chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse via company representative refers to a 25 year old female patient who was a smoker. On 14-OCT-2014, the patient was vaccinated with the first dose of GARDASIL, (lot# reported as K001632, expiration date June 2016), 1 single shot, intramuscular injection. Concomitant therapies included TRI-SPRINTEC and WELLBUTRIN (dosages/frequencies/manufacturers unknown). On 14-OCT-2014, hours after the patient received her first dose of GARDASIL, she called the office stated that she felt dizzy and high as if she had taken pain medication and it was recommended the patient go to the emergency room. The patient sought medical attention by call the office, but it was not confirm if the patient went to the emergency room. The outcome of the events was unknown. Additional information has been requested.
pt recvd vax; had episode of cyanosis;gasping for breath;PC to paramedics;to er;had 2 more episode of cyanosis while chest X-ray & blood was being drawn;may have had emesis blocking air passage;may be held breath & turned cyanosis;
2 months old patient was administered with pentacel not immediately after mixing but it was kept in the refrigerator, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 2 months old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiration date not reported) not immediately after mixing but it was kept in the refrigerator, via unknown route in unknown administration site as prophylactic vaccination on 22-Sep-2020 (PT: poor quality product administered). It was his first immunization.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to deteriorated drug administered (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information on the batch number for this case.
30 min after admin. pt was taking her doll and hitting head against the wall. Never done before, usually gets upset if she drops her doll. Grumpy part of the day post immunization. H/A started and lasted through next day. Mom tx w/ orals. Back of neck sensitive, esp (R) side. Woke up q 30-60 min. Slept on mom's chest but still waking up. Didn't want to use her leg, wouldn't bend x 2 days. Knot in muscle where injection given. Temp 101.9 degrees. Mom requested events be reported.
Right after getting a Flu immunization patient was feeling faint and fell to the floor. Patient did not injure her head. Immediately her feet were elevated and clothes loosened. After a few minutes patient felt better. Liquids and food given to patient.
Pt fainted within 5min after the vaccination of hep A for several sec in the office. No vomiting noted.
Disseminated varicella zoster virus diagnosed in a 9-year old 2-dose varicella vaccine recipient. Painful rash in bilateral dermatomes. History of malignancy and chemotherapy treatment. Treated with IV acyclovir. No complications.
6 hours post vax, the pt noted the injection site becoming swollen and warm to touch. Three days after the shot, the swelling became worse covering 15 cm in diameter over the left arm and torso with tenderness and warmth to touch. Pt sought medical help and was treated with Motrin.
Woke up with rash on left arm, looked like ringworm but after biopsy, it was psoriasis... I don?t know if it was an affect of vaccine but i bever had it befirecalso my friend broke out all over his back, had biopsy, determined to be Dermatitis  after he received 1st shot of Merderma...
A nurse gave one mililiter instead of 0.5 mililiter; Case reference number US-BN-2022-004893, is a spontaneous case report initially received on 15-Dec-2022 from a health care professional via Communication (reference number: USBAV22-2136) and concerns female patient born 29-Apr-2003.  The patient's relevant medical history and concomitant medications were not reported.  On 13-Dec-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00014) administered subcutaneously, at unknown anatomical location, at dose reported as 1ml (2 vials) (explicitly coded as 'Overdose'), for monkeypox prophylaxis.   Additional information received from Bavarian Nordic on 15-Dec-2022 included local BN case ID.; Reporter's Comments: A female patient born in 2003, was vaccinated with first dose of Jynneos vaccine, administered subcutaneously, at unknown anatomical location, at dose reported as 1ml (2 vials, which is considered as overdose), for monkeypox prophylaxis. Overdose is considered listed per company conventions. The patient's relevant medical history and concomitant medications were not reported. At this point, it is unknown if a patient experienced any adverse events with Jynneos vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient born in 2003, was vaccinated with first dose of Jynneos vaccine, administered subcutaneously, at unknown anatomical location, at dose reported as 1ml (2 vials, which is considered as overdose), for monkeypox prophylaxis. Overdose is considered listed per company conventions. The patient's relevant medical history and concomitant medications were not reported. At this point, it is unknown if a patient experienced any adverse events with Jynneos vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
High fever, severe headaches, sores and blisters around my mouth and lips, face swelling, discomfort on the left side of my face
Child became pale and listless ("not moving") around 19:30 and was taken to ER. He was given Tylenol "for low grade temp". Observed for a while and sent home. Mother reported reaction to pediatrician, the next day.
patient received ADACEL on 6/16/23 and then the same vaccines administered 6/27/23 with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA201354.  This case involves a 11 years old male patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] on 16-Jun-2023 and then the same vaccines were administered on 27-Jun-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Prophylactic vaccination.  On 27-Jun-2023, the patient received a dose of 0.5 ml (dose 1) once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: u7624aa; expiry date: 06-Feb-2024; strength: standard) via intramuscular route in the right arm for Immunisation.  On 27-Jun-2023 the patient received adacel however the same vaccines were administered 16-Jun-2023 with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  It was reported, "Caller transferred from Medical assistant asking what further steps need to be taken after a patient received ADACEL AND MENQUADFI yesterday. The patient had received Menquadfi and another tdap vaccine 11 days prior at a different location. Caller states that they don't know if the patient received Adacel."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv vax on 10/21/98; on 10/22/98 pt exp red/swollen/warm/firm/sensitive/increased in size vax site
Information has been received from a certified medical assistant (C.M.A.), concerning a patient of unknown age and gender. On 14-JAN-2013, the patient was vaccinated with a dose of ROTATEQ (dose, route and frequency were not reported) (Lot #: 0529AA; expiration date: 13-DEC-2012), that had expired. There were no adverse symptoms reported. Additional information has been requested.
pt states that his tongue became tingly.  He developed headache and a sore left arm.  Both hands and arms became very sore that lasted for about a week.  He had extreme fatigue for 2 weeks.  On 4/2/2021  pt still has a dull headache that will not go way.
16 year old patient received two doses of Menactra within 5 months, no AE; Initial information received on 14-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received two dosing of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported) via unknown route in unknown administration site on 20-Aug-2019 and on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.   It was also a case of actual medication error due to extra dose administered. It was reported that at the time they did not know that the child previously had vaccine back on 8/20/2019. if the child will be okay after receiving 2 vaccines within 5 months. The child received their first Menactra vaccine on 4/2015.  At the time of reporting, no adverse event was 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 and Module VI of the 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.  Information on the batch number was requested.
Intensely itching rash on left buttock went to Ed on 4/9/11 and was given Rx for Valtrex (switched to Famvir)and nupercainal
I had a sore for about a day after receiving the vaccine. In 02/2023, I began not feeling well with a deep cough and just terrible in general. I tested negative for COVID-19. I went to my doctor and was diagnosed with bronchitis.  I was given a prescription for an antibiotic and a cough suppressant.
Plan: Patient has been reassured that the localized erythema is normal given that this is the site of her COVID-19 booster.  Patient has been counseled to keep the area clean and dry, avoid scratching or abrading the surface of the erythema, and to use over-the-counter Benadryl as needed for itching.  Patient has expressed understanding. Follow-up: No follow-up provider specified. Subjective: Patient ID:  is a 28 y.o. female who presents today with a chief complaint of: No chief complaint on file. 28-year-old female patient presents to express care with concerns about a possible reaction to COVID-19 booster which she received approximately 72 hours ago.  Last evening she noted an area on the right deltoid, site of the injection, felt warm.  She noted there was redness.  She drew a circle around it last night and then again this evening as the redness had spread outside of the first circle.  Patient
Information has been received from a physician concerning a 4 year old female patient who on 28-MAY-2003 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. The physician reported that on 22-MAY-2006 the patient experienced mild lesions. There was no other adverse reactions except the varicella lesions, a few lesions, with no fever and no pruritis. No lab or diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint reported. Additional information is not expected.
The patient is a 10yo M who inadvertently received his 3rd covid vaccine of the 12 and over dosing. No symptoms, physician aware, child had no adverse events or adverse symptoms during his 15 minutes wait after the vaccine
Narrative: 6/18/2022 - Pt's sibling called advice line with following complaint: Patient's sister called with concern of low grade temp today and temp of 101.2 this evening and she gave him Tylenol. She reports a rash to his right hip. Sister denies any cough in patient. Triage completed and advised to clinic within 12-24 hours. Sister encouraged EMS due to patient immobility from CVA last year. She states she will monitor the patient if the temperature goes back up she will call EMS. Patient is nonverbal and bed bound. Sister states he had 3-4 episodes of diarrhea today ,which she states is his baseline daily. 6/21/22 Nutrition note - Home visit with patient and sister. Patient was seen sitting up in hospital bed sleeping. Sister feels patient had a reaction to the PNA vaccine last week with fever and diarrhea. She spoke with NP during visit. His appetite was not affected and continues to take adequate fluids. Sister reports loose stools improved somewhat with Metamucil until possible reaction to PNA vaccine. 6/21/2022 Nurse Pract. Note: Sister reports that pt received pneumonia Vaccine last week. She states that on Friday she noted that pt started to have low grade fever. She reports on Saturday she noted that injection site was red, warm to the touch and there was a red rash that was spreading. Pt also began having fever of 101 and diarrhea. She reports she contact the advice line at that point (6/18/22). She did not take patient to ED. She gave him Tylenol and monitored rash. Pt still having some diarrhea but rash is starting to resolve. . Denies dyspnea or facial edema.
The effect happened at 7:00 pm in the evening I got headaches, chilled, I did not get enough sleep because of  coughing a lot and my left shoulder is painful and heavy  some ,skin itchy in my arms and face.
Persistant indurated 1cm papule with erythema, pruritus, mild hemorrhage, and lichenification still present 9 months later.
Patient was given a pneuomvax 23 with out an order and when it was not needed. Patient had previously received the prevnar 12 in 2019 and the pneumovax 23 in 2020. No harm was done to the patient.
Muscle aches, followed by swollen lymph nodes noted in armpit of arm injected with the vaccine. Noted 2 swollen lymph nodes. Low grade fever prior to going to bed. By the morning symptoms had resolved other than swollen lymph node which remained swollen over next few days.
25OCT in PM lt arm itchy, swollen, hot; 26OCT lt arm more swollen about size of 2 eggs, red, hot, hurts when touched;
shortly p/recvd DTP/OPV/HIB mom described the pt as being pale, listless & not self for about 6 hrs; no treatment required;
Soreness to injection site; Rash on either side of groin; A spontaneous report was received from a consumer concerning a 79Years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness to injection site and rash on either side of groin.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, 1 day prior to the onset of the event soreness to injection site the patient received their first of two planned doses of mRNA-1273 (011L20A) intramuscularly in the left deltoid shoulder muscle for prophylaxis of COVID-19 infection.  On the same day, on the day of vaccine administration, the patient experienced soreness at the injection site.  On an unknown date, the patient developed a rash on either side of groin.  Treatment for the event included 1 percent hydrocortisone to treat the event rash on either side of groin.  Action taken with mRNA-1273 in response to the event was not reported.  The event rash on either side of groin was recovering/resolving (rash was getting better).  The outcome of the event soreness to injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a patient who was vaccinated with a first and second oral dose of rotavirus vaccine on 24 Jul 2006 and 06 Nov 2006. No adverse events were involved. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
She has a knot on the arm at the injection site; Itches like when you get a cut and it starts to heal; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Aug-2021 and was forwarded to Moderna on 29-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (She has a knot on the arm at the injection site) and PRURITUS (Itches like when you get a cut and it starts to heal) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced VACCINATION SITE MASS (She has a knot on the arm at the injection site) and PRURITUS (Itches like when you get a cut and it starts to heal). At the time of the report, VACCINATION SITE MASS (She has a knot on the arm at the injection site) and PRURITUS (Itches like when you get a cut and it starts to heal) outcome was unknown.            No treatment medications were provided.   This case was linked to MOD-2021-300288 (Patient Link).
Dizziness, Myalgia & Fever Narrative:  Per nursing report:  "took 2nd dose of Moderna vaccine @3pm on yesterday, 1-25-21. States this morning c/o body aching, dizziness and fever."
Patient received the Pediatric/Child Dose (10mcg/0.5ml) in error for first 2 doses of the 3 dose series. Patient required adult doses. No adverse effects occurred from either incident. Following CDC Guidance to anyone under-dosed to restart the series for adult dose.
neck, shoulder, elbow, wrist,knee stuffiness and pain: numbness both hand and fingers, H/A
Sore Arms and legs; Fever Low grade; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arms and legs) and PYREXIA (Fever Low grade) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced MYALGIA (Sore Arms and legs) and PYREXIA (Fever Low grade). At the time of the report, MYALGIA (Sore Arms and legs) and PYREXIA (Fever Low grade) had not resolved.            No concomitant medications reported. No treatment information provided.
2:35 reported nausea -vomited undigested food.  b/p 98/60  2:40 oriented b/p90/60    2:52 SPO2 100% pulse 86  2:55 b/p 90/70 denies discomfort 3:00pm pulse 104 PSo2 100% Released.  Mother informed to seek medical attention for any further problems.  Call 911 for any breathing problems and notifiiy her MD of events.
"Allergy attack," Runny nose, Sore eyes, "Heated sinus."
INCORRECT VACCINE WAS GIVEN, NO TX NEEDED. MD SPOKE WITH PEDS ID AND CONFIRMED THAT THERE ARE NO SIGNIFICANT CLINICAL RISK TO THE CHILD AND THAT THE CHILD WOULD HAVE TO BE RE- VACCINATED ACCORDING TO THE CDC STANDARDS.
received 3 shingrix vaccinations; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2021) and Shingrix (2nd dose received in September 2021).   In November 2022, the patient received the 3rd dose of Shingrix. In November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional Information: GSK Receipt Date: 30-NOV-2022 and 01-DEC-2022 Reporter's Comments: The patient had reported the case for himself/herself. The patient received 3 Shingrix vaccinations. No further information provided. The reporter consented to follow up. Additional Supportive Information: The patient received the 3rd dose of Shingrix, which led to extra dose administered.
Left leg stiffness about 2 hours after injection that lasted 20 minutes. Several intermittent episodes over the past 12 days lasting just a few seconds of left leg stiffness and abnormal gait. No fall and always weight bearing. No muscle tenderness, erythema or knot. No joint swelling, redness, tenderness or calor.  Walks and runs well. No abnormal gait noted prior to vaccine. Both parents and grandmother have noticed the abnormal gait and leg stiffness.  No fever. No falls. No rash.
Massive amounts of clotted menstral blood every cycle since 2nd dose. I have never been pregnant nor had a miscarriage but I was convinced I had a miscarriage because I examined the clot that came out of me and I, likely incorrectly, was certain it was a fetus.  Did not think it was a side effect of the vaccine until a client mentioned his wife suffered menstral clotting since taking the vaccine. Never had clots and heavy bleading before. Also, after first dose I passed out in the waiting area, husband caught my head, says I woke up screaming and passed out again, woke up in wheelchair in back, they held me until my blood pressure raised to normal level. This may be unrelated though, not sure........................
Itchy on injection site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PRURITUS (Itchy on injection site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable Treatment medicines were not reported   Reporter did not allow further contact
Swelling, heat, redness, pain. Spoke with physician and started BENADRYL 50mg.