chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cutaneous sensory symptoms (tingling, burning sensation on the skin, also alternating superficial sensation of hotness and coldness); Spontaneous report received on 11FEB2020 via health authority, Regulatory Authority.  A physician reported that a 33-year-old female consumer had cutaneous sensory symptoms (tingling, burning sensation on the skin, also alternating superficial sensation of hotness and coldness) (PT: Paraesthesia), while being on oral Vivotif (lot number: 3003308), intramuscular Boostrix polio (diphtheria vaccine toxoid/pertussis vaccine acellular 3-component/polio vaccine inactive 3v (Vero)/ tetanus vaccine toxoid) (injection solution; lot number: AC39B131BF) and intramuscular Havrix (hepatitis a vaccine inactive; suspension for injection; lot number: AHAVB995AB;) for immunisation. The consumer received Vivotif, Havrix and Boostrix polio on 22JAN2020. On 23FEB2020, she had cutaneous sensory symptoms. She had a tingling, burning sensation on the skin. Also, alternating sensation of heat and cold superficially. This was distributed bilaterally on the arms, hands, legs, feet and face. She had no clear skin rash. Action taken with Vivotif with respect to the reported event was unknown while that of Havrix and Boostrix polio was not applicable. The symptoms were not resolved at the time of report.  Company Comment: A consumer received Vivotif dose and on the next day she had cutaneous sensory symptoms including tingling, burning sensation on the skin, and also alternating superficial sensation of hotness and coldness (Paraesthesia). This patient received Havrix and Boostrix polio vaccination along with Vivotif on the same day. Paraesthesia was distributed bilaterally on arms, hands, legs, feet and the face. The event was not resolved at the time of the report. Considering the event occurred one day after taking Vivotif, the causality of the event is assessed as possible (confounded by Havrix and Boostrix polio vaccine). The case is considered serious due to the medical significance of the event. Paraesthesia is unlisted as per USPI.; Sender's Comments: Company Comment: A consumer received Vivotif dose and on the next day she had cutaneous sensory symptoms including tingling, burning sensation on the skin, and also alternating superficial sensation of hotness and coldness (Paraesthesia). This patient received Havrix and Boostrix polio vaccination along with Vivotif on the same day. Paraesthesia was distributed bilaterally on arms, hands, legs, feet and the face. The event was not resolved at the time of the report. Considering the event occurred one day after taking Vivotif, the causality of the event is assessed as possible (confounded by Havrix and Boostrix polio vaccine). The case is considered serious due to the medical significance of the event. Paraesthesia is unlisted as per USPI.
Painful for 2 days after the shot on left arm where the injection was given. Diarrhea and fatigue on the fourth day. on the sixth day, the arm was red, tender, and spreading downward.
3 welts appeared on face & started itching;no resp distress or sx given DPH & Epi
Pt became light headed and unable to stand upright. Increased respiratory rate and generalized shaking noted. No rales/stridor/wheezing noted.
Papular rash. Mom took 4 digital photos of the rash, it's very impressive. I'd be glad to send them for your review.
Headache, Myalgia, Fever, CoughWheeze & Diarrhea Narrative:
Discomfort under the left armpit and left testicle- feels like swollen glands
Tested positive for COVID 19/headache/chills/coughing; Tested positive for COVID 19/headache/chills/coughing; Dizziness; joint pain all over the body; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and wife). This is report 1 of 2.   A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache, dizziness, joint pain all over the body and chills, coughing on 17Jan2021. Patient was trying to figure out for a lot of the symptoms how long does it last. His symptoms started 17Jan2021 morning. The second dose for patient is scheduled on 02Feb2021. The patient was tested positive for COVID 19 on Wednesday, 20Jan2021. He stated he reported a few days ago about some symptoms they had. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056973 similar report from same reporter
no adverse event; AE filed due to the medical assistant pulling out the needle since the patient moved.  They are not sure if the patient received any of the medication.; This spontaneous report was received from a healthcare business professional/ administrator and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 07-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided) but the needle was pulled out by a medical assistant since the patient moved. It was not sure if the patient received any of the vaccine (accidental underdose). No other issues or concerns were noted (no adverse event).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002271:
Have noticed now several weeks after vaccination that several of the hand joints are extremely enlarged where they were never like that before, especially on thumb and first finger. Also, overall very painful joints.  Also, joints in hands locking when using.
after I left I was standing at my door when I feel invisible bugs biting my whole body everywhere all over my body but on august 2nd of this year  it felt like I was being stung by the tip of a knife all over my body. and believe me I still don't feel good. and it has not stoped its still ongoing
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The nurse stated that on an unknown date, the patient was vaccinated SC with was 0.5 ml M-M-R II (lot# not provided) two weeks early. Nurse was not sure exactly when the first dose was given, but was sure the second dose was give too early. No other co-suspects were reported. No concomitant medications were reported. The patient did not sought medical attention. No adverse effects reported. Additional information has been requested.
Pt. states that after receiving the 3rd dose of Moderna Booster 12/20/2021, started experiencing symptoms 12/21/2021 of Migraine, dizziness, weakness, Left arm pain, fever, and chills. Still continuing to experience symptoms.  No noted Primary visit/communications.
Skin irritation and redness at the site of the vaccination just  like psoriasis; Skin irritation and redness at the site of the vaccination just  like psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Skin irritation and redness at the site of the vaccination just  like psoriasis) and VACCINATION SITE ERYTHEMA (Skin irritation and redness at the site of the vaccination just  like psoriasis) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Psoriasis (Had an psoriasis injection 7Nov2021.). Concomitant products included LOSARTAN for Blood pressure.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE IRRITATION (Skin irritation and redness at the site of the vaccination just  like psoriasis) and VACCINATION SITE ERYTHEMA (Skin irritation and redness at the site of the vaccination just  like psoriasis). At the time of the report, VACCINATION SITE IRRITATION (Skin irritation and redness at the site of the vaccination just  like psoriasis) and VACCINATION SITE ERYTHEMA (Skin irritation and redness at the site of the vaccination just  like psoriasis) outcome was unknown.            No treatment information was provided.  Patient was taking sleeping pills.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2021: Nonsignificant followup appended.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
extreme pain 8 out of 10; deep breath it hurts even more; sore for 3 weeks, lingering; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme pain 8 out of 10), PAIN (deep breath it hurts even more), VACCINATION SITE PAIN (sore for 3 weeks, lingering) and FATIGUE (fatigue) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter. .    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (extreme pain 8 out of 10), PAIN (deep breath it hurts even more), VACCINATION SITE PAIN (sore for 3 weeks, lingering) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (extreme pain 8 out of 10), PAIN (deep breath it hurts even more), VACCINATION SITE PAIN (sore for 3 weeks, lingering) and FATIGUE (fatigue) outcome was unknown.            Treatment medications of the patient were not provided. No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
lt deltoid pink, sl swollen, moving arm freely;3AUG redness, swelling, hardness @ site;warm to touch, no pain, moving freely, no fever;? cellulitis;
103 fever, chills, headache, swollen arm at injection site - 48 hours later still swollen arm and headache
Tiredness day after vaccine; Also next day, lymph node inflammation (left armpit swollen) and also in front under collar bone (left side); Overall pain on left side nothing on the right side; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 14Apr2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control, seafood allergy, shellfish allergy, mushrooms allergy and pistachios allergy. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 24Mar2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 16:00, day after vaccine the patient experienced tiredness.  Also, next day the patient experienced lymph node inflammation (left armpit swollen) and also in front under collar bone (left side). The patient had overall pain on left side nothing on the right side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, lymph node inflammation and overall pain on left side were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 60 year old female with depression, benign tumor, osteoporosis, hyperlipidemia and adverse drug reactions to allergies to AMBIEN, VICODIN, PROZAC and sulfonamide who on 08-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant drug therapy included LIPITOR, BONIVA, aspirin 81 mg and fluoxetine HCl.  On 08-JAN-2008 the patient "felt out of it, dumb, absent, sedated and fatigue."  She felt better the next day.  On 10-JAN-2008, the patient "felt weird."  The patient's arm was swollen and sore."  The affected area was about the size of a silver dollar, and was raised and bruised.  The patient also experienced itching, anxiety and as if her heart was racing.  The patient was seen in the physician's office for medical attention.  Lab diagnostic studies performed included an EKG and a heart rate of 73.  The patient was treated with BENADRYL for the itching but she only took one dose.  The patient's symptoms have not resolved at the time of this report.  There was no product quality complaint.  Follow-up information received from the reporting physician indicated that the patient had a history of adverse drug reactions to AMBIEN (paradoxical reaction), PROZAC ("shaky") and hypersensitivity to sulfonamide (hives) who on 08-JAN-2008 at 10:50 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658324/1821U) in the lateralis area.  Additional information has been requested.
Flu like symptoms treated with 2 325 mg aspirin dosed every 4 to 6 hours.
Painful, swollen right arm, numbness, lethargy, inability to work following day, some difficulty breathing - pt did not seek treatment.
Patient got flu shot on 10/20/18. She called the pharmacy on 11/5/18 to inform that she still has pain on the left arm that she got the flu shot. She noted that she only has the pain when she moves her arm but has no pain when the arm is still. She said that she started felling the pain a day after she got the flu shot. She said that she took some Ibuprofen today and got some relief though. Patient was advised to use some warm/cold compress & to contact their PCP. Patient's Dr's office was contacted today. (spoke to person at about 3:45pm)
Pt recvd OPV/MMR/DTP the evening of the inject pt had a sl fever the following morning had a t101, listless & had aching under armpit, dec appetite, pale;
p/vax pt diffuse rash; D; severe irritability/crying; still present at evaluation, 7/7/99
STINGING HEADACHE FROM 1/8 TO 1/10. CHILLS ALL DAY ON 1/9. TOOK TYLENOL EVERY 4 HRS
gradual major headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (gradual major headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, Stroke and Shortness of breath. Concurrent medical conditions included Heart disorder. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Cardiac disorder, FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) for Heart disease, unspecified.    On 29-Dec-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (gradual major headache). At the time of the report, HEADACHE (gradual major headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had ibuprofen that was prescribed to him before, so asking if he could take these. No treatment medications were reported.
the patient received an extra ACT-HIB and IPOL dose with no reported avderse event; patient who was supposed to receive DAPTACEL and IPOL, but instead was given PENTACEL and IPOL, with no adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case from a physician and consumer/ non healthcare professional via Global Media Information (under reference 00789175).  This case involves a 4 year old patient (unknown gender) who received an extra ACT-HIB and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) dose (extra dose administered) as patient was supposed to receive DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL), but instead was given DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO) and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) [wrong product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect PENTACEL (VERO), dose of suspect IPOL (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to extra dose administered and wrong vaccine administered (same day latency).  It was reported "Physician states that a 4 year old patient was supposed to receive DAPTACEL and IPOL. However he received PENTACEL and an extra dose of ACT-HIB instead. Because of this, the patient received an extra ACT-HIB and IPOL dose. The Physician asks if there will be a harmful effect from the ACT-HIB and IPOL doses. The Physician was in a hurry and did not have time to provide any AE information. He asked that we email any information and then call him back."  At the time of reporting, no adverse event reported.  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. 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.  There will be no information available on the batch number for this case.
Information has been received from a health professional concerning a 86 year old female with asthma, chronic obstructive pulmonary disease, dust allergy, pollen allergy and mold allergy who on 10/11/2005, between 11:00 and 16:00, was vaccinated IM in the right deltoid with a 0.5ml second dose of Pneumococcal 23v polysaccharide vaccine (lot 646501/0497N). Concomitant therapy included a dose in the left arm of influenza vaccine unspecified. On 10/12/2005 the patient presented to the doctor office. She had a knot on the right arm, was feeling funny and had pain in her right arm up to her neck. She was treated with cetirizine hydrochloride Zyrtec and no lab were done. At the time of this report she had not recovered. Follow up information indicated that the patients right arm was swollen down to the elbow, she had pain that ran down her arm and had a strange or funny feeling. There was a knot on her arm where the injection was given. It was reported that the patient recovered on an unknown date. Additional information is not expected.
Hives on arms and legs (Sunday 11/1/15) getting better Monday 11/2/15.
Jynneos vaccination error no wheal .  Follow up administered 0.5 SQ given.
blacked out/lost consciousness; started shaking and couldn't hit the keys; felt sick like she had the flu; felt sick like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out/lost consciousness), TREMOR (started shaking and couldn't hit the keys), MALAISE (felt sick like she had the flu) and INFLUENZA (felt sick like she had the flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out/lost consciousness) (seriousness criterion medically significant), TREMOR (started shaking and couldn't hit the keys) (seriousness criterion medically significant), MALAISE (felt sick like she had the flu) (seriousness criterion medically significant) and INFLUENZA (felt sick like she had the flu) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out/lost consciousness), TREMOR (started shaking and couldn't hit the keys), MALAISE (felt sick like she had the flu) and INFLUENZA (felt sick like she had the flu) outcome was unknown.            No concomitant product information were provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: This case concerns a 75-year-old female with serious unexpected events of loss of consciousness, tremor, malaise, and influenza. Event latency within hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-295447 (Patient Link).; Sender's Comments: This case concerns a 75-year-old female with serious unexpected events of loss of consciousness, tremor, malaise, and influenza. Event latency within hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.