chrisvoncsefalvay/vaers-outcomes huggingface dataset:
incorrect product storage; No additional AE; a dose of ROTATEQ was inadvertently administered after it's expiration date; This spontaneous report was received from a licensed practical nurse, referring to a 6-month-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 29-MAR-2022, the patient was vaccinated with the third dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707459, expiration date 27-MAR-2022, previous dose#: 2, 2 milliliter, strength was not provided) orally for prophylaxis (expired product administered). Other suspect therapies included hepatitis b vaccine (recombinant)(manufacture unknown) (lot# 7574E, expiration date: 29-DEC-2022, intramuscular (IM)), pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) (also reported as PCV13)(lot# ej4559, expiration date: 30-JUN-2023, IM) and diphtheria vaccine toxoid, hib vaccine, pertussis vaccine, polio vaccine inact, tetanus vaccine toxoid(DTPA IPV HIB VACCINE) (lot# U5544AA, expiration date: 10-JUL-2022, IM). The medication error occurred in the storage in clinical Practice (product storage error). The operator of vaccine was a healthcare professional, who was trained. The patient had no adverse reaction from occurrence. No additional adverse event details.
Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of the Gardasil. Subsequently, the patient had an "abnormal Pap test and was HPV positive." It was reported that the patient had a normal pap result prior to receiving the Gardasil. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Muscle hot to the touch; Injection site bumpy; Injection site swollen; Injection site itchy; Muscle fatigue; Lymph node pain; Pain at injection site; Redness at injection site; A spontaneous report was received from a 38-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness and pain at injection site, muscle fatigue and lymph node pain, injection site bumpy, swollen, red and itchy and muscle hot to the touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 026L20A) intramuscularly in her left deltoid for prophylaxis of COVID-19.  On 30 Dec 2020, the patient experienced redness and pain at the injection site.  On 03 Jan 2021, the patient stated she started to experience muscle fatigue and lymph node pain on left arm.   On 06 Jan 2021, the patient noticed her arm became bumpy, swollen, red and itchy.   On 07 Jan 2021, the patient woke up to her arm being big, swollen, firm, rem bump and her muscle hot to the touch. Patient still fatigued and still has lymph node pain in her arm. Treatment included ibuprofen and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, muscle fatigue, lymph node pain, redness and pain at injection site, injection site bumpy, swollen, red and itchy and muscle hot to the touch were unknown.; Reporter's Comments: This case concerns a 38 Y/O M who had NS events of unexpected injection site warmth, injection site papule, muscle fatigue and expected injection site pain, injection site swelling, injection site erythema, injection site pruritus, lymph node pain. Event onset the same day as first dose mRNA-1273. Treatment ibuprofen and cetirizine. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
After waiting the 15 minute observation period, pt became dizzy when she was walking out to leave.  She then fell, landing onto her left arm.  She was observed for one hour, vital signs taken every 15 minutes.  Patient continued to complain of nausea.  Patient was then transferred to the emergency department.
he wants to know how long he is supposed to feel like sleeping all day; Lymph nodes swollen; Sore throat; loss appetite; achy; Tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient receive first dose of BNT162B2 (Batch/lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 22Dec2020 10:58 at single dose (injection in to left arm) for COVID-19 immunization. Medical history included asthma from 2013 and ongoing (Started seven years ago). The patient's concomitant medications included ongoing fluticasone propionate, salmeterol xinafoate (ADVAIR) powder inhalation, 550, one puff by mouth every 12 hours for asthma. The patient experienced lymph nodes swollen, sore throat, loss appetite, achy, tired, all on 22Dec2020, feel like sleeping all day on an unspecified date. He stated he is a firefighter and received the vaccine yesterday. He initially stated he wants to know how long he is supposed to feel like sleeping all day. He later stated after getting the vaccine he had side effects. His lymph nodes were swollen, he feels achy, and tired. His lymph nodes started swelling around 4 yesterday afternoons. He started to feel better last night and today since he started moving around. He would say comparing to last night the outcome of lymph nodes swelling is about the same. He also started to experience a touch of sore throat. When he touched his lymph nodes he can tell it was swollen. He also had a loss of appetite. He stated he just did not feel like eating. He did not have lunch. He ate some little pieces of an orange and ice cream to make his throat comfortable. When he woke up this morning he is not feeling as bad as he was yesterday. He has been more active throughout the day and does not know if that had anything to do with it. Feeling tired started around 2 yesterday afternoon. The outcome of events for lymph nodes swollen, feel like sleeping all day was unknown, for sore throat, loss appetite was resolving, for other events was not resolved.
While not life threatening, I have had joint pain. After dose one of Pfizer COVID vaccine, I began having arthritis pain throughout my body. It lingers even now on 8/15/2021. I have had to wear wrist braces, apply OTC cream, and take an OTC pain reliever. The pain has disrupted my sleep and limited my normal activities at work and hone. These pain management measures are not things I had to do in my daily life prior to the vaccine. I also continue to have a scratchy throat and mild cough. I just wanted to report my personal experience in hopes of contributing to what others might expect with the vaccine.
Information has been received from a physician concerning a 12 year old female who on 05-AUG-2005 was vaccinated with a dose of VARIVAX(Merck). On 10-AUG-2005 the patient experienced pain in her left arm injection site. This was followed on 13-AUG-2005 by appearance of greater than 100 injection site lesions which the physician believes to be characteristic of shingles lesions. The patient was seen by a health professional at a facility on an unspecified date and on 17-AUG-2005 the patient began a 10 day course of treatment with valacyclovir. A second 10 day course of valacyclovir was necessary. The patient was also given Vicodin for pain. There was no information regarding the patient's present status. No product quality complain was involved. The physician considered the adverse experiences to be other important medical events. Additional information has been requested.
patient developedred swollen arm on 7-20-2007 in the right arm. on 7-20-07 parent called back regarding patients arm having increasing swelling along with neck and chest.patient was not haveing any difficulties with breathing. on 7-23-07 patient called to inform doctor that patient doing better but arm was still swollen.on 10-02-07 patient came in saying that child is developing welts periodically in the sam arm, since the vaccine.
BODY ACHE; CHILLS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a 23 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, and low fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low fever and body ache was not reported. This report was non-serious.
Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable
Benign paroxysmal positional vertigo would cause intense discomfort when first laying down or first sitting up.  It made it difficult to exercise and move around.  It also caused nausea. Doctor prescribed meclizine and Eply maneuvers to treat.  Symptoms decreased significantly after the first week of treatment and largely went away  three weeks later.
Client complained of feeling of heaviness in chest.  Client monitored by EMT/Paramedic in ambulance at the site, EKG normal per healthcare personnel but client requested to be transported to ER
After 7-8 days I noticed redness at the site. Then the redness grew larger with some swelling and slight itching
Starting 10/09/2022, I developed a minor sore throat in the evening. On Monday, it started out as sneezing and a runny nose in the afternoon. Monday evening, I started having body aches along with the sneezing and runny nose. On Tuesday, I woke up with body aches, a fever of 102, minor cough, headache, burning eyes, runny nose and I mostly stayed in bed until mid afternoon. When I did get up, my skin was pretty sensitive to touch. I took a COVID test that day and it was almost instantly positive. I called the doctor that day and they scheduled my telemedicine appointment for that coming Monday and sent a Z-PAK immediately which I started. When I spoke to them, they put me on a steroid (MEDROL dose pack). I slowly got better each day after the telehealth visit. On Thursday, I just had a cough, runny nose and headache. Even today I still have a head cold: Sneezing, coughing and runny nose. I'm slowly getting better but the head cold is lingering.
Flu dose given on 9/28/18 and 10/12/18 on a 26 y/o.
Received DTAP on 7/15/02. Quarter-sized erythema and induration noted the day of immunization, progressively increasing to the present area of induration. 12cm X 17cm area at 48 hours, post vax. Physical exam: afebrile, playful toddler with normal gait.
Patient indicates "mild reaction". Inj. site is red and swollen (small bump). She is experiencing some pain and also has a sore throat. Said she feels sick.
Increased erythema, warmth & tenderness of the right thigh - increasing 8 x 8cm - was treated with KEFLEX for possible cellulitis due to the degree of induration, warmth & tenderness.
General aches and pains and mild flu-like symptoms evening and overnight.  Again, same symptoms on 12/22/2010 and 12/23/2010, this time requiring ibuprofen to be able to sleep.  Nothing more thereafter.
Nurses gave all the mentioned vaccination at a time. After the immunization, my son started getting infantile seizure.  We visited to hospital Neurologic  team. They gave high doses of Keppra, ACTH injection, Sabril medicine and Onfi. My son was one month in ICU. He was getting silent seizure. He has too much delay too in growth. He can not speak, walk properly, and remain on his world.
Excruciating pain in the upper left arm shot was given. Pain lasted ten (10) days.
hives over my entire body; itching on the trunk of my body that spread to the entire body by that evening.; This is a spontaneous report from a contactable consumer (patient).   A 37-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 15Apr2021 15:00 (at the age of 37-year-old) (Batch/Lot Number: EW0158) as dose number unknown, single for COVID-19 immunisation. Medical history included none. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced itching on the trunk of my body that spread to the entire body by that evening (medically significant) on 19Apr2021 06:30 with outcome of not recovered, hives over my entire body (medically significant) on 20Apr2021 with outcome of not recovered. Events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course of events was as follows: On Monday 19Apr2021 patient started out with itching on the trunk of his body that spread to the entire body by that evening. He went to the doctor on that day and was told to take an antihistamine Benedryl. The next day as this continued he developed hives over his entire body. After dealing with them for a day he sought medical attention again and was given a steroid shot to counteract the reaction. He was beginning to feel a little better but have a lot of recovery left. COVID was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Large local red rash at the injection site. Hot to the touch, very itchy. Applied cortisone topical and took PO Benadryl  for a few days. The rash started to improve after three days of taking Benadryl.
No adverse effects reported; expired VARIVAX was administered to a patient; This spontaneous report was received from a nurse and refers to a 19-year-old male patient. His pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 22-JUL-2020, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R017365 was found be not a valid number with a reported expiration date of 06-JUN-2020 (exact dose and route of administration were not reported) for prophylaxis. There were no adverse events reported. The outcome was not reported.
Arm red, sore, swollen, and rash down arm, bruising as well took Benadryl and Tylenol.
The patient had redness, fatigue, arm pain, and felt unwell starting about 12 hours after. The redness continued to widen to a circle of around 4 inches in diameter by day 3. The arm pain  and fatigue started decreasing on day 4.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 08:00 (Lot number: EW0217) at the age of 49 years as dose 3  (booster), single. for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular, Time: 08:30 AM), administration date: 16Mar2021, when the patient was 48 years old, for Covid-19 immunization, reaction(s): "Feverish (99-100F), felt feverish", "Body aches, achy", "felt tired", "Pain at injection site", "lethargy (Need to sleep)"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular, Time: 08:30 AM), administration date: 23Feb2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Oct2021 08:00, outcome "unknown", described as "Receiving the booster shot "; FATIGUE (non-serious) with onset 28Oct2021 07:00, outcome "recovered" (29Oct2021), described as "felt tired"; PYREXIA (non-serious) with onset 28Oct2021 07:00, outcome "recovered" (29Oct2021), described as "slight fever"; PAIN (non-serious) with onset 28Oct2021 07:00, outcome "recovered" (29Oct2021), described as "a little achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, pain. Additional information: There was no other vaccine in four weeks. After receiving her 2nd vaccine shot, the next day she felt feverish and achy and tired, by the following day she felt fine. After receiving the booster shot, the patient had the same symptoms the following day and the day after that she felt fine. It was reported as non-serious. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021297739 same patient/reporter/drug in different doses with similar events.
This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, intramuscular injection, lot number N030849 and expiration date on 09-JUN-2019, for prophylaxis (dose and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of 47.1 degrees Fahrenheit for 1 hour, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
EXPECTED SIDE EFFECTS; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced expected side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expected side effects was not reported. This report was non-serious.
urticaria, generalized;had lumpy areas devel in areas where pt had heparin SC p/surgery;
Flushing; Redness in face, big red patch on forehead and cheeks; Forgetfulness, memory is foggy; Weakness; Feels weird, doesn't fee herself/almost feels like a zombie; she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe; Pounding headache, Her headaches have continued 24/7, she has nails in her head; Her eyes were swollen and droopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine headache (once a year) and Asthma (used her inhaler as needed and not very often).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head) (seriousness criterion medically significant) and EYE SWELLING (Her eyes were swollen and droopy). On an unknown date, the patient experienced FLUSHING (Flushing), ERYTHEMA (Redness in face, big red patch on forehead and cheeks), MEMORY IMPAIRMENT (Forgetfulness, memory is foggy), ASTHENIA (Weakness), FEELING ABNORMAL (Feels weird, doesn't fee herself/almost feels like a zombie) and DYSPNOEA (she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe). The patient was treated with MORPHINE (intravenous) at a dose of UNK dosage form. At the time of the report, HEADACHE (Pounding headache, Her headaches have continued 24/7, she has nails in her head), FLUSHING (Flushing), ERYTHEMA (Redness in face, big red patch on forehead and cheeks), MEMORY IMPAIRMENT (Forgetfulness, memory is foggy), ASTHENIA (Weakness), FEELING ABNORMAL (Feels weird, doesn't fee herself/almost feels like a zombie) and DYSPNOEA (she needs her inhaler more often due to shortness of breath/ She feels like she can't breathe) had not resolved and EYE SWELLING (Her eyes were swollen and droopy) outcome was unknown.            No concomitant medications were reported.  Lab data included a Computed tomography (CAT) scan in the emergency room with unknown results.  Other treatment medications included antibiotics and steroid injection.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-187087 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A nurse reported that a 56 year old female received an injection of Pnu-Imune 23 on 11/16/00 and within hours, post vax, the pt developed an injection site reaction characterized by redness, pruritus and swelling which extended from the site of the injection to the elbow. She was treated with Atarax (hydroxyzine) and Medrol (methylprednisolone). This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474939.
Pt. states that after receiving the 1st dose of Moderna 08/18/2021, started experiencing symptoms 08/18/2021 right after of stuffiness, eye pain, dry cough, mucus, and drainage. Slight chills, body aches, arm numbness, drowsiness, and weakness in the left arm. Currently breastfeeding (concerned), no noted Primary visit.
About 6 hours after receiving the vaccine I felt bad enough to go to the Emergency Room, I did not go because I was hoping it would pass,  I felt 100 times worse than I did when I had Covid.  I had full body chills, I was shaking back and forth, my head was pounding so hard it felt like someone had a hammer to it, I got in a hot bath and it felt ice cold to me, I was throwing up, couldnt lay down because every part of my body that was touching something was in terrible pain.  Could not sleep.  The next day I had all of the same symptoms except I was sweating a lot along with everything else.  These symptoms lasted three full days.  It has now been exactly three week, I still have pain in my arm the shot was is, it hurts to raise it.  I also still have an incredibly awful headache that will not go away, I hadn't had a headache is years and years prior to this, I overall have not felt well ever since I got the shot and my reaction was incredibly awful.  Now I have concerns about my headache and body aches that still are not subsiding.