chrisvoncsefalvay/vaers-outcomes huggingface dataset:
broken dosage of Prevnar 13  received / One syringe arrived broken; This is a spontaneous report received from contactable reporter (Other HCP and Consumer or other non HCP) from product quality group and medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2018, Expiration Date: 31Oct2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "broken dosage of Prevnar 13 received / One syringe arrived broken". Additional information: NDC: 0005-1971-01. Description of complaint: Received 1 box of 10 and 1 of the syringes arrived broken but the packaging was sealed and intact. Product strength and count size dispensed: 1 Prevnar 13 syringe. The sample of the product is available to be returned, already got notified of prepaid mailer. No patient involvement. She did not even finish opening the package. Prevnar 13V PFS Suspensions 0.5mlx10 Broken/Cracked/Leaking Prior To Use. Called reporter and requested photos, initial mailer sent. Reporter clarified that the syringe was broken upon opening it. For a broken syringe nozzle for Prevnar 13V PFS, this event assessment is reportable.  Follow-up attempts are completed. No further information is expected.
Recipient reports itching left arm  and rash on  left arm noted the day after receiving the vaccine. She added that the itching is gone and no new bumps have appeared.
Within first 30hrs of receiving vaccine:  chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees).  Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27)  Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced.    By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
This case involves an unknown age and unknown gender patient who had coughing, sneezing, runny nose and throat scratchy after receiving vaccines MODERNA COVID-19 VACCINE and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date in Oct-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Flu.  On an unknown date in Oct-2022, the patient received a  dose of suspect MODERNA COVID-19 VACCINE not produced (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2022, the patient developed a non-serious event of coughing (cough), sneezing, runny nose (rhinorrhoea) and throat scratchy (throat irritation) (latency: unknown) following the administration of INFLUENZA VACCINE and (latency: unknown) following the administration of MODERNA COVID-19 VACCINE..  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown
Began with shortness of breath, reserve inhaler taken. Generalized red rash and itching followed. Swelling of face and eyes. Coughing began.
received the 2nd dose with one month respect the 1st dose.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 Information: GSK receipt date: 04-Apr-2022 Reporter's comment: The patient received the 2nd dose of Shingrix with one month of different respect the 1st dose. The reporter did not provide Shingrix lot number or expiration date as it was not legible. The reporter consented to follow-up. Additional Supportive Information: the patient received 2nd dose earlier than recommended interval, which led to shortening of vaccination schedule
Patient reports passing out and being transported to the emergency room via ambulance after experiencing severe pain in the right arm. She had severe pain in the right arm, chills, sweating and nausea. Once EMS arrived patient was in and out of consciousness and unable to assist them in maneuvering herself. Once in the hospital patient had hypotension as well and was admitted for 24 hours following 6 hours in the emergency room.
Nervous, anxiety. Seen by on site EMS . Discharged home at 12:15 p.m.
Breakthrough case admission after 5 vaccines  Moderna 3/16/21 lot# 044A21A;  Moderna 4/13/21 Lot# 025B21A;  moderna 12/13/21 lot# 031H21A;  Moderna 7/13/22 lot# 058A22-2A; Moderna 11/7/22 lot# 062F22A
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. Concurrent conditions, medical history and concomitant medication were not reported. On 10-JUL-2017, the patient was vaccinated with an incomplete dose of GARDASIL 9 (Lot # reported as "M07770" expiration date 01-JUN-2019) (Dose, route and anatomical location were not provided) for prophylaxis. A dose was drawn up from a GARDASIL 9 vial, but needle was not attached to syringe tightly. Consequently, some of GARDASIL 9 leaked out and trickled down on patient's arm. The nurse was not sure how much of GARDASIL 9 dose the patient actually received. No adverse effects reported.
Info has been received from a health professional concerning a 23 year old white female who on 7/28/04 was vaccinated with a dose of MMRII. Subsequently, the pt became pregnant (LMP 5/22/04). The pt had no prior pregnancies. The pt took prenatal vitamins during her pregnancy. The pt had ultrasounds on 10/15/04 and on 12/16/04 (results not reported). The pt had an upper respiratory infection 19 weeks from LMP and on 2/11/05. At 19 weeks LMP the pt was given azithromycin (Zithromax), "Z-pack", butoconazole nitrate (Gynezol), terconarole (Terazol). The pt had a viral GI upset in 12/04. In 2/05, the pt had taken metoclopramide hydrochloride (Reglan) (10 mg), promethazine hydrochloride (Phenergan), and benzonatate (Tessalon). On 3/1/05 (40 weeks from LMP) the pt gave birth to a normal 6 lb 9 oz male. There were no complications and no congenital anomalies. No further info is available.
A report was received from a health care professional on 12/17/2003 concerning a 6 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.
2nd inject of Hep B vax given 23JUL92 AM that later afternoon felt fatigue, weakness in legs lasted almost a wk; gradually getting better didn't know if it was from vax or whether was coming down w/something & then recvd vax;
Based on mother's report, pt seemed uncomfortable from her vaccines in the late afternoon/early evening. Mother administered a dose of infant Tylenol. Shortly after the dose, pt developed facial flushing, eye lid swelling and labored breathing. Family activated 911 and pt was taken by ambulance to the Medical Center emergency department. Mother reports that she improved while en route to the ED. No intervention was required in the ED. She was discharged home that evening without specific treatments.
Rc'd shot 1/31/07, on morning of 2/2/07 pt noticed swollen lymph nodes in neck. No treatment received.
pain at the injection site; pain at the injection site and also the armpit near the injection site.; Caller received Prevnar 20 vaccine when he was 65 y/o then another dose when he turned 66 y/o, would like to know if getting a 2nd dose is correct.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (DOSE 1, SINGLE), when the patient was 65 years old, for immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site"; AXILLARY PAIN (non-serious), outcome "unknown", described as "pain at the injection site and also the armpit near the injection site."; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Caller received Prevnar 20 vaccine when he was 65 y/o then another dose when he turned 66 y/o, would like to know if getting a 2nd dose is correct.".  Additional information: The caller received Prevnar 20 vaccine when he was 65 y/o then another dose when he turned 66 y/o, would like to know if getting a 2nd dose is correct. Caller also mentioned having pain at the injection site and also the armpit near the injection site  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Fever; body aches; headache; facial pain; fatigue; throbbing & burning of injection site on upper left arm and up into side of neck; This is a spontaneous report from a contactable 67-year-old non-pregnant female reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 16Feb2021 at 12:00 as single dose in left arm for covid-19 immunization. The patient's medical history included breast cancer in 2018 and IBS (Irritable bowel syndrome). Known allergies included many antibiotics. The concomitant medications included colecalciferol (Vitamin D), cyanocobalamin (B12), calcium, amitriptyline and anastrozole (ANASTRAZOL RONTAG). On 17Feb2021 at 02:00, the patient experienced fever, body aches, headache mainly facial pain, fatigue, and throbbing & burning of injection site on upper left arm and up into side of neck. The patient did not take treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sharp pain in temples, shooting pains through my hips and knees. The sharp pains are not subsiding with any treatment.
Pt recvd vax 27JAN92 & had fever 104.9 & febrile seizure @ MD office; 31JAN seen in ER; had 2 seizures & hospitalized; motor exam revealed sl hypotonic pt w/delayed motor function & scoliosis;
Fever; Chills; Body aches; Fatigue; Sinus headache for about 24 hours; Very flu like; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: tw0151) via an unspecified route of administration in the right arm on 13Apr2021 at 11:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took Amoxicillin and experienced severe rash. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 21:00, the patient experienced fever, chills, body aches, fatigue, sinus headache for about 24 hours and very flu like. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, fatigue and very flu like was recovering; while that of sinus headache was recovered on 14Apr2021.  No follow-up attempts are needed. No further information is expected.
Sore arm, fatigue about 12 hours, then 4 days after the injection I woke up in the middle of the night itching intensely all over, especially my lower legs. I developed a very red rash, mostly on my lower legs up to the knees, some slight rash on forearms. I used topical benadryl and it went away, but came back later that day. That lasted 36 - 48 hours and was completely gone.
Patient was talking to RN, stated she "felt funny", lost consciousness, seemed to seize and lost respirations. Epi pen administered and she began breathing and regained consciousness. Went to emergency department for evaluation and released to home.
itch at injection site; Rash and itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itch at injection site) and VACCINATION SITE RASH (Rash and itch at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itch at injection site) and VACCINATION SITE RASH (Rash and itch at injection site). At the time of the report, VACCINATION SITE PRURITUS (itch at injection site) and VACCINATION SITE RASH (Rash and itch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Joint pain in shoulders, hips, lower back, muscle weakness, fatigue; also limitation on range of motion in legs and arms; tylenol then aleve then predisolone; still on perdisolone which has eliminated all symptoms except pain in shoulders in morning and after noon fatigue
This spontaneous report was received from a registered nurse refers to two patients of unknown age (gender unspecified). On 20-NOV-2012, the two patients were vaccinated with a dose of PROQUAD (merck), (lot number, expiration date and route not reported) which was improperly stored. No concomitant medications were reported. No symptoms were reported. Additional information is not expected.
Several vesicular lesions on extremities. Abdomen and back. Tx - calamine/benadryl
Pt has red bumps on chest, neck, back. No itchiness, no fever, no HA, no generalized itching no pain no swelling positive take to vaccine. Pt vaccinated 6 days ago for small pox. C/o red bumps, plus lymph node pain and swelling x 2 days.
p/vax mom breastfeeding on a schedule & child did not awaken to be fed around 5PM;attempted to stimulate & waken child x 45min;slow to come around & did not want to eat until 7PM;colicky next day;
On 9/10/2012, this 83 year old female (average build 130lb 64 inch) received her pneumococcal vaccine (Merck 0025AE) and Influenza Split virus (UH713AA) to her right arm. She remembers rubbing the site after and moving arm about. She is right handed. She stated her right arm remained sore all day and was unable to sleep on her right side due to deltoid/arm tenderness. On awakening 9/11/2012 she noticed her vaccine site/right deltoid was red, swollen and tender. She denied any fever, nausea, vomiting, headaches, myalgia/arthralgia (other than right arm), or restriction in ROM of right arm. She had no loss of sensation, numbness or tingling to right arm/hand/fingers. Her grip was normal. This discomfort persisted with increased redness extending down to right elbow as of 9/12/2012 which prompted her to seek medical care. Exam by her PCP and HC 9/12/2012 documented the following: Afebrile (98.2), Right arm with full ROM greater than then left arm (due to prior humeral fracture). She is able to grasp both hands and extend over head but not with arms at full extension, they're bent due to prior left arm injury. She can extend her right arm directly over her head w/o restriction. Right arm Hawkins and Apley scratch test negative, Yergason's test positive to right arm with pain in bicep but strength intact. Mild pain to palpation of anterior and posterior acromioclavicular joint. She has full sensation and ROM to right elbow, wrist and fingers. Sensation and ROM to left elbow, wrist and fingers = to right. Neurologic exam normal. Skin: Reddened skin to right lower upper arm was warm to touch. Arm circumference: right 28cm and left 25 cm. Bruising noted to right deltoid (yellow-brown skin discoloration at 5 cm circular pattern) with pale pink redness about injection sites and bright pink/red skin to lower 1/2 of her upper arm (redness stops at elbow) measured 12cm height by 18cm length encircling 2/3 of arm. No discoloration to posterior portion of lower upper arm. She has a small flat bright red macule to lateral arm in center of reddened skin that has been there for years without change. On 9/14/2012 she advised the swelling and redness to her right upper arm had resolved with 3-day course of steroid but the arm was still tender to deltoid region where bruising was noted on deltoid. She has full ROM and no paresthesia or weakness to the left hand. She advised she did not use any antibiotics. On 9/18/2012 she advised full resolution of the contusion and had no reflare of swelling or any discomfort to her right arm off steroids.
Information has been received from a registered nurse concerning herself a 73 year old female with no allergies, Zollinger-Ellison syndrome, osteoarthritis, gout, high blood pressure and a history of knee operation (date unspecified) who "sometime in the last month to 6 weeks" (in approximately July 2011), was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number were not reported). Concomitant therapy included hydrocodone, atenolol, allopurinol and COUMADIN. "About a week ago" (on approximately 02-SEP-2011), the patient developed blisters on the back side of her right arm above her elbow in a circular pattern. It itches, burns and she felt it all the time painful. On an unknown date, the nurse was taking CELEBREX a while back there and went into third stage kidney failure, the nurse stated that she had not been taking CELEBREX any more and was not taking it when she received ZOSTAVAX (Merck). The patient did not seek medical attention. The patient did not receive any treatment for the events. "A whole battery of every thing" laboratories were performed no results were provided. At the time of the report the patient had not recovered. Upon internal review, went into third stage kidney failure was determined to be an other important medical event. Additional information has been requested.
Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  The nurse reported that patient received vaccine in question as a booster dose, nurse did not have information on the patient's first two doses. It was not known which arm the patient received the vaccine. It was reported that 26 Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions. Storage condition at the time of the excursion: refrigerated storage.  The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-MAR-2022, 9-MAR-2022 and 10-Mar-2022. Maximum Temperature was 49 degrees Fahrenheit, Minimum Temperature was 37.7 degrees Fahrenheit, excursion duration : several temperature excursions.  The vials were not visualized. Number of vials/doses impacted: 10 Vials 100 doses.  Proposed desired Use by Date: (date of vaccination clinic, patient appointments, etc. that HCP would like vaccine administered from the vials in question)- 16 MAR 2022 The nurse reported that patient did not experience any adverse reactions or side effects to the Moderna COVID-19 vaccine. Treatment information was not provided.
Mom reported that pt broke out with rashes from his torso down to his legs. Blotchy red itching, burning sensation. Mom stated at 2pm, he was also weak. This am all rashes resolved and not feeling weak anymore.