chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received both doses of Pfizer COVID-19 vaccine, on 1/9/2021 and 1/31/2021.  Pt had symptoms of COVID and was tested through employee health on 4/23/2021.  She came back positive.  No hospitalization.
pt recv vax 25NOV96  10AM & by 2PM pt had uncontrollable crying that mom could not get stopped-happened again 29NOV96 when pt became blue in the face & was taken to ER @ local hosp for eval;
This spontaneous prospective report was received from a consumer refers to a 30 year old female patient. No pertinent medical history was reported. On 06-APR-2015, the patient was vaccinated with VARIVAX inj (Merck) while she was pregnant. Pregnant gestation was reported as 2 and half weeks and LMP was approximately on an unknown date in March 2015. Trimester(s) of exposure was first trimester. Pregnancy outcome was outcome pending. Due date and date of conception were unknown. Lab tests include blood test for pregnancy and results were unknown. Patient sought medical attention. Treatment was not given to the patient. Action taken was not applicable and outcome of event was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Case number PHEH2012US013858 is an initial spontaneous report received from a nurse on 09 Jul 2012. This case refers to 11-year-old male patient. He was vaccinated with MenA lyophilized conjugate component of MENVEO (batch number: A11071) mixed with sterile water on 09 Jul 2012. He did not receive MENCYW-135 liquid conjugate vaccine component of MENVEO. No adverse event was reported following vaccination.
a 6 month old child just received the Dtap- IPV component of the Pentacel vaccine/will give the child the Acthib; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who received a 0.5ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] only with Dtap- IPV component without ACT-HIB part (lot UJ062AAA, Dtap-IPV vial lot- UJ108AA) expiration date: 24-Jul-2020 via intramuscular route in the left thigh on 30-Apr-2019.  The patient's past vaccination(s) included Pentacel on 28-FEB-2018 first dose. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included was PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was an actual medication error due to inappropriate reconstitution technique.   Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
The patient developed a sore about the size of a quarter around the injection site. This appeared about one week after receiving his second shingrix vaccine. Patient stats that his arm was really sore like someone had punched him.  After a few days the sore scabbed over. No other symptoms noted.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-APR-2007 it was reported that the patient developed a localized reaction that was bad enough to have the patient back to see the pediatrician. There was no additional information to report. Additional information has been requested.
Pt received high dose vaccination on 10/26/20. Woke up early this am (10/27) feeling poorly. Headache, nausea, body aches, low grade fever 99.7. tx Tylenol 500mg - 1000mg q 6H prn, push fluids call if not resolved. Check BP Discussed stroke/CVA + going to ER
I had the injection late morning. Beginning in the afternoon I became progressively more tired, with generalized muscle soreness into the evening. I went to bed very tired with muscle soreness and even a pressure deep in the mid-line of my head. I had a fretful nights sleep, but felt some better in the morning with some tiredness and muscle soreness remaining. I would add the I'm in good physical condition. I run 5 miles four days a week and lift wights for an hour or more three days a week.
Starting at 9am the next day, getting severe headaches/migraines. Took 500mg acetaminophen at 9:15 followedby 400mg ibuprofin at 10am and neither helped.  Still receiving headaches so terrible i cannot function at 5pm. I dont usually get headaches.
PATIENT HAD EXCESSIVE THIRST AND A SLIGHTLY SWOLLEN TONGUE AT THE SAME TIME AS ANOTHER NURSE. SHE DRANK COLD WATER AND SAT DOWN AND FELT A BIT BETTER. SOME TIME LATER (POSSIBLE 1HR?) SHE FELT HER TONGUE GO NUMB. SHE WAS STILL VERY THIRSTY AND COMPLAINED OF SHAKING AND FEELING LIKE SHE HAD PRESSURE/A WEIGHT ON HER CHEST. WHEN I ARRIVED TO CHECK HER OUT A FELLOW NURSE WAS CHECKING BP, PULSE OX, AND LUNG SOUNDS WHICH ALL CAME BACK NORMAL. NO REDNESS, RASH, OR HOTNESS TO INJECTION SITE. NO SWELLING AT INJECTION SITE. NO RASH ON THE CHEST. SHE WAS GIVEN 25MG OF BENADRYL AND WHEELED TO THE ER FOR FURTHER EVALUATION
This spontaneous report was received from a registered pharmacist refers to a 65 years old male patient. On 02-AUG-2012, the patient was vaccinated subcutaneously in his left with 0.65 ml of expired ZOSTAVAX (lot # 669263/1361Z, expiry 15-JAN-2012). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Bruising, swelling, redness, itching and warmth around injection site which worsened over time. Patient applied ice to the area. Patient was seen in our office on 09/17/2015 and treated for Cellulitis. She was placed on Cefadroxil for 10days.
Child with fever and generalized tonic-clonic seizure for less than 10 minutes.  10/9/07 Reviewed hospital medical records which reveal patient experienced fever & seizure including shaking lasting approx 10 min followed by period of unresponsiveness.  Seen in outlying ER, given antibiotics & antipyretic & transferred to higher level of care.  Admitted 9/12-9/13/2007.  Neuro consult done. FINAL DX: febrile seizire. 10/18/07 Received vax record but no lot #s provided.  Lot numbers & dose confirmed via phone as correct on report.
late for dose two of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination is not applicable for this report. Pharmacy intern reported a patient was late for dose 2nd of Shingrix and the patient was not received 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up. No further information was reported.
Headache, vertigo, nausea, poor concentration and balance x 5 day.
Patient's father falsified at pharmacy in order to obtain his vaccination early, giving the pharmacy a DOB of 8/9/2009 rather than his actual DOB of 11/9/2009.  This falsification was caught and notice was given to Pharmacy on 9/2/21.  Two phone calls to the father were attempted, but he hung up the phone once, and would not answer the second time so a voice mail was left to confirm that he has not had any adverse effects due to early vaccination.  Patient's PCP was notified of the vaccination and it was requested that her nurse attempted to contact Patient's father to confirm that patient has not experienced any adverse effects and to confirm that he will need to consult his PCP for further vaccinations of COVID 19 after 11/9/2021.
On Thursday 9/16 started experiencing left eye twitch, tremor, right and left arm numbness, lower leg and feet numbness, and feeling of numbness down neck wrapping into diaphragm area.
Jansen COVID-19 Vaccine EUA  Chills, headache, body aches, fever (101.3), trouble sleeping and pain at injection site.
That very same evening, I was extraordinarily weak and achy. I did go to bed early and woke a couple hours into sleeping and had a fever of 103. It was so bad, I got ice packs, drink water and took TYLENOL. I went to my chiropractor, because my lymph nodes were really swollen. I was sick with a serious fever. Under my arm it was so swollen I could barely put my arm down. I have been waiting to see if it will go away, but I still feel a debilitating fatigue and I feel my chest is heavy. It's aggravating my asthma. The lymph node is still swollen but it's not as huge as it was yesterday. The swelling has gone down today. This is the left arm.  The pain went through to my shoulder blade and all the way up my neck, shoulder blade and chest. It's all still really sore.
within 24 hours onset of vertigo, fever which resolved within two weeks but then became sick constantly with fatigue, nausea, body aches, insomnia. now diagnosed w/ hashimotos and in a hyperthyroid state. have an appt w/ endocrinology for further workup.
2 pts who recvd 3 doses of Engerix-B & did not respond; no tx given;
the needle was not properly sealed with the syringe and the vaccine leaked; no adverse event; patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked), UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine) and NO ADVERSE EVENT (no adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked) and NO ADVERSE EVENT (no adverse event). At the time of the report, DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked), UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked) and UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine).    It was unknown if patient was under any concomitant or regular medication.  On an unknown date in 2021, patient received first dose of COVID-19 Vaccine (unknown route, lot number unknown).   No treatment medication was provided.   Reporter did not allow further contact
/// Left upper arm from deltoid injection site ( redness with 30mm X 15mm ///).
Non stop crying for 4-5 hours then fussy all night long. No fever. Better the next day.
fever-hot/cold sweats-fine red rash (generalized UR discomforts;
swollen lymph node 3-7 days after injection; This is a spontaneous report from a contactable consumer. A 27-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left on an unspecified date (age at vaccination 27-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Feb2021, patient experienced swollen lymph node 3-7 days after injection. No treatment received for the AE. Patient has no Allergies to medications, food, or other products and patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Inject site red & swollen area 5" across - was iced over noc; Encouraged to use arm & APAP for pain;
Patient got rash over her body. has complained about burning sensation and itching.  Red spots over her boday including behind the neck and on back. The bandage plaster placed area was red to the marking of the bandage
Thursday night he was fussing and complained of ear pain. On Friday February 10, we took him to the doctor. They looked in his ears and diagnosed an ear infection. He is on antibiotics and is fine with no more symptoms.
C/O itchiness on nape of neck @ HS on 3/12/09. Dx with hives by MD on 3/13/09 Hives prominent on trunk, groin + axillary with intense itching.
severe weakness; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (severe weakness), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (severe weakness), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, ASTHENIA (severe weakness), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Information has been received from a consumer who is the mother of an 11 year old patient with no relevant medical history who in June 2003, was vaccinated SC with a first dose of hepatitis B virus vaccine. There was no concomitant medication. In June 2003, the day after vaccination, the patient developed a fever and the next 2 days was nauseous and had vomiting. Since that time, he had been having some flu-like symptoms, rash and nausea, without vomiting. He is losing 3-4 pounds a week. Each time he eats, he would feel like vomiting. It was noted that he has been sick since he received the vaccine and has missed many days of school because of the symptoms. Lab data included blood tests, stool tests, and other work up with negative results. The caller also noted that doctors cannot find what is wrong with him. Subsequently, the patient had not recovered and was still experiencing symptoms on and off. Unspecified medical attention was sought. There was no product quality complaint involved. Other company vaccines administered included OPV on 5/28/92, 7/30/92, 6/27/93 and 5/7/96; diphtheria, tetanus toxoids and pertussis on 5/28/92, 7/30/92, 10/1/92, 10/27/93 and 5/7/96; Haemophilus b Polysaccharide vaccine  on 3/23/98. Other not specified on 11/6/01. The fever, nausea, vomiting, flu-like symptoms and weight loss of 3-4 pounds a week were considered a significant disability. Additional information has been requested. Follow-up info on 9/26/03, from the physician indicated that the "adverse events" reported by the mother are not adverse events from the vaccines of MMR and hep B virus vaccine. The physician noted that the child had been diagnosed with a "psychiatric anxiety disorder" and he is on Zoloft for this. "He is now doing better." The physician also noted that "GI" had also seen the child for his issues of nausea, vomiting and weight loss which are not related to the vaccines. Additional info has been requested. Follow up on 10/28/2003: "Additional follow up information from the physician received on 10/15/2003 indicated "this was not an adverse Hep B reaction" and that the patient was on "psych" medication.  It was also noted that "this was an anxiety reaction" and the patient was "better".  No further information is expected."
Information has been received from a health professional concerning a 7 year old male who on 06/28/1996 was vaccinated with the first dose of Varivax, in the arm. Concomitant therapy, that day,  included  the fourth dose of Tripedia in the arm, and the third dose of Orimune. On 05/09/01, the pt was diagnosed w/chicken pox. The pt sought unspecified medical attention. Subsequently,the pt recovered. No additional information is available.
Mother states area of injection site red, swollen, itching she c/o of leg hurting. I have an allergy to eggs event happened 10/14/06 the day with receiving the shot.
HIVES on her belly; Arm is extremely itchy; Arm is red; big patch above site of injection which goes of in 2 to 3 days; Arm is painful; Arm is hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (HIVES on her belly), INJECTION SITE PRURITUS (Arm is extremely itchy), INJECTION SITE ERYTHEMA (Arm is red), RASH (big patch above site of injection which goes of in 2 to 3 days) and INJECTION SITE PAIN (Arm is painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (HIVES on her belly), INJECTION SITE PRURITUS (Arm is extremely itchy), INJECTION SITE ERYTHEMA (Arm is red), RASH (big patch above site of injection which goes of in 2 to 3 days), INJECTION SITE PAIN (Arm is painful) and INJECTION SITE DISCOMFORT (Arm is hard to touch). At the time of the report, URTICARIA (HIVES on her belly), INJECTION SITE PRURITUS (Arm is extremely itchy), INJECTION SITE ERYTHEMA (Arm is red), RASH (big patch above site of injection which goes of in 2 to 3 days), INJECTION SITE PAIN (Arm is painful) and INJECTION SITE DISCOMFORT (Arm is hard to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Had redness and swelling 2.5" diameter at area of shot. Was itchy and painful. MOTRIN/TYLENOL.
Felt slightly dizzy right after getting vaccine and felt an ?adrenalin rush? but these symptoms resolved after about 9 minutes.  Then was preparing to leave the observation area at about 1030 her ears started ringing.  Ringing is constant and prominent.  It so far is not getting any better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Apr2023 at 17:00 as dose 6 (booster), single (Lot number: GJ3268) at the age of 66 years, in right 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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 May2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid (lot number GG4082)  from 09May2023 to 14May2023.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was not reported). A couple of years ago on an unknown date the patient experienced shingles. The outcome of shingles was unknown. Additional information has been requested.
This initial information was received from a nurse concerning an approximately 34 years old female patient with diabetes, simvastatin (manufacturer unknown) allergy (CASE #1211USA007941), LIPITOR allergy, VYTORIN allergy (Case#1211USA008157) and latex allergy who on 01-NOV-2012, the patient was vaccinated intramuscularly in the right arm with a dose of 0.5 ml PNEUMOVAX23 lot # (H012650), exp date 27-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 01-NOV-2012 the patient developed redness and swelling at the injection site of the right arm 5 hours after administration of PNEUMOVAX23. The patient was evaluated at the emergency room on the same date and was treated with vancomycin IV and LOVENOX injection. On 02-NOV-2012, the patient was evaluated in the emergency room again and was diagnosed with a superficial thrombosis of the right cephalic vein. On the same date, the patient was admitted to the hospital and on 04-NOV-2012, the patient was discharged from the hospital. Details of hospitalization were not known at the time of report. The nurse stated that the thrombosis was attributed to a reaction to the IV administration of vancomycin. On an unspecified date, the patient recovered from the events. It was reported that the patient sought medical attention by going to hospital. This is one of several reports from the same source. Additional information has been requested.
Reports soreness/redness at shot site arm, wheezing, SOB began approx 3 hrs post IZ continuing throughout night-is recovering this am.
Information has been received from a physician and the office manager concerning an 18 week old male patient who on 27-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
I've had migraines before, but I had literally the worse headache of my life in January of 2022. My doctor didn't think much of it, but it recurred in February and lasted a few days and caused some vision issues. I went to a different doctor for a second opinion who found an aneurism which required surgery for repair.