chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second shot . Two weeks later / shingles / Still breaking out with a spot here and there; Little bumps; Little bumps itching like crazy; Prescribed / valacyclovir. Still breaking out with a spot here and there; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and Valacyclovir at an unknown dose and frequency. On an unknown date, 2 weeks after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced shingles, swelling, pruritus and lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the swelling, pruritus and lack of drug effect were unknown.   It was unknown if the reporter considered the shingles, swelling, pruritus and lack of drug effect to be related to Shingrix and Valacyclovir.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix vaccine and experienced 2 weeks later shingles, little bumps and itching. The patient thought the shot was going to prevent out breaks of shingles. The doctor prescribed the valacyclovir for shingles but Still breaking out with a spot which led to lack of drug effect. The reporter consent to follow up was Unknown.
This spontaneous report as received from a registered nurse, concerning a 15 year old female patient with type 1 diabetes mellitus. On 01-JUN-2017 the patient was vaccinated with the first dose of GARDASIL 9 lot # M016193 for prophylaxis and on 02-AUG-2017, the patient received the second dose of GARDASIL 9 lot # N003703. Concomitant therapies included insulin and levothyroxine sodium(manufacturer unknown).  Approximately in June 2017 (reported as couple days later), the patient experienced nausea, abdominal pain and diarrhoea. On 03-AUG-2017 (reported as following day), the patient experienced nausea, abdominal pain and diarrhoea. The outcome of nausea, abdominal pain and diarrhoea was reported as recovered/resolved. The outcome of nausea, abdominal pain and diarrhoea was reported as not recovered/not resolved.
Stiff neck and occipital headache that has never gone away.  The severity waxes and wanes, but the headache remains constant every day.
11 year old patient was given DAPTACEL instead of ADACEL,with no AE; 11 year old patient was given DAPTACEL,with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00416895) and transmitted to Sanofi on 05-Jan-2021.   This case involves a 11 years old male patient who received a standard 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. (lot number C5624AA, expiry date: 10-Jun-2021) once via intramuscular route in unknown administration site for prophylactic vaccination (Product administered to patient of inappropriate age) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Wrong product administered) on 30-Dec-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HPV VACCINE (HPV VACCINE) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  This was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).   Case detail: The reporter stated that a 11-year old male accidently received Daptacel and not the ordered Adacel. The reporter stated that the prescriber ordered the Adacel but the Medical Assistant in the office administered Daptacel and wanted to know if the patient was going to be ok.  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 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.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 3:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 3:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.41.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. Vaccine BUD date was 10-Mar-2021. The vial were only punctured right before administration and the dose was drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Subsequent to receiving varicella virus vaccine live the pt developed a welt about 3/4 inches in diameter just above the injection site. Pt was treated with ice and the swelling decreased. The physician had a concern about the particular lot of vaccine.
Patient presented with acute rhabdomyolysis. Had received influenza vaccine 1 day earlier. Patient had worked out, but not unusually, however he admitted to lifting at the gym. Also, patient had taken anabolic steroids for some time (months). The acute relation of the flu vaccine, however, raises possible questions.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical, history, concomitant medications, drug reactions or allergies was provided. On 11-OCT-2016, the patient was vaccinated with an expired dose of PROQUAD injection, 0.5 ml, expiration date 01-OCT-2016 (route of administration and lot # were not reported). No adverse effects reported. Additional information has been requested.
Patient given Janssen COVID-19 vaccine and told to wait in front of pharmacy in the designated chairs so we could watch for allergic reactions. About 10 minutes later, patient came up to the consultation window asking what type of symptoms we look for allergic reaction. I asked her if she had a rash, throat swelling or a hard time breathing. She said her throat was swelling. She couldn't swallow much. I grabbed the emergency toolbox and got the adult EpiPen ready. Gave her the injection through her scrubs at 9:45 am on the right thigh. The other pharmacist called 911. Emergency services showed up and got their reports. The patient left in the ambulance for follow-up monitoring.
Woke with extreme stomach pain and vomiting. Shivering and fever. Had to go to the ER
adult patient received a pediatric dose of Engerix B; adult patient received a pediatric dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 35-year-old male patient who received HBV (Engerix B pediatric) (batch number X9FT7, expiry date 31-MAR-2024) for prophylaxis.   On 06-OCT-2023, the patient received Engerix B pediatric. On 06-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received a pediatric dose of Engerix B) and adult use of a child product (Verbatim: adult patient received a pediatric dose of Engerix B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2023 The pharmacist reported that an adult patient received a pediatric dose of Engerix B which led to underdose and adult use of a child product. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
axillary adenopathy several days after vaccination, resolved; received JEV #2 on 4/18; that afternoon, developed malaise, severe headaches and sweats; on 4/19 developed diffuse myalgias, and then chest pain, headaches, sweats; chest pain worse lying down than upright; took acetaminophen; on 4/21 prescribed toradol; admitted 4/22 with myocarditis after recurrent episodes of positional chest pain, abnormal ECG and elevated troponins obtained in ED. The follow up received on 4/25/03 states per telephone f/u reporter stated pt also received smallpox vaccine on 4/11/03. Currently he is fine clinically and may be discharged from hospital today (4/25/03) after on MRI is completed.
burning sensation; swelling; rash on the arm; hot to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 18th January 2023).   On 09-MAY-2023, the patient received the 2nd dose of Shingrix. On 10-MAY-2023, 1 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation), swollen arm (Verbatim: swelling), rash (Verbatim: rash on the arm) and skin warm (Verbatim: hot to touch). The patient was treated with ibuprofen. The outcome of the burning sensation, swollen arm, rash and skin warm were not resolved.   It was unknown if the reporter considered the burning sensation, swollen arm, rash and skin warm to be related to Shingrix.     It was unknown if the company considered the burning sensation, swollen arm, rash and skin warm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023068695   Additional Information: GSK Receipt Date: 12-MAY-2023 The consumer stated that she received her second dose of Shingrix and the following day she experienced rash on the arm with a burning sensation that was hot to touch with swelling.  The patient took Ibuprofen to treat these symptoms. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023068695:Same reporter
Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw area; Mouth pulls weird; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Felt loopy; Some weird palsy going on in his face/mild palsy in the left side of the face/Felt like face was heavy on left side or drooping/left side of his face was sagging; This is a spontaneous report from a contactable consumer reporting for himself. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on 23Mar2021 14:40 at single dose for COVID-19 immunization. Medical history included he had some previous nerve damage in his neck that had not been acting up in about a year. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (Lot Number: EL9269) on 02Mar2021 for COVID-19 immunization. On 24Mar2021, patient had some facial numbness and mild palsy in the left side of the face. He stated he had some previous nerve damage in his neck that had not been acting up in about a year, but it was acting up then. He stated it was the feeling like when you go to sleep on something, and it felt heavier. He asked what he should do, if he should seek medical attention and for information on this. After providing information from the Prescribing information, he asked if the Bell's Palsy went away in these individuals in the clinical trials? He stated his wife just said that the left side of his face was sagging. He stated he did not think it was a stroke though because he could move that side of his face and can articulate everything. He felt loopy but did not feel like it was a stroke. Patient reported that basically he felt numbness on the side of his face and cheek. There were reactions when he smiled, it seemed a little bit off. There was a weird feeling and numbness in his face. The numbness went from his cheek up on to the temple area and jaw area, the numbness was primarily on the left side of his face. Patient had nerve damage in his neck already. Patient wanted to know if he should go somewhere with it, was it ok, what was going on with the numbness in his face. Patient thought the numbness in his face and cheek had worsened. Felt like face was heavy on that side or drooping:  Caller reported that looking in mirror, the left side of his face did not react the same. Patient's face felt like it was heavy or drooping on the left side, but that it pulls up higher. Patient reported that his face looked ok. Mouth pulls weird: Patient reported that this could be from his prior nerve damage, it was like he had got some weird palsy going on in his face. Patient stated that he just wanted someone to tell him dude wait it out, go to the emergency room, go to the doctor. Patient inquired if the facial numbness was because he had prior nerve condition and if the Covid-19 vaccine had exacerbated his existing nerve condition. The outcome of the events were unknown.
41 hours after the second dose, I have a hot, itchy rash all over my torso.
Pt recv vax on 2/16/99; on 2/27/99 pt exp chills, fever, malaise x 2 days; tx=fluids & rest
Information has been received from a registered nurse concerning a 12 year old male who on 15-JUL-2008 was advertently vaccinated with a dose of ZOSTAVAX (Oka/Merck) (LOT# 657675/0618U) instead of VARIVAX (Oka/Merck). No adverse effects were reported. This was a human error. The responsible vaccination nurse was new. Both ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck) vaccines were stored in the same freezer next to each other and the nurse picked the wrong vial. The registered nurse did not have any suggestions. The patient's outcome was unknown. The patient did not seek medical attention. The registered nurse also reported the same events for patient's sibling (refer to WAE# 0807USA05537). Additional information is not expected.
No adverse event; inadvertently administered an expired dose of a monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 071B22A and 071B22A) for COVID-19 prophylaxis.     Patient has no allergy, concomitant diseases and risk factors.    On 01-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 29-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported. No adverse event was reported by the patient after the administration.  No treatment drug details was reported.
Information has been received from a 42 year old female with drug highly allergic to BIAXIN and also to Quinolones, who on Tuesday, 16-NOV-2010 at 3 pm was vaccinated IM on left arm with a 0.5 ml dose of PNEUMOVAX 23 (lot number not provided) to prevent pneumonia. Concomitant therapy included cefdinir. On 16-NOV-2010 the patient experienced some pain throughout the day. The patient stated that she developed a fever that rose to 102 degrees, and she could not get the fever down below 100.6 degrees, even though she took ibuprofen and acetaminophen. The patient also experienced "nausea" and her arm felt like it was on fire. The patient felt "immobilized" by her symptoms. No lab diagnostic studies performed. The patient sought unspecified medical attention. At the time of report, the patient's present status was not recovered. Additional information has been requested.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient plans to repeat dose on 4/22/2021.
On June 18th in the evening I began to feel like I was getting a cold. The next morning I knew I was sick because I had a fever and felt like I had a bad cold. The next day I still had a fever but my cold symptoms were improving. I took a home COVID-19 test on Monday the 20th and it was positive. Nasal congestion, cough, fever was 101.5, and I felt like I had been knocked down. These symptoms began to get better on the 20th but my fever did not break until June 21st.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02959200) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 17-Jun-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: positive (Positive) positive.     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.   Patient had two pregnancies which were live and full term birth.   Concomitant product was not provided.  The patient did not have any complications or acute illnesses during this pregnancy till date.  Treatment medication was not reported.
Medical assistant administered high dose flu vaccine to pediatric patient by mistake. Patient has not adverse reaction. Provider was made aware and parent notified.
Patient reported redness to site 24 hours after administration. Also reported she felt feverish. Reported redness spread. Presented to clinic 72 hours after receiving vaccine for complaint of increased redness to arm surrounding injection site. Treated for cellulitis.
approx 2 days p/vax pt devel fever of 105 the next day fever was 107; pt had stiff neck; seen in ER adm to hosp but released p/tests & IV fluids; fever resolved next day;
Subsequent to third dose of oral typhoid pt broke out in large hives over most of the body. Pt was seen by a physician and treated with prednisone.
Day after 2nd shot in right arm I had pain in both arms, both legs, and back muscles.   my elbows and fingers hurt too..Really bad headache.    in afternoon i took a 325 mg Tylenol and my headache and fell asleep..  When I woke an hour later, my headache was a little better, but still ached in muscles.    the second day after shot my muscle pains were minimum,
sore eye rids and underneath the eyes; sore forehead; Fever; Wrist band; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (sore eye rids and underneath the eyes), PYREXIA (Fever), ARTHRALGIA (Wrist band) and HEADACHE (sore forehead) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced PYREXIA (Fever) and ARTHRALGIA (Wrist band). On 14-Feb-2021, the patient experienced EYE PAIN (sore eye rids and underneath the eyes) and HEADACHE (sore forehead). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE PAIN (sore eye rids and underneath the eyes), PYREXIA (Fever), ARTHRALGIA (Wrist band) and HEADACHE (sore forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
BP-200/120 BP-190/200 (ASYMPTOMATIC) P-80 BASLINE: LIGHTHEADEDNESS. RECENTLY RESTARTED ON HTN MEDS BY PCP. VERBAL ORDER: INCREASE AMLODIPINE TO 10 MG + LINOPRIL TO 40 MG. FLU (SDA) SXHEDULED WITH PROVIDER FPR 3/22
A red rash appeared 9 days after the shot and is still there.  It is somewhat itchy.
Muscle tightness to bilat shoulders and neck. Tension headache. Rash across shoulders and chest.
HTN experienced.  First noted on 12/27/2020 and confirmed on 12/30/2020.