chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a dose of shingrix on 12/23, also received a dose in 11/1; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 23rd December 2021, the patient received the 2nd dose of Shingrix. On 23rd December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not have consent to share any patient details. The reporter consented to follow up.
Pt was given a flu shot on Monday. On Thursday, pt experienced muscle weakness on one side, slurred speech, confusion, trouble swallowing. He was sent to Emergency Room. Brain scan revealed it was not a stroke. MRI - possible ADEM Brain demyelination. Given IV treatments/saline solution.  6/26/09 Hospital records and DC summary received DOS 11/07/08 to 11/10/08. Assessment: Left hemiparesis, schizophrenia, dyslipidemia, Charcot-Marie-Tooth. Presented with acute onset left hemiparesis. Paresthesias left hand. Speech dysarthric.   9/23/09 Medical records received: ICD9 codes: 272.4, 356.1, 785.0, 295.9, 342.9, 323.9, v158.1, E939.3
*Patient experienced substantial aches, nausea, fever (greater than 102), headache, cough x 3 days thus far
felt numbness to tongue with slight pressure to throat without difficulty breathing or SOB; also felt "buzzed" within a few minutes (20 minutes) of receiving flu vaccine; however, did not return to clinic until a little over an hour later
Patient should have received the bivalent vaccine but instead she received the non-bivalent covid 19 pfizer vaccine.
Information has been received from a registered nurse through the pregnancy registry for GARDASIL concerning a 20 year old female patient with zithromycin allergy who on 29-NOV-2006 was vaccinated with the first dose of GARDASIL 0.5 mL IM and on 30-JAN-2007 with the second dose of GARDASIL 0.5 mL IM. Concomitant therapy included NUVARING. The patient became pregnant during the GARDASIL series. Approximately around December 2007, the patient delivered a male child early at 35-36 weeks gestation with a congenital anomaly that was diagnosed with cardiomyopathy (also reported as cardiac defect). The patient received all her prenatal care with an OB-GYN physician. It was unknown if the patient received the third dose of GARDASIL. The patient sought medical attention at office visit. Cardiomyopathy (cardiac defect) was considered a congenital anomaly by the nurse. Additional information has been requested.
Lethargy, aches, nausea/dry heaves, inappetance, pain at injection site
Within 24 hours of receiving Pneumococcal shot pt developed red, warm, painful area from injection pt left deltoid to just above the elbow. No previous reaction to Pneumonia shot. Treated with Prednisone for 3 days. Rest and sling to affected arm.
Achy, couldn?t sleep, upset stomach, pain in sternum,  for about 36hours; cough for a week
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 19-FEB-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot #: L013429, expiration date on 21-JUL-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The Licensed Practical Nurse reported that the doses of GARDASIL 9 lot #: L013429 with expiration date on 21-JUL-2017, underwent a temperature of -5 degrees C during 2.5 hours. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
redness/at the injection site; swelling at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received shingrix vaccination and complained of redness and swelling at the injection site. The reporter was not able to collect any more information. The reporter did not consented to follow-up.
TIA stroke on 25th of February 2023 at Apx 10:30pm, next morning headache & neck stiffness on 26th of February 2023. Shortness of breath & chest compression on February 27th 2023.
Sore arm, itching, swelling & bruise at injection site.  Headache
One of my partners was the same way, tested positive after getting the vaccine; One of my partners was the same way, tested positive after getting the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patient. This is the second of 2 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer biontech Covid-19 Vaccine, solution for injection, lot number and expiation date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive after getting the vaccine. The outcome of the event was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (SARS CoV2 test positive) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2020510419 same reporter/ drug/similar events, different patient
red, warm arm with a induration of 2x3.5 inches; neck pain; red, warm arm with a induration of 2x3.5 inches; Patient woke in the night two nights ago with feeling as if she is being bitten; pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times; headache; red, warm arm with a induration of 2x3.5 inches; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a female patient who experienced red, warm arm with induration of 2x3.5 inches (erythema, skin warm and vaccination site induration), neck pain, woke in the night two nights ago with feeling as if she is being bitten (sleep disorder), pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times (paraesthesia) and headache, while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a 1 mL dose of suspect RABIES (HDC) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious red, warm arm with induration of 2x3.5 inches (erythema, skin warm and vaccination site induration), neck pain, woke in the night two nights ago with feeling as if she is being bitten (sleep disorder), severe pin prickling sensations that feels like she is being bitten  also a rippling feeling down her left calf that happened a couple of times (paraesthesia) and headache, (unknown latency) following the vaccination.  The reporter asked if it is something that she needs to go to urgent care about. Also asked are the pin prickling sensations she experiencing severe such that she need to see care and is it serious.  It was also reported that she is glad for the need for only 4 shots due to her symptoms of side effects.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was not recovered from the reported events.  There will be no information on the batch number for this case.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 09-MAR-2016, the patient was vaccinated with a dose of MMR II, lot # L024266, expiry date 01-JUL-2017 (dose, route of administration and anatomical location were not specified). The administered dose of MMR II underwent excursion at 11 Celsius degrees for 15.5 hours. No previous temperature excursions were reported. No adverse events were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
1 of 4 pts who recv vax from the same vial (immunized between 8JUL-13JUL) who exp a fever; None of the children had sz; This pt exp a low-grade fever;
Within five hours, my head was pouring with mucus and I began to cough. I had no pain at the injection site on my arm. I wanted to sleep, and was exhausted. The symptoms increased over the next seven days. Finally, on Thursday, April 15, I began to feel better. The clear mucus which ran so heavily from my nose began to dissipate. My cough is getting better. The hardest thing was pervasive exhaustion for eight days. I didn't run a fever, but noted I was sweating way more than normal.
bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022,  after starting mRNA-1273 (Spikevax), the patient experienced CONTUSION (bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller). At the time of the report, CONTUSION (bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller) outcome was unknown.            No concomitant medications were reported.  The patient did not experience any side effects or adverse events from the first dose. One bruise was the size of a coin on her left arm several days after receiving her second dose of the Moderna Covid-19 vaccine.   No treatment medications were reported.   Reporter did not allow further contact
Numbness and pain left upper arm, pain radiates to left lower arm. Unable to lift arm over head, unable to open jars. No redness or swelling. Treatment includes Ibuprofen for 1 week. If no improvement, will obtain an ultrasound or MRI.
Sore; Difficulty moving arm/difficulty lifting his arm up and down; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reportered by patient's wife. The patient received Shingrix in his left arm. Within 1.5 hours of receiving the Shingrix, the patient's arm became sore and he had difficulty lifting his arm up and down. These symptoms resolved 3 days later. The reporter would not provide any additional details.
Pt c/o rash and hive during office visit. Per NP, pt had no SOB, respiratory distress, chest pain of fever. Pt. received no treatment since syptoms were improving. Also, pt declined antihistamine at the time.
Lt deltoid region red; swollen to the touch. Very warm measured 5 x 6. Pain throughout left arm and shoulder area.
Case number PHEH2012US003974 is an initial spontaneous report received from a nurse on 14 Feb 2012. This case refers to a 72-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1100501) intramuscularly at a dose of 0.5ml on 28 Oct 2011. On 30 Oct 2011 he began to develop open sores all over his body. The outcome was reported as ongoing at the time of this report.
face is warm/ hot to touch / feft arm was hot to touch; still see the mark where the needle went in; red / redness is 3-4 inches wide/ redness is 2 inches down from where the shot was given; I am freezing; pain under my arm/ pain in left arm; left arm swollen / whole upper arm is swollen; hard to sleep; not good; everyday chills; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (left arm swollen / whole upper arm is swollen), NASOPHARYNGITIS (I am freezing), SLEEP DISORDER (hard to sleep), FEELING HOT (face is warm/ hot to touch / feft arm was hot to touch) and VACCINATION SITE DISCOLOURATION (still see the mark where the needle went in) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included INTERFERON BETA-1A (AVONEX) for Multiple sclerosis.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen / whole upper arm is swollen), SLEEP DISORDER (hard to sleep), MALAISE (not good) and CHILLS (everyday chills). On 12-May-2021, the patient experienced NASOPHARYNGITIS (I am freezing), FEELING HOT (face is warm/ hot to touch / feft arm was hot to touch), VACCINATION SITE DISCOLOURATION (still see the mark where the needle went in), ERYTHEMA (red / redness is 3-4 inches wide/ redness is 2 inches down from where the shot was given) and MYALGIA (pain under my arm/ pain in left arm). The patient was treated with PARACETAMOL (TYLENOL) on 04-May-2021 at a dose of 500mg. At the time of the report, PERIPHERAL SWELLING (left arm swollen / whole upper arm is swollen), NASOPHARYNGITIS (I am freezing), SLEEP DISORDER (hard to sleep), FEELING HOT (face is warm/ hot to touch / feft arm was hot to touch), VACCINATION SITE DISCOLOURATION (still see the mark where the needle went in), ERYTHEMA (red / redness is 3-4 inches wide/ redness is 2 inches down from where the shot was given), MALAISE (not good), CHILLS (everyday chills) and MYALGIA (pain under my arm/ pain in left arm) had not resolved.
first shot in 2020, Covid hit. Never got the second; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in December 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not applicable for this report. The patient had received a shot of Shingles vaccine and due to Covid hit, the patient never got 2nd shot, which led to social problem. The reporter stated that (Centers for disease control and prevention) CDC said that get 2nd shot and did not need 3rd shot.
patient saw black stars in his eyes and fainted. Fainted for about 5 seconds and came back very pale white. Has history of vasovagal reactions post injections. After laying down on flat surface for about 20 minutes with water and chocolate bar he started feeling better and his face got more color.
patient stated that his arm turned yellow; patient thinks he has not been getting the vaccine in the right place and thinks he has gotten it too low; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves male patient of an unknown age who experienced arm turned yellow (yellow skin), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Fluzone High Dose. The patient's medical history, medical treatment(s) and family history were not provided.  On 04-SEP-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious his arm turned yellow (yellow skin) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also the case of actual medication error due to vaccine administered at inappropriate site. The patient thinks he has not been getting the vaccine in the right place and thinks he has gotten it too low.  (Other relevant tests included no lab data.)  Final diagnosis was his arm turned yellow after the vaccine.   It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for arm turned yellow after the vaccine.  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.  Information on the batch number was requested.  Documents held by sender: none.
This spontaneous report was received from the registered nurse refers to a 8 week 5 days old male patient. The patient's concurrent conditions were not reported. The patient's historical condition included breech in third trimester. The patient's drug reactions and allergies were not reported. The patient's concomitant medications included hepatitis b virus vaccine, pneumococcal conj vaccine and PENTACEL. On 03-APR-2018, the patient was vaccinated with ROTATEQ (dose, units and frequency not reported) (lot # N032566 and expiration date: 01-MAY-2019) orally. It was reported that, on 03-APR-2018 (also reported as 04-JUL-2018) ROTATEQ was stored at a temperature that was greater than 8 degree Celsius (C) (product storage error). The administered vaccine with the lot# N032566 was stored outside of required temperature range on 26-MAR-2018, and kept in required temperatures until 27-MAR-2018. It was mentioned that the physician and manufacturer notified based on the data received from the global medical, it was determined that the stability and potency of the ROTATEQ could not be supported. A letter was sent to patient's parents to let them know about the situation and appointment has been made to revaccinate the patient at free of charge. This is one of the reports received from the same reporter.
Disruption in menstrual cycle.   Multiple periods in one month.  Extremely heavy menstruation with cramping.  All out of character of usual cycle.
Swelling in the injection site; Redness in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number X4TJ3, expiry date 12th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (For tolerance of 1st dose refer case US2020012202.).   On 18th January 2020, the patient received the 2nd dose of Shingrix. On 19th January 2020, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient recevied vaccine and on next day had redness and swelling in the injection site of approximately 3 to 4 inches. The reporter consented to follow up. For tolerance of 1st dose refer case US2020012202.