chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine at 1230 and reported to medical staff at around 1510-1512 of unusual pain and urticaria at injection site. Patient presented with a large wheal on injection site with pain radiating outward. Patient was treated with pressure and cold packs. Patient was released on their own recognizance as they are a Physician. Briefed to report to emergency care if any trouble breathing or anaphylaxis develops. Reaction was unprecedented to the patient who receives an immunization annually for multiple years.
patient's HSV2 titer results 9 days after receiving 1st dose of Shingrix on 2/28/21 / Positive HSV2 titer 9 days after receiving 1st dose of shingrix; This case was reported by a physician and described the occurrence of herpes simplex test positive in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex test negative (received a HSV2 (Herpes Simplex virus type II) titer last year).   On 28th February 2021, the patient received the 1st dose of Shingrix. On 9th March 2021, 9 days after receiving Shingrix, the patient experienced herpes simplex test positive. On an unknown date, the outcome of the herpes simplex test positive was unknown.   It was unknown if the reporter considered the herpes simplex test positive to be related to Shingrix.  Additional details were provided as follows: The patient had a new consistent sexual partner since sometime after the first titer last year from the reporting date. The patient had positive HSV2 (Herpes Simplex virus type II) titer after receiving 1st dose of shingrix. The reporter wanted to know if Shingrix had any effect on HSV2 (Herpes Simplex virus type II) titer. The reporter consented to follow-up.
15JAN97 pt lt arm was hot to touch, inflamed & swollen from sl above inj site to elbow;MD stated lt arm was inflamed & infected & pt placed on ATB;mom states pt scratching immun area;pt states arm hurts when someone touches area;
The shot was painful and deep. I thought it was burning at first but immediately was unable to drive with the arm. Soreness went away in a couple of days afterwards. Pain has come back a couple of weeks later. Shoulder pain and stiffness with arm movement. Restricted movement. Shoulder is sore to the touch. Flu shot was given during prenatal appointment .
started w/deep aching pain in lt shoulder radiating 50 shoulder & back-tingling -numbing in fingers;sl subsidence;went to MD today;post inject-couldn't lift arm or rotate shoulder;
Child had vaccines 2/1/16. On 2/16/16 mom brought child into office with 2 small papules and reddened area on the lt thigh has had x 2 wks. BACTROBAN oint prescribed.
Within hours of vaccine I had terrible pain and unable to use my arm for two weeks. Still having pain and lkimited use of arm. Saw my doctor again, went to the ER and had x rays. No Help for problem and pain.
30 min after the vaccine shot, my left hand was tingly and went numb. my hand returned to normal 10  minutes later.   After receiving the vaccine on 3/1 5P,  i woke up on 3/5 to a swollen left upper eye lid. It is now 3/8 10 am and it is still swollen. I have medicated eye drops that i am using but its not going down as fast as it should. My eye is not red and there is no discharge. my eyelid is just swollen.
patient reported swelling, knot in neck, right sided facial numbness. Injection site redness/soreness. Also reported severe reactions to first dose Pfizer COVID 19 Vaccine (severe headache, muscle pain, injection site redness)
Swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck; Swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck; This is a spontaneous report from a contactable other HCP (patient reported herself). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 25Jan2021 02.00 PM as single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient's medical history included anxiety and depression. No known allergies. Concomitant medications included iron supplements and desogestrel/ethinylestradiol (DESOGESTREL AND ETHINYL ESTRADIOL) (both received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (COVID 19, Pfizer) via an unspecified route of administration to her left arm on 06Jan2021 03.00 PM as single dose for Covid-19 immunization. On 26Jan2021 07:00 PM, the patient experienced swollen and painful lymph node at base of the neck (over the clavicle) on left side (side of injection) and tender lymph nodes on the right side of the neck. The events were assessed as non-serious. The patient had been tested for COVID-19. Covid test type post vaccination, nasal swab in Oct2020 showed negative and saliva test in Nov2020 showed negative. She did not receive any treatment in response to the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
I had headache, body aches, and fatigue. I was fine within 3 days.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unspecified dates, the unspecified patients were vaccinated with improperly stored doses of VAQTA (lot #L048222 and expiry date 19-DEC-2016) (dosing regimen was unknown by the reporter). No concomitant medications were reported. The vaccine was exposed to temperature of 30 Fahrenheit for 12 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Joint pain; lymph node swollen; Fever; Headache; Muscular pain; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; where she got the second vaccine, it is swollen and red and it is still so sore; Not feeling good; This is a spontaneous report from a contactable consumer. This consumer reported for unknown patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection. Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single for COVID-19 immunization. Patient got the COVID vaccine the other day, the second shot and has several symptoms and they did not seem to be going way, lot of joint pain, lymph node swollen, fever, headache, muscular pain, redness, where got the second vaccine, it was swollen and red and it was still so sore, patient could not move it and in response to further probing, reporter stated, no, not eight to ten minutes, patient (my wife) was not feeling good for that many questions. Reporter wanted to know, recommend anything to do? Do we just have to go to a doctor to have them look at it? Further probing could not be initiated as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The outcome of the events were unknown.   No follow-up attempts are Possible. No further information is expected.
Large area of rash on arm where  COVID  vaccination was given.  Also some rash on both arms between elbows a d wrists
Patient began to feel feverish the day following vaccination and experienced vomiting and chills, general unwell feeling for 2-3 days following dose.
I am not quite sure if this is from the booster but wanted to let you know that I developed serious hives and they have lasted off and on till now, April 2022.  When my dermatologist saw me, my body was covered and certain areas swollen, like my ear on the right was double the size.  I ask her if it could be a reaction to the booster, about two weeks earlier, and she said probably not.  However, I want to tell you the facts. I am basically a healthy 69 year old.  Very petite (4'10") and weigh about 100 lbs.  I received the same dose as my nephew who is 310 lbs. . Now I have this cronic urticaria (I read up on it) and am learning to live with it.  Could the booster have stimulated my immune system  to be over active and have caused this?  Has anyone else reported anything like it?  I will not be getting a 4th dose as I feel I may have too much in my system.  Just wanted you to know.  Thank you.
Urticarial rash starting 7 days after the immunization, without fever, joint pain or swelling, that resolved after 7 days.
Hives noted on face, arms, legs.  No hives noted on abdomen.  No respiratory or mouth involvement
Swollen and painful lymphnode in right arm and right groin area-began on day two post vaccination and lasted four full days
On 10/5/16, patient reported swelling and pain throughout his injected arm within a day of vaccination. Pt read VIS provided to him, realized it was a potential effect of the vaccine. No remaining symptoms at time of reporting.
Fever (intermittent) for 72 hours with high of 102 degrees. Head to toe rash (hive like) 48 hours out. Rash remains present 7 days out. Mom monitored and reported to Imm. Clinic. Consult made with Local Pharmacist and CDC consult. on 7-31-18.
Complaining about a disconnect between head and body; Noticed a downward trend in strength; Sleeping a lot more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant) with onset 2021, outcome "not recovered", ASTHENIA (non-serious) with onset 2021, outcome "unknown", HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "since the caller's husband received the Pfizer Covid 19 Vaccines, the caller has noticed a downward trend in the patient's strength, the patient is sleeping a lot more and the patient is complaining about a disconnect between head and body. The patient states the disconnect between head and body feels like the patient is in a control tower, something is going on down there but a long ways away and not like it use to be. The patient's ability to do anything is limited to 3 or 4 hours a day". The lot number for bnt162b2 was not provided and will be requested during follow up.
No immediate post vaccine symptoms other than slight clear rhinorrhea and mild sneezing for a few hours. By evening about 12 hours post vaccine felt fatigue and some increase in mild baseline myalgias.  During night sleep significantly disrupted by generalized myalgias, along with some strange transient paresthesia.     Such that at about 4:30 AM I texted my 3 workplaces that I did not expect to go to work that day.  Went back to bed, woke up around 9:30 AM 1/8/2021 and nearly all myalgias resolved, still fatigued but better.  Paresthesia's were transient and resolved.  Went to work after all.  Today, Saturday 1/9/21 woke up and all symptoms resolved.
Localized feeling of heat at the vaccination site at 8 days post vaccination date. Several hours after noticing that the site was hot, began to feel pain at the injection site (mild/uncomfortable but not severe enough to warrant painkillers or allergy medication)
Pt recvd 2nd dose of Hep B vax 15MAR91 & devel linear, urticarial rxn @ inject site; PE was nl; inject site was bruised next day & persisted x 3 days; @ time of report pt had recovered;
Left arm pain & redness -> soreness in arm increased to very sore. Warm, red at site.
ITCHING; CANNOT SLEEP; This spontaneous report received from a consumer concerned an 89 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: pacemaker, and vitamin b12 down (B12 down since a long time), and other pre-existing medical conditions included: The patient had other health problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included cyanocobalamin for vitamin b12 down.  On an unspecified date, the patient experienced itching, and cannot sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching and cannot sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20221162412.
Extreme pain in muscle for two days after injection.  7 days later a raised red rash appeared which is quite itchy.
the place becomes more red; very itchy; site was red and itchy; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (site was red and itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (the place becomes more red) and VACCINATION SITE PRURITUS (very itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (site was red and itchy) and VACCINATION SITE PRURITUS (itchy). On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (the place becomes more red) and VACCINATION SITE PRURITUS (very itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (site was red and itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (the place becomes more red) and VACCINATION SITE PRURITUS (very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
A non-serious spontaneous report of five month pregnant lady received FLUMIST was received from a health professional concerning a 22-year-old female. Neither patient's medical history nor obstetrical history reported for this patient. On 28-Oct-2010, five month pregnant female received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Pain at site immediately after vaccine, pain with movement. Two days later redness and swelling developed at site and approximately 5 cm surrounding site.
Patient got up and walked to the waiting room where he got very dizzy and passed out. He struck the back of his head and was minimally responsive for a few minutes. After coming to, he was sitting in a chair and got very dizzy and pale. EMS was called and evaluated him and felt he could go home. He has scheduled follow up with his PCP.
Initial report was received 09 April 2010 from a consumer who is also the patient. A 63-year-old female patient had received a PANDEMIC INFLUENZA A/H1N1 VACCINE (manufacturer, lot number, route, site and specific date of administration not reported) possibly during February 2010, and three to four days later, she experienced a loss of her sense of taste and sense of smell. It was not reported if the patient had any concurrent illness at the time of vaccination. Concomitant medications included Ativan, Elavil, Coumadine, Atenolol, and Zovasa. The patient had a past history of anorexia and "sulfa ?" allergy. At the time of the report, the patient's sense of smell and her ability to "taste anything" had not returned. Outcome was unknown. Documents held by sender: None.
Not feeling well; headache; tired; cough; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well, headache, tired, and cough. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sore arm, low grade fever, tiredness, cold chills, aches (lower back, knees, neck),headache.
Received vaccine in left arm in afternoon. Felt like foot was falling asleep that night. Woke in morning limping, favoring right leg, had stomach ache. Wasn't himself all day, still limping. Afebrile. As of 03/01/21 pt has fully recovered and is back to baseline.
09/29/2009 - L arm red at DTaP injection site (l deltoid). 09/30/2009 - L deltoid, red warm, edema and tender. 10/01/2009 - l deltoid increased swelling, warmth, tenderness. L Neuro changes sent to hospital circumference of l arm 2" bigger than r.
1 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.; 21 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old male patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 25-SEP-2023, the patient received the 2nd dose of Engerix B pediatric .5 ml. On 25-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 1 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.) and adult use of a child product (Verbatim: 21 year old came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose.). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter was a nurse practitioner reported that 21 year old patient came in for their 2nd dose of Engerix but received the pediatric 0.5 ml dose, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
At about 1030 am I began to have red spots on my neck, by 5-530 pm I had red raised rash all over face and neck, and my throat was itchy, took Benadryl all symptoms resolved about 2 hours after Benadryl
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided  it was reported date of registration on 5/7/2021
Patient had a redness at the site of injection till 11/13/10. She felt sick all night & until next morning after getting a vaccine.
Case number PHEH2012US015346 is an initial spontaneous report received from a nurse on 31 Jul 2012 and a follow up received on 27 Aug 2012: This report refers to a 24-year-old male patient. His medical history included of gastro esophageal reflux disease and allergy to penicillin. He was given only the MenA powder component of MENVEO vaccine (batch number: A10134) reconstituted with the sterile water instead of MENVEO diluent, intramuscularly on 31 Jul 2012. No other adverse reaction was reported following this administration error. The patient was asked to return on an unspecified date for revaccination. Follow up received from the nurse on 27 Aug 2012: Updated that the diluent used was sterile water (not the sterile diluent from mumps rubella vaccine as previously reported), medical history and allergy history.
15 minutes after injection, customer complained about metallic taste, tongue slightly swollen with small bubbles on each side of tongue. No difficulty in breathing. We asked to stay 15 minutes more for observation. Had tightness in the chest 5 minutes later. Called 911. Operator asks not to give water/benadryl/epipen.  EMT arrived 5 minutes later and assessed.  Watch 15-20 minutes later walked her out to car. We checked 6:45 pm still have metallic taste and just little swollen on tongue.  Called 3/5/21 @ 2:30pm no more symptoms., only from the JNJ shot. tiredness
Immediate dry throat. Thereafter, tightening of throat and difficulty swallowing until given benadryl 4 hours later. Covid arm, red hot at injection site for 1.5 weeks.
A 16 year old patient who received initial vaccination series on 03/30/21 and 04/20/21 received a booster dose on 12/4/21 in error. Attempted to contact patient about error.
Severe Headache; throwing up profusely; cough; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe Headache), VOMITING (throwing up profusely) and COUGH (cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Severe Headache). On an unknown date, the patient experienced VOMITING (throwing up profusely) and COUGH (cough). At the time of the report, HEADACHE (Severe Headache), VOMITING (throwing up profusely) and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient is 15 years old and received Pfizer vaccine.  At date of administration vaccine was only approved for those aged 16 and above.
I had vaccination on 09/28/2022. On 03/16/2023 I started to experience intense fatigue and a low grade fever. On 03/17/2023 I tested COVID-19 positive. I contacted my physician and was prescribed PAXLOVID and metformin. I had a rebound of COVID-19 and I am now on my second round of PAXLOVID.
Client states site of injection became red, warm to touch and painful. Called for advice. Was told to apply warm compresses and to take acetaminophen for pain. To call if further adverse affects. Client seen on 9/28/2011 and was noted to have a scabbed area at site of injection. No drainage, no inflammation. No pain.