chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a lawyer and described the occurrence of neurological damage in a male subject who was vaccinated with Hep B vaccine (Engerix B) and or unidentified Hep B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which were attributed to cumulative mercury toxicity. The following information was received via medical records: the subject received Hep B vaccination on 5/30/1995, 6/29/1995 and 7/23/1995. All vaccinations were identified in the vaccine record as manufactured by the manufacturer, however, the 7/23/1996 Hep B reflected a different manufacturer lot number and was therefore identified as Engerix B. At approx one year of age, the subject was crawling, and taking a few steps, and was speaking some identifiable words. Between birth and approx four years of age, the subject experienced recurrent fevers and chronic coughing. In Dec 1994, at 30 months of age and prior to Engerix B vaccination, the subject underwent speech and language testing and was determined to have expressive and receptive language skills at the 18 to 23 month level. A progress note dated 10/12/1998 noted that over past 3 to 4 months at night screams with severe leg pain. Between 12/98 and 1/99 the subject continued to experience fevers and coughing, and in Sept 1999 was diagnosed with probable asthma. He underwent re evaluation between 2/10/99 and 5/11/99. Evaluation revealed that the subject was communication at a higher lever overall, and was noted to maintain eye contact and to show improved memory. Between 9/99 and 12/99, the subject continued to exhibit marked phonological awareness skills. Between 6/00 and 7/00 the subject continued to show improvement without meeting all language objectives. During this third grade year, he experienced academic difficulties that were not considered to be fully explained by his handicapping condition speech and language impaired. The subject exhibited clumsiness and poor coordination, difficulty shifting subjects or trying new things, and a mildly abnormal response to pain. An evaluation performed an on unk date did not indicate that the subject was truly autistic, however he was diagnosed with pervasive developmental disorder. On 8/3/00 the subject was enrolled in a speech program through school. He was described at the time as an average student. The subject was re evaluated In Sept 2001 by a psychologist following a recommendation that the subject be provided special education services under the categorical disability of autism. Findings were consistent with previous recommendations including continued speech therapy, with the subject exhibiting overall variability in performance, without consistency with a particular intellectual or cognitive disorder. Signs of possible neurological involvement included slow processing speed, occasional staring into space and motor clumsiness. The subject manifested some features of autism without meeting all criteria for the disorder.
Menstrual period was due by 8/17/21, and as of 9/02/21 it has still not occurred.  No history of irregular periods, not on any hormonal contraceptives, not pregnant or at risk of becoming pregnant. Currently taking 50mg once per day of Spiro for acne since February 2021, and no other medications.
Redness, warmth, and slight swelling at the injection site in the left arm.  Appeared about a week after the injection and is still there after 5 days.
Flu-like symtoms; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness). On 01-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness) had resolved. Not Provided          Concomitant medication use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-093357 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up document received on 4-AUG-2021 contains Non-Significant information.
Vaccine administered Feb. 9, 11. Reaction Feb.22-27. Quarter sized raised welt at injection site.
This spontaneous report was received from a pharmacist concerning a 62 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with two doses of VARIVAX as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported).  On an unknown date, the patient tested negative for varicella titers (Varicella virus test negative). The outcome of varicella virus test negative was unknown. A product quality complaint was not involved. The causality between varicella virus test negative and VARIVAX was not provided. Additional information has been requested.
The patient stated  that he developed a cough that started the day after the vaccine.  He states he has coughing fits that seem to last for a minute or two then go away for a couple of hours before returning.  He describes the cough as dry.   He states that the frequency of the fits have decreased but have not disappeared completely.
The day after the vaccination I listless and had no appetite. I was very worn out. I felt like that for three days. Everything smelled bad and I didn't feel like eating anything. My sense of taste was still present. No energy or motivation for two weeks. I tested negative for both Influenza A and B and Covid-19 test was positive. I have gotten the second dose of the vaccine and I was very tired but only for 24 hours. I got the injection in the right arm.
This 15 year old received a second booster of the Pfizer Covid vaccine. He received it 5 months after his first booster and does not have an underlying immune compromising conditions.  Received Second booster outside of CDC recommendations He had no residual affects and did not have any reactions
Pt was administered the Pfizer Bivalent 12+ dose to a 6 year old.  This patient never completed the original series.  This patient receive only 1 of the original Pfizer vaccines received 11/15/2021  At this time pt has not experienced any adverse side effects
Pt recvd vax & exp flu sx, moderate to severe lethargy & malaise, body aches & severe joint pain;
Noticed skin around belly was red and itchy. Then gradually the skin on the back was itchy. Rash between thighs developed a day later, following with inner areas of both arms a day later. Same itchy red rashes developed on both feet another day later. Burned like being bitten by ants. Took OTC Benadryl the first four days before seeking a MD who prescribed prednisone. Directions to take 2 10mg tablets every day, quantity 10 tablets. Also I took one OTC Zyrtec a day.
Information has been received from a pharmacy intern referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 08-JUL-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K009876 with expiration date 19-MAR-2016; dose and route unknown). Concomitant therapy was not provided. No adverse effects reported. Additional information has been requested.
pt recvd vax; swollen, erythematous & tender discharge from inj site (R thigh) eventually dx as sterile abscess;
This case was reported by a consumer and described the occurrence of autism in a 30 month old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The reporter is the mother of the patient. A physician or other health care professional has not verified this report. On unspecified dates, the patient received administrations of Engerix B (lot ENG5216A and lot ENG5300A2) and Infanrix (lot DTPA543A2 and lot DTPA553A2). The dose numbers for these vaccinations were not provided. At an unspecified period of time following the administrations of Engerix B and Infanrix, on 11/21/04, the patient experienced autism. The event was ongoing at the time of initial reporting. Comment: Autism was assessed as medically serious (OMIC).
Patient was administered flu vaccine subdermally as it was mistaken for the tuberculin test. The patient experienced edema and mild redness where injection site occured.
This initial spontaneous case received from other non-health professional on 13-Oct-2017, concerning a 25-year-old female pregnant patient. The patient had not significant medical history and concomitant medications were not reported. The subject's last menstrual period date was not reported. The gestation age of the patient was 16 weeks and there was no evidence of defect of adverse findings from prenatal test. No spontaneous abortion/still birth was reported and had no family history or congenital anomaly, as it was the first pregnancy of the patient. It was reported that, the patient did not use any contraceptives. No medications were taken by the patient prior or during the pregnancy. On 13-Oct-2017, at 16 weeks of the gestation age (second trimester) the subject was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number and expiry date: not reported). It was reported that, the patient did not experience any adverse event after receiving the vaccine. The outcome of the event was not reported. It was reported that, the patient was interested to get enrolled in the pregnancy registry. She gave explicit permission for an agent to contact her via phone  or email to enroll in the study and for additional information regarding the registry. The estimated date of delivery was on 30-Mar-2018. It was reported that, there were no adverse reactions experienced by fetus. The reporter assessed this case as non-serious.
1400 patient appeared to have generalized hives. More predominant to face and neck. Reported feeling itchiness to body. VS: B/P 140/82, temp 98.2, respiration easy non labored. Patient reports she suffers from unknown allergies and has a history of recurrent hives. Usually takes CLARITIN to manage it. Rash/hives spread to her abdomen and back. At 1410 BENADRYL 50 mg IM given to Left deltoid. At 1430 Redness subsided. Released with supervision of a friend. B/P 120/72. Alert and awake. Instructed to follow up with physician if allergy was to flare up with any respiratory issues to call 911. Follow up next day, patient reported to work.
high fever 104 R w/irritability 4 hrs p/vax;cooling measures given, DPH given, children Motrin given;temp cam down in 2hrs;pt was alert & playful @ discharge
Fever greater than 104° for 24 hours. Syncope for 24 hours following that.
a super painful headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Single), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "a super painful headache".  Additional information: Patient took the 2nd dose yesterday (04May2021) and can't remember the exact date of the 1st dose, he just said 3 weeks ago and was experiencing a super painful headache. He was asking if he can take some Advil.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain / at the injection site; swelling at the injection site; felt tired, fatigue; fever; stomachache; receiving / first dose / on 05Jan2021/ is under 50 years of age; medical order to receive it even though is under 50 years of age; This case was reported by a physician and described the occurrence of injection site pain in a 41-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included crohn's disease.   On 5th January 2021, the patient received the 1st dose of Shingrix. On 5th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, fatigue, fever, stomach pain, inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue, fever and stomach pain were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, fatigue, fever and stomach pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported for himself. The patient received dose of shingrix in the left deltoid. After vaccination, the patient experienced pain and swelling at the injection site, felt tired, fatigue, had a fever, stomachache and had not recovered till the time of reporting. The patient had medical order to receive Shingrix even though he was under 50 years of age, which led to and inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
Pt reports pain around injection site, slight swelling in left arm within a few hours after injection. Later that day, pt reports slight fever/chills. Side effects subsided within 24 hours. Pt did not use any fever reducing products.
body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This is the first case out of two cases.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Lot number: EN6207, Expiration Date: 03Jul2021) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL HCL; HYDROCHLOROTHIAZIDE. The following information was reported: PAIN (non-serious) with onset 17Mar2021, outcome "unknown", described as "body ache".  No follow-up attempts are possible. No further information is expected.
she found out she has covid about 2 hours ago; she found out she has covid about 2 hours ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation (consumer provided lot number "ER8734" and expiration date "Jul2021", unspecified to which dose). Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications for for high blood pressure. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "she found out she has covid about 2 hours ago". The patient stated she had both doses of the Pfizer covid 19 vaccine on 5Apr2021 and 27Apr2021. She found out she has covid about 2 hours ago before the report (28Dec2021).  The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. When probed regarding the name of test, the patient stated, "I don't know my doctor did it. I had the blood test."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Doni had a Headache and Stomach Ache the following day after the Shot. He felt Sick all day,  stayed in Bed all day. Gave him Tylenol at 8:00 am   and  again at 2:00  pm. He felt better the later that night.
Right away after receiving the vaccination patient felt dizzy, overheated and light headed. Patient sat down, had some water, and received ice packs placed on the neck. After about 10 minutes patient felt okay, he then sat in an airway with a breeze and felt back to normal after another 10 minutes. Called patient to check in about 3 hours after event with no response.
This spontaneous report was received from a physician via field representative refers to a 24 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 09-JUL-2018, the patient was vaccinated with first dose of GARDASIL 9, intramuscularly for prophylaxis (lot#, expiry date and dosage details were not reported). On the same day, the patient experienced symptoms of "feeling like a limp noodle, mental fogginess, chronic headache, muscle fatigue". The patient's mother called physician. The outcome of the event "feeling like a limp noodle" was unknown and the outcome of other events was reported as not recovered. The reporter did not provide any causality assessment.
03/22 at nighttime, I began feeling achey and my temperature was unstable. I couldn't sleep throughout the night from discomfort. My left arm was in a lot of pain, my neck, lower back, legs - all aching and hurt to move. This lasted until 3/23 around 6:00pm.
Achy arms, neck and legs. All are symptoms of my fibromyalgia, but it increased them quickly and drastically starting about one hour after injection. To treat just resting and drinking more water
Dose from a vial that had been in the refrigerator for more than 2 weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dose from a vial that had been in the refrigerator for more than 2 weeks) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Dose from a vial that had been in the refrigerator for more than 2 weeks). On 23-Apr-2021, PRODUCT STORAGE ERROR (Dose from a vial that had been in the refrigerator for more than 2 weeks) had resolved.        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.   Concomitant medication list was not provided. Treatment information was not provided
Patient parents reported their daughter "froze 2 times like a seizure happened" a few days after the second Pfizer dose had been given. Patient also reported dizziness, arm soreness, and many severe headaches. patient mom said her daughter has recovered, however she continues to have some headaches.
Red swelling and itchy arm reported. Gave BENADRYL went to ER was given KEFLEX 500.
Medication Error: 2nd Moderna vaccine given 2 weeks early.  Patient given first dose at health clinic and registered for 2nd dose at  Health Clinic  not realizing they were different.  was holding a Moderna first dose clinic and patient able to register through PrepMod.  COVID vaccine card with 1st dose info was seen by Physician Assistant observing for reactions when error was realized.  Patient states she had a harsh reaction- headache, fever, chills, bone and muscle aches, fatigue for litter over 24 hours.
Immunization was given after BUD of 12-8-22. Moderna manufacturer was notified and case #  was assigned. The Lot of AS7166B was tested and found per Moderna the vaccine DID have the necessary activity to protect against the SARS-CoV-2 virus at the time of administration. Patient and patient's PCP notified.
Patient received influenza vaccine at work (employee at hospital) in the morning of 10/1/07.  Later that evening, around bedtime, patient developed nausea and vomiting.  Patient states she is "only 55% better" by 10/4/07.
HPV#3 given on 7/23/08 in office. Pt reports vaccine site red, swollen and itchy. Started evening of 7/23/08. treatment was ice and BENADRYL as needed. Patient recovered.
Severe Fatigue, Pain in my muscles and Uncontrollable Muscle Cramps that would Not go away or even relax until I went to the er at on 7/16/21
7/27, 10 pm- dizziness, lethargy, mind "floating", all over body aches, headache, fever, and chills. Lasted until 7/29 in AM. Pain at injection sire still present. 7/28- developed several bumps on face, especially on jaws on both sides.  This continues but is lessening.
Nightmare; Crazy thoughts; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Nightmare) and THINKING ABNORMAL (Crazy thoughts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHTMARE (Nightmare) and THINKING ABNORMAL (Crazy thoughts). At the time of the report, NIGHTMARE (Nightmare) and THINKING ABNORMAL (Crazy thoughts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash/hives on chest, shoulders and down both arms, better after Benadryl
I had slight bleeding for 4 days  from my vagina after my 1st vaccine dose on 12th march 2021 and heavy bleeding and stomach cramps after my 2nx dose. I am also have palpitations which come.and go
On 10/18/2009, noticed that muscle hurt when raising right arm; glands in right side of neck slightly swollen. On 10/19/2009 @appx. 1:30 PM, arm at vaccine site began to itch. Upon touching arm, noticed whelps/hives - very red. Used Benadryl cream; called doctor. Nurse called back, said to take liquid Benadryl - 25 to 50 mg every 6 hrs. If began to have difficult breathing, should go to e/r. Hives went away after several hrs; arm became very red - increasing in size (from shoulder to elbow inside arm; about 1/2 way around arm). This lasted until afternoon of 10/22/2009. Also had low-grade fever during that time.
Woke in early AM with headache, sensation of tachycardia diffuse aching, fever to 101.
I had chills fever and achiness. Nausea about a week after I had a red spot appear in my eye. My arm was sore.
Pt. given immunizations 3/02/04 on left shoulder, pt. presented to clinic 03/04/04 with a 4cm red, hot, tip (at near on left shoulder) site of injection.