chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is my first booster (my second shot in the two dose shot gave me a reaction as well). I ran a high fever, above 100 degrees (I normally do not even have normal 98.6 temp), even though I did tylenol every 4 hours. My left arm at the injection site has been very tender since the shot, even 6 days later and was swollen at the injection site. My lymph nodes under my arm and up to my collarbone on my left side were also very painful and swollen. On Friday night, after hving run moderately high temp all day, I got very sweaty and plummeted in temperature down to 93.4. I have had an overall headache, different from my typical migraines, and have felt dizzy and off since getting the shot.
3 minutes after the vaccine was administered I had a Complement Immune System Pathway reaction.  I have been dizzy every since. I have had intestinal issue. the next day I almost fainted and my heart was racing. I went to the ER with palpitations dizziness and elevated blood pressure. EKG (dr said it was normal but I retrieved the report which says inferior infarction and abnormal ECG) and blood pressure(138/83)  readings taken.
Same evening, child broke out with itchy rash on face and trunk.  Child was lethargic all evening.  Also, child had temperature that day - lasted for 2 days - increased to 102.5.  Rash disappeared by following AM - after 2 doses of oral Benadryl.  Also, experienced nausea.  Sore throat, decreased appetite and stomach pain day after vaccines.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that a patient received an expired dose of PNEUMOVAX23 lot# 0491AE, expiration date: 15-SEP-2013 on 29-OCT-2013. No adverse effect reported. Additional information has been requested.
Presented on 8/24/05 with c/o flu like sx. following his smallpox vaccination 9 days prior. Noted with elevated temp of 100.5. C/O chills, shakes, and inability to sleep for the past 3 days. Started with cough the am of the 24th. Has been using Tylenol/Ibuprofen for fever and chills.
This spontaneous report as received from a medical assistant refers to 1 of the two different patients of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. On an unknown date within minutes after receiving the GARDASIL 9 the patient experienced arm pain. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of pain in extremity was unknown. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality compliant reported. This is one of the two reports from the same source. Sender's Comments: US-009507513-1803USA004532.
Heart pain, this actually happened after both shots. The pain went away but it was enough That she never mentioned it to me out of concern
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose, after 12 hours of first puncture.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose, after 12 hours of first puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose, after 12 hours of first puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-348276 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received and reporters details updated.
1 week (8/16/21) after vaccine had onset of dizziness causing a fall. On 8/19/21 had another fall hitting head and had to go to the ER.  Hospitalized for 1 night with numerous testing.  Continues to be dizzy -walking with walker along with assistance.
Arm very sore and very swollen. 2 inch larger arm circumference on the arm where I got the shot.  Hurts to move arm. The pain is the entire biceps muscle, and also the back of the arm near the injection site. Skin slightly red.
Starting early last week I was having awful pain in calf. Went to ER and they gave me an ultrasound. Diagnosed with dvt. I?m not for sure saying it is from the vaccine just that I definitely think it could be as I have no other factors that would make sense of why me, a young 26 year old healthy girl has a blood clot.
Patient developed rash on both arms 1 week post vaccine injection. He tried hydrocodone and rash got worse. When he came for f/u several weeks later, I saw the rash but at that time the lesions were in advanced process of healing.
Menactra exposed to - 51 Fahrenheit for about 14 hours, with no adverse event; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from a physician.   This case involves an 11 years old male patient for whom reported MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] exposed to - 51 fahrenheit for about 14 hours.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS PERTUSSIS VACCINE); and HPV VACCINE.  On 18-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6919AA and expiry date: 13-Apr-2022] via an intramuscular route at left deltoid for prophylactic vaccination.  It was case of actual medication error due to product storage error [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Experienced the common side effects that have been listed with the 2nd dose: lethargic, muscle aches and pains (severe), headache, nausea, nasal congestion, chills. They all gradually kicked in from the evening of 4/20 and got worse throughout 4/21.  Only noticed mid-morning on 4/21 that I had a black tongue. It wasn't swollen or anything... it didn't hurt. But it was black. No idea when that began. I only noticed it around 11am. Tried googling it but found nothing.  I called the Health Dept, but they didn't know what to tell me. I spoke to one of their nurses, but she said if it wasn't painful or affecting my breathing, it was probably nothing to worry about. They told me to call a representative of the City, but he never picked up the phone. I tried calling the CDC 24 hour helpline, but I couldn't get through to a human being.  My tongue has gradually been getting its normal color back, starting at the tip and slowly working its way back. It's now 8.30pm. My tongue is still discolored, but it's nothing like it was.
Fever from 99 to 102 over a 3 day period, severe arm pain, back, legs, neck and head pain
TINGLING ON THE TIP OF MY TONGUE!!!  ITCHY SCALP AND SKIN LEGS AND ARMS STARTED  ABOUT  HOUR AND HALF AFTER SHOT   DRANK WATER IT LASTED 15 TO 20 MINUTES.  SOME DAYS STILL  ITCHY AND TIRES ALSO  EXTREME FATIGUE
1/3 of lower arm redness, from site of injection down on (L) arm. Swelling at site of injection. Improving with time, no treatment.
Pt stated immediate pain at injection site. Localized significant swelling without erythema at site of injection. (left deltoid)
Red, and itchiness noted to injection site first 24-48 hours. 7 days later, raised, reddened area (length of emp index finger) noted.
Client had hep B vaccine 11 am on 9/16/02, at 1pm becam edizzylightheaded and sweating (hives started on stomach and inner arm went away that night). 4pm had diff. breathing-used inhaler she was routinely with diffs. breathing hx of asthma about 6pm was same as 4pm, was okay after that. She did not seek medical attention. reported alone when returned for PPD reading on 9/19/02.
On 4/28/99, the pt received his first IM deltoid dose of Lymerix.  Subsequently, he experienced brachial plexitis. An MD visit was required, treatment is unknown.  The most recent information received 12/7/99 reports the condition of the pt as unknown.
1/2 hour after receiving the vaccine she felt like her she felt like her throat was swelling and scratchy.  She said it scared her , and she ended up  stopping at a store and took Benadryl and then she was ok. She?s doing better today but her Lymph nodes are swollen under her arm.
pt recv vax & the next day pt devel 2 areas of petechiae on each side;
This spontaneous report have been reported from a female patient of unknown age, who was reporting on herself. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) injection (reported as "Pneumonia vaccine"; dose and route of administration were not reported) and with a dose of an unspecified influenza virus vaccine (reported as "flu shot"; dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced some unspecified adverse reactions. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between the event and the suspect vaccines was not provided. Additional information is not expected as the patient declined to take part in the adverse event report.
Dizziness, Headache, fatigued, pain in left arm @ injection site  Narrative:
After Janssen vaccine shot, patient was asked to sit and wait for 15 minutes. During the wait time patient was walking around and felt fine. About 10 minutes later patient looked a little pale. Told him to sit down and gave some water and a power bar. Patient had a seizure and past out for a few second. Patient regain consciousness and we lay him down on the ground. Breathing was normal. We called 911 and when EMT checked his vitals, his blood pressure was low. Patient was then taken to hospital for further monitoring.
Mood swings, joint pain, fatigue, nausea, itchy skin on March 01 2003 was diagnosed with GERD in April 03 and given Prilosec. Proteinuria on May 2005 was later sent to ER because of vomiting profusely. Diagnosed with focal segmental glomerulosclerosis. Currently on Meds. Rashes May 2005 depreciating strength in left arm Jun 05. Additional terms from Medical Record rec'd 01/18/2006: preexisting condition--chronic back and shoulder pain/sr Per 60 day follow up report-Painful joints in neck, lower, upper back, itchy skin, rashes, nausea, vomiting, fatigue, memory loss (short term) unable to focus. Depreciated strength in left side arm, shoulder. I have been to numerous specialist and I can not find out what is wrong with me. There is no other logical explanation I have too many symptoms for doctors to understand.
Rec'd phone call from mother on 11/12/02 at 8:50am. Mom reports that within one hour of vaccine, child started scratching at Lg. She reports leg from groin to knee (swollen), red, raised area above inj site. Warm to touch, denies fever of resp distress.
11DEC91 pt fever 104 13DEC91 rash on shoulder & neck spoke w/nurse on 13DEC91 told to contact MD cool bath & dec temp; Dad states temp dec pt doing fine now;
My arm is red and  Swollen. It is hard to the touch. I have had a headache and very tired. My legs started hurting at work  , they felt very heavy andI barely made it through the rest of the afternoon.    Today I've been very fatigued and Nauseous, and as of last night I haven't ate much much. Not very hungry
I began feeling an itchy irritades right eye symptoms over the weekend but I didn't give much attention to it. By the following Monday after the vaccine I had woken up with a red itchy right eye, I thought I had just cought a case of pink eye which I had twice before in my life so I kept the area clean and suspecting it would clear up within a day or two as it normally had done in the past. It wasn't until after two days after that the condition was only worsening, now my eye was red and swollen, itchy and painful barely able to open and oozing yellow greenish puss, when I finally decided something was worse than any infection I had ever gotten. To avoid infecting anyone else I reamined locked in my room avoiding all contact even with my own husband and son. I scheduled a doctor's visit with Dr.  over video to avoid further contamination, since the infection and condition of my eye was very clearly visible. Dr. agreed that I had a severe Conjuctivitis condition developed on my right eye and immediately prescribed: Polymyxim B- trimethoprim ophthalmic 10000 units 1mg to  drop in eye for 7-10 days every 3 hours. I followed his medical instructions exactly and it took over 7 days for the swelling and redness and pus gradually disappear. After almost 2 weeks of finishing the medication my right eye remained smaller than the left which can be seen in my forward facing pictures.
07/16/03: Mom reported per phone call 20 to 40 episodes daily of eyes rolling back, falling backward then usually getting right back up-started "a few days" after well child care 5/6/03. Seen in office 7/16/03 and referred to neurology.
Patient presented to clinic on 08/02/2023 with redness and swelling to left arm. Patient afebrile, denies pain, itchiness to left arm. Per mother she noticed arm on morning of 08/02/23. Dr. diagnosed as cellulitis of arm and 1 gram of rocephin was given in clinic. Dr. also prescribed Sulfamethoxazole-Trimethoprim oral suspension 7.5ml BID for 10 days. Patient has follow up appt 08/03/2023 to see how he is doing after rocephin injection.
Patient developed pain in the constant right arm after receiving the vaccine. He can move normally but when he moves his arm above his shoulder, the pain is worse.
C/O FLUSHING AND/OR SKIN EDEMA, NAUSEA, VISION BLUR LESS THAN 10 SECS. BP 10:40a 107/70, 78, 18; bp 10:46 128/80, 90, 18
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative reported similar events for two patients. This is the second of two reports for a female patient. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain injection site and swollen arm on an unspecified date with outcome of recovered. Pain and swelling went away on their own without treatment or medications. The information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018036967 same reporter/drug/event, different patient.
COVID 19; COVID 19; This is a spontaneous report received from a 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 19Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "herpes" (unspecified if ongoing); "Carrots allergy/peas allergy" (unspecified if ongoing); "Allergic to cats" (unspecified if ongoing); "Allergy: fir trees" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 05Oct2023 to 10Oct2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331385 same patient, different drug/event;
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L048848, expiry date: 09-AUG-2018) (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
This morning upon awaking was unable to rise from bed, semi-paralysis, peed in the bes as was unable to move any extremities to allow me to get up! Fever, chills, badly shaking, unable to walk unaided. some confused thinking. Unable to call out for help or recall how long I had remained motionless.
Persistent and severe migraine headaches; heavy pressure in the occipital region and ears; Neck stiffness/ache accompanied by acute pain radiating to the shoulders; Neck stiffness/ache accompanied by acute pain radiating to the shoulders; This is a spontaneous report from a contactable consumer. A 41-years-old non female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8727, dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 as dose 1, single for covid-19 immunization. The patient's medical history included diabetes and drug hypersensitivity from an unknown date. Concomitant medications included metformin and insulin detemir taken for an unspecified indication. on an unspecified date, the patient experienced persistent and severe migraine headaches, heavy pressure in the occipital region and ears, neck stiffness/ache accompanied by acute pain radiating to the shoulders and neck stiffness/ache accompanied by acute pain radiating to the shoulders. Patient received treatment for events. The outcome of events was not recovered.No follow-up attempts are possible. No further information is expected.
Approximately 4 months after my booster shot, I contracted COVID-19 and experienced the following symptoms: Lung congestion (4 weeks), Diarrhea (still experiencing), nasal Congestion (4 weeks), headache that lasted about 3-4 days. I took antibiotics for treatment, and it did not help improve my condition.
The pneumococcal polysaccharide vaccine (23) was administered on 12/01/2014.  By that afternoon I was experiencing itching, redness, swelling and quite a bit of pain in my left arm above my elbow near the injection site. Later in the evening of 12/01/2014 by arm was very painful, still red with a rash and more swelling. On Tuesday, 12/01/2014 I started to swell on the lower left arm at and below the elbow. The itching sensation was gone but I still had the rash.  There was quite a bit of swelling below the elbow as well as pain.  The pain in my arm above the elbow had lessened quite a bit. By Tuesday evening, the swelling above the elbow had lessened as well but I continued to have swelling and pain at and below the elbow.  The rash was covering a greater distance  around the injection site and below.  My temperature was normal throughout the entire time of the adverse reaction.  I called facility and talked with the doctor on call.  He suggested taking Benadryl. I took the first dose of Benadryl on Tuesday around 10:00 p.m.   By Wednesday morning, the swelling and pain in my upper arm had lessened even more.  The rash continued as did the pain in my lower arm.   I took the Benadryl all day on Wednesday.   By Wednesday early evening, the pain in my entire arm had lessened quite a bit.  The rash was almost gone and the swelling around my elbow had decreased a little.  This morning (Thursday) my arm is still a little sensitive when touched but the rash is gone and the swelling is has reduced so that my upper arm looks like it is almost back to normal.  The swelling on my lower arm has decreased dramatically but is still a little swollen.
Information has been received from a physician. The physician recommended one of her patients to receive GARDASIL, but the patient's mother said no because one of her friends who was a physician, their daughter received a dose of GARDASIL, and subsequently experienced deaf. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Upon internal review, deaf was determined to be an other important medical event. No further information is available.
Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever  - woke up very lethargic ; as day went on had severe fatigue. About six pm strike fever; headache and fatigue (fatigue was the worst). Muscle aches started on the 10th and through the 11th. Next day (11th) no more fever; still fatigue but not as bad (moderate). By 11th in evening was feeling better that night. But still did not feeling well at all. On 12th - joint pain on 12th; and swelling and redness  and it had heat  and some pain on injection site (maybe had before but I didn't notice before). Took advil through all of this. Still have  a mild headache off and on and today as well.  And feeling fatigue now, too.  No longer taking Advil.
9/4/14 patient returned to pharmacy to report joint pain in left hand (started 9/2/14). Joint pain in right knee (started 9/1/14).
2 x 2 cm area to right upper thigh erythema, hematoma. Benadryl and Motrin OTC PRN.
Fever of 104 for 3 days, vomiting, body aches and chills
This spontaneous report as received from a pharmacist refers to a female patient. In approximately 2013 9reported as "past couple weeks") the patient was vaccinated with a 0.65 ml single dose of ZOSTAVAX by injection route (lot # and exp date were not reported). Pharmacist said (in 2013) after getting ZOSTAVAX, the patient had a "red line that went down her arm" from the injections site. The line was resolved in a couple days" (in 2013). Additional information has been requested.
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.