chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 4-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Since receiving the vaccine especially the 2nd shot both received in same location left shoulder upper arm area my arm has been stiff, feel a lump, omitting heat, and pain as well as difficulty when trying to raise my left arm to chest level with increasing pain/difficulty to lift arm over head. I thought that it would go away after a few days, I have tried to gently massage the lump out but it remains stiff. It has been now more than 2 months since receiving the last Moderna vaccine and I am still having these issues. Why is this happening? Have others reported the same ? When will it go away? Will it go away?
After receiving the first dose on Thursday afternoon, I noticed an itchy area on my chest Sunday afternoon, but didn't pay attention to it.  On Monday morning, the spot was larger and tingly.  By Tuesday there were blisters so I called the dermatologist and saw them on Wednesday.  I was given a prescription for Valacyclovir 1 gm tab to take for 7 days and Triamcinolone 0.1% OIN to use on the spot.  It went away in a few days though the spot is still discolored.  There are no other lasting effects.
Pt started wtih peripheral edema around 1/1/2021 which progressively worsened and then signifcantly worsened overnight after 2nd dose. Complete work up in ED with normal CBC, CMP, UA, negative LE doppler, negative chest CTA, normal ECHO.
This spontaneous report as received from a consumer via Clinic refers to a currently 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
5/31 pt given full vial of vaccine 6/6 pt's wife reports that flu like symptoms he was experiencing are not improving
12-Dec-09 MMR shot administered. 18-Dec-09 Fever (38.7C), no energy/listless, sleeping a lot, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 19-Dec-09 Fever (38.1C), no energy/listless, slept 16 hours, agitated a lot upset by small things, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 20-Dec-09 Fever (37.5C), low energy/listless, agitated a lot upset by small things, irritable, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose. Simple fall results in hard crying. She cried if she fell down without being hurt. She would normally not cry for these types of falls. She had 1 staring episode in the afternoon. She looked down and to the side. She did not respond when her name was called repeatedly. The staring episodes are what we are and were concerned about. 21-Dec-09 Fever gone, still agitated, upset by small things, cries easily over things she wouldn't normal cry about, stuffiness, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon. She ate a lot. She would eat and then want to eat again (even though she didn't actually eat much food) 20 minutes later as if she forgot she just had a snack. Congested 1 side of nose. She started adding s (plural) to all words or an a to the end of all words i.e. corna for corn, or corns. She is still doing this occasionally as of April 2010. 22-Dec-09 Cranky, congested 1 side of nose, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon, ate a lot. 23-Dec-09 More like her normal self, went to pediatrician in the morning, spent the day at the hospital, blood and urine normal, hoarse voice. 24-Dec-09 Congested 1 side of nose, gasping, otherwise OK, hoarse voice. 25-Dec-09 Congested 1 side of nose, otherwise OK. 26-Dec-09 Like her old self but with occasional gasping, morning stuffiness. 27-Dec-09 Happy again, still gasping occasionally, morning stuffiness. 28-Dec-09 Happy, normal self, still gasping occasionally, 1 staring episode about 10 seconds long at 10:30 AM.
Got the 2nd shingle shot yesterday / 4 years after the first one; Headaches; Fatigue; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose approximately 4 years ago from the day of reporting).   On 1st May 2021, the patient received the 2nd dose of Shingles vaccine. On 1st May 2021, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. In May 2021, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache, fatigue and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient itself. The age group was not reported but selected as adult as per the vaccine indication. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule and experienced headaches and fatigue. The patient's blood pressure was 160/90 mmHg and pulse rate were 104 beats/min. The patient asked if he or she was okay. The follow-up would not possible as no contact details were available.
Mother stated patient became sick 2 days after receiving the vaccine, had UGI endoscopy, has h-pylori and is still very ill. 6/20/08-records received-4/17/08-C/O diarrhea, lethargy and feeling weak since date of vaccine. PE:WNL. Assessment flu syndrome. 5/28/08-C/O abdominal pain, nausea weight loss. Unable to eat. Tender epigastric area.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Medical facility was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines were reported.  No treatment medication were provided.   This case was linked to MOD-2022-542869.
After vaccination, deep sciatic and outer thigh nerve pain along the dermatome caused numbness and tingling down to the outer right foot.  Over time this progressively worsened to impact ability to sleep and move leg decreasing overall quality of life.  Patient treated with anti-inflammatories, stretching, and yoga practices.  No other identified causes.
Joint/muscle soreness and headache began evening of 11/5 and persisted through Monday evening 11/8 On Sunday 11/7 - severe nausea, vomiting and diarrhea for about 12 hours along with continued headache and muscle/joint soreness
8cm x 7cm area of erythema with mild swelling and mild tenderness. Pt c/o itching
The patient stated that certain directions that she moves her arms causes her server pain in her right arm. She is dealing with the pain. She takes an anti inflammatory medicine  that she is trying to get off of.
24-30 hours after vaccine pt broke out in hives all over hands and face on and off x 3 days. Given Benadryl with relief.
Sore arm; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Insomnia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Insomnia). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-022904 (Patient Link).
Child woke up in morning of March 8th, 2011 with large - approx. 5 cm edematous/erythematous, warm area on left arm. Prescribed diphenhydramine - will follow-up.
Intermittent abdominal pain and loss of appetite for 5 days. Slept all day 6/7/16. Negative ultrasound for intussusception.
Left arm tricep nerve pain and burning sensation.  Limited movement raising  arm upwards without pain.
Information has been received from a physician concerning a female who was vaccinated with a first dose of Gardasil. Subsequently, two weeks after vaccination, the patient developed swollen and painful joints and an enlarged spleen. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
R arm SQ area - Red, swollen size of lemon, L arm IM area -  Red, swollen size of "50 cent piece". Benadryl and warm compresses
Vaccines ordered MMR, Varicella, Prevnar and Hib. Vaccines administered MMRV, Varicella, ActHiB, Prevnar. Notified Dr. and parent was notified. No treatment initiated.
Large rash noted at Injection site, radiating down to elbow. Itching, redness, and edema at injection site. Rash has been going on for 2 week post-injection.
pt admitted to hosp; positive for COVID; O2 requirements increased and pt needed to be intubated with mechanical ventilation; went into renal failure requiring hemodialysis; septic shock; DNR/active management; tracheostomy and PEG tub placement; pt had a large pneumothorax requiring emergency chest tube; pt's condition continued to decline and she went into asystole and died in the hosp
There was no adverse event noted.  Client was given Tdap injection rather than a flu vaccine. No record of client having Tdap in past.
Initial report received from a non-healthcare professional (Patient wife) on 08 January 2013 and follow-up information received on 10 January 2013. A 33-year-old male patient, who had no illness at the time of vaccination and did not receive other medications, had received an intramuscular 0.5 ml dose 1 of FLUZONE (Lot number UH729AB with expiration date 30 June 2013) in right deltoid on 07 January 2013. On 07 January 2013, immediately after vaccination, the patient had sore arm from injection site down and dizziness. "Following morning" (08 January 2013) the arm was still sore and the neck was also sore on the same side as arm (right side). Corrective treatment was not reported. Laboratory investigations were reported as not applicable. As of 09 January 2013, the patient had fully recovered from the events. Documents held by sender none.
Rash; Migraine; Fever; Fatigue; Extreme pain when touching anything like wearing clothes; Skin felt extremely raw; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 04May2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included severe multiple allergies, possible autoimmune illness which was undiscovered and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lamotrigine (MANUFACTURER UNKNOWN), norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI), propranolol (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA); all for unknown indication from unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 15:30, the patient experienced rash, migraine, fever, fatigue, extreme pain when touching anything like wearing clothes, and her skin felt extremely raw. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash, migraine, fever, fatigue, extreme pain when touching anything like wearing clothes, and her skin felt extremely raw was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to multiple patients of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (strength, dose and frequency unknown) subcutaneous. On an unknown date the patient experienced injection site reactions following ZOSTAVAX vaccination, but smaller in size (half to silver dollar in size). The outcome of injection site reactions following ZOSTAVAX vaccination, but smaller in size (half to silver dollar in size) was unknown). No further information has been reported. This case # 1312USA011095 is linked to case # 1312USA009925 via same reporter link. Additional information has been requested.
swollen elbow joint you could barely touch; headaches; left arm was swollen; lump on left arm near elbow which is tender; lump on left arm near elbow. which is painful; lump on left arm near elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swollen elbow joint you could barely touch), PERIPHERAL SWELLING (left arm was swollen), TENDERNESS (lump on left arm near elbow which is tender), PAIN IN EXTREMITY (lump on left arm near elbow. which is painful) and MASS (lump on left arm near elbow) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm was swollen), TENDERNESS (lump on left arm near elbow which is tender), PAIN IN EXTREMITY (lump on left arm near elbow. which is painful) and MASS (lump on left arm near elbow). On an unknown date, the patient experienced JOINT SWELLING (swollen elbow joint you could barely touch) and HEADACHE (headaches). At the time of the report, JOINT SWELLING (swollen elbow joint you could barely touch), PERIPHERAL SWELLING (left arm was swollen), TENDERNESS (lump on left arm near elbow which is tender), PAIN IN EXTREMITY (lump on left arm near elbow. which is painful), MASS (lump on left arm near elbow) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Ultrasound scan: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10-MAY-2021; Reporter details updated. Medical history, lab tests details updated. New events Peripheral swelling, Tenderness, Pain in extremity and Headache added.
Immunization clinic - Health Care Center 02/19/2022 at 10:17 AM. Fifteen minutes after Pfizer dose #2 vaccination (10:17 AM) the mother reported that the child was not feeling well. Child stated she felt very tired and dizzy. Vitals checked BP115/72 Pulse 82 O2 sats 100% on RA. Orange juice was offered which she drank and tolerated well but stated she was still very tired and did not feel like herself and was taken by wheelchair from Immunization clinic to ED. On route to ED, the transporting nurse noted that the child had some jerky movements of her legs and body.
Golf-ball size Red, hard bump on injection area. Found 11/09/2014 and took to a doctor on 11/12/2014. Doctor perscribed Amoxicillin & Clavulanate Potassium.
Symptoms started around the day of vaccination which included cough and shortness of breath. Developed nausea and vomiting which led to presentation to emergency department.  Patient was admitted and treated for COVID-19 infection.
11 am first time receiving flu shot. After 10 minutes, became diaphoretic. C/O of slight dizzy. BP 100/60, P80, R160 received epinephrine, declined to call 911, declined to call physician. Symptoms subside BP 120/184, P80,R16 after 25 minutes 11:25 am. Advised to contact physician if symptoms returned.
Fever beginning about 24 hours later. Rose to 100.6. Sore arm. Fatigue. Big red circle around site 30 plus hours later.
Infanrix booster dose to 12 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB VACCINE).   On 28-AUG-2023, the patient received Infanrix. On 28-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix booster dose to 12 month old patient).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-AUG-2023 A medical assistant called to inform that earlier that day, a 12-month-old received a dose of Infanrix. Such dose was supposed to be administered in November. Which led to Inappropriate age at vaccine administration.  Also, the reported said that it was administered along with ACTHib vaccine. The reporter did not consent to follow up.