chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrible sinus headache; Tendon pain/ shoulder feels like a tendon pain in the arm; Shoulder is hurting him deep in the shoulder joint; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Horrible sinus headache), TENDON PAIN (Tendon pain/ shoulder feels like a tendon pain in the arm) and ARTHRALGIA (Shoulder is hurting him deep in the shoulder joint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  Previously administered products included for Product used for unknown indication: SHINGRIX (In right arm) in 2021 and INFLUENZA VACCINE (In left arm) in 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE and SHINGRIX. Concomitant products included COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS HEADACHE (Horrible sinus headache), TENDON PAIN (Tendon pain/ shoulder feels like a tendon pain in the arm) and ARTHRALGIA (Shoulder is hurting him deep in the shoulder joint). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (Horrible sinus headache), TENDON PAIN (Tendon pain/ shoulder feels like a tendon pain in the arm) and ARTHRALGIA (Shoulder is hurting him deep in the shoulder joint) outcome was unknown.            Patient stated that he took ibuprofen which seems to level the symptoms out a little bit but it always returns.   This case was linked to MOD-2021-396066, MOD-2021-396164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jan-2022: Patient's historical vaccine, Treatment medication, Additional events and Vaccine anatomical location were updated. On 03-Jan-2022: Contains no new information.
shared with me that the second dose of the COVID-19 shot gave him CIDP; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "shared with me that the second dose of the COVID-19 shot gave him CIDP". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom called MD office to say that pt had been crying for 5 hrs p/getting vax; later mom said pt cried 1 1/2-2 hrs & sounded like pt was hurting; lt leg swollen not red OK p/that;
Received Moderna vaccine at approximately 4:05pm on 12/26/2020.  Within 15 minutes, developed flushed feeling throughout body, developed strange taste in mouth, mouth and tongue felt numb and tingly.   Was given 2 Benadryl, symptoms improved, resolved within 6 hours.
My first injection I had tightness of the throat that lasted less than a minute and then I had a common side effects of pain at the injection site and tiredness . My second Covid injection my throat felt like I could not swallow and then I had severe tiredness where I was in bed all day  only up for 4.5  hours, pain in the abdomen,  pain above my hip bone, pain across my breast, pain above my eyes, headache and severe tiredness. Also pain at the injection site. Still with a headache. In total I was down for a day and a half. I notified my physician of these side effects.
ACUTE PULMONARY EMBOLISM 9/14/2022 ADENOCARCINOMA, BODY OF PANCREAS ACUTE PULMONARY EMBOLISM 9/14/2022 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 9/14/2022 GI HEMORRHAGE ACUTE PULMONARY EMBOLISM 9/14/2022 MALIGNANT ASCITES
Made her sick; Hurt everywhere; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Made her sick) and general body pain (Verbatim: Hurt everywhere). The outcome of the sickness and general body pain were recovered/resolved.   It was unknown if the reporter considered the sickness and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. Reporter's youngest sister got the vaccine which made her sick and hurt everywhere for a couple days but she has not gotten the shingles since.  Reporter reports that he/she been getting them (shingles) since reporter was 15 year old, now reporter is 63 year old. Reporter reports of having bad gene, immune problems and used to be have shingles once a year. Now Reporter trying to get shingles clear and get vaccine. Reporter reports if one had chicken pox, over 50 year age, one should get the vaccine. Reporter reports shingles caused nerve damage and made reporter feel like having the flu, and pain. Reporter reports of having shingles about once a year, but now, in past year, Reporter is trying to get rid of them, clear up completely to get vaccine.
Patient came in for vaccines. I gave her Tdap, MMR, and Hep B we were out of Varicella. I had checked system and saw she recieved flu and varricella on 9/20/23 but didn't even think I couldn't give her MMR it just didn't dawn on me. Front desk came to where I was vaccinating and asked if I had finished charting on that patient and I told her I had and I showed her and I even told her she already had flu and varicella vaccine on the 20th and she said can't give live vaccines within 4 weeks of each other and I told her oh yah thats right. She asked if I had put it in vaccine histories and I hadnt yet but would.
ill; liver transplant; This serious case was reported by a consumer via call center representative and described the occurrence of liver transplant in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced unwell (Verbatim: ill). The outcome of the liver transplant was unknown and the outcome of the unwell was not reported.   It was unknown if the reporter considered the liver transplant and unwell to be related to Shingrix.     It was unknown if the company considered the liver transplant and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-NOV-2023 The patients wife reported more than one year ago patient received a first dose of Shingrix. The patient never received second dose because he got ill. The doctor recommended him not to receive the second dose. The patient was immunocompromised. In January 2023 patient had liver transplant. The reporter did not consented to follow up.
The patient came in the day after receiving the vaccine and was experiencing a painful and itchy, red rash from the injection site down to a little above the elbow. She did not complain of any systemic symptoms. According to the patient she noticed it today. She said it did not appear to be spreading or worsening.
Experienced angioedema approximately 24 hours post inoculation. Administered 50mg oral Benadryl with no response. No respiratory distress.
Patient reported aching and numbness from shoulder to fingertips of injected arm (left arm)
severe headache; loss of appetite; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were reported. On an unspecified date, after first Covid vaccine dose, patient tried to work on his laptop, after five minutes of staring, he got a severe headache and has not been working for the past two to three weeks because of it. His doctor put him on Motrin and Tylenol. The patient also had loss of appetite. Therapeutic measures were taken as a result of severe headache. The patient wanted to know if those side effects were normal to experience. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Early in the evening after pt's 2 mo PE & shots she had an episode that resembled repetitive mono reflexes. Followed by 30 - 45 minutes when she was not really alert or responding normally. Felt to be a post-vaccine seizure with postictal period. Patient subsequently back to normal. No repeat episodes since.
Grand Mal seizure.  55 hours post vaccine.  Lasted 15 minutes and required emergency rescue medication Nayzilam. He has seizure disorder but his seizures are well controlled. Typically only has one post op brain surgery or due to illness/infection.  Has less than 10 in his life. Phoned one of his physicians to report the seizure and discuss situation.  Was told to just watch for other symptoms or side effects.  He recovered from seizure and rescue med.  Notified two other doctors of the event the next work day.
Discharge Provider:  Primary Care Provider:  Admission Date: 7/26/2022 Discharge Date: Jul 28, 2022  PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: Pt. is 50 y.o. with Crohn's disease on infliximab, hypothyroidism, OSA on CPAP, non-insulin-dependent type 2 diabetes mellitus, for evaluation of dyspnea, chest pain, fever, malaise which started on 07/25 and was found to have COVID-19 and hypoxic respiratory failure. She completed 3 days of remdesivir as an inpatient due to her immunocompromised state. She also was given a 10 day course of decadron. After 3 days in the hospital, she improved and was able to be weaned off oxygen. She was noted to have asymptomatic sinus bradycardia but was otherwise well and eager to discharge home.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Vomiting-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-, Additional Details: Pt was inadvertently given 2/3(0.2ml) of a 12+ pfizer dose when should have had 5-11 y/o dose, incorrect vial placed in pediatric vaccine bin, pt mother said took pt to ermergency room and was given benadryl for swelling of face by Dr., given 1x 25mg benedryl and sent home, said pt also vomitted 4 times prior to ER and mild facial rash.
Cellulitis type reaction. hot to touch , pain, tightness and swelling, hard to move arm. given Doxycycline 100 BID for 10 days
Information has been received from a medical assistant concerning a female who on 09-JAN-2009 was vaccinated with a dose of RECOMBIVAX HB, mixed with ADACEL into the same syringe. On approximately 09-JAN-2009, after vaccination, the patient experienced redness at injection site. The patient was seen at in the office on 12-JAN-2009 and the injection site of the right arm was red. At the time of this report, the patient was not recovered. Additional information has been requested.
Sore throat, hives, swelling under arm where injection given starting 1 day after immunization.  Symptoms come and go X few weeks.  Pt tired BENADRYL with some relief.
Information has been received from a 71-year-old female consumer with diabetes, hypertension, depression and "bladder problems" and no known drug allergies who on 17-SEP-2007 was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax (Oka/Merck). Concomitant therapy included Metformin, atorvastatin calcium (LIPITOR), samarium Sm 153 lexidronam pentasodium (QUADRAMET) and oxybutynin. On 24-SEP-2007 the patient developed "pain in my arm around where I received the shot. It also throbs and itches a bit and may be a little swollen." Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information received from the physician indicates that the information will be forwarded to the pharmacy that administered the vaccination. Additional information has been requested.
Unsure related , but extreme congestion almost immediate sinus infection and both ears infected and bronchial tubes (I never have sinus or ear aches ever my whole life).  Started on 6/16 went to fast pace and after over two weeks went to doctors office and still having problems  as of today 7/19/21.  Will not go away! I have never had anything like this that will not clear.
12 hrs after shot: lasted 24 hours. Severe headache, neck ache, backache, non-stop shooting pains in every conceivable muscle, fatigue, fever (104), nausea, vomiting, severe weakness, dizziness, unable to focus or get out of bed, and sore/dry throat and watery eyes that crusted my eyelashes shut. Too sick to call an ambulance!
Weakness, Diaphoretic, Chills, Paleness, Slight Stomach Pain, Little nausea, shortness of breath.
Redness, swelling, warmness at injection site. Keflex 250 mg 15 ml every 6 hours for 10 days.
POST VACC DAY 6 AUTOINNOCULATION (BLISTER BURST RESULTING IN A GEOGRAPHIC MACULAR RASH TO AXILLA AND ANTERIOR CHEST WITH SOME SMALLER ISOLATED MACULES POSTERIOR NECK AND LEFT ANTERIOR THORAX) LOW GRADE FEVER 99.6 F WITH ADENOPATHY IN THE AXILLA
Pt. seen in our office on 5-22-07 and diagnosed with shingles to (R) lower extremity. Pt has numerous raised lesions to (R) LE
Developed nausea, lethargy, h/a & diarrhea; sx persisted for 5 to 6 days & dec in intensity;
COVID-19 symptoms started on 07/03/22; tested positive 07/03/22. I might have had fatigue the day before but no sore throat. I could tell I wasn't feeling well when I woke up, he morning of 07/03/22. I had a nose that poured liquid and I couldn't control it and it was a faucet turned off and I had severe nasal and chest congestion and an awful headache and slight fever. Symptoms lasted about 10 days and it took 17 days to test negative. 07/03/22 I went to ER because I went downhill because my leukemia doesn't fare well with COVID-19 and I was in terrible shape. I had wanted the monoclonal antibodies and they refused to give me one because the pharmacist didn't think it would help. 2 days later I was able to get the monoclonal IV antibodies at an urgent care center. I also got a steroid injection at the ER and they gave me a pill that looked like BENADRYL and wrote me a prescription for azithromycin 250 mg (5 pills) and a MEDROL dose pack 4 mg and I filled those on 07/05/22 and took them for a period of time for 5-6 days and then got the bebtelovimab infusion on the 5th. On the 3rd when I went to ER I had gotten to the point that I thought I was going to die because symptoms got severe. I couldn't breathe out of my nose because nose was stuffy and I couldn't breathe out of mouth. I didn't have oxygen reader with me so I don't know what oxygen was but I felt like I needed to be in the hospital. I still have congestion and left ear sensitivity and irritation but other than that I feel like I completely recovered from it. I did have monoclonal antibodies prior to contracting COVID-19 and I had that infusion in February 2022 and I am supposed to get another infusion next month. I am in a study and they tested for antibodies after each shot and I got 0 after the first 2 and for the 3rd one I got 1000/8500 antibodies but they tested me after 30 days and it dropped 60% so they vaccines aren't giving me a lot of protection. I have not gotten tested for the 4th.
About roughly two weeks after covid vaccination, patient's right forearm began to swell with patches of a hive-like rash.  She went to an urgent care and was treated with steroids which did not help.  There is no pain with the swelling.  She later followed up with her PCP regarding the issues.
This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored GARDASIL 9, lot #,expiry date, concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Additional information has been requested.
2/2/21 1st Moderna shot was at 10 am, by 4 pm I was shaking uncontrollably with chills.  I had on fleece pjs and three blankets laying in front of fireplace and could not get warm.  Headache out of this world.  Every joint in my body hurt.  My ankles were so swollen I could barely walk.  I missed three days of work.  3/4/21 2nd dose of Moderna.  Same as above only joint pain was much worse.  Chills and then breaking out in sweats.  I?ve missed two days of work as of now with this shot.  It?s really wiped me out.  I haven?t been able to eat or sleep much because I hurt so bad.  My knees, ankles, and neck seem to be the worst.  I?ve never experienced joint pain as bad as these two times.  I could barely walk to the bathroom.
Nurse  gave the entire content of the vial of  Pfizer vaccine which was not diluted.
sore right injection site Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site Arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site Arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site Arm) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-265242 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow-up received on 14 Seo 2021  included no new information
PATIENT RECEIVED FIRST DOSE OF MODERNA AT 10:35AM AND COMPLAINED THAT SHE FELT HER TONGUE IS STARTING TO SWELL UP AND ASKED FOR AN EPIPEN TO BE ADMINISTERED. PATIENT WAS GIVEN EPIPEN 0.3MG INSIDE THE CONSULTATION ROOM. PHARMACIST ASKED IF PATIENT REQUIRED 911 ASSISTANCE? PATIENT DENIED 911 ASSISTANCE AND WANTING TO WAIT INSTEAD. PHARMACIST WAITED WITH PATIENT FOR 10 MINUTES AND PATIENT STATED SHE IS FEELING BETTER. PHARMACIST INSTRUCTED A TECHNICIAN TO FURTHER MONITOR PATIENT FOR ANOTHER 15 MINUTES. PATIENT STARTED TO COMPLAINED SHE IS FEELING HUNGRY DUE TO NOT EATING ANYTHING ALL MORNING. PHARMACIST WENT AND GOT A BOTTLE OF APPLE JUICE TO THE PATIENT. AFTER 15 MINUTES, PHARMACIST CHECKED AND PATIENT STATED SHE IS FEELING ALL BETTER AND CAN LEAVE. PHARMACIST INSTRUCTED PATIENT TO TALK WITH HER PRIMARY PHYSICIAN ABOUT HER REACTION TO THE VACCINE AS WELL AS REPORT TO VAERS.
A mother reported that her 4 year old son received his 5th dose of Acel-Imune and a dose of IPV vaccines on 4/19/01. The following morning, an injection site reaction characterized by swelling, induration, warmth and pain. The child was subsequently examined by a physician; a dx of "local reaction" was made. On 4/23/01, he developed a fever of 103F which persisted "for the remainder of the week"; he was treated with Tylenol (paracetamol). The child experienced leg pain and difficulty in walking. He was again seen by a physician; blood tests and a throat culture were done and the results were negative. On 5/2/01, he developed a fever with a maximum temperature of 104.5F and was examined at a local ER. He was treated with Motrin and sent home. On 5/3/01, the child was examined by an "ID physician". The physician's impression was "mono"; testing was performed and results were negative. The fever resolved on 5/4/01. On 5/8/01, he experienced leg pain and equilibrium imbalance. Follow-up information was received from the physician on 8/10/01. A blood culture and antibody tests for EBV and CMV were performed; the results were negative. On 5/1/01, the child was examined by a physician; "obvious" tonsillitis was noted. The infectious disease specialist who examined the child considered an adenovirus infection "likely responsible" for the fever and tonsillitis. The child recovered.
had chills that noc p/vax woke up nauseated, vomited then vomited 4-5 times throughout the day;had major muscle aches that AM;called by MD phoned in prescription for phenergan suppository;cont to have muscle aches;cont w/muscles aches;
no side effects; adult dose of VAQTA given to a pedriatric patient; This spontaneous report has been received from a nurse regarding a 17-years-old pediatric of unknown gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 24-JUL-2020, the patient was vaccinated with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 milliliter (frequency and route of administration were not reported; Lot # S030588  has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date 20-OCT-2020). It was reported that the patient's pediatrician was concerned with the dose administered. The patient did not experience any side effects.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010018:
Patient describes a hard lump forming that is red and tender and also warm to the touch. Advised to watch for improvement over next 2-3 days.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of VARIVAX (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004627: US-009507513-1709USA004629.
Eleven days post vax the pt developed a red, slightly, raised rash at the injection site. Follow up states additional information has been requested.