chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started to feel under the weather; sweated it out; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweated it out) and VACCINATION COMPLICATION (started to feel under the weather) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 939902) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure).   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced HYPERHIDROSIS (sweated it out). On 17-Sep-2021 at 2:00 AM, the patient experienced VACCINATION COMPLICATION (started to feel under the weather). The patient was treated with PARACETAMOL (TYLENOL) on 17-Sep-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (sweated it out) outcome was unknown and VACCINATION COMPLICATION (started to feel under the weather) was resolving.            No concomitant medications were reported.
Fever, erythema multiforme, urticaria, pruritus and swelling, warmth at injection site.  Acetaminophen.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-MAY-2014, the patient was vaccinated with VARIVAX (Merck) 1350 U Vial (lot # and expiry date unknown), 0.5 ml, subcutaneous. The pharmacist reported that the patient, who was intended to receive ZOSTAVAX, inadvertently received a dose of with VARIVAX (Merck). It was reported that this was related to staff error. No adverse effects were reported. No product quality complaint. Outcome of the reported event was unknown. Additional information has been requested.
Break through bleeding despite continuous use Karica to prevent periods due to severe bleeding from fibroids. Bleeding volume is 2 to 3 ounces daily for 1 month. Provider recommended to discontinue Kariva to see if allowing a period would stop the bleeding. After a severe bleeding period, daily bleeding of 2-3 ounces continues at six weeks with no slowing
at 1050 staff reported that the pt.  was sewating alot and feeling dizzy.  BP=156/96 P=105, R=16  at 1055 BP = 138/95, P=94, R=16.  Pt reports hx of HTN.  At 11:08 BP=151/92 P=92, R=16, discharged with husband.
Left arm was very red, warm to touch, macular lesions noted at injection site, area approx 4 cm in size. Mother reported child had fever of 103 F with pallor and listlessness. Pt referred to clinic, but did not follow-up as of 07/12/05. Phone call to father states arm has healed, and pt is recovered
Injection site pink and warm to touch, about one inch in diameter. 11/1/04: faded, skin temp same over hand/ arm.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-FEB-2016, the patient was treated at physician office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
41 Years  old Female  presenting with palpitations starting earlier today around 1630 after receiving the COVID vaccination. Patient states they experienced SOB for approximately 30 minutes following the vaccination. Positive for chills and lightheadedness. Patient states their autoimmune disease is not currently normal, the "antibodies are attacking the thyroid".  Unknown manufacturer and dates given of vaccine.
Head turned to one side, both hands drawn, eyes rolled back in head & pt wet on self, this happened within 5 min of vax & lasted about 1 min. Pt layed around for 2 days c/o being tired. No other symptoms. Physician unsure if related to vaccine or not
Patient got lightheadedness, blurred vision and ringing in ears. Gave her diphenhydramine and offer a water. Her symptoms got better gradually. She stayed at the pharmacy about 25mins and left after her symptoms gets cleared.
Information has been received from a pharmacist concerning her 22 month old white daughter with a history of low haemogloblin and no drug allergies who on 29-MAR-2007 at 10:00 AM was vaccinated on left arm with a first dose of varicella virus vaccine live (Oka/Merck). Suspect secondary therapy on same day included a first dose on right arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). Concomitant therapy included sodium fluoride (+) vitamins (unspecified) (POLY-VI-FLOR DROPS). There was no illness at the time of vaccination. On 29-OCT-2007 at 7:00 PM the patient was diagnosed with shingles. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the pharmacist who stated that on 29-OCT-2007 the patient developed a rash on arm at injection site. On 12-NOV-2007 the patient recovered. No diagnostic laboratory tests were undertaken. No further information is expected.
Arm stiffness for 1 day after vaccination Other relevant Hx: injection site reaction, arm stiffness x1 day
Non-stop nausea, vomiting, headache, body aches, high fever, chills & MASSIVE fatigue for 3 days. Then massive fatigue for 5 more days. It?s been 3 weeks and I still feel fatigued and get clammy/hot and cold
Starting the morning after receiving the vaccine, I woke up with shoulder pain and arm soreness. It started to get a little better over the next several days and one week later it began to get worse. My neck muscles on the left side became stiff and painful and my upper (cervical) spine had tingling sensations and slight pain. On 10/30/2021, my shoulder is extremely painful and it hurts to lift my arm. My neck is still stiff and still have tingling in my cervical spine. I have nerve pain in my left thigh and left ankle off and on.
vesicular lesions at the site of injection; Lesions were uncomfortable; lesion, pruritic; lesion, mildly painful, stinging sensation; vesicular lesions at the site of injection; This case was reported by a physician and described the occurrence of injection site reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (1st dose received on an unknown date, refer case US2022AMR127520).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced injection site reaction, injection site discomfort, injection site itching, injection site pain and vesicular eruption. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction and vesicular eruption were not recovered/not resolved and the outcome of the injection site discomfort, injection site itching and injection site pain were unknown.   It was unknown if the reporter considered the injection site reaction, injection site discomfort, injection site itching, injection site pain and vesicular eruption to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127520   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's comment: The patient received dose of Shingrix vaccine and approximately 2 weeks after the vaccination experienced vesicular lesions at the site of injection. The lesions were uncomfortable (pruritic and mildly painful - stinging sensation). The reporter stated that currently the lesions were still active. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2022AMR127520:Same reporter
24 hours after the vaccine I developed a painful 4" circle rash, headache, fever, chills, tiredness ,  The  chills, tiredness that lasted 36 hours however the rash is still there at the same size with a fever on it is still ongoing.  I still have the  headache and fever however it lower in pain-level.
swelling on pinky toe; purple pinky toe; negative COVID-19 test; itching on feet; Hives on feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on feet), URTICARIA (Hives on feet), SWELLING (swelling on pinky toe), SKIN DISCOLOURATION (purple pinky toe) and SARS-COV-2 TEST NEGATIVE (negative COVID-19 test) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BUPROPION and ARIPIPRAZOLE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itching on feet) and URTICARIA (Hives on feet). On 06-Apr-2021, the patient experienced SARS-COV-2 TEST NEGATIVE (negative COVID-19 test). On an unknown date, the patient experienced SWELLING (swelling on pinky toe) and SKIN DISCOLOURATION (purple pinky toe). On 03-Apr-2021, PRURITUS (itching on feet) and URTICARIA (Hives on feet) had resolved. At the time of the report, SWELLING (swelling on pinky toe), SKIN DISCOLOURATION (purple pinky toe) and SARS-COV-2 TEST NEGATIVE (negative COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine.
Severe body aches (flu-like); Severe body aches (flu-like); This is a spontaneous report from a contactable Other HCP. A 33-years-old non pregnant female patient received second dose of BNT162B2 (COMIRNATY, formulation solution for injection), intramuscular, administered in Left arm on 01Feb2021 07:15 (Batch/Lot Number: EL3246) (Age at vaccination: 33 Years old) as single dose for covid-19 immunisation. Medical history included asthma. Patient did not had allergies to medications, food, or other products. The patient previously received first single dose of BNT162B2 on 04Jan2021 09:00 AM intramuscularly on left arm at single for Covid-19 immunization (Lot number: EL3246).On 01Feb2021 16:00 the patient experienced severe body aches.The events were considered as non-serious by reporter. No treatment was given to patient. The outcome of events severe body aches was not recovered. The action taken in response to the events for bnt162b2 was not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Swelling of arm - double deltoid size. Redness that extended to elbow. Pain. Itching. Diarrhea. Lips blistered. Body wide flu, aches, pain. Taking BENADRYL, TYLENOL, applying ice packs.
Patient had an injury to her foot several days prior to vaccination, with some pain to the area since.  Received 2nd dose of vaccine on 1/26, several days after injury. Within a few days after vaccine, patient developed calf pain and some discoloration of foot. On 1/31, she presented to the ED for evaluation. Xrays and ultrasound ordered - ultrasound positive for DVT. Patient started on Xarelto and discharged with instructions for follow up with PCP and repeat ultrasound.
Pt developed a raised, firm red spot at the injection site. Pt has implanted BC in same arm as injection. Pt experienced first period in 1 1/2 years.
Few red spots on face and extremities, mild fever for two days. Breakthrough varicella.
SEVERE DIZZINESS; WEIRD SENSATION IN HANDS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-APR-2021, the subject experienced severe dizziness. On 25-APR-2021, the subject experienced weird sensation in hands. On 25-APR-2021, the subject experienced fatigue. On 25-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 27-APR-2021, and the outcome of severe dizziness, fatigue and weird sensation in hands was not reported. This report was non-serious.
A few minutes post-vaccination, the patient developed a splitting headache that radiated from the neck up over the head. He had pain down his arm and leg on the opposite side (as well as itching-arm only)the vaccine was administered in. Nausea developed and became worse as time passed. No injection site reaction or trouble breathing reported. Once patient reported that his muscles hurt and he hurt everywhere EMS was called. The patient was transported to Hospital and discharged prior to the end of the clinic with Tylenol and Tums.
Pain from  idiopathic peripheral neuropathy increased in arms, hands and feet; Pain from  idiopathic peripheral neuropathy increased in arms, hands and feet; This is a spontaneous report from a contactable consumer (patient). An elderly female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 11Feb2021 at 11:30 AM as single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 21Jan2021, at 10:45 AM as single dose for COVID-19 immunization. Medical history included neuropathy. Concomitant medications were not reported. The patient did not received other vaccine in four weeks and also did not received any other medication in two weeks. The patient did not have covid prior to vaccination and not tested for covid tested post vaccination. There were no known allergies. On 13Feb2021 at 09:00 AM, the patient experienced pain from idiopathic peripheral neuropathy increased in arms, hands and feet. No treatment was received. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Swollen arm at site of shot as well as swollen under arm pit. Headache, chills
tachycardia, hot, anxiety when I woke up.  It calmed down after about 2 hours.  Following that, chills and muscle aches, fatigue
Patient turned red and became limp 5 minutes after receiving vaccines. Stats at 96%, no wheezing, no stridor. Patient was given 5ml of Claritin and oral steroid 10mL. Patient monitored for 30 minutes.
Left arm with edema, redness, pain, and warmth extending down to elbow.  Seen for evaluation on 6/11/13 and treated for allergic reaction and cellulitis.
Information has been received from a pharmacist concerning a female patient who was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed Shingles two weeks after vaccination. The patient did not seek medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning an approximately 23 month old female patient with hypoplastic left heart syndrome and no drug reactions/allergies who on 08-JUN-2011 was vaccinated with the first dose of ROTATEQ orally (dose unknown, lot # not reported). Concomitant therapy included aspirin, digoxin, LASIX, captopril and ranitidine. "Now" the patient had a gastrostomy tube. The nurse did not have any information on the reason the patient needed a gastrostomy tube at this time. It was unknown if the patient sought medical attention. The outcome of "had a gastrostomy tube" was unknown at the time of the report. Follow-up information has been received from the registered nurse concerning the patient who was vaccinated with the first dose of ROTATEQ (lot # 669832/0259AA) and concomitantly received the first dose of PENTACEL, ENGERIX-B and the first dose of PREVNAR 13, (Lot numbers not reported). The registered nurse did not know why the patient had the Gastrostomy tube inserted. The patient had a physician's visit on 19-SEP-2011. The patient was seen with the Gastrostomy tube in place. Follow-up information has been received from the registered nurse concerning that this patient did not have a "reverse reaction". She had a gastrostomy tube. So we contacted the company to see if we could administer it this way. We came to the decision not to give it per gastrostomy tube. She received a dose at an earlier age that had been p.o. but no problems arose with the dose. Additional information is not expected.
c/o dizziness. Color pink. O2 sat 96%. HR 100. BP 112/76. Alert & oriented x4. Speaking clearly.  Gait steady. Ate crackers & drank juice, then denied further dizziness.
Delayed reaction (COVID arm), 10 days after vaccine. Red raised hives near and around the vaccine site. Itchy and warm to touch. May have started the night before as I noticed it in the morning.
pt recv vax 6JUN97 & devel hives sometime p/vax;
pt recv vax 9MAR98 & 23MAR98 went to ER has muscles aches, fever & rash;pt stated legs & arms hurt, arms have feeling of paralysis from time to time;skin warm;pale in color;dx myalgia;BP 148/114;R22;t97.9;
Hospitalized after a fall with a traumatic dehiscence of prior surgical wound unrelated to COVID 19 infection of 11/17/2021.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 01-JUL-2015, the patient was vaccinated inadvertently with VARIVAX, 0.5 ml once, via intramuscular route (strength, lot # and expiration date were not reported) for prophylaxis. No concomitant medications were reported. No adverse effect was reported. Follow up information has been received from the pharmacist on 02-SEP-2015, concerning the 5 years old male patient. It was reported that, on 01-JUL-2015, the patient received the second dose intramuscularly of VARIVAX lot # L004653 (expiration date was not reported) and received also the second dose subcutaneously of M-M-R II lot # K015374 (dose and expiration date were not reported), fifth dose of KINRIX. The reporter emphasized there was no adverse event, only VARIVAX was given by the incorrect route. Additional information is not expected because all correspondence was received. Reporter information, suspect and concomitant therapies and narrative were updated.
This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patient's concurrent condition, medical history and concomitant medications were unknown. It was reported that doses of PEDVAXHIB Lot # L030870, expiry date 10-AUG-2018 (dose and route were not reported) that had been exposed to 34.4F for 2 hours and then back in the range, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had not had previous temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number L030870 has been verified to be a valid lot number for PEDVAXHIB. Additional information has been requested.
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5.    Day 5 Morning - rapid test negative, fever 99.9.  Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly.  Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine.  I am an allergig person whose eosinophils report for duty quickly and obviously too much!   I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included.  Your call.
Information has been received from a physician referring to an adult female patient of unknown age. On unspecified dates in the past, the patient was vaccinated with 3 separate doses of M-M-R II injection (strength, dose, frequency and route were not provided). On an unknown date, the patient was referred to the physician because the patient had failed to respond to the M-M-R II (no therapeutic response). This was discovered when the patient had antibody titers checked and it was found that the patient had not responded. The outcome of the events was unknown. Additional information has been requested.
Case number PHEH2015US026370, is a combined initial spontaneous report received from a pharmacist on 15 Dec 2015. This report refers to a 55-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517801 and expiry date: Jun 2016) intramuscularly on 13 Dec 2015. On the same day after vaccination in the evening, the patient experienced swelling of lymph nodes in throat/swelling around his throat. The patient was advised to take antihistamine and he was treated with CLARITIN, because the patient did not want to be drowsy at work. The patient did not experience any difficulty breathing or swallowing. The outcome of the event was reported as condition deteriorated (swelling gotten worse). Seriousness and causality of the event was not reported.
pt recv vax 13JAN97;had a gen sz 14JAN97 assoc w/fever;cont to run high fever & was adm to hosp 15JAn-16JAN97;
Patient notified the pharmacist who administered the vaccine on 1/6/21 stating presence of a nodule/bump, tenderness and warmth at the injection site. The pharmacist advised to seek medical advice in case of infection. Patient says the provider recommended to monitor for now and thinks it may be an allergy. Pharmacist will continue to follow up with patient to make sure symptoms are improving.