chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling of the entire upper arm; injection site swelling; pain at the injection site; needle was in his arm for a long period of time longer then any other vaccine he has had; This spontaneous report was received from a male patient of unknown age. The patient stated that he has never had any problems with vaccines in the past. There was no information about the patient's concurrent conditions, allergies and concomitant therapies provided.   On 25-JUN-2021 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one 0.5 milliliter injection into unspecified arm (strength, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient stated that during the vaccination the needle was in his arm for a long period of time, longer than any other vaccine he has had (wrong technique in product usage process).  On the vaccination day, the patient had a reaction to the vaccine. He experienced swelling of the entire upper arm, injection site swelling and pain at the injection site. The patient used ice and heating pad to relieve experienced symptoms. At the time of this report, the patient was recovering from the mentioned events.   The reporter considered all events to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Patient said he had pain his left arm after the shot, then it became inflammed and  red as the days progressed. Today when he  came in, it was red, hot to the touch  and inflammed.
Information has been received from a physician concerning a female who on 31-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 21-JUN-2007 the patient developed a full blown case of shingles just above the hip area.  The patient sought unspecified medical attention.  Additional information has been requested.
severely sick; no energy to get up; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D 3), ACETYLSALICYLIC ACID (ASPIRIN 81) and LEVOFLOXACIN (LEFOX [LEVOFLOXACIN]) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Patient was having cholesterol medicine at night and Cholesterol injection every other week on Tuesday as concomitant medication. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
pt recv vax & 3 to 4 hr later pt exp inability to move lt arm;could not feel anything but felt pain;exp throbbing;pt also devel swelling of tongue & slurred speech;pt did not exp a local rxn @ inj site;pt hosp for observation;
No adverse event at this time. Patient received his second dose of the Moderna COVID-19 vaccination only 14 days after his first dose (given 04/20/2021). Patient reported no adverse effects while under observation at the clinic and he was instructed to seek medical attention immediately should he begin to have any unusual symptoms.
pt recvd vax & 24 hrs p/vax pt devel a linear type of induration @ inject site (lt thigh); MD visit 48 hrs p/vax -site described as hot to touch w/ a woody feeling; not cellulitis;
COVID test result Positive; sinus; weak; flu like; decreased appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; LOSARTAN; ALOGLIPTIN. The following information was reported: COVID-19 (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "COVID test result Positive"; DECREASED APPETITE (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "flu like"; SINUS DISORDER (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "sinus"; ASTHENIA (non-serious) with onset 16Dec2022 at 04:00, outcome "recovering", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19, sinus disorder, asthenia, influenza like illness, decreased appetite.  Clinical course: Dose received 1 (bivalent was false), prior to getting the COVID booster on 15Dec2022 I had not had any COVID, Flu, or cold like symptoms. I was feeling fine. One Day later after getting the COVID booster I developed several symptoms coughing, headache, sinus, weak and sore muscles flue like, low grade temp, decreased appetite. No covid prior vaccination. No other vaccine in four weeks. COVID tested post vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swollen lymph nodes resulting in tonsil removal, tingling  and numbness in tongue,  constant ringing in ears,  possible hearing loss
syncope, felt dizzy, passed out for few seconds, asked to call paramedics, around 12/55 pm 7/23/21 , all his vital was ok, no hospitalization needed
I did not start to feel negative effects until a few hours after the shot. That afternoon and evening is when the arm pain began along with the redness. Hot and hard lump formed on arm where shot was given. For the next 4 days, I was incapacitated with weakness and fatigue. Severe body aches and pains in every muscle and joint of my body. Arm where shot was given was immobile with shooting pains all the way into the shoulder and arm pit and down to the fingers. My lower back was particularly painful. Severe headaches and sensitivity to light. No appetite. Severe nausea. Back and forth from chills with rigors to being hot and feverish. I did not check my temperature during this time. I would suspect I had a fever though, but I was taking NSAIDs around the clock so that may have prevented a high fever. The medication helped mildly but did not take away the symptoms. It is now 3/5/2019, five days after my shot was administered. I am still weak and fatigued. I have headaches and constant arm pain. The severity of the arm redness, hardness, hotness and pain have reduced considerably but still makes it difficult to use the arm. It gets very tired quickly and hurts more with engagement of the biceps and triceps. I still cannot sleep on that side.
mild neuro symptoms; Initial information received on 11-May-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a patient of unknown age and gender who experienced mild neuro symptoms,  after receiving vaccine YELLOW FEVER VACCINE -  [YF-VAX].  The patient's past medical history included received an organ ( Organ transplant.)  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an organ from the vaccinated individual who received an unknown dose of suspect yellow fever vaccine, unknown formulation and strength, ( lot number and expiry date:  not reported)  via unknown route in unknown administration site for prophylactic vaccination. The organs of the vaccinated individual were donated. Some of these organ recipients developed neurologic symptoms and YF virus was found in cerebrospinal  fluid (CSF) or brain tissue.  On an unknown date the patient experienced mild neuro symptoms (neurological symptom) (unknown latency) . This event was assessed as medically significant.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (mild neuro symptoms).  At time of reporting, the outcome was Unknown for the event mild neuro symptoms.; Sender's Comments: Sanofi company comment dated 17-May-2022: This case involves patient of an unknown age and gender who experienced mild neuro symptoms after receiving organ from vaccinated person with YELLOW FEVER VACCINE - [YF-VAX] . Case will be reevaluated post further update on concomitant medications, concurrent condition during vaccination, underlying disease, laboratory investigations excluding alternative etiologies for the reported event which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Immediately following vaccination 10/30/6, pt developed lump on R arm where tdap was given.  The following AM pt woke up with itching dots under that same arm & throughout the day developed itching under her shirt which she attributed to the tags inside her clothing.  When her husband was cutting the tags from her clothing that afternoon, he observed that there were welts at sight of tag & on legs and belly.  Visited family MD @ 2-3pm that day as breakout was increasing and now encompassed entire body.  She was given a shot of "prednisone".  About 8pm that evening, her mother observed that her neck and eyes were swelling and the pt was complaining of her throat tingling--her mother observed her throat was full of welts.  In the interim, the pt took one Benadryl po.  The patient also did an Aveeno bath & used Aveeno lotion.   By the following AM the welts had subsided.  The patient was afraid to go to bed that evening, because she feared she would quit breathing with the tingling feeling she was having in her throat.  Family MD attributed rxn to thimerisol in flu and dtap vaccine pt rcv'd 10/30/6.
Patient returned on 10/12/20 for follow up. It was at that  time the patients mother notified the provider of an "eczema like" rash that formed on the childs right arm as a straight line from his shoulder down his arm. Mom states the rash formed within a day or two after receiving the vaccines.
Bad headache and Nausea from 4:00am until 5:00pm.
Arm very sore at injection site a few hours after vaccination, and for about 2-3 days afterward. Moving the arm helped alleviate the soreness. Also took a bath and ibuprofen.
2ND BOOSTER, 4TH OVERALL DOSE OF PFIZER COVID-19 VACCINE PRESENTED WITH BODY ACHES, LOW GRADE FEVER AND HEADACHE OCCURING WITHIN 12 HOURS POST-VACCINATION
shingles; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 22Apr2021 at 15:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08May2021 at 21:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir.  The clinical outcome of the event shingles was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Pt received the varicella vaccination on 5/11/22, on 5/12/22 she noticed a large red area at the site of the varicella vaccination. On 5/13/22 a large area of redness had spread down her upper arm.  She called the clinic to inquire about treatment and a Virtual visit was scheduled with Dr. at that time.
This spontaneous report as received from a medical assistant refers to a pediatric patient of unknown age. On 05-JUL-2013 the patient was vaccinated with VAQTA, (intramuscular, 1 ml; lot number unknown). The medical assistant noted that the pediatric patient was administered an adult dose of VAQTA. No adverse event was reported. Additional information has been requested.
Severe body aches, weak, dizzy,  fever, runny nose,  chills, sweating for 5 days with ongoing continued weakness.  Call doctor, was advised to take OTC painkiller. It did not relieve the symptoms.
Received COVID-19 vaccine on Thursday (01/07/2021). Injection sight soreness started in the evening and lasted through Saturday (01/09/2021). Woke up at 5am (Tuesday, 01/12/2020)  with a  headache and took some ibuprofen. Went back to sleep and woke up at 630am sweating with mild body aches. Fever/ chills and body aches worsened Tuesday evening into Wednesday. Resolved Thursday afternoon. Symptoms managed with ibuprofen and fluids.
Very severe excruciating pain in left arm. Could not move arm.  Felt like nerve pain, very sharp, and stinging.  Pain subsided over 3 days.
Initial report received on 05 March 2007 from a health care professional. A 25-year-old female patient had received a first dose injection of YF-Vax, lot number UE984AA, on 26 February 2007. Route and site of administration were not known. The patient had a history of anaphylaxis to steroids and Stevens-Johnson Syndrome (6 years ago) after taking Biaxin. Two days post-immunization, the patient experienced severe fatigue and "just not feeling well." On 04 March 2007, she began experiencing severe back pain which "continues." The patient "called the doctor should be seen by infectious disease doctor." The patient had not been examined by a physician at the time of this report. Recovery status was marked as unknown and not recovered. Follow-up information received on 23 April 2007. The patient also received Typhim Vi (lot number 3001160) per os on 26 February 2007, IPV (lot number Z 548) subcutaneously (site of administration not reported) on 26 March 2007 and Menomune (lot number, route, site and date of administration not reported). She did not have any illness at the time of the vaccinations and she was taking Singulair and Atarax. The patient did not see a physician. On 03 March 2007, she was feeling well, completely recovered.
Client left clinic Tuesday early morning and later in the evening around 11pm client reports fever 100-103 degree and vomiting through night fever continues through today @ 12 noon.
Information has been received from a physician concerning an 11 year old female who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Two weeks after vaccination, the patient developed four pox. It was reported that she was afebrile. Unspecified medical attention was sought and medication was not needed to treat the outbreak. There was no product quality complaint involved. Additional information has been requested.
NO ADVERSE EVENTS, BEYOND USE DATE WAS 03/25/22 AND APTIENT WAS GIVEN A DOSE ON 03/26/2022 FOR THE EXPIRED VACCINE
I experienced heart palpitations and fluttering whenever I sat up in a chair or leaned forward.  This lasted only a few seconds but was consistent beginning 2-3 days after the first dose.  The palpitations and fluttering began to fade about 2.5 weeks later but reappeared after I received the 2nd dose 3 weeks later.  The palpitations/fluttering finally went away 2-3 weeks after the 2nd dose and I have had no issues since.  In total, I experienced the palpitations for about 6 weeks.
two 16 year old patients that received the Moderna covid vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two 16 year old patients that received the Moderna covid vaccination) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 02B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 03-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two 16 year old patients that received the Moderna covid vaccination). On 03-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two 16 year old patients that received the Moderna covid vaccination) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-067524 (Patient Link).
no adverse event; Nurse called to report a temperature excursion PROQUAD was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 20-JUL-2021 the patient was vaccinated with an improerly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 time dose, lot number T027294, expiration date 08-FEB-2022 (route of administration was not reported) for prophylaxis. No adverse event was reported.  The temperature excursion was of -12.6 degrees Celsius (°C) for 15 minutes. The vaccine has previous temperature excursions on unknown dates from -10°C to 8°C with an average of 3.3°Crs and 45 minutes and between -50°C and -15°C with an average of -15.1°C for 15 minutes. The call was due to digital data logger.
~ 8 hrs after vaccination (3am) woke up w/severe chills, muscle & joint ache, headache, Difficulty sleeping. Got up 2.5 hrs later than normal - symptoms worse - difficult to walk downstairs. Stayed home from work - also stomach-area pain (not nausea) & loss of appetite. Took 2 doses of ibuprofen - somewhat improved - worked next day but symptoms lasted 2 more days. Muscle pain in arm from injection lasted ~ 4 days but not concern. Main symptoms of feeling like "hit by a truck" & chills were-headache were and for several days. Didn't go to Dr. so she is not aware of side effects.
Patient came in complaining that she was having weakness and dizziness.  She was having trouble standing up from seated position.  She was also having trouble walking in a straight line.  Her husband was with her and drove her to the ER after leaving the pharmacy.
Just after midnight, I was watching TV with my brother after smoking a medical pre-roll (I'm a medical marijuana patient). Shortly after, I began feeling dizzy. I finished my glass of water and the dizziness subsided for roughly ten minutes, before returning even worse than before.  I went to get more water and after filling my glass and closing the refrigerator, I was barely able to walk the few steps from my kitchen to the living room to lie down on the couch.  At this time, my chest started feeling tight, and I had a light tingling sensation in my feet and lower body.  When I closed my eyes, the dizziness got worse, and laying in certain positions made the tightness in my upper chest become painful. I continued to drink water and ate a little, but the episode lasted between 30-60 minutes of mild discomfort ranging to a decent amount of pain. There was a moment when I had considered going to the hospital, but after eating, drinking, and doing some controlled breathing, the pain lessened I ended up falling asleep on the couch.  I woke up feeling considerably better, but decided to call out of work so I wouldn't do any strenuous activity. On occassion I still feel like there's a little bit of pressure or tightness in my upper chest,  but nothing painful or debilitating like the night of the incident
Information has been received from a consumer concerning her 12 year old daughter with a history of surgery for birth defects and allergic to erythromycin who on 15-JAN-2007 and 16-FEB-2007 was vaccinated with a first and second dose of Gardasil, respectively. There was no concomitant medication. On 22-FEB-2007 'last night", the consumer's daughter experienced headache, sore throat, neck pain and her lips were swollen. No medical attention was sought. No laboratory studies were performed. At the time of this report, the consumer's daughter had not recovered. It was also reported that she tolerated her first of the vaccine with any events. The consumer plans on having her daughter receive the third dose of the vaccine. No product quality complaint was involved. Additional information is not expected.
Itching at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itching at the injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O25620A) for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient experienced Itching at the injection site.  The patient was treated with Tranquilizer.  Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced a non-serious expected event of Injection site pruritus on the same day after receiving their first of two planned doses of mRNA-1273 (Lot #O25620A).  Treatment included Tranquilizer. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
AFTER INJECTION PATIENT COMPLAINED OF THROAT BURNING. ( LIKE TIRED MUSCLES).  GAVE PATIENT DOSE OF BENADRYL 25MG LIQUID
ITCHING, SWELLING, RAISED ABOUT 1 INCH AT THE SITE AND ABOUT THE SIZE OF AND EGG CUT IN HALF
Vaccination on 1/5/21. Developed redness and swelling and itching to injection site on 1/12/2021. Took Benadryl and applied topical hydrocortisone to area on 1/12/21.  Seen in clinic on 1/13/21. DX Cellulitis. Started on Duricef 1/13/2021 and advised on supportive care.
This case was reported by a physician via sales representative and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with HAVRIX 720, GlaxoSmithKline.  Concurrent vaccinations received the same day were unspecified, but may have included live attenuated measles, mumps (strain not specified), rubella vaccine (MMR).  In 2007 on an unspecified date within the last two weeks of this report, the subject received unspecified dose of HAVRIX 720 (unknown).  Immediately after vaccination with HAVRIX 720, the subject experienced swelling injection site.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was probably related to vaccination with HAVRIX 720.