chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms/whole body pain/fever Swollen armpit leading to pain in fingers, neck and chest pain.  Unable to put arm all the way down due to pain and it being swollen. The pain is currently getting worse and its been 3 days.  Ball like feeling in armpit that causes a lot of pain.  Whole arm was swollen for about 12 hours but has since gone down.
hosp ICT x 14 days;dx w/encephalomeningo radiculitis unk origin (etiology) severe peripheral neuropathy facial Bell Palsy;h/a, gen weakness & malaise;abn CSF;ataxia;residual cramps;aching joints;
Immunizations given. Pt taken to car by father brought him back in screaming uncontrollable, urticaria, lips swelling. Give .12 epi sub Q and give Zyrtec 1 tsp with MD orders.
Patient arrived to store to receive second dose of shingrix vaccine and was inadvertently administered the moderna covid vaccine. She had previously received two doses of Pfizer covid vaccine. Last dose on 2/24/21.  The patient reported muscle aches and fatigue following moderna vaccine administration but no other adverse reactions.
Arm Soreness Started diarrhea on the 19 of Dec, went away on the 20th. Woke up on the 22nd around 1am with really bad abdominal pain and diarrhea.
A non-serious spontaneous report of FLUMIST administration to pregnant female (28 weeks pregnant) was received from a consumer concerning herself, a 34-year-old female. FLUMIST was administered on 17-Sep-2009. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy. On 16-Oct-2009, the follow-up information was received. As of 16-Oct-2009, there have been no adverse events or any side effects. The patient is currently 32 weeks pregnant and the birth is expected on 14-Dec-2009. The patient was asked to inform about any adverse events or side effects until the end of pregnancy.
Left arm  2" diameter sized reddish spot at injection site, noticed early next morning, slight soreness, no itch That evening there was a large pink area (hives) between inj. site and elbow  4"diameter,  no pain, no itch   Over next couple of days area didn't increase in size, but started itching slightly By Nov15, redness disappeared.  Slight itching occasionally yet.
Pt reported feeling woozy, dizzy, and nauseous after walking out to waiting room after receiving shot. Approximately 3 minutes after shot was given I was called out to the waiting room as the patient had passed out. I helped her mother lower her to the floor and by the time we lowered her down she was regaining consciousness. After about 5 minutes she was feeling better and we moved her into the immunization room to wait for EMS. EMS came and evaluated her and determined she was ok to go home
patient had shingles vaccine 2 days ago; must choose to get 2nd dose close to shingles vaccine or outside window; A spontaneous report was received from a pharmacist concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and two days prior her scheduled second dose the patient had the Shingles vaccine. Now patient has to choose either to get the second dose very close to the shingles vaccine or waiting and getting the second dose outside of the recommended window (Inappropriate schedule of drug administration).   The patient's medical history was not provided.  Concomitant product use included the shingles vaccine (22-Jan-2021).   The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 21-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.  On 20-Feb-2021 the patient received the shingles vaccine.  The reporter stated that patient must choose to either get the second dose of Moderna's COVID-19 vaccine (mRNA-1273) very close to the shingles vaccine or wait and get the second dose outside of the recommended window.  No treatment information was provided.    No relevant laboratory details were included.  Action taken with the drug in response to the event was not reported.  The event, inappropriate schedule of drug administration, was considered recovered/resolved.; Reporter's Comments: This refers to a case of a female patient who received mRNA-1273 (lot # not provided) and then received shingles vaccine one month after, close to the scheduled administration of the 2nd dose of mRNA vaccine, thereby necessitating a planned administration of the mRNA second dose outside of the recommended window. No associated AEs have thus far been reported.
Pt c/o heart palpitations and lightheadedness.  Paramedic assessed pt; HR-188; B/P- 171/105; SpO2- 99% on RA; completed 4 lead EKG- showed sinus tachycardia.  C/O itching and rash noted on chest.  Paramedic started 20G IV in R wrist and gave 50 mg of Benadryl. Transported to hospital.
On 9/28/00, vaccine given and in the evening, child was sleepy. On 9/29/00, child started shaking his head and became limp and sleepy and had a slight fever. On 9/30/00, child was taken to ER. On 10/01/00, child was taken to doctor who told the parents it could be related to DTAP.
This spontaneous report was received from an approximately 71 year old female consumer, reporting on herself. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2011, the patient was vaccinated with unidentified pneumococcal vaccine (manufacturer unknown) 1 shot, subcutaneous, (lot# and expiration date were not reported). Concomitant therapy was not reported. The consumer wanted to know the safety of pneumococcal vaccine (manufacturer unknown), as she was concerned about side effects, she stated that on an unknown date in 2011, she experienced peripheral swelling and pain in extremity, reported as "swelling and pain in her arm". The patient did not seek for medical attention. The outcome of peripheral swelling and pain in extremity was reported as recovered on an unspecified date. This is one of two reports received from the same reporter. Additional information is not expected since there is not contact details.
Patient developed body aches and chills 4-5 hours after administration of vaccine. 12-14 hrs after vaccination, patient developed severe body aches, very severe myalgia and arthralgia. this was accompanied with severe fatigue and chills. Over the next 24 hrs, developed low grade fever, maximum reordered temperature was 100.5F.  Myalgias were significantly worse with 3rd dose, as compared to 2nd dose -- described as severe pain all across back and shoulder, felt like muscles tearing apart. Arthralgias - pain in both knees and ankles, accompanied with difficulty in walking.  Symptoms slowly evolved after 36-40 hrs.  Local reaction - pain and swelling at injection administration site. This was also significantly worse as compared to vaccine dose 1 and 2. Pain is still ongoing on day 4 but milder now.
then the second shot I got the chills; it's still sore on top; I had a bump there; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208 and expiry date: Jun2021), via an unspecified route of administration, in Arm Left, on 16Mar2021, as DOSE 2, SINGLE for COVID-19 immunization (Age at vaccination: 63 years). The patient medical history included asthma. Concomitant medication included metoprolol (METOPROLOL), lorazepam (LORAZEPAM), tiotropium bromide monohydrate (SPIRIVA) for asthma, dextromethorphan, guaifenesin, paracetamol, pseudoephedrine (BENYLIN 1), ibuprofen (IBUPROFEN) and salbutamol sulfate (VENTOLIN HFA) for asthma. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date: Jun2021), via an unspecified route of administration, on 23Feb2021, as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient got the chills, very bad chills for one day, for 5 hours actually, just for 5 hours. The patient further stated, Now, first two shots that she got, the first one was simple, the second one, the lady seemed like she took the needle and grounded it in my arm. This lady put it in the left arm up a little higher and she have still like it's still sore on top, she had a bump there, yeah, the bump is gone away. On an unspecified date, the patient underwent lab tests and procedures which included weight: Weigh about 141(pounds) lbs on, around 140 (pounds), 141 (pounds) seems like. Outcome of the events were recovered on an unspecified date.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Bells Palsy  Vaccinated 10/13. Symptoms started 10/30
Patient had child via c-section on 6/9/2021. Received dose #1 of Pfizer 6/15/2021.  Had normal post-partum bleeding.  Second dose 7/6/2021.  Approximately 7/7/2021 she started having increased vaginal bleeding, darker and with an odor following by intermittent generalized abdominal pain.  Pain progressed to become constant and included low back pain and some nausea.  OBgyn ruled out other causes of increased increased post-partum bleeding, suspected having early menses (though is breastfeeding) vs AE of recent Pfizer vaccines.  On 7/14/2021 she had sudden severe abdominal pain, and was diagnosed with acute appendicitis in the ER (Presbyterian Dallas).
Arthritis painful attacks, worse and regression psoriasis, eczema, dizziness, agressive Tinnitus itching of whole body.  Extremely tired
Did not feel well next day - fainted about 1 PM - taken to emergency room by family member - treated in emergency room & spent night in hospital for observation
Narrative: 87yo male in home hospice care died on 8/29/2021. Pt had a hx of a debilitating hemorrhagic stroke in May that results in weakness, dysphagia, cognitive impairment, and aphasia. Patient had a prolonged hospitalization and then completed short-term rehab. He was readmitted to facility on 8/11/21. He then transfered to home hospice on 8/25/21 and died on 8/29/21. Pt had received covid 19 vaccines on 4/13/21 & 5/11/21. Death is not related to vaccines.
After receiving the Pfizer vaccine, I started to have really bad menstrual-like cramps (each time on the same day). I never was on my period or even got my period, but for some reason I would get cramps after getting the vaccines.
Administered Moderna vaccine to individual under age 18. Moderna only approved for individuals 18+
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 63-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because the facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.   This case was linked to MOD-2022-501575 (Patient Link).
Approximately 15 minutes after administration of vaccine, patient experienced twitching on left upper eyelid off-and-on for approximately 10 minutes.  Twitching resolved.  Blood pressure was checked at 09:50am (161/109).  HR=76.  Patient clinically stable.  No medications were administered.  Patient was advised to follow-up with PCP regarding blood pressure concerns and released at 10:10am.
Patient was admitted to hospice services on 2/11/21. Patient received vaccination on 3/2/21. On 3/16/21, patient developed severe ineffective breathing and is requiring palliative management of respiratory symptoms. Patient also suffered swelling to jaw and fever of 102 F. Patient is a DNR and appears to be approaching end of life.  Patient was on the following medications prior to the current event: Citalopram, Quetiapine, Simvastatin, Furosemide, Miralax, Potassium Chloride PO, Vitamin D3, Zinc, Tylenol.
Patient reported erythema, soreness, and edema on her left deltoid beginning 24 hours after vaccination.  By 48 hours after the vaccination she reported the symptoms spreading across the back of her neck and to her right shoulder. The symptoms have since receded to a 6x7cm area on her left deltoid over the following 48 hours.  She reported no fever.
After about 20-30 minutes had a red flushing in face in neck.  No swelling or breathing issues.  Started going away after about an hour and after 2 hours was completely gone.  Only flu like symptoms since then for about 48 hours after injection.
Body ache; Headache; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (extremely tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Bipolar disorder and Arthritis. Concomitant products included CLONAZEPAM for Anxiety, DICLOFENAC SODIUM for Arthritis, LAMOTRIGINE (LAMICTAL) for Bipolar disorder.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (extremely tired). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (extremely tired) outcome was unknown.            Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable    This case was linked to US-MODERNATX, INC.-MOD-2021-076526 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076526:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at an medical office facility for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
inconsolable crying for 6 cont hr would not breast feed either;low grade fever;gave APAP q 4 hr for 24 hr;lt leg sl swollen & warm;
back pain; a bad thing; not being able to work; cold sweats; pressure on his chest and back; feeling like she couldn't breath; numbness in her hands; pain in feet; headaches; severe body aches; arm pain; pain in knee; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats) and CHEST DISCOMFORT (pressure on his chest and back) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet), HEADACHE (headaches), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee). At the time of the report, BACK PAIN (back pain), VACCINATION COMPLICATION (a bad thing), IMPAIRED WORK ABILITY (not being able to work), COLD SWEAT (cold sweats), CHEST DISCOMFORT (pressure on his chest and back), DYSPNOEA (feeling like she couldn't breath), MYALGIA (severe body aches), VACCINATION SITE PAIN (arm pain) and ARTHRALGIA (pain in knee) outcome was unknown and HYPOAESTHESIA (numbness in her hands), PAIN IN EXTREMITY (pain in feet) and HEADACHE (headaches) had not resolved.            Concomitant medications were not provided.  Treatment information was not reported.  The patient reported that her HCP (Healthcare Provider) thought she had symptoms of COVID-19, but her tests came back negative with no reported date. The patient's bloodwork was normal as well.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt presented with redness and hives on her hands bilaterally. The pt had clear lung sounds and NO OTHER sign of allergic reaction. The pt's vitals ere monitored and she was calmed. The pt admitted to other similar reactions due to anxiety. After being calmed and assessed the pt's symptoms resolved. Total time symptomatic was <10 min.
Patient had syncope, dizziness, ringing of ears, chills. BP 144/92 P73 RR17. Given water and recovered, discharged home in stable condition
Patient given booster dose instead of second dose. Error discovered immediately after administration. Offered to administer additional 0.25 ml dose per  recommendation so patient  will complete the second dose. Patient declined. No adverse signs or symptoms noted after 15 minute observation.
Mild rash with occasional itching on the forearms. No change since the shots (nearly three months ago). [This is not a serious problem. I am reporting it only because somebody said that you want to keep track of all side-effects, no matter how small.]
TOOK SECOND DOSE ON DAY 5; This spontaneous case report was received from a consumer (PVX2019-138) on 15-Jan-2019. The report describes a 23-year-old adult male consumer who "took second dose of day 5". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer did not follow the directions for Vivotif properly. He took the doses on 07-Jan-2019, 11-Jan-2019, 13-Jan-2019, and 15-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took second dose of day 5" was not applicable.  The clinical outcome of the event "took second dose of day 5" was unknown.  Company's Comment: The causality of the event "took second dose of day 5" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose of day 5" was considered as not applicable.
Shingles in ear/shingles, issues on face, ear and mouth; shingles, issues on face, ear and mouth; Shingles in mouth/shingles, issues on face, ear and mouth; ear filled with blisters; Horrible case of bronchitis; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster otitis externa in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant), shingles, oral herpes, blister, bronchitis and feeling miserable. The patient was treated with diazepam + isopropamide iodide (Valtrax), gabapentin, steroids nos (Steroids) and antibiotics nos. On an unknown date, the outcome of the herpes zoster otitis externa, shingles and oral herpes were not recovered/not resolved and the outcome of the blister, bronchitis and feeling miserable were unknown.   It was unknown if the reporter considered the herpes zoster otitis externa, shingles, oral herpes, blister, bronchitis and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles 3rd time. The patient had 1st Shingles shot in October 2020 and had the shingles in the month of August and still had issue in his/her face, ear and mouth. The ear was filled with the blisters and had the horrible case of bronchitis in the middle of that. The patient had 2 rounds of steroids and high powered antibiotics besides the 14 days of Valtrex and gabapentin which was still taken by the patient. The patient felt miserable and would not wish it on his/her worst enemy.
The following day, I experienced severe joint pain, specifically in the hips. The symptoms lasted 10 hours, until I took Excedrin, which gave relief.  My arm was also very sore at injection site, for 3 days. Symptoms were not relieved with Excedrin.