chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient with no spleen; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 70-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jan2017 as dose number unknown, single (Batch/Lot number: unknown); pneumococcal vaccine polysacch 23v (PNEUMOVAX), in 2017 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPLEEN DISORDER (non-serious), outcome "unknown", described as "patient with no spleen".  Additional Context: This case has been considered invalid-other as info not qualifying for AE reporting-medical information initially. Caller had a question about Prevnar 20.  She has patient with no spleen that had Pneumovax and Prevnar 13 in 2017 and she wanted to know if she gives the Prevnar 20 vaccine is that good for the rest of patients life?  She said she does not have the patient's information and the patient called her with the question.  Caller declined to complete report.  Full details unable to be obtained.  Follow up (02May2022):The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (02May2022), this case now contains all required information to be considered valid. This is a spontaneous follow-up report from a contactable Pharmacist. This Pharmacist reported for a patient that: Updated information included: Patient age and gender.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was fine after 1st Pfizer shot on 3-11-21. I have had nothing but problems since 2nd Pfizer shot on 4-1-21. I started with severe vertigo and left ear pressure on 4-3-21. I have never had this problem in my life. I was okay by 4-5-21, and I though everything was fine. On 4-15-21, the severe ear pressure in my left ear returned along with the severe vertigo. I have now had 24-7 vertigo daily since 4-15-21. I went to my family doctor, on 4-16-21. I was given meclazine which has done absolutely nothing. I feel absolutely awful, and it is at its worse after 6 pm. I can not live like this. Daily activities are an absolute chore now.
Severe flu like symptoms, including low grade fever lasting 3 days. Severe headache, dizzy, weak, unable to eat for 36 hours.
her son's arm is really sore after his vaccinations were administered; This spontaneous report was received from the patient's mother and refers to a 13-year-old male patient. There was no information regarding his medical history, concurrent conditions and concomitant medications provided.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On an unspecified date, after the vaccination, the patient's arm became sore. At the time of the report, the patient had not recovered from the event.  The causality between the event and the suspect vaccine was not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009815:
Information has been received from a literature article concerning a 21 year old female patient developed uveitis following administration of GARDASIL. The patient had as a pre-existing conditions Crohn's flare and arthralgia. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 0 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
very agitated, constant unconsolable crying x 24; fever 104 w/in 24hrs; took to MD 2 1/2hrs p/inj given; APAP given q 4hrs-MD office gave Motrin-seemed to help
Information has been received from a public health registered nurse concerning a 19 year old female pt with an obstetrical history that included one previous pregnancy and no live births due to a miscarriage that occurred 11 1/2 weeks from the last menstrual period and with no birth defects noted in the previous pregnancy. On 3/20/03 the pt as vaccinated with a second dose of MMR II (640237/1479L). The pt had received the first dose of MMRII on 11/15/95. The pt was instructed about pregnancy before being vaccinated and reported that she was on birth control pills. The nurse reported that the pt's husband called the health dept on 4/16/03 and reported that they found out that the pt was pregnant. Her last menstrual period was 2/20/03. It was reported that the pt received the vaccine 4 weeks after her last menstrual period. Unspecified medical attention was sought. The pt's pregnancy was confirmed by a positive pregnancy test, which was done on an unspecified date. The estimated date of delivery was reported to be 11/27/03. It was reported that the pt was taking prenatal vitamins-iron. Follow up info received reported that nineteen weeks from her last menstrual period the pt underwent lab evaluation which revealed that on 6/6/03 "Triple Mark-normal." Lab evaluation also revealed "PN lab-normal," "Diabetes-normal" and protein in urine toward end of pregnancy. An ultrasound done on 8/18/03 revealed oligohydramnios. It was reported that thirty four weeks after the last menstrual period the pt experienced "Group Beta Strep" which was treated with antibiotics before delivery. On 11/20/03 the pt had a "C-section due to failure to progress." She gave birth 38 weeks from her last menstrual period to a male infant whose birth weight was 7 lbs 3 oz. The infant was normal and it was reported that the infant had no congenital anomalies and he did not have any complications. Upon internal review C-section due to failure to progress was considered an other important medical event (OMIC). No further info is available.
booster given less than 6 months; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months). On 06-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported. No Treatment informations were reported.
This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), DYSPNOEA (Difficulty during breathing), ASTHENIA (Extremely no energy, tired and weakness) and PAIN (Pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic migraine (Worse) since 08-Mar-2019 and Blood pressure high (worse) since 13-Dec-2018. Concomitant products included PARACETAMOL (TYLENOL) from 23-Mar-2021 to an unknown date for an unknown indication. On 23-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), DYSPNOEA (Difficulty during breathing), ASTHENIA (Extremely no energy, tired and weakness), PAIN (Pain), COUGH (Uncurable cough), FATIGUE (Extremely tired) and VOMITING (vomiting). 20-Apr-2021, the patient experienced FOAMING AT MOUTH (white glue like substance run out of my mouth) and SLEEP APNOEA SYNDROME (stop breeathing in sleep, disgusting sounds). At the time of the report, HAEMATEMESIS (blood in vomit, mucus), CHEST PAIN (chest pains), ASTHENIA (Extremely no energy, tired and weakness), PAIN (Pain), COUGH (Uncurable cough), FOAMING AT MOUTH (white glue like substance run out of my mouth), SLEEP APNOEA SYNDROME (stop breeathing in sleep, disgusting sounds), FATIGUE (Extremely tired) and VOMITING (vomiting) had not resolved and DYSPNOEA (Difficulty during breathing) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. This case was linked to MOD-2021-187349. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Reporter details, patient's medical history and additional events were added. On 13-Jun-2021: The follow up included no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
On 10/7/03 Pediarix and Prevnar administered on R thigh under aseptic sterile condition. Reportedly that night got swollen inflammed in few days went to cardiologist following him and admitted for evaluation and monitoring. Sonogram was done. No pus/ infection but inflammation (=). Pt had similar reaction on 7/11/03 on L thigh when Hib and Prevnar was administered-reported previously to VAERS.  Nurse follow up on 07/21/04 states: "cellulitis, hypersensitivity." Medical record states abcess. msv
myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-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, less than 2 years after receiving Shingrix, the patient experienced myalgia. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The shingrix batch number was unknown. The physician reported that, after vaccination with dose of Shingrix, the patient experienced myalgia, which was relieved by acetaminophen and resolved in approximately two days. The reporter consent to follow up. No further details were provided. For tolerance to 2nd dose, refer case US2019162043.
Bruising, redness, and warm skin at the injection site as well as mild pain/discomfort in the same shoulder
was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 17th January 2023, the patient received Havrix. On 17th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: Nurse reported a patient was administered an expired dose of havrix on 17th January 2023 and expired on 16th December 2022. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received dose of Havrix which was already expired on 16th December 2022.
A little injection site soreness; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The patient was reporter's friend.  A female patient in her 40's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 5 decade as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "A little injection site soreness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: Reporter's female friend, mid-40s told reporter, she had a little injection site soreness and fatigue following her 1st dose of Pfizer COVID vaccine. She also told me her husband (mid-30s) experienced pain at the time of the injection of his 1st dose of the Pfizer COVID vaccine. These were all reported to me 21Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per phone call with patient on 04/29/2021 at 10:38 am: At around 3:00 am on 03/19/2021, the morning after receiving his vaccine, patient states he began a 102 degree fever, chills, shivering, and nausea "worse than the nausea when I had COVID in November." patient adds that he was hospitalized for COVID-19 in November 2020. After six days of these post-vaccination symptoms he called his primary care provider, told patient that between his COVID infection and first dose of vaccine, his antibodies were extremely high and causing his symptoms to lag on. Doctor recommended holding off on getting the second dose of vaccine, and in about six months they would discuss administering the Janssen vaccine. Doctor did not ask that patient come in to be examined or tested, nor did he recommend any medications to include OTC. Patient's symptoms went on for seven days total, and he states that he has fully recovered.
He wasn?t feeling well after getting the vaccine. I asked him if he was able to breath then his grandmother told me that he has a type of disability that prevents him from expressing his feelings.  Then he was trembling and sweating and started to cry so I didn?t take any chance. I injected him with Epipen right away then I let my technician call the emergency who came in less than 5 minutes and took care of him.
received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 6th October 2022, the patient received Havrix. On 6th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-OCT-2022 Reporters comment:  The patient received the havrix vaccine which was expired on 18th June 2022. The reporter consent to follow-up. Additional Supportive information: The patient received Havrix, which was already expired in 18th June 2022, which led to expired vaccine used.
pt states he felt fine until about the 10th day 3/8/2021 he started getting flu like symptoms.  He has SOB, diarrhea, headache, sweats, muscle pain, cough, chills, and fever.  On 3/11/2021 pt is still having these symptoms but is feeling a little better.  Pt is taking Robitussin, Aleve, Vicks Av.
Headache, Arthralgia & Fever Narrative: fever, headache and joint pain morning after COVID shot #2.
Itching under arm and neck; Deathly sick; Felt like needles in her arm and legs; Dry throat; Thirsty; Memory became horrible/"can't think of words"; Lips peeling off; Leg shake; Asthma; Sinus problem; Difficult in walk; Left arm Pain; Headache; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat) and THIRST (Thirsty) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Thyroidectomy (14 years back). Concurrent medical conditions included Asthma (On and off) and Food allergy (Sugar). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CLORAZEPATE DIPOTASSIUM (TRANXENE) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), PAIN IN EXTREMITY (Left arm Pain), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and PARAESTHESIA (Felt like needles in her arm and legs) and PAIN IN EXTREMITY (Left arm Pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Normal. On an unknown date, X-ray: Normal.     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.   Treatment: Steroids
Periorbital, lip, facial edema, transient urticaria in child with chronic eczema. Medical records states nausea. msv
developed a very small cold sore on my lip/developed Another cold sore; This is a spontaneous report from a contactable 43-year-old female other health professional (patient). A 43-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an intramuscular route on 14Jan2021 at 16:30 (at the age of 43-years-old) as a single dose in the left arm for covid-19 immunisation. The patient's medical history included asthma and of HSV-1 (extremely rare-once every 2-3 years). The patient had allergies to eggs, different varieties of fish. The patient concomitant medications included levocetirizine dihydrochloride (XYZAL), Ibuprofen, Tramadol. On 21Jan2021 (6 days after vaccination), the patient developed a very small cold sore on her lip that did went away quickly and was completely healed within 3-4 days. After 4 days that she developed another cold sore, this time larger that she still currently had and patient due for the 2nd vaccine the next day. Patient concerned as this was not normal for her and wanted to know the vaccine lowered immunity where it would cause this kind of response and would the 2nd vaccine make this worse. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The events were assessed as non-serious. The patient was not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Hives all over body from head to feet- noticeably appeared 9 days after Moderna booster shot. Currently on 2nd day of prednisone oral 20mg 2 times a day for 5 days and levocetirizine 5mg every night.  Symptoms are still present but not as itchy.
Approximately 6 hours after taking the shot, I suffered severe lower back pain and inflammation that was notable for being very localized between the lower lumber and the sacrum, felt hot to the touch and a sense of lower pressure back pressure. This appeared to occur suddenly, while seated on a couch. I have no previous issue with lower back pain, as I regard myself as fit and healthy.   The pain made it extremely difficult for me from sit up, stand, and walk. I chose to "slide" to best move with some relief. I went immediately to take Extra Strength Tylenol tablets (325mg) at 8pm. And within 20'mins the severe pain subsided. However, the pain remained mild and I was able to walk. At 12 midnight, the severe pain again returned, which similar symptoms with standing and walking. I again took Tylenol tabs and the pain subsided within 20 minutes. At this time I went to sleep for the day, but noted discomfort, while turning.   The following day (04-June-2021) I felt fatigue and noted that I had a slight fever (99.8-100.2'F), which lasted for most of the day and evening. I continued to take Tylenol tabs (325mg) every 4 hrs, to modulate the pain, which I sensed would return.  By 05-June, I felt 98% better, but the lower back pain was still present, mild. The pain has since left after the 4th day  post-vaccination.