chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lower back pain; felt very bad 24 hours; pain in the abdomen area; cannot sleep more than couple of hours in night; sleep deprivation; loosing my strength; can't move, cant exercise, freeze up; sciatic pain; chills; Sever joint pain, shoulder pain, hip pain, all my joints are hurting, soreness of joint, tendon sorreness; fever; can't drive too long; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), FEELING ABNORMAL (felt very bad 24 hours), ABDOMINAL PAIN (pain in the abdomen area), INSOMNIA (cannot sleep more than couple of hours in night) and SLEEP DEFICIT (sleep deprivation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 BACK PAIN (Lower back pain), FEELING ABNORMAL (felt very bad 24 hours), ABDOMINAL PAIN (pain in the abdomen area), INSOMNIA (cannot sleep more than couple of hours in night), SLEEP DEFICIT (sleep deprivation), ASTHENIA (loosing my strength), HYPOKINESIA (can't move, cant exercise, freeze up), SCIATICA (sciatic pain), CHILLS (chills), ARTHRALGIA (Sever joint pain, shoulder pain, hip pain, all my joints are hurting, soreness of joint, tendon sorreness), PYREXIA (fever) and FATIGUE (can't drive too long). At the time of the report, BACK PAIN (Lower back pain) and ARTHRALGIA (Sever joint pain, shoulder pain, hip pain, all my joints are hurting, soreness of joint, tendon sorreness) had not resolved, FEELING ABNORMAL (felt very bad 24 hours), CHILLS (chills) and PYREXIA (fever) had resolved and ABDOMINAL PAIN (pain in the abdomen area), INSOMNIA (cannot sleep more than couple of hours in night), SLEEP DEFICIT (sleep deprivation), ASTHENIA (loosing my strength), HYPOKINESIA (can't move, cant exercise, freeze up), SCIATICA (sciatic pain) and FATIGUE (can't drive too long) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment for the event included special hip waist to support to ease pain, special pillow, special cushions
About 18 hours after my second shot, I was suddenly and severely slammed with extreme pain, shaking, trembling, spasms, inability to talk or breathe easily... My body shook uncontrollably and every inch of me was in severe pain. I crashed and slept for3 or so hours.  The SHAKING was uncontrollable tremors and pain.
got the flu; sick for 4 weeks; still fighting left over symptoms weakness; Initial information received on 08-Jan-2023 regarding an unsolicited valid social media serious case from a consumer/non-hcp.  This case is linked to case 2022SA520933(CLUSTER).  This case involves an unknown age male patient who got the flu, sick for 4 weeks and still fighting left over symptoms weakness after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a serious got the flu (influenza) (unknown latency) following the administration of influenza vaccine. The patient was hospitalized for this event. On an unknown date the patient developed a non-serious sick for 4 weeks (illness) and still fighting left over symptoms weakness (asthenia) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got the flu and sick for 4 weeks and was Not Recovered / Not Resolved for the event still fighting left over symptoms weakness.; Sender's Comments: Sanofi company comment dated 13-Jan-2023: This case involves an unknown age male patient who got the flu, sick for 4 weeks and still fighting left over symptoms weakness after receiving influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, medical history would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Blood and mucous in stool, urgency to use bathroom. Serious enough by end of week to schedule doctor appointment for March 4
Patient received FLUZONE HD on Wednesday 10/9/12 and reported hot, swollen rash local to injection on 10/11/12. He felt very ill. Pharmacist recommended TYLENOL for pain/fever/chills. Patient was advised to see a doctor.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (muscle pain in the vaccination site, but doesn't have problems with it, just wanted to report it) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 06721A) for COVID-19 immunization. No medical history reported. On Sep 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 24, 2021, patient experienced vaccination site pain (muscle pain in the vaccination site, but doesn't have problems with it, just wanted to report it). At the time of the report,  vaccination site pain (muscle pain in the vaccination site, but doesn't have problems with it, just wanted to report it) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. On Sept 24, 2021, the pain started. The patient reported the second dose was scheduled for Oct 20, 2021.
Information has been received from a health professional concerning a 15 month old male with no drug allergies, a food allergy to milk and eggs, and no pertinent medical history who on 2/15/04 was vaccinated SC with a first dose of VARIVAX (Merck). Concomitant vaccination on the same day included an IM fourth dose of PREVNAR (lot # 495-942). There was no other concomitant medication. There was no illness at the time of vaccination. On 2/23/05, the patient developed varicella breakthrough. Unspecified medical attention was sought. The outcome was reported as recovered. There were no laboratory diagnostic studies performed. A product quality complaint was involved. Additional information has been requested. No further infromation is expected.
Very cold which caused severe shaking. Resting heart rate of 103 to 105 bpm. Vomiting. Loose stools. Felt like I had something hot burning me inside my skin. Headache which I think was caused by the dehydration caused by vomiting and loose stools.
Initial information regarding unsolicited case received from nurse on 25-Oct-2013: This case involves an elderly female patient. The patient's past medical histories and concomitant medications were unknown. In October 2013, the patient received FLUZONE HD (lot number, route, site of vaccination and expiration date were not reported). In October 2013, the patient experienced headache, shaking, generalized aches and pains, soreness at injection site. The patient self-medicated with TYLENOL and aspirin. Symptoms are resolving. No further information provided. List of documents held by sender: none.
11 months after the vaccine I was diagnosed with prostate cancer and received 2 months of radiation treatments. 2 months later, I had a heart attack, cardiac catherization and 2 days after the cath I had to have Open Heart surgery.  Before this I was healthy, active, trim and considered in excellent shape.
PNEUMOVAX 23 give at 1030Am on 03-29-17. Patient reported itching at about 11:20 AM and her Rt upper arm started swelling. She went to urgent care at 5pm that day while at urgent care had a syncope like episode. Given a steroid injection. BENADRYL, pain meds. Put ice pack on injection site. Discharged at 930pm that night.
pt recvd vax 13APR94 & w/in 10 mins of inject pt devel swelling of the face & lips; mom reported also devel hives & exp a closing of throat; pt was seen in ER & exp considered to be life threatening;
inconsolable crying that lasted 48hr starting w/in 24hr of vax;resolved p/3 days;
Rec'd call from pt's mom on 8/18/04 c/o left arm red and swollen and painful. No fever. Mom brought pt in to have arm checked, Dr checked arm and area was 10cmx5cm erythema and warmth, treated with cool compresses and Benadryl. Contacted Health Dept and reported incident. On 8/23/04 f/u phone call to pt's mom and stated area did become larger next day but now subsiding.
The week following the booster shot, my blood pressure and heart rate were elevated for a few days. During the holiday, my menstrual cycle came on early after cramping a few days before. When I returned to my doctor, I informed him that I had the booster shot, and that my blood pressure and heart rate changed for a few days post vaccination, and that my period came on early. After returning to my doctor the second time, I informed him that I was still spotting, and my period had not gone off, and I tried scheduling an appointment with my gynecologist, but there were no appointments available until 2022. My doctor reviewed my labs with me, and to make a long story short, I was started on a blood thinner, and informed that I would not be able to take the MRna vaccine again.
Site: Bruising at Injection Site-Mild, Additional Details: Mom does not want to provide any information as Dr is monitoring her health but wants to make sure issue gets resolved
It started with pain and significant swelling and redness in arm within 24 hours. It progressed to high spiking fevers past 103, confusion, cough and lethargy and physical/muscular pain.  My white blood count plummeted to about 1 and I had to go the the ER twice and have many medical visits.  I was confused and week for about 2 months.
Pt was given the Moderna COVID vaccine at 1141.  At 1150, she reported that she was nauseous and itchy.  Pt received Benadryl 50 mg IM and one dose of Epipen.  She continued to c/o itchiness and began to have numb lips, throat irritation and chest tightness.  She was transported to the ER and was subsequently admitted to our inpatient floor for observation overnight and discharged on 5/1.  On 5/2, she was readmitted for observation after her symptoms returned and was discharged later that day.  During her stay, she received Benadryl, Zyrtec, epinephrine, solumedrol, albuterol and pulmicort nebs, famotidine, hydroxyzine, prevacid, and prednisone.
Slight headache and intermittent dizziness starting about 1 hour afterwards. By 8 hours afterwards: fever of 100.1, with chills, aches, and joint pain. Woke up at 4:15 AM with a fever of 103.4, now 24 hours later fever is 101.9. Acetaminophen takes the edge off the fever. The only unusual/unlisted symptom I'm having is muscle cramping.  I was warned that people who had COVID (I had it in March 2020) may experience side effects, so I'm not particularly concerned.
It altered my period.  It began 2 weeks earlier and heavy. Lasted it about 2 weeks with spotting on and off.  My period is very regular and little.
patient received incorrect dose of vaccine- patient should have received the different formulation, but the adult (12+) vial was used and diluted/administered according to the specifications (1.3ml diluent and 0.2ml dose). Mom reports sore arm, but no other side effects at this time.
Had shingles vaccine, had shingles 2 times after vaccine/Suspected vaccination failure; Had shingles 2 times; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-FEB-2023 Reporter's Comment: The physician reported that the patient received a dose of Shingles vaccine but had shingles two times after the vaccine and doctor wanted to know if he starts patient on Nucala and asked could it cause patient to get shingles again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. As per narrative Shingles vaccine coded as suspect.
Shortness of breath 36 hours after injection.  Shortness of breath lasted 10 minutes.
At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 13-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021 at 4:00 AM, the patient experienced PRURITUS (At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas). At the time of the report, PRURITUS (At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in April 2016 (reported as "within the last month"), the patient was vaccinated with a dose of ZOSTAVAX 1 dose (lot # reported as M006117, expiration date: 08-AUG-2017; route was not provided). On an unknown date in 2016 (reported as "a couple of days after receiving the vaccine"), the patient developed cellulitis, warmth, a raised area and itchiness around the injection site and returned to the physician's office due to the events. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient had only mild localized redness and injection site pain after her first immunization on 2/17/2021. On 2/26/2021 patient started itching all over. No visible hives were present. But the diffuse itching persisted day and night. She was seen for this on 3/1/2021 and was diagnosed with hives vaccine reaction, delayed hypersensitivity reaction. I checked with Immunology and the feel she can still receive the 2nd vaccine and monitor her symptoms.
Throwing up until theres nothing to throw up any more, then continuing to throw up any bit of liquid I try to take in, now experiencing dehydration. Hiccups. Hot flashes & chills. Extremely labored breathing. First period of vomiting lasted from midnight to one am, and second period lasted from 5 to 6 in the morning. Night terrors all night. Really feeling like I can barely breathe.
Information has been received from a registered nurse concerning a 13 year old male patient who on an unspecified date was vaccinated with PROQUAD (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck). It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
headache, body aches, fever (100.4), sinus pressure/pain (burning sensation)
Peeing a lot; Tremendous chills; Red mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Peeing a lot), VACCINATION SITE ERYTHEMA (Red mark at the injection site) and CHILLS (Tremendous chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Angina pectoris. Concomitant products included METOPROLOL for Angina pectoris.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red mark at the injection site). On an unknown date, the patient experienced POLLAKIURIA (Peeing a lot) and CHILLS (Tremendous chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 14-Feb-2021, VACCINATION SITE ERYTHEMA (Red mark at the injection site) had resolved. At the time of the report, POLLAKIURIA (Peeing a lot) and CHILLS (Tremendous chills) had resolved.            Treatment medication include Tylenol. Concomitant medications include statin and vitamins. patient stated she had taken in a lot of fluid as she was "peeing a lot".  Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-038242 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Events- tremendous chills and peeing a lot updated. Event outcome for this two events recovered/resolved updated.
No adverse events immediately following injection. Patient returned to the pharmacy the following day (almost 24hrs later), and described not sleeping well last night due to major soreness in left arm. And currently feeling nauseous (about 24 hrs post injection) while working outdoors in the heat.
shingles; inappropriate schedule of vaccine; This case was reported by a nurse and described the occurrence of shingles in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received Shingrix vaccine about 8months ago, however never follow up with the 2nd portion of the vaccination series. He came into clinic at the time of reporting with what appears to be the shingles.  The reporter reported that could this be possible given the vaccine wasn't live and should he get the 2nd portion of the series, even though he was beyond the 2-6 month time interval, which led to incomplete course of vaccination.
No adverse events. Patient received vaccine that was outside of temperature excursion allowed. (store in freezer for 2 weeks + 1 week expiration). Patient was notified 6/21/22.
numbness and loss of muscle control in right wrist and fingers. Narrative: Patient obtained MRI to rule out possible stroke is receiving care with Physical Therapy, Occupational Therapy and Neurology.
Low grade fever (38 to 39 degree Celsius) Chills Muscle & joint pains Easy fatigability Nausea Loss of appetite Triggered my asthma - I'm on Seretide 1 to 2 puffs PRN
A BIT OF CONGESTION IN THE CHEST; BODY ACHES AND SORE; MILD FEVER; NEAR CONSTANT HEADACHE; VERY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced a bit of congestion in the chest, body aches and sore, mild fever, near constant headache, and very tired. The action taken with covid-19 vaccine  was not applicable. The outcome of the mild fever, body aches and sore, a bit of congestion in the chest, near constant headache and very tired was not reported. This report was non-serious.
Received 1st dose of vaccine Monday, March 29th, 2021 around 5 pm. Tuesday morning, shortly after awaking, right ear starts ringing. Happens again in succession less than 10 minutes apart. Wednesday evening, right ear rings again, twice in succession less than 10 minutes apart. Thursday morning, after awaking, left ear starts to ring, similar to the right ear the days prior. By Thursday night, constant ringing inside head. Sound seems to be muffled. Extreme difficulty in sleeping since. By Friday, ringing is constant, heavy pressure on both ears, seems as if there is heavy suction placed on both ears. Saturday visited local Urgent Care Clinic and was diagnosed with Tinnitus-Bilateral. Referred to an ENT. Pressure and ringing is constant and persistent. Visited ENT on Wednesday, April 7th, 2021, was diagnosed/confirmed with Tinnitus. Difficulty with concentration, sleep, hearing. Rising stress and anxiety.
Information has been received from a physician concerning a 6 month old female who on 24-NOV-2006 was vaccinated with her first dose of Rotateq (LOT # not provided). On 30-JAN-2007, she was vaccinated with her second dose of Rotateq (LOT # not provided). On 23-MAR-2007, the patient developed intussusception and was hospitalized. An air contrast enema was performed. Subsequently, the patient recovered from intussusception. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.  4/17/07 Received medical records from hospital which reveal patient experienced fever, fussiness, bloody stools & projectile vomiting.  Had recently been treated for otitis media, was awaiting ear tube placement & had yeast infection.  Temp on admit was 103.3  RUQ palpable mass noted w/guarding.  Admitted 3/24-3/25/07 for observation s/p barium air contrast enema successful reduction of IS. FINAL DX: Intussusception, reduced by barium air contrast enema.
Temperature of 102.5, headache, sore throat, body aches Took ibuprofen to control fever