chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of moderately severe grade 2 myalgia, arthralgia, and fatigue approximately 16 hours after vaccination. Mitigated partially with ibuprofen. Symptoms lasted from 0400 through around 2100 same day.
headache is bad that i can even bend my head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache is bad that i can even bend my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache is bad that i can even bend my head). At the time of the report, HEADACHE (headache is bad that i can even bend my head) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
About one hour after getting the shot, I became very dizzy, it lasted about one hour then slowly went away. No treatment.
As soon as my vaccine was done in my left arm, I bled. I had tingling feeling in my arm, felt like I needed to rest my arm. I was asked to sit down for at least 15mns. The tingling went away, during the night my arm was painful, the next morning I couldn't lift my arm up due to the pain. The pain in my left arm lasted until Saturday night. Sunday night, I had chills, coughing, my right arm now was hurting, couldn't not lift it up just like it was in my left arm. Wednesday, January 20th, 2021, the tingling in my left arm was back but this time with my hand shaking, shaking so strongly that it scared me. There was tingling, shaking and felt like I needed to drop my arm.  Thursday January 21st  and Friday January 22nd, my hand kept shaking and felt like I needed to drop my arm. The tingling feeling in my arm has not stop since then and so is the shaking of my hand.
A FEW MINUTES AFTER OVERSEAS IMMUNIZATIONS COMPLETED HE SAID HE WANTED THE TYPHOID TODAY ALSO. NO TYPHOID GIVEN TODAY.  WRITING UP CHARGE PAPERS-OBSERVED CLIENT BECAME VERY PALE, SAW BLACK SPOTS AND FELT FAINT.  SITTING IN CHAIR-DRINKING OJ, MOIST AND COOL CLOTH TO FOREHEAD & WRISTS-PERFUSE PERSPIRATION-ASSISTED FROM CHAIR AND LAID DOWN, ELEVATED FEET ON PILLOWS-CALLED NURSE TO HELP MONITOR AND INCIDENT REPORT.  BP 118/76 P 73 @2:48 PM ALERT & ORIENTED X3.  ATE CRACKERS AND OJ. DANGLED, BP 106/80, P68.  STOOD WITH ASSISTANCE.  TO CAR WITH FRIEND DRIVER @3:45 PM. AFTER EVENT, STATED HE FELT WEAK WHILE OBSERVING FRIEND GET SHOTS BEFORE HE RECEIVED HIS.
Closterfobic in the open air crushing feeling. 4 hours. Major nerve pain through out body. 4 hours.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient who experienced swelling at site, while received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious swelling at site following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Final diagnosis was swelling at site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling at site.
No further AE reported; Gardasil 9 underwent a temperature excursion and was administered to a patient.; This spontaneous report has been received from a Registered Nurse and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 27-JUL-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) (dose number, vaccination scheme frequency, route and anatomical site of administration were not provided; lot number 1687290, that was verified to be valid, expiration date reported and established as 06-SEP-2022) as prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 59 degrees Fahrenheit (F) with a time frame of 15 minutes, which was detected by data logger (product storage error). No previous temperatures excursions were reported. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Marked local reaction - disable from usual activity x 3 days. No fever. No abscess.
Information has been received from a health care worker concerning a 54 years old female patient with arthritis and allergy to Ibuprofen, who on 07-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 667915/1111Z, Exp 02-MAR-2012) 0.5 ml, intramuscularly. Concomitant therapy included simvastatin (manufacturer unknown), ACIPHEX, SOMA, HALCION, NEURONTIN, PERCOCET and alendronate sodium. On 08-MAR-2011, the patient developed severe joint pain all over her body including neck, after receiving PNEUMOVAX 23 (lot # 667915/1111Z, Exp 02-MAR-2012). The patient also had headaches and nausea. It was reported that the patient received TYLENOL for the treatment of the Adverse events. The patient sought unspecified medical attention. No Lab diagnostics studies were performed. At the time of the report the patient's outcome was not recovered. The reporter requested a lot check due to the patient's adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning the 54 year old female patient with IBP allergy and no illness at time of vaccination, who on 07-MAR-2011 at 9:00 am was vaccinated into the left arm with the second dose PNEUMOVAX 23 (lot # 667915/1111Z). The physician reported that on 08-MAR-2011 the patient developed diffuse arthralgias which required emergency room/doctor visit and resulted in persistent or significant disability/incapacity (weeks). At the time of the report, the patient had improved and diffuse arthralgias were better. Diffuse arthralgias were considered to be disabling by the reporting physician. Additional information has been requested.
Patient experienced headache, fever, chills, and severe fatigue. A rash developed at the injection site and was itchy and painful.
Rash at site of injection; itchy, red, bumpy (size/feel of mosquito bites)
I had lymphadenopathy in my left armpit that started day 1 after vaccine of 2nd. Lymph nodes are still painful on day 2 but swelling of lymph nodes have decreased
04/09, ~11:15 a.m.:  Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.:  Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.:  Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.:  Went to bed and slept 04/10, ~2 a.m.:  Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue
itching, hives, rashes at different locations of body, overstimulation of histamines (congestion build up)  nurse at site said to use Benadryl (still using daily at day 6) and drink lots of water.
breathing changed; headaches all day and night; tiredness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8727) via an unspecified route of administration in left arm on 06Apr2021 as single dose for covid-19 immunization. The patient was 42-years-old at the time of vaccination. Patient relevant medical history included high blood pressure from unspecified date and is ongoing (she was on Atenolol for it, but her doctor took her off because her blood pressure was normal), sinus issues from an unspecified date and is ongoing. The concomitant medication included pseudoephedrine hydrochloride (SUDAFED 12 HOUR) taken for sinus issues and it is ongoing. She asked if the headaches and tiredness experienced were also reported as side effect to the vaccine. Response: used headache and fatigue info following the 1st dose of the vaccine under Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 to 55 Years of Age Safety Population of the Full EUA PI, LAB-1457-7.0, revised: 06Apr2021. Caller asked if the change in her breathing was reported as a side effect of the Pfizer-BioNTech COVID-19 vaccine. Response: For the change in breathing pattern used section Drug or Food Interaction / Concomitant Administration of the VR-Consumer Inquiry Management (Off-Label or No Info). Added currently, symptom pertaining to breathing is under signs of a severe allergic reaction can include: Difficulty breathing from section What are The Risks of The PFIZER-BIONTECH COVID-19 mRNA vaccine?" of Fact Sheet for Recipients and Caregivers, LAB-1451-4.0, revised: 06Apr2021. Patient experienced on 07Apr2021 headaches all day and night, on 06Apr2021 was tired, on 10Apr2021 breathing changed and are persisting. Headaches are not as bad, but they are still there she has taken Tylenol for the headaches. The outcome of the event headache was unknown for tired was recovering and for breathing changed was not recovered.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "DVT" (unspecified if ongoing), notes: being treated for DVT using Eloquis; "Some fresh fruit" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11Nov2022 to 16Nov2022.  Clinical course: No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Injection site was itchy.  After I scratched at the site, the lymph nodes in the left underarm (near the site) began to hurt and swell.  The lymph node swelling is still present, as well as the injection site swelling.  I am using acetaminophen and generic Allegra to control the symptoms.
100 degree fever for 18 hours Intense body pain for 6 hours Headache
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX, 6 months before the date of reporting. The patient felt like she was coming down with the flu for about the first week after the dose. The patient did not want to provide her address for follow up.
Tongue Sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Tongue Sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOSSODYNIA (Tongue Sore). At the time of the report, GLOSSODYNIA (Tongue Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History information was reported. No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact
This spontaneous report was received from a nurse referring to a 1 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 16-MAY-2018, the patient was vaccinated with an improperly stored dose of VAQTA lot# N026997, expiration date 10-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of 9 Centigrade degrees (°C) to 25 °C (10.2°C), during 52 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA007879.
Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later.  I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.
Reddened & swollen 8cm x 10cm area around inject site, painful to touch; pt afebrile
patients were vaccinated with Fluarix after being out of range; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that 300 patients were vaccinated with Fluarix after being out of range for 2 weeks.  The reporter did not consent to follow-up.  The health care professional provided limited information since didn't have expiration date of the vaccine, or any other demographic details from vaccinated.
A report was received from a health care professional on 22OCT2003 concerning a 41 year old female vaccinee who experiened tenderness, swelling and hardness at the site of injection approximately 1 to 2 hours after receiving Fluvirin SC on 21OCT2003. On 21OCT2003 the vaccinee received Fluvirin SC, 1-2 hours after receiving Fluvirin the vaccinee experienced some tenderness , swelling and hardness at the site of injection. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 3FEB2004: Further information was received from a health care professional on 3FEB2004 indicating that the vaccinee experienced local pain, swelling and redness 2-3 days following vaccination . The local pain, swelling and redness lasted 1.5 months. There was no further sequelae. Follow up pending. Cross reference with PJP200300874.
Information has been received from a literature article concerning a 18 year old female patient developed uveitis, following administration of GARDASIL. The patient had as a pre-exising conditions asthenia. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 2 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.
Pt. states that after receiving the 1st dose of Phizer 07/31/2021, started experiencing symptoms 08/01/2021 of dizziness, fatigued, pain in the left hip, difficulty moving left leg, and joint pain. Pains have increased since having the 1st dose, back pain consistent. No noted Primary visit. Still continuing to experience symptoms.
TRANSIENT NUMBNESS; TINGLING DOWN BOTH ARMS FROM FOREARMS DOWN TO HANDS; CHILLS; FEVER; This spontaneous report received from a pharmacist concerned a 30 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced fever. On 19-MAY-2021, the subject experienced tingling in both hands. On 20-MAY-2021, the subject experienced transient numbness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, and fever on 19-MAY-2021, and had not recovered from transient numbness, and tingling in both hands. This report was non-serious.
Patient reported no additional AE; a 54-year-old male patient was administered Gardasil 9; This spontaneous report was received from a pharmacist concerning a 54-year-old male patient.   The patiente's concurrent conditions, medical history, and concomtiant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration not reported) (lot # S033308, expiration date not reported, but upon internal validation stablished as 08-APR-2022) for prophylaxis (product administered to patient of inappropriate age) (onset date / date first identifiesd reported as 08-MAR-2021). The patient did not report additional adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
After getting the Janssen vaccine my hands have been constantly cold. They only get warm after I sit on them for about 10 minutes.  Sticking them under blankets/etc doesn?t help.
itchy left arm around injection site. Warm to touch. Used hydrocortisone cream.
Right upper outer aspect of the are reddened, tender, warm to the touch. some swelling into the axillary lymph gland. aslo itching.  4 1/2 inches long by 3 1/2 inches @ the widest point
Patient has swelling from shoulder to elbow for 3-4 days after injections were given skin at injection site hot to touch. Patient feels reaction from HPV - no MENACTRA.
About 14-15 hours post 2nd vaccination a little full body ache and hot.  Awoke sweating.  At injection site painful to the touch.  Took ibuprofen.  Slept and awoke for my day at ~ 17 hours post injection. Had been sweating and felt hot, never did take temperature.  Full body aches and mild headache.  Went to work. All day was achy.   Left side of body was all day achy joints.  My entire body caught up around 24 hours post injection with achy joints.  Took more ibuprofen as needed throughout day.  Sweaty off and on throughout entire day,  fatigued.  Joints, noticed mainly my hip joints, painful/achy.  At home ~ 31 hours post injection still hot, sweating.  Took temperature at home.  Oral = 99.6 aural = 100. 6.  I took temperature again a few times throughout rest of evening and maintained a low grade fever of previous temperatures.  Slept, still hot during sleep, not as much sweating.  Next day felt better.  Still very mild pain at injection site with a little itch.
About 10 hours after my second dose of the Moderna COVID vaccine I developed a fever (100°F), headache, sore arm at injection site, body/joint aches, and fatigue. I went to sleep, slept poorly. Took tylenol the following morning, at 8:15am. Fever reduced to 98.7°F, headache reduced, body aches reduced and I took a nap from about 1:00-3:30pm. 2/4/21 I returned to work with only a mildly sore arm at injection site.
She reports she had second vaccine on Jan.8th and developed a temp. 102, body aches, felt horrible. She called PCP and had COVID swab 1/10 at urgent care with neg. result.
Patient pumped breast milk as usual but 12 hours after the vaccination pumped strikingly green breast milk. Since then the milk color has returned to normal. Patient denies change in diet, vitamin supplementation, health.
Redness, nausea, fever, chills, fatigue started 2 hrs after receiving vaccine - got better with time but symptoms lasted approximately 1 1/2 days.