chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; night sweats; knees felt like the joints inside were swelling; became difficult to walk; golf ball sized hardness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NIGHT SWEATS (night sweats), JOINT SWELLING (knees felt like the joints inside were swelling), GAIT DISTURBANCE (became difficult to walk) and VACCINATION SITE INDURATION (golf ball sized hardness on injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-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 PAIN IN EXTREMITY (sore arm), NIGHT SWEATS (night sweats) and VACCINATION SITE INDURATION (golf ball sized hardness on injection site). an unknown date, the patient experienced JOINT SWELLING (knees felt like the joints inside were swelling) and GAIT DISTURBANCE (became difficult to walk). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), NIGHT SWEATS (night sweats), JOINT SWELLING (knees felt like the joints inside were swelling), GAIT DISTURBANCE (became difficult to walk) and VACCINATION SITE INDURATION (golf ball sized hardness on injection site) outcome was unknown. Not Provided          No concomitant medications were reported.
Vasomotor response, then complains of dizziness, blurred vision, pounding headache in the back of the head then moved to the front of his head, forehead area. Here 1 1/2 hours when leaving complained of itching all over. Had a fever over the weekend and a headache. Much better.
Persistant crying starting 4-5 hours after vaccine. Mild swelling of Right thigh.
Delay in monthly menstrual cycle after dose 2 of vaccine. Cycle is now 6 days overdue.  Following dose 1 of vaccine, my men?s tusk cycle which typically last 3-4 days, lasted for 9 days.
Fever > 100 x 2 days. Rash x3 days - red circular hives. Right TM red - CEDAX, 1 tsp every day ORAPRED 1 tsp po every day x 5 days.
This spontaneous report as received from a pharmacist concerning a female patient of unknown age who on 08-APR-2013 was vaccinated with a 0.65ml dose of ZOSTAVAX, subcutaneous (Dose and lot # not provided). The pharmacist stated that patient was prescribed prednisone 30 mg, titrating down for approximately a week and half on 30-MAR-2013. Patient was prescribed the prednisone by an unspecified ear, nose and throat physician for unspecified reason. At the time of reporting, the patient's outcome from the event was unknown. Additional information is not expected.
He could almost sleep 24 hours a day; Does not have any energy; Loss of appetite; Joint pain, right wrist is so painful that he can hardly move it; A lot of fatigue; Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (He could almost sleep 24 hours a day), ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite), LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, LISINOPRIL, GLUCOSAMINE and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSOMNIA (He could almost sleep 24 hours a day), ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it). 04-Mar-2021, the patient experienced FATIGUE (A lot of fatigue). In March 2021, the patient experienced LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HYPERSOMNIA (He could almost sleep 24 hours a day), LIMB DISCOMFORT (Had an episode where his arms felt so heavy that he could not move it,his arms felt 3 times the size they are) and FATIGUE (A lot of fatigue) outcome was unknown and ASTHENIA (Does not have any energy), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Joint pain, right wrist is so painful that he can hardly move it) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021 included no new information.
Cough, red eyes, hoarse voice, chest tightness. Started 2 hours after vaccine was given and lasted for 1 day.
I got the Pfizer shot around 10:00, and until evening I just had a sore arm. By 9:30 my head and body were aching, and I was starting to run a fever. About 10:30 pm I started vomiting, and continued vomiting every little bit all night long! My fever was over 102.1 (I know because I took my temperature after vomiting, brushing my teeth, and drinking a little cold water) My head felt like it wanted to explode, and my body was aching so bad all over! The nausea was severe! Around 9:30 am I finally stopped vomiting, but still felt nauseous.  It?s 1:36 in the afternoon and my head continues to hurt to where I don?t even want to turn my head or eyes, body still aches, and I still feel nauseous .
This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. On 03-MAR-2014, two patients were vaccinated with ZOSTAVAX (dose, unit, route, lot# and expiry date unknown) that has exposed to 38.6 Fahrenheit (F) for 1.5 hours. No adverse events were reported. The outcome of two patients was administered doses of ZOSTAVAX that were exposed to 38.6F for 1.5 hours and no adverse event was unknown. No further information was provided. Additional information has been requested.
vaccinated 01/25/2005. at site of varicella vaccine began having quarter sized red spot several hours after vaccination on 01/27/05  became red warm and swelled the area 50% larger than normal.
PATIENT HAD A 5 INCH RASH BELOW THE INJECTION AREA.  WHEN SHE CONTACTED THE PHARMACY ON 9/4/2019 THE DAY AFTER THE IMMUNIZATION, THE RASH WAS GETTING BETTER.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-DEC-2015 at 17:51, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
approx 3hr p/vax pt had hives covering chest & back;taken to ER & treated w/DPH & pred;
Myalgia Narrative:  8 hrs after vaccine generalized ache/fatigue/tired day 1 and 2
Pt had a syncopal episode 5 minutes after receiving the vaccine. He was sitting when he began to felt lightheaded and put his head down. Pt loss consciousness for a few minutes, fell off his chair and sustained a closed head injury. In addition, he sustained a chipped tooth to the lower incisor. He sts he has experienced similar events before after seeing blood or receiving shots. Pt also reported that he did not eat or drink prior to coming. Denies CP or SOB.
Pt said his left arm was still sore from shot he got in Sept. He said he mentioned it to his Dr today at visit. He said Dr said we might have poked or pinched nerve. He said his arm was sore to lift and sleep on. Prescriptions for prednisone and triamcinolone were given. Technique used to give shot was to feel shoulder then make C with left hand and give shot in middle of C with right hand.
This spontaneous report as received from a registered pharmacist refers to a 69 year old male patient. On 23-MAY-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot number H021710. The patient experienced a reddened area at injection site on 24-MAY-2013 (it was reported the patient had the redness for 7 days). He confirmed that there was no itching, pain or any kind of rash at injection site. No treatment was given. The patient had sought unspecified medical attention via visiting office. No laboratory test was performed. The outcome of a reddened area at injection site was reported as recovering. Additional information has been requested.
Information has been received from a general practitioner concerning a 66 year old female with a history of pituitary adenoma, diabetes insipidus, pituitary hormone deficiency, pancreatitis, chronic obstructive pulmonary disease, allergic rhinoconjunctivitis and nephrolithiasis who on 16 June 2006, was vaccinated (route unknown) in the left upper arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 650833/0882P, Batch # NC72130). About twelve hours later, she developed severe swelling of the whole left upper arm including the elbow joint, with redness, warmth and severe pain in this arm. She had to call the emergency doctor, who administered cooling and prescribed ciprofloxacin. The outcome was not reported. No further information is available. (OMIC)
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 07-JUN-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: hypercholesterolemia, and the patient had no known allergies. The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient had suspected clinical vaccination failure (Dose number in series 1). The patient received second dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The patient additionally received third dose of non-company suspect vaccine included: Pfizer Biontech covid-19 vaccine (Tozinameran) (Dose number in series 3) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on MAY-2022 for prophylactic vaccination. On MAY-2022, the patient experienced severe Covid symptoms (suspected covid-19 infection) (Dose number in series 3). The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on MAY-2022 and last dose on 11-MAY-2022 for treatment of COVID-19. The patient 48 hours after finishing paxlovid drug, the Covid symptoms returned and were much more severe than initial symptoms. Concomitant medications included simvastatin. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with a product quality complaint.; Sender's Comments: V0-20220606747-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
I have developed Essential Tremors (ET) because of the vaccines. This was diagnosed by my neurologist with appropriate tests. I did not have these prior to the vaccines, and every time I got another vaccine it got worse and worse. There is no cure for ET, I have to live with this the rest of my life. I have trouble doing everything in life as I shake like crazy whenever I use a muscle. I am not even able to hold a glass or mug without spilling or dropping it.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), on 04Mar2021 as dose 2, single (Lot number: EN6203), in right arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: other medical history: Arthritis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.
Pfizer Bivalent Covid Vaccine was given over the 12 hours counter time period. The vial was moved to the counter at 5:15pm on 10/7/222, and was first puncture at 5:40pm on 10/7. Vial was not discarded, and vial was used on 10/8/22 at 1:36pm.  Spoke with our Clinical Pharmacist who was able to obtain information from the Pfizer website. She was able to refer to Summary of Data. No additional follow up is needed.
My dad got the Moderna Vaccine on Tuesday, January 12, 2021 in his left arm at the Mall injection site for the Health Department. He was told that the side effects could mean his arm hurting, tiredness, headache, and even a low grade fever. Additionally, the site informed us both (as I was with him to get the injection) that this was all normal and not to seek medical attention unless these symptoms last longer than 72 hours. That evening, my dad was experiencing all of those symptoms, and went to bed at 7pm. A little after 10am on Wednesday, January 13, 2021, when he awoke, my dad went to the bathroom vomiting. This was where he collapsed and went into cardiac arrest. Fire/Rescue was dispatched about 10:30am after my mom started CPR. County Fire Rescue EMTs and Paramedics continued CPR and other attempts at reviving him all the way to Hospital Emergency Department. He was pronounced dead at 12:14pm on Wednesday, January 13, 2021. We have no doubt my dad, following the instructions of the injection facility, thought he was just experiencing the side effects of the vaccine. He had no chance. Had this injection been done in the RIGHT arm, perhaps he could have recognized the arm numbness being that of an impending heart attack. We really miss Dad. He served this country with distinction for over 50 years, and we believe his country failed him.
Approximately 6 hours after vaccine, patient started feeling fatigued and aches. Approximately 12 hours after vaccine, patient started experiencing lip, throat, tongue. Patient had visible shortness of breathe (per mother), excessive sweating. Patient was given Benadryl routinely for 24 hours. No pain medication was administered.
Presented to hospital on 2/11 with increasing shortness of breath and hyperglycemia. COVID + 2 weeks ago. Placed on high flow oxygen with saturations in the 90s and insulin drip. Required intubation and mechanical ventilation. Place on CRRT. Had PEA arrest and awakened a few days later able to follow commnads. Placed on vasopressors to maintain BP.  Started on argatroban drip due to venous thromboembolic disease. Continued to need increased ventilator settings with tachycardia and hypotension. On 3 vasopressors with hypotension. CXR showed severe pulmonary edema. Family decision to transition to comfort care.
Chest pressure, shortness of breath, fatigue, and periodic episodes of heart racing or thumping - a few times a week from shortly after vaccine to present (a month)
Evening of vaccine (L) arm site (PNEUMOVAX) felt warm. Said next day felt sick. Went to Dr. 9/29. Diagnosed serum sickness, gave Prednisone 10mg & Hydrocodone/APAP 10/500. Also told to take BENADRYL and Aspirin. Sent to ER 9/30. Kidneys were functioning. Gave Rx for PERCOCET 5/325. Lymph node underarm is size of apple. Protein in kidneys.
Chest pain, SOB, DOE Pt presented to hospital - transferred to university hospital - underwent LHC which was clean - Troponin rose to 2.23 - ESR, CRP elevated - active chest pain, EKG w/ diffuse ST elevation - myopericarditis  - Cardiac MRI  - colchicine/ibuprophen  - developed NSVT, required beta blockade
Within 10 minutes of vaccine patient had widespread urticaria, with swelling of the lips--POX 98% no evidence of breathing trouble.  At 11:35 AM had 30mg of orapred.  At 11:45 AM he had complaints of severe abdominal pain with wretching but no vomiting. At 11:50 AM he was given epinephrine 1:1000 0.15mg IM.  911 was called and he was taken to the Hospital--according to ER report he had Benadryl elixir 17.5mg PO was observed for four hours and sent home on Benadryl 12.5mg/5ml 7.5ml every six hours and Prednisolone solution 15mg/5ml 5ml two times a day for five days--diagnosis was anaphylactic reaction.
according to the provider, the patient may experience more soreness in the arm of where the vaccine was given. At time of administration, patient did not report any adverse reactions.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 7-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the third dose Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000456: US-009507513-2302USA000412: US-009507513-2302USA000403: US-009507513-2302USA000949: US-009507513-2302USA001303: US-009507513-2302USA001305:
The day after injection: pain inside the shoulder joint (not muscular); significantly reduced range of motion especially in lifting arm over head. Treated with heat and ibuprofen. No improvement. It felt like the needle was still in the joint. No progress for 3 weeks, at which point pharmacy called me to say the lot of vaccine had been recalled by CDC for improper storage and I needed another shot. I did get that, and also started physical therapy, at which point I was advised that I probably had SIRVA. Saw an orthopedist 10/21/21 who confirmed this and prescribed more physical therapy and a course of oral steroids.
Headaches and entire back pain for 18 days after vaccine. Headache and back pain were 9/10 on pain scale. Felt like someone hit me in the back of my head with a baseball bat and the same with my entire back. I could not bend over for the first hour when I woke up
This retrospective cohort study report has been received from the authors of a published literature. This paper described a 9.5-year cohort study evaluating the incidence of herpes zoster after concomitant administration of ZOSTAVAX (ZVL) and PNEUMOVAX 23 (PPSV23). A retrospective cohort study was conducted from 01-JAN-2007 to 30-JUN-2016. The exposed cohort (concomitant vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL and PPSV 23 on the same day from 01-JAN-2007 to 31-DEC-2014. The comparator cohort (prior vaccination group) consisted of 60 years of age and older who were vaccinated with ZVL during the same period as the exposed cohort but were previously vaccinated with a dose of PPSV 23 from 365 days to 30 days prior to receiving ZVL. Both groups had been continuous members in the year prior to date of ZVL vaccination, allowing for a 31-day gap in membership. The patients from both groups were followed from the date of ZVL vaccination until the date of herpes zoster occurrence, termination of membership (allowing for a 31-day gap), death, or 30-JUN-2016, whichever was earliest. This report refers to 445 elderly (age 65 years and older) patients. On unknown dates the patients were concomitantly vaccinated with ZOSTAVAX (lot#, expiration date, dose, route and frequency unknown) and PNEUMOVAX 23 (lot#, expiration date, dose, route and frequency unknown) for prophylaxis. The prescribing information stated that these vaccines should not be given concurrently (product use issue). On unknown dates, the patients experienced incident severe herpes zoster. The outcome of the events was unknown. The reporter considered vaccination failure and herpes zoster to be related ZOSTAVAX. This is one of several reports received from the same literature (linked report MARRS #1804USA008699, 1804USA010350, 1804USA010351, 1804USA010352, 1804USA010377).
24 hrs after vaccine administration I experience fever, chills, body ache and tiredness. Recovered in 18hrs after initial onset of symptoms. Then 18 hrs afterword i started experiencing sore throat.  Symptoms are scratchy sensation in the throat with raised red bumps only. No difficulty swallowing, No swollen tonsils, no fever, no chills, no headache, no nausea, no diarrhea   or other symptoms. No medication where taken. I rested at home. Sore throat feels getting better.