chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PLEVA skin reaction; Initial information received on 16-Apr-2021 regarding an unsolicited valid non-serious case from a non health care professional (Patient's father) via Media Information (inquiry reference number: 00565102).  This case involves a 7 years old male patient who had PLEVA skin reaction after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Patient's parents stated that their son was not allergic to eggs, and that they were pretty sure he was not allergic to latex, or at least a latex allergy was not something that had ever come up.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 22-Sep-2011, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (total, lot VH460AA and expiration date not reported) via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious PLEVA skin reaction (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was reported that patient's father was asking for a list of ingredients for the 2011-2012 season flu vaccine. The reason he was asking, was that his son had a skin reaction to that vaccine, and since his son will be getting a Covid-19 (coronavirus disease) vaccine soon, probably the Pfizer, they want to compare ingredients and try to avoid a recurrence of the skin reaction.  No laboratory data reported.  Patient's father stated that the PLEVA was treated for a few months with medications (unspecified).  The patient recovered from the event on an unknown date.  It was reported that patient's parents stated that the adverse reaction was reported at the time to the pediatrician and to the Centers for Disease Control (CDC).
Excessive sweating; Full body aches day one; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 hours (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and migraine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); both started on an unknown date for unknown indication. It was unknown whether the patient had any allergies to medications, food, or other products. 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 medications or vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient experienced full body aches day one and excessive sweating and body aches on day 2 (06Apr2021). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events full body aches and excessive sweating were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 14 year old black female with no known drug allergies who on 28-OCT-2007 was vaccinated IM in the right deltoid with the first dose of GARDASIL (Lot# not reported).  There were no concomitant medication reported.  Subsequently on an unspecified date the patient experienced pain bilaterally in both arms up to her shoulders.  On 25-JAN-2008 the patient had a serum creatine kinase test which was reported to be 97 (WNL).  At the time of this report it was unknown if the patient had recovered from the arm pain.  Additional information has been requested.
Approximately 15 minutes after receiving vaccine, patient experienced stiffness and discomfort on left side of neck and shoulder and tingling/numbness in left arm.  Patient received vaccine on left arm.  Tingling progressed  to stomach and left side of face and left side of forehead  Temp=98.6F, O2=96%   BP=153/106  HR=71 at 08:50am.   BP=143/90 at 08:54.  Tingling improved on left arm at 8:55am.  Patient reported back becoming stiffness and tingling along both shoulders at 8:57am.  Tingling in left arm and stomach improving.  Patient released from clinic at 9:07am.
covid symptoms the 28th and tested positive; covid symptoms the 28th and tested positive; This is a spontaneous report from a Pfizer sponsored program from a contactable Nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 around 2 pm at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 28Dec2020 the patient experienced covid symptoms the 28th and tested positive. The patient underwent lab tests and procedures which included covid test positive on unknown date. The outcome was unknown.    The information on the batch/lot number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and COVID-19 test positive on the same day.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
An incident occurred where a resident received the Covid vaccine twice. The facility incorrectly split the residents in two units. The resident that was listed in Unit 2 was actually from unit 1. The facility is a single floor building. The first dose was administered by team 2 at 12:01 PM and the second dose was given by team 1 at 12:48 PM. Prior to vaccinating the residents. A store intern, informed the nurse, that a consent form was missing and nurse insisted she had one and to vaccinate her. The consent form was actually with the Unit/team 2. The patient is alert and oriented and is not experiencing any symptoms or side effects. She has been checked on every 30 minutes and is doing fine. The facility?s administrator documented the incident apologized for the mistake.
PAIN IN NECK; EYE PAIN; STOMACH PAIN; MUSCLE ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included headache. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pain in neck. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and was recovering from headache, pain in neck, eye pain, muscle ache, and fatigue. This report was non-serious.
CMA neglected to use the diluent to mix COVID vaccine (5-11yrs) and administered the vaccine to the PT. When I was aware of the situation, informed Dr. She wanted me to contact Pfizer for risks and recommendation to the PT. Pfizer stated there is a greater chance of the PT having Local & Systemic reactions. Pfizer said the contact CDC for further recommendation. CBC agreed with Pfizer but wanted the Incident reported to VAERS. Dr spoke with Patient's father to inform him of the situation and see if Patient was experiencing any symptoms. Father stated child went to school and feeling fine. Dr  explained signs & symptoms to watch out for.
Arm and shoulder pain , lack of range of motion , radiating pain down to the fingers , unable to lift arm
This case was reported by a healthcare professional (who was also the subject's mother) via a GSK representative, and described the occurrence of lymph node swelling a 15-year-old male subject who was vaccinated with Boostrix (GlaxoSmithKline). There were no concomitant medications or vaccinations. On 8 May 2009 the subject received unspecified dose of Boostrix (unknown route, right arm). On 9 May 2009, the morning after vaccination with Boostrix, the subject experienced lymph node swelling in the right arm. The subject was treated with Tylenol and/or Advil. The swelling had improved on 10 May 2009, and more on 11 May 2009. The subject refused Tylenol on 11 May 2009 "since it was better". The healthcare professional considered the event was probably related to vaccination with Boostrix.
day p/vax devel small lump @ inj site;2nd day area was very large, hard, bright red, & itchy;this cont x 4 days a/sx began to dec;today there is still a small lump @ site
About half an hour after getting my booster shot, I started to feel like it was slightly harder to breathe and had to walk slower. I had a slight shortness of breathe and overall heavy feeling in my chest area. I went straight home to rest and felt better after a few hours. At this point, I started to experience a low fever but it went away by the next day. I currently do still experience a slightly heavy feeling in my chest area from time to time when I sit down after walking at a moderate pace, which is not what I normally feel after walking at such pace.
This spontaneous report as received from a physician via company representative and a nurse refers to a female patient of unknown age. The information regarding medical history, drug reactions/allergies, concurrent conditions and concomitant medications was not reported. On 05-APR-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of administration, lot number and expiration date were not reported). On the same day, after sitting 15 to 20 minutes post vaccination, she required further resting. She had to lay down on exam table for several additional minutes. It was unknown if any further treatment was given (also reported as no treatment given). The outcome of the event was reported as not recovered at the time of the reporting. There had been no further adverse events reported. The causality between the event and GARDASIL 9 was not reported.
PATIENT CALLED ON SATURDAY SEPT 16 AND STATED SHE HAD GOTTEN HER FLU SHOT TWO DAYS PRIOR AND NOW HER ARM IS RED AND SORE AND IS SWOLLEN THE SIZE OF A BASEBALL. SHE HAD NOT DONE ANYTHING AT THE TIME TO TREAT IT.
Lethargic (couldn't wake at all), pale, screaming, staring seizures.
Patient says after he received PNEUMOVAX-23, the next day, the area was red, swollen, extremely sore, painful, couldn't pick up arm for 3-4 days. There was a redness circle that spread around arm and shoulder. This subsided in one week. This occurred in left arm.
Normal sore arm @3hrs, mod to severe all over body aching, chills started @8hrs lasted through the night about 12 hrs. accompanied by headache.  Fatigue after that but feeling better, then @32hrs lymph nodes under vaccinated arm became very swollen, about 1/2 tennis ball size, painful pressure with arm down at side.  Still swollen @48 hours (time of reporting) but otherwise feeling well.
Swelling of hands/ Swelling in the hands more than usual; general body pain/ pain in body; Pain in hand/ Pain in hands as a burning pain; Vaccination adverse reaction/ill effects on the left side of body; Vaccination site bruising/ bruises alot more often; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction/ill effects on the left side of body), VACCINATION SITE BRUISING (Vaccination site bruising/ bruises alot more often), PERIPHERAL SWELLING (Swelling of hands/ Swelling in the hands more than usual), PAIN (general body pain/ pain in body) and PAIN IN EXTREMITY (Pain in hand/ Pain in hands as a burning pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate Free). On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK (Citrate Free). In December 2020, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction/ill effects on the left side of body) and VACCINATION SITE BRUISING (Vaccination site bruising/ bruises alot more often). In April 2022, the patient experienced PAIN (general body pain/ pain in body) and PAIN IN EXTREMITY (Pain in hand/ Pain in hands as a burning pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of hands/ Swelling in the hands more than usual). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction/ill effects on the left side of body), VACCINATION SITE BRUISING (Vaccination site bruising/ bruises alot more often) and PAIN (general body pain/ pain in body) outcome was unknown and PERIPHERAL SWELLING (Swelling of hands/ Swelling in the hands more than usual) and PAIN IN EXTREMITY (Pain in hand/ Pain in hands as a burning pain) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Subsequent to receiving an injection of Flu Shield, pt was seen by a physician who diagnosed hepatitis B. Physician indicated in a follow-up report that he does not believe the pt developed hepatitis B as a result of the vax.
Breakthrough Case of COVID, I had a mild fever, congestion in my head and chest, muscle aches, and exhaustion. Went to the Dr. to get Paxlovid which is the anti viral medication.
Patient reported chest tightness after the vaccine into the night which resolved itself the next morning. Patient reported hives the next morning lasting 5 days. Redness at the site of injection presented itself after 7 days of the vaccine and was still there on 06/13/21
was extremely comfortable not at all nervous or scared to begin, bp 160/102, 15 mins later bp 253/127. Third bp check at 11:25 bp 131/86 10 mins later bp 129/84.
Started out with mosquito bite looking area at site of injection next day, then on Saturday started to see hives on ankle areas and smaller dots of hives spread out on leg areas/calves. Hives spread on ankles and calves and then spread to wrists and arms. Mother started to give child benadryl on Monday night and hydrocortisone cream and symptoms have been improving. Hives are slowly decreasing in size. Patient stated her right shoulder (injection given on right deltoid) started to hurt on Tuesday.
Health Department (HD) received her shot record prior to her coming to our vaccine clinic as this is standard practice for our agency. On her record that was faxed to HD, it only had her Covid 19 vaccine on it, with a date  08-24-2021. She was at our agency for other vaccines, so we administered her 2nd dose of  Pfizer. After clinic this PHN was in contact with the nurse and there were other shot records that HD hadn't received prior to client's appointment. Client had her Covid 19 first dose on 08-03-2021. Client received 3 Pfizer vaccines- 08-03-2021, 08-24-2021 and 09-13-2021. The record stating she had her first dose of Pfizer wasn't given to HD prior to client coming to receive vaccines. No adverse reactions were noted after vaccine was administered on 09-13-2021.
pt recvd vax; devel fever of 103 in 12 hrs; pain in joints; arthralgia, malaise; had vax every w/out a problem;recovered;
Case number PHEH2011US010118, is an initial spontaneous report received from a nurse on 21 Nov 2011 and a follow up received on 17 Dec 2013. This report refers to 65-year-old female patient. Her medical history and concomitant medications were not reported. She had no history of vaccination. She inadvertently received MENVEO (batch number X11022) at a dose of 0.5 ml intramuscularly into the left deltoid on 15 Nov 2011. No adverse event occurred following this administration. Follow-up was received from the nurse on 17 Dec 2013: Updated vaccination history, batch number, site and route of MENVEO.
This spontaneous report, which refers to a male patient of unknown age, was received from a company representative via the patient's mother. At the time of the report, the patient was 6 years old. No medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with rotavirus vaccine (manufacturer unknown), administered orally by default (lot number, expiration date, dose and frequency were not reported). No concomitant therapies were reported. On an unknown date, the patient was taken to an unspecified hospital since he experienced severe diarrhea and a fever of 103 degrees (unspecified units). The reporter also indicated that her son had experienced gastroenteritis every two or three weeks since the vaccination (date unspecified) but no action was taken when the patient had visited a gastroenterologist. Additionally, it was mentioned that the vaccination with rotavirus vaccine (manufacturer unknown), was not discontinued. The outcomes of severe diarrhea, gastroenteritis and fever of 103 degrees were reported as not recovered. No causal relationship was provided between the events and vaccination with the rotavirus vaccine (manufacturer unknown). There was no quality complaint reported. Additional information has been requested.
WEAK, CHILLS, JOINT PAIN, SORENESS, AND CHEST PAIN.
This spontaneous report has been received from a male patient of unknown age referring to himself. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose and route unspecified). On an unknown date the patient was vaccinated with second (extra) dose of PNEUMOVAX 23 (lot number, expiration date, dose and route unspecified), even though he was not considered high risk. No adverse event was reported. Additional information has been requested.
Pain in shoulders, esp when sleeping; more in left arm (injected arm) than right arm. Pain comes sharp.  Has not gone away in 6 mos.
Found an extra / vial alone / Guessing / a patient / received Menveo vial 1 liquid portion / alone; Found an extra / vial alone / Guessing / a patient / received Menveo vial 1 liquid portion / alone; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA439A, expiry date 31st August 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered only the liquid containing antigens C, W-135 and Y of Menveo without mixing the solution with the powder (antigen A), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The details regarding the patient was not reported. The reporter consented to follow up by email.
WIthin a few minutes of receiving the vaccine, she said her head was tingly and she didn't feel well. When she stood up, she felt dizzy and had to sit back down. The doctor had her come back into the back and checked her vitals, provided her snacks/water and monitored her for about an hour. After that, they helped bring her to the car for me (to ensure she didn't fall). When we got home, she went to her room and rested the rest of the day due to continuing to feel dizzy. When she woke up the next day, she felt better and was just tired. I made sure before she received the second dose that she drank a full bottle of water and she did not have the same reaction with it. She ended up contracting covid after the second dose.
Tested positive for Covid-19.  Symptoms include cough, sore throat, congestion, running nose, fatigue and light-headedness.; Tested positive for Covid-19.  Symptoms include cough, sore throat, congestion, running nose, fatigue and light-headedness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3248), on 22Mar2021 as dose 2, single (Lot number: EL3248) and on 01Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 42 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "recovering" and all described as "Tested positive for Covid-19.  Symptoms include cough, sore throat, congestion, running nose, fatigue and light-headedness.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive, notes: Nasal. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Addition information: Known allergies was none. Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination.
5 hours after I started feeling sick (fluish) and very dizzy. I get dizzy a lot. I went home and went to bed. The next morning I was too weak to shower but I had a procedure at 7 am on my left eye. I came home and went back to bed. I started taking Tylenol about 1200 mg every 12 hours and 2 small 12.5 mg of Benedryl. On Friday morning I was feeling a little better, but took the day off work. I tried to shower and when I undressed I noticed my torso was a complete rash from my groin, my shoulders, front and back.
11/8/06 Complained of soreness right arm. 11/8 awakened with redness, soreness, pain, itchy (size of dime). Developed fever 103 - 11/9 around 3 PM, headache, eyes burn, hurt. Alternating Tylenol, Motrin. TC from Mom - 11/13 - Ok. 11/10 - playing, no fever. Today arm still red - slightly itchy - in school. No PCP involvement.
Extreme itchiness (onset day after vaccination). Extreme swelling of all joints (onset 30 hours after vaccination). Went to Clinic on 10/25/2008 and was prescribed "Tapered Oral Steroid Therapy, Dexpac Jr. 10 Day."  Was able to fill prescription midday 10/26/2008. Very little mobility on 10/26 due to swelling and joint pain.