiting. She has been evaluated by her internist as well as ENT and neurologist. They feel the reaction is probably associated with the vaccine and have diagnoses labyrinthitis. She is improving but still has some dizziness. She has been treated with antibiotics and steroids.
After my vaccine my lips tingled. It was at the pharmacy. My lips went numb with pins and needles. When I got home, I got a fever and had a bad headache. I had a headaches on and off for a good month and felt very tired. Today I have no symptoms.
Patient hospitalized with covid-19 late November of 2020. Then received 2 doses of Pfizer vaccine on 1/13 and 2/2 of 2021. He has myelodysplasia and is receiving Vidaza. He was admitted on 3/19/21 with PNA symptoms. last cycle of Vidaza was 2/22/21-3/2/21. he tested positive for SARS-CoV-2 RNA x2 on admission. Uncertain if delayed shedding or reinfection. CXR with LUL Pneumonia. WBC 0.5, ANC 0, Procalcitonin initially 1.14 peaked next day at 14.7. patient was initiated on dexamethasone, piperacillin-tazobactam, and doxycycline. clinically felt to be more of a bacterial process, but could not rule out COVID-19 re-infection.
Acute hypoxic respiratory insufficiency secondary to Covid pneumonia with concerns for possible superimposed bacterial pneumonia.  feeling increasingly sick, with fevers, nausea, chills, shortness of breath, loss of taste, and poor appetite.  Please take Augmentin 1 g twice daily for 1 day. Please continue taking dexamethasone 6 mg once daily for the next 5 days. Please start taking Lipitor 40 mg once daily.
Student felt dizzy, nauseas and complained of stomach pain.  After 15 minutes of observation, water, and cold pack to forehead, student felt better.  Instructed to parent if symptoms return or worsen to seek medical attention.
Administered an expired vaccines; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccines) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   On 07-Apr-2022, HCP thaws out the vial and the patient received 2nd booster.  The vial did not undergo any temperature excursions.  The treatment information was not reported.   This case was linked to MOD-2022-539487, MOD-2022-539488 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
This spontaneous report as received from a nurse practitioner refers to a 43 year old female patient with hypothyroidism, polycystic ovary syndrome and no allergies or drug reactions. The patient may have had previous vaccinations with M-M-R II, however this is unknown. On 19-NOV-2012, the patient had M-M-R II titers drawn and the mumps titer was low. Subsequently, the patient was vaccinated with lot # (669943/0187AA), M-M-R II) on 20-NOV-2012 (subcutaneous administration). No other co-suspects were reported. Concomitant medications included: SYNTHROID. The M-M-R II titers were then repeated on 27-DEC-2012. The mumps titers were better on 27-DEC-2012, however, now the measles titers were low after being normal in the titers drawn on 19-NOV-2012. No treatment information was reported. It was reported that the patient situation was unchanged. She sought medical attention because of the event. The relatedness for M-M-R II. Additional information has been requested.
Arm was pretty sore; Entire head (gum and face) completely numb; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was pretty sore), HYPOAESTHESIA (Entire head (gum and face) completely numb) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was pretty sore), HYPOAESTHESIA (Entire head (gum and face) completely numb) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event NOS, at an unspecified dose and frequency. On 13-Mar-2021, HYPOAESTHESIA (Entire head (gum and face) completely numb) and HEADACHE (Headache) had resolved. On 16-Mar-2021, PAIN IN EXTREMITY (Arm was pretty sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: 107 (High) 107.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Fine rash of palms of both hands, both arms, slight rash on torso, bright red rash on both lets.  Did not take any medications to help.  Denies itching, shortness of breath  no vomiting or vomiting, no vomiting or other symptoms.
Upper left arm (injection site) very sore; headache; 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 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 24Oct2023 at 16:15 as dose 1, single (Lot number: HG4664) at the age of 48 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 24Oct2023 at 20:00, outcome "not recovered", described as "Upper left arm (injection site) very sore"; HEADACHE (non-serious) with onset 24Oct2023 at 20:00, outcome "not recovered". Therapeutic measures were not taken as a result of injection site pain, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Near Syncope- new onset Atrial Fibrillation; ED visit resulting in hospitalization.
Tingling in lower extremities (mostly below knee) bilaterally within first 5 minutes or so.  Followed by tingling tip of tongue and portion of lower lip tingling.  Itchy/tingly sensation back of throat on right with very slight hoarseness and slight chest tightness.  Also noted some ectopy on my Kardia monitor--looked like PACs, but lots of interference in the reading. Symptoms not severe enough to use albuterol inhaler.  By two hours, they had completely abated.  Primary care doctor notified on 3/24/21 for counseling as to future immunization plan.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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 Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient woke up with pain radiating up and down arm, especially near the elbow. Patient took 800 mg of Ibuprofen at that time. Patient was able to go back to sleep after awhile. She thought it would just go away eventually. But it has not. She comes into our office today complaining of radiating pain in L arm still since that morning.
Pain in upper right thigh, pain and numbness  in right arm, headache, fatigue, nausea, chills, fever.  Pain in thigh occurred about 20 minutes after injection and has not subsided. All other symptoms began about 2 hours after injection and gradually got worse throughout the day.  So Fran was initially taken for nausea. Tylenol was taken for the pain. It did not eliminate all pain but made it much more tolerable and helped with nausea.
About two and half hours after receiving the shot, patient got itchy on his chest. By three hours after the shot, he noticed a rash on his upper chest. By three and a half hours after the shot, I (his mom) saw him and looked at his chest: it had chicken-pox like rash with additional bumps around the sides of his abdomen and a few bumps on his mid and upper back. Also, there were some bumps on his thighs. He saw the doctor the following day to determine if he had a rash-reaction, chicken pox, or something else. The doctor said her findings were inconclusive. She said it could be a reaction, it could be chicken pox (which she had only seen two cases so she was not sure if it would present this way), or it could be atopic dermatitis (we had used another detergent two weeks prior... with no skin reactions). The chicken pox like rash continued to spread down his abdomen and back, and up the back of his neck towards behind the ears. He has also had one or two clear pox (scabs) on his leg bumps.
Chills, fever, body aches, fatigue, headache.  treated with Tylenol and Motrin
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she had the shingles after the Shingle shot. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Patient received 0.25ml instead of full 0.5ml for his first dose. mistake was immediately noticed and rectified. We immediately gave an additional 0.25ml, as per protocol.
Unsure if any relation to vaccine, but in case. . . Since the night of 10/23/06, the day she got Flumist, she has had sparse episodes of heart-racing associated with clammy skin and shortness of breath.  We are now working her up for SVT.  No such problems before then.
I am having and sever tinnitus since 20th December 2021, and multiple episodes of vertigo. I went to see Dr. on 21st December 2021 I went to see Dr. on 01/11/2022
No additional adverse event; fue patient was inadvertently administered a dose of V ARIV AX fuat had been improperly stored; This spontaneous report was received from a practice manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 10-MAR-2020, the patient was vaccinated with a dose of improperly stored dose varicella virus vaccine live (oka/merck)(VARIVAX) ) injection, lot # S021322, expiration date 09-JUL-2021 (route of administration was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No additional adverse event was reported.  On an unknown date, the temperature excursion was (-8.3) degrees Celsius, for a time frame of 24 minutes. There was not reported if previous temperature excursion occurred. The digital data logger was involved.
Have had acid reflux for a long time, it has gotten worse so I got an EGD, at this time gastritis and esophagitis was discovered (I have had previous EGDs that were clear), based on my follow up questionnaire for the vaccine I was encouraged to report, probably NOT vaccine related but still an event I suppose