chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNABLE TO SLEEP; FELT AN ACHINESS ACROSS SHOULDERS; FELT CHILLED WHICH ONLY LASTED FOR ABOUT 20 MINUTES; FEELING TIRED; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin, batch number were not reported, expiry: unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced unable to sleep, felt an achiness across shoulders, felt chilled which only lasted for about 20 minutes, and feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep, felt chilled which only lasted for about 20 minutes, and feeling tired, and the outcome of felt an achiness across shoulders was not reported. This report was non-serious.
recvd photo from MD w/note attached on 14DEC92 to inform of severe local reaction of last from DTP; photo taken 28OCT92 16DEC92 dad state pt had fever but doesn't know the exact temp;
Initially red, itchy eyes, BA/C. Later SOB, fainting and fever up to 102.
My left lymph node is swollen and painful; My left lymph node is swollen and painful; Dose 1 and Dose 2 taken on same date; Dose 1 and Dose 2 taken on same date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 (Lot number: EW0164) at the age of 40 years as dose 2, single and administered in arm left, administration date 18May2021 14:30 (Lot number: ER8730) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 18May2021, outcome "unknown" and all described as "Dose 1 and Dose 2 taken on same date"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Jun2021 16:00, outcome "not recovered" and all described as "My left lymph node is swollen and painful". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: Facility type where vaccine was administered was Other. No other vaccine were received in four weeks. No covid prior vaccination and not tested for covid post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
6th day-mild headache; 7th-11th day-severe headache. MD prescribed Ultracet on day 7 and she continued with taking pills (3 times daily) until day 16.  12th-14th day-moderate headache. 15th-17th day-milder headache (18th day resolved).
Lower lip edema/Only edema in lower lip; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK5730, via an unspecified route of administration in the left arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history included Graves' disease with hypothyroidism and epilepsy; and had dermal filler 2 months ago (in 2020) in both top and bottom lip. Concomitant medication included levothyroxine. The patient was not pregnant. The patient previously took aspirin bayer and experienced drug hypersensitivity. The patient was not diagnosed with covid prior vaccination nor was she tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lower lip edema and mentioned that she had dermal filler 2 months ago in both top and bottom lip. Only edema in lower lip. Have image if needed. No changes in medications, no changes in soap, skin care or makeup. The event occurred on 07Jan2021 at 05:00 AM with outcome of not recovered. The event was reported as non-serious. Therapeutic measures were taken as a result of lower lip edema/only edema in lower lip which included famotidine and CLARITIN.
First, the person giving the vaccine injected me high in the left shoulder, near the top of the biceps tendon. It was higher up than any flu shot I have ever had and not in the fat part of the muscle. I have been experiencing intermittent  weakness and pain radiating down my left arm. It sometimes extends around to the back of the shoulder but mainly running down the arm. It seems to get worse as the day progresses and makes it hard to get comfortable when sleeping. I do not generally do hard physical labor with that arm so there is no reason for it to suddenly become weak and painful.
4"x4 1/2" local reaction the next day with soreness and erythema. Tx ice packs and Tylenol. Checked with physician for other tx - no further necessary.
Information has been received from a physician concerning a 12 month old female with no allergies and no medical history who on 5/18/04 was vaccinated SC in the arm with a first dose of varicella virus vaccine live (lot # 648047/1346N). Concomitant vaccine therapy given SC in the thigh included a first dose of MMR (lot # 646123/0682N). There was no other concomitant therapy. On 5/19/04 the patient developed a rash and a fever. The patient's parent gave her acetaminophen. On 5/20/04 the patient was seen in the physician's office with an erythema multiforme rash on her chest, abdomen, back, face and upper extremities. There was no rash on her lower extremities and she was still febrile. Diphenhydramine was ordered. The patient was sent to the emergency room. Subsequently, the patient recovered. It was noted that the patient had no adverse reactions following prior vaccinations. No product quality complaint was involved. Follow up information indicated that the adverse event onset was on 5/20/04 in the AM. The outcome was reported as recovered. No further information is expected.
wound up in a 10-week prednisone Crohn's flare/wound up in a bad Crohn's flare; got severely sick/it messed her up/it kicked her immunity; she did not get the second dose of the vaccine/Patient is receiveing the second dose of the vaccine tomorrow, which is more than 36 days after the first dose; high fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CROHN'S DISEASE (wound up in a 10-week prednisone Crohn's flare, wound up in a bad Crohn's flare) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Crohn's disease, Gut pain, Blood pressure management and Disorder thyroid. Concomitant products included LISINOPRIL for Blood pressure management, AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Crohn's disease, MESALAZINE (MESALAMINE) for Gut pain, ESTRADIOL for Hormone level abnormal, LEVOTHYROXINE for Thyroid disorder.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (wound up in a 10-week prednisone Crohn's flare/wound up in a bad Crohn's flare) (seriousness criterion medically significant), ILLNESS (got severely sick/it messed her up/it kicked her immunity), PYREXIA (high fever) and INTENTIONAL DOSE OMISSION (she did not get the second dose of the vaccine/Patient is receiving the second dose of the vaccine tomorrow, which is more than 36 days after the first dose). The patient was treated with PREDNISONE ongoing since an unknown date for Crohn's aggravated, at an unspecified dose and frequency. At the time of the report, CROHN'S DISEASE (wound up in a 10-week prednisone Crohn's flare/wound up in a bad Crohn's flare) and ILLNESS (got severely sick/it messed her up/it kicked her immunity) outcome was unknown and PYREXIA (high fever) and INTENTIONAL DOSE OMISSION (she did not get the second dose of the vaccine/Patient is receiveing the second dose of the vaccine tomorrow, which is more than 36 days after the first dose) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's high fever lasted 3 to 4 days following administration of mRNA-1273.  Company comment: 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 recv vax & 2 days p/vax pt exp high grade fever, recurrent chills, sweats, chest pain, joint ache & trouble walking;sx resolved p/2wk;pt did not require prescription therapy to treat sx;
chills; fever; Stiff neck; headache; aches; Malaise the morning after vaccination; fatigue; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3248, expiry date not reported) on 12Jan2021 15:00 at single dose via an unspecified route of administration in the left arm for COVID-19 immunization.  Medical history included allergy to eggplant, allergy to acetylsalicylic acid, COVID-19 from an unknown date and unspecified if ongoing, ulcerative colitis from an unknown date and unspecified if ongoing , psoriasis from an unknown date and unspecified if ongoing. The patient previously received the first single dose of BNT162B2 (lot number EL0140) on 22Dec2020 09:00 in the left arm for COVID-19 immunization. The patient was not pregnant. Concomitant medication included adalimumab (HUMIRA), apremilast (OTEZLA), calcium carbonat/colecalciferol (VITAMIN D 2000), dl-alpha tocopheryl acetate (VITAMIN E [DL-ALPHA TOCOPHERYL ACETATE]), aloe vera/pramocaine hydrochloride (ATARAX ANTI ITCH LOTION). The patient had not COVID test post vaccination. The patient experienced malaise the morning after vaccination on 13Jan2021 05:00; 26 hours after administration (on 13Jan2021 17:00), the patient got chills, fever (100 degrees Fahrenheit), stiff neck, headache, aches; the next 36- 48 hours continued with stiffness, fatigue (onset date unspecified, in Jan2021). No treatment received for the events. The events were resolved 55 hours after administration (14Jan2021 22:00).
My injection was Friday June 4th around 930am. After returning home Friday after my 2nd Moderna Covid-19 vaccination I went to sleep. I woke up a little while later EXTREMELY cold and shaking very bad. My head was pounding and hurting so bad and I felt like I had the worst flu ever. I could not hardly move my left arm and it hurt really bad. The rest of my body felt shaky and weak. I covered up with multiple blankets and turned my A/C off using an app on my phone. I needed to pee but i felt so bad I couldn't bring myself to get up and walk to the bathroom. I wanted to go to the hospital but I was home by myself. I fell back asleep and woke up later still feeling the same only now I was sweating so much I no longer needed to pee. I fell back asleep and didn't wake up until around 6 am when my husband got home from work. I was so tired I just wanted to sleep. He gave me some ibuprofen and I went back to sleep. I woke up around noon feeling a bit better. I laid in bed watching TV and napping. Eventually I felt better that Saturday afternoon/evening. I had a bad headache every day after that until around Wednesday that I got rid of using ibprophen. On that Monday night following my injection I was driving and I got a sudden extremely sharp pain in my heart and my left leg and arm jerked hard and my left side of my face contorted. I felt fine immediately after no lingering pain. Then yesterday I had an aching pain in my left chest but then it went away
10 hours after vaccination: chills, shivering, lasting for 4-5 hours 14 hours after: extreme fatigue, headache (took Relpax) muscle and joint aches all over, slight dizziness, nausea  30 hours after: fever, 101F added to  all of above symptoms  (took Esgic and Tylenol)  60 hours after (3rd morning after vaccination): palpitations, rapid breathing, shortness of breath (lasting about 5 hours, thereafter somewhat decreasing) (less fatigue, no more muscle/joint/headache)
Pt recvd Hep B vax IV rather than IM on 13AUG91 & stated felt like was in an echo chamber & devel a dry mouth; w/in 10 mins sx subsided;
Developed an abscess two days after injection, abscess has grown bigger than a quarter in 2 months
The MMR and Hep A vaccines were given on 5/22/07.  On 5/30/07 my child had an incident where she appeared extremely pale, was dizzy and staring into space and she almost passed out.  On 5/31/07 she had a temperature of 101.2 and was hot and cold and sweaty.  On 6/1/07 she had another incident where she appeared pale and spaced out.
Raised rash the size of a baseball at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Raised rash the size of a baseball at the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Patient medical history was not provided.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and LISINOPRIL for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE RASH (Raised rash the size of a baseball at the injection site). On 03-May-2021, VACCINATION SITE RASH (Raised rash the size of a baseball at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Redness, swelling and warmth at site of MMRV injection. Due to multiple allergies patient was treated with Benadryl and ranitidine.
I had swollen Lymph nodes down the left side of my body. It went from my head down to my neck, chest, under my arm and back areas. It lasted about a month until it stoped.
Pt recv vax on 12/8/98; on 12/11/98 pt exp jumpiness, quick temper, irritable, twitching of shoulders & head
Client c/o a flush feeling immediately after receiving the vaccine.  Client seen and assessed by EMT and VS are:138/95, HR 0, O2 100%.  15 minutes into observation client verbalized that sensation had gone away and was cleared to go by EMT.
After 10 minutes after receiving vaccine, patient developed red rash on forehead and temples. Rash resolved after 15-20 minutes.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Medium
Bad chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore  arm), FATIGUE (Tired), CHILLS (Bad chills) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified.   On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore  arm) and FATIGUE (Tired). On 16-Feb-2021, the patient experienced CHILLS (Bad chills) and PYREXIA (Fever). On 23-Jan-2021, PAIN IN EXTREMITY (Sore  arm) outcome was unknown. On 17-Feb-2021, CHILLS (Bad chills) and PYREXIA (Fever) outcome was unknown. On 19-Feb-2021, FATIGUE (Tired) outcome was unknown.               Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow-up added as reporter email address needs to be removed.
he had bowel movement and it came out red; feeling drowsy from the shot; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0171) via an unspecified route of administration on 01May2021 13:00 at first dose, single for covid-19 immunisation. Medical history included Diabetes mellitus, High blood pressure, Blood cholesterol increased, back disorder. Concomitant medications included fenofibrate; metformin; gabapentin for his back; losartan; empagliflozin (JARDIANCE); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); atorvastatin; fish oil; glimepiride, acetylsalicylic acid (ASPIRIN CHILDREN) (St. Joseph Children Aspirin) and multivitamin once a day. patient stated he went to get the first vaccine shot yesterday around 1 O'clock in the afternoon and then late at night on around 8 O'clock he had bowel movement and it came out red and that's never happened to him before. And he have been feeling kind of, every time he sit up for he go for a walk he feel drowsy. He was still, its the next day and he was still feeling drowsy from the shot. He went through this pamphlet they gave him after the shot and it didn't say anything about having any effects on his bowel movement. he want to know if there is something he should worry about. Consumer stated, Blood work was couple of months before. He had a Cologuard test recently. And the test came back positive. He called last night when he was on the phone for like almost two hours and nobody picked up and he felt asleep. No treatment received for the events. Outcome of feeling drowsy from the shot was not recovered and outcome of the other event was unknown.  No Follow-up needed; information about lot/batch no. cannot be obtained. No further information is expected.
Presented with rash on both hands at 14:55 post tetanus vaccine at 14:17. BP and HR elevated. PT was shaky. Benadryl 25 mg lm given at 15:09.
received 0.25 ml of bivalent dose; No Adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant medications were reported. Reported that reporter was giving 0.25 ml instead of 0.5 ml of Moderna bivalent vaccine. Reported that 19 patients received the half doses on 15Sep2022, 22Sep2022, 29Sep2022, and 06Oct2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662961:Same reporter
BACTERIAL INFECTION AT INJECTION SITE REPORTED TO US 11/17/2017.
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-NOV-2021.includes reporter information, patient demographics, dosage information.
Narrative: Pt reports that he feels that he had received the Pfizer vaccine, dose #1 on 2/23/21-notes approx 2 weeks later had experienced dizziness and difficult speech that did resolve on its own. He also reports a recurrence of this event approx 2 weeks after his booster (dose#3) that he had received on 10/15/21. He states 5 events with these symptoms since having received these vaccines and he feels these symptoms are related to the corresponding vaccines. Of note, patient notes a pmh inclusive for dizziness, but feels this dizziness is related to the given vaccines as noted.
I82.4Z1 ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN 12/11/2021 LOWER GI HEMORRHAGE I82.4Z1 ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN 12/11/2021 GI HEMORRHAGE
Initial report received from a health care provider on 28 September 2007. A 50-year-old male patient, who is a physician, had received an intramuscular left deltoid injection of FLUZONE, lot number U2441AA on 26 September 2007 and 24 hours later, experienced dizziness, lightheadedness, pallor and felt clammy. Blood pressure - pulse readings: lying - 110/70, 56, sitting - 118/70, 60 and standing - 130-90, 72. He was unable to continue seeing patients and was driven home. Five hours after the onset of symptoms, the patient stated they felt 80 percent better. The patient was reported to have received their flu vaccinations annually and had no prior events with prior flu vaccinations received. The patient had not been ill at the time of vaccination and had no pre-existing medical conditions. The patient had recovered from the event on 28 September 2007. No further information was provided.
I developed fever, chills, fatigue, muscle aches, and joint pain which I contributed to the vaccine. When I woke up 3 days later with a large rash on the left side of my abdomen I sought medical treatment and was diagnosed with shingles.
On Monday night, after the vaccination on Friday, about 10:00 I began to feel pain in my neck, both shoulders, and across my chest. Sleep was fitful and finally impossible, with every breath being painful. We went to ER about 6:00 A.M., thinking it was either a heart attack or COVID. I was checked very well, with good results. EKG was fine, Oxygen at 97%, chest x-ray looked good, white blood count was good, but platelets were low. A subsequent flu test and COVID test both came back negative. My symptoms were constant for several hours then diminished, increased, and diminished until Friday when I felt largely symptom free.