chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
Swelling [and redness] on the injection site; Redness on the injection site; Patient had 1 ml dose administered/gave a 1 ml vaccine mistakenly to a patient instead of 0.5ml; This is a spontaneous case initially received from other non-health professional on 13-Nov-2018, concerning a 77-year-old, elderly, female patient.  The patient's current conditions included arthritis, hypertension, hyperlipidemia, gastroesophageal reflux, hypothyroidism, and psoriasis. The patient's concomitant medications included levothyroxine (levothyroxine sodium), furosemide (furosemide sodium), Metoprolol ER (metoprolol tartrate), simvastatin, dapsone, Amlodipine (amlodipine besilate), calcipotriene (calcipotriol), Zyrtec (cetirizine hydrochloride) and acetaminophen.  On 13-Nov-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 1 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 02944611A, expiry date: 28-Jun-2019] for active immunization against influenza. The patient was administered 1 ml vaccine mistakenly instead of 0.5ml (explicitly coded as overdose). It was reported that, there was no problem during administration of vaccine.  On the same day, after administration of vaccine, the patient experienced swelling and redness on the injection site. The patient did not require any treatment for the events.  On 15-Nov-2018, the patient recovered from the events swelling and redness at the injection site. The outcome of the event overdose was unknown.  The reporter considered the case as non-serious.  Non-significant follow up received on 26-Dec-2018: Non-significant follow up received on 26-Dec-2018: Added reference number (Info Number: SEQ18-07584) in the additional information tab. No changes were made in the narrative.  Significant case amendment (13-Nov-2018): Deleted classification 'special case with no AE', in the general tab. Added new events swelling and redness at the injection site. The patient did not require any treatment for the events. On 15-Nov-2018, the patient recovered from the events swelling and redness at the injection site. Amended narrative accordingly.  Non-significant case amendment (13-Nov-2018): The verbiage for an unknown indication' was removed for concomitant medications in the narrative.; Reporter's Comments: A 77-year-old female patient was administered Afluria QIV mistakenly 1 ml instead of 0.5 ml (overdose) and experienced swelling and redness at the injection site on the same day after administration.The company assessed causality of the events swelling and redness at the injection site as related due to plausible temporal relationship between the events and suspect vaccine and due to the vaccination site-specific reaction. The company assessed the causality of the event overdose as not related due to accidental nature of the event (medication error).
He lost strength on his left arm and it is very painful; Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful; arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful; Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (He lost strength on his left arm and it is very painful), BONE PAIN (Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful), VACCINATION SITE PAIN (arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful) and MYALGIA (Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced BONE PAIN (Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful), VACCINATION SITE PAIN (arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful) and MYALGIA (Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful). On an unknown date, the patient experienced MUSCULAR WEAKNESS (He lost strength on his left arm and it is very painful). At the time of the report, MUSCULAR WEAKNESS (He lost strength on his left arm and it is very painful), BONE PAIN (Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful), VACCINATION SITE PAIN (arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful) and MYALGIA (Arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone/ very painful) had not resolved.            No concomitant medication was reported.  Patient's height  was reported as 5'11".  Patient reported that he experienced a very severe adverse event to the Moderna Covid-19 vaccine on his left arm  where the injection was administered. Pain was constantly there during the day and it became more intense during nighttime when he was resting. The pain was stabbing. He had lost strength on his left arm and it was very painful. It started a couple of days after the 2nd dose.  It was reported that symptoms had worsened.  Treatment medication was not provided by the reporter.  Patient never had COVID postive test or diagnosis   This case was linked to MOD-2022-474417 (Patient Link).
Developed a tachycardia junctional rhythm which is well documented as a change from my normal heart rhythm.
This is a spontaneous report from a contactable pharmacist based on information received. A patient of unspecified age, ethnicity, and gender received a single dose of PREVNAR, via an unspecified route of administration on 16OCT2014. The patient's medical history and concomitant medications were not reported. On an unspecified date in OCT2014,, the patient experienced injection site reaction of redness, swelling, hardness and itching. The clinical outcome for the events of injection site reaction of redness, swelling, hardness and itching in was unknown. Follow-up attempts completed. No further information expected.
Fever Very bad chills Body shaking uncontrollably  Weakness Fell down when getting out of bed x2 Confusion Talking & making no sense
Received GARDASIL #3 5/21/12 Mom in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, client felt dizzy & she fell on the floor. Sustained a rugged laceration on nasal bridge & nose bleed. EMS took her to hospital.
Patient stated a history of allergic reaction to the influenza vaccine in the past.   Patient insisted on receiving Covid vaccination.  Patients primary care provider was called and gave approval for patient to receive vaccination.    About 10 minutes after receiving vaccination the patient stated sinus pressure which quickly proceeded to complaints of his throat feeling  "funny and tight".   ERT was called and patient was given a dose of Epinephrine and transferred to the emergency department.
Fever greater than 102, high BP above 130/90 (typical is 110/70), extreme fatigue, migraine, whole body muscle pain and excessive sweating for about 12-18 hours.    All of the symptoms that I had from covid in 12/2020, all rolled into one for 12-18 hours minus the loss of smell.
developed angioedema; This serious case was reported by a pharmacist via call center representative and described the occurrence of angioedema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-AUG-2023, the patient received the 1st dose of Shingrix. On 19-AUG-2023, 1 days after receiving Shingrix, the patient experienced angioedema (Verbatim: developed angioedema) (serious criteria GSK medically significant). The outcome of the angioedema was resolved.   It was unknown if the reporter considered the angioedema to be related to Shingrix.     It was unknown if the company considered the angioedema to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The health care professional (HCP) reported that the patient received her 1st dose of Shingrix and developed angioedema the following day.  The patient had recovered but had no information on how long the angioedema lasted.   No other information was known. The reporter consented to follow up.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 5 of 15 (see case IDs A0860669A, A0860688A, A0860690A, A0860691A, A0860693A - A0860702A for the other reports).
At 8 hours after the shot. I started to feel chills all over my body. Also had joint pain. At 6PM next day I started feeling better.
Used gray-top Pfizer Covid-19 instead of bivalent booster 11/22/22
Patient received FLUZONE at one store then BOOSTRIX and MMR at another store. After receiving the shot, the patient felt faint and dizzy. The following actions were completed: 1) patient was seated in safe area with supervision by pharmacist, 2) emergency protocol followed; EPIPEN at station; supervision at all times, 3) assessment was performed; no shortness of breath; patient felt slightly dizzy and faint but did not fall; patient was given orange juice and high sugar content snacks, 4) reassessed every 5 minutes, showed significant improvement after 10 minutes; patient stayed for approximately 20 min total, 5) patient went back to MD office to let them know of the situation, patient is okay and being monitored, 7) VAERS submitted.
area had some soreness, swelling, redness lt scar;checked by hlth dept on 27JUL95;no other treatment received
Pt experienced localized erythema and edema approximately 2/3 of upper arm and fever. Rash described as pruritic. Temperature at time of recheck was 98.1
Information has been received from a nurse practitioner concerning a female in her early 20's who on 09-SEP-2008 was vaccinated with the first dose of GARDASIL and experienced a vaso vascular episode or seizure following administration of vaccine. There was no concomitant medication. The patient received the vaccination and stated that she did not feel well. The patient was assisted to a chair and laid her head back against the wall. The patient called a nurse and had placed her head on the desk. Effort was made to have the patient sit up and placed her between her knees. She became rigid and made snorting noises. The patient was lowered to the floor and woke up in a few seconds. She was pale and clammy, blood pressure was 108/72. Patient was treated with an ice pack to the back of the neck. Within 15 minutes the patient reported feeling better and went home. the events were considered to be disabling. Additional information has been requested.
Extreme dizziness - hit about 16 hours after injection, lasted 12-18 hours Extreme tiredness - same as above Sore armpit in same arm as injection - lasted 4-5 days
12 hours after I had chills and could not get warm. Then 3 hours after, I had a fever of 102 that did not subside for 24 hours. I also had intermittent body aches, headache, nausea and increased thirst.
Information has been received from a physician concerning a 4 1/2 year old male who on 03-APR-2007 was vaccinated SC with a second dose of ProQuad (lot # 656887/0150U). Concomitant therapy included ibuprofen (MOTRIN). On 04-APR-2007 the patient experienced a red-hot, raised, and sensitive to the touch sensation around the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
achiness; severe dizziness; arm soreness; tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achiness), DIZZINESS (severe dizziness), VACCINATION SITE PAIN (arm soreness) and FATIGUE (tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), DIZZINESS (severe dizziness), VACCINATION SITE PAIN (arm soreness) and FATIGUE (tiredness). At the time of the report, PAIN (achiness), DIZZINESS (severe dizziness), VACCINATION SITE PAIN (arm soreness) and FATIGUE (tiredness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Additional Details: Pt started off experiencing dizziness and shakiness. The dizziness subsided but pt was experiencing a possible anxiety atack. BP and pulse slightly elevated. Pt had not eaten all day and it was late afternoon so she was given chocolate and water. After 30 minutes, pt was able to leave on their own with friend.
Symptomatic, started on 7/13 with fever, fatigue, cough, headache, & muscle aches.
I got a shingles vaccination on 7/19/07.  Within an hour I felt a stinging, burning sensation on my neck. The pain continued, sometimes intermittently. On 7/23/07 a rash developed along the route of the pain.  My doctor was unavailable, so I saw Dr. also of the same practice. Dr. diagnosed shingles.
devel severe dermatitis followed by neuritis, hepatic enzymes elevation, arthritis requiring steroids for control;
pt recvd vax;approx 3 hrs later devel cough,eyes felt like sand in them,blurred vision,constricting in throat w/ trouble swallowing,swelling of face;now lips numb but swelling down;Md thought conjunctivitis part of diff situation;pt better;
Persistent vomiting and diarrhea all morning. I then took patient to the hospital and they admitted her for observation for 12 hours and had to administer fluids because she was dehydrated. I had advised the doctor that my son had a very similar reaction to the vaccine when he was a baby in 2006. After hospitalization we decided to not finish the series.
Patient received first dose of Moderna Vaccine 2/25 and second dose 3/35.  He was seen 4/15. He reported that within 24 hours of second dose, he developed abdominal pain, chills, fever, and body ache. Fever, chills and body aches lasted 1 day. Abdominal pain persisted and is mostly is post prandial and associated with GERD. The pain was at first severe, has gradually improved and no longer referred to his back. Pain is not associated with nausea or blood in stools. Breathing makes pain worse. He does not use alcohol. He has reduced food intake for fear of triggering the pain.
Initial report received from a health care professional on 25 Aug 2010: On 25 Aug 2010, this child received a intramuscular dose of only the MenCYW-liquid conjugate component of MENVEO (batch number: 100003) without being reconstituted with MenA lyophilized conjugate component. Subsequently, after this medication error was recognized the child was administered a full dose of MENVEO after reconstituting the MenCYW-135 liquid conjugate component with the MenA lyophilized component. No adverse reaction had occurred following this administration. Follow up report received from the physician's nurse on 03 Sep 2010: The patient with medical history of asthma and allergy (unspecified) was vaccinated only the MenCYW-135 liquid conjugate component of MENVEO without being reconstituted with MenA lyophilized conjugate component at dose 0.5 ml and batch number: 100003 on 25 Aug 2010.
24 hours after presented normal side effects (redness and swelling the size of a quarter near the injection site). 48 hour after, the injection site swelled 4x the size so it was the size of my palm, was itchy, bright red, raised about 1/2? off my arm, tender to the touch, incredibly hot, and I slept for nearly 24 hours. 72 hours after, the swelling and redness spread slightly, my arm stung, ibuprofen, Tylenol and cold packs were not making a difference on my site. This was when I contacted my doctor and she informed me it was ?Covid arm?, which was normal. Now, 96 hours after, the swelling has increased to the size of my hand, the redness has decreased and the soreness and heat of my sore has decreased. I was advised to take Benadryl, so that may have helped.
C/O HEADACHE AND INCREASED EYE MOVEMENT AFTER COVID  IMMUNIZATION SHOT (ADMIN. TIME:  0946) 0955:  VS:  111/75, P:  80; 02 SAT:  97%  R.A.; 1000:  VS:  117/72, P:  80; 02 SAT:  98 % R.A. Left alert/oriented x3 with spouse
local skin reaction to DT vax manifestating as focal edema & tenderness w/o erythema or systemic sx;
Information has been received from a physician's assistant concerning an 18 year old female who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection. In June 2007, on an unspecified date the patient experienced "seizures and became code blue" after receiving Gardasil. Medical attention was sought. No further information was provided. Upon internal review, seizure is considered to be an other medical event (OME). Additional information has been requested.
Pt recv vax approx 7/96; post vax pt exp muscle aches; tx=physical therapy
Extremely heavy and lengthy menstrual cycle after both doses of Pfizer covid vaccine.; Extremely heavy and lengthy menstrual cycle after both doses of Pfizer covid vaccine.; Alopecia Areata; This is a spontaneous report from a non-contactable consumer (Patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Lot number and expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 26May2021 16:00PM as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Lot number and expiry date: not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization (age at Vaccination: 42). Medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient had not received other vaccines within 4 weeks prior to the vaccination and had not received other medications within 2 weeks prior to the vaccination. The patient was not diagnosed with COVID-19 before, and not tested post vaccination. On 26May2021 16:00PM the patient experienced extremely heavy and lengthy menstrual cycle after both doses of pfizer covid vaccine, and alopecia areata. The patient had visited doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care for the events. Events assessed as non-serious. Therapeutic measures were taken as a result of extremely heavy and lengthy menstrual cycle after both doses of pfizer covid vaccine, and alopecia areata includes Iron infusion and steroid treatment. The outcome of the events was reported as not resolved.  Follow-up activities closed: No follow-up attempts are possible.
Information has been received from a health professional concerning a 15 month old patient who on 08-JAN-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine instead of PREVNAR (Wyeth) by accident. Per the reporter the office keeps all of the vaccines in the same refrigerator and someone new grabbed the wrong vile. The new person has since been re-trained. The patient was not given PREVNAR and is doing fine. Subsequently, on 08-JAN-2008 the patient experienced inappropriate age and wrong vaccine administered. The patient is not experiencing any known symptoms and no further information is available. Additional information has been requested.
Swollen gums, sore throat, low grade fever, fatigue- all started within 12-24 hours of vaccination; treated with advil/tylenol and warm salt water gargling
Vaccine was mislabeled with frozen storage expiration date of 11/01/2021. This should have been labeled with expiration date for refrigerator storage which would have been 10/03/2021. Vaccine was administered to employee on 10/29/2021