chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever x 2 days, pain in the neck, back & swelling of left arm, lethargic & chills. Tx: warm soaks, AUGMENTIN 875 bid & Ibuprofen.
itching; swollen; red; It was 3.5 inches long and 2.5 inches wide; rash; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red) and INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Feb-2021, the patient experienced PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red), INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itching), SWELLING (swollen), ERYTHEMA (red), INJECTION SITE HYPERSENSITIVITY (It was 3.5 inches long and 2.5 inches wide) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included cold compress and hydrocortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter contact information was updated.
Pt. reporter SOB, rushed to ER about 3 hrs after shot. Per Pt. - was given BENADRYL & Prednisone. Released from ER at about 10:30 p.m.
Patient developed warmth and redness surrounding injection sites on left arm.  Started 11/04/2003.
This is a spontaneous report from a contactable consumer reported for himself and a contactable pharmacist. A 73-year-old male patient received PREVNAR 13 (Lot # M20640, exp. date Apr2017), intramuscular at 0.5 ml, single in the left deltoid on 16Dec2015 12:15. Medical history included prediabetes, adhesive capsulitis, blood cholesterol abnormal on ongoing. Concomitant medication included pravastatin 40 mg, 1x/day and COQ-10 200 mg softgel, 1x/day, both on ongoing for cholesterol. On 16Dec2015, the patient experienced persistent left deltoid pain with outcome of recovering. Also the patient reported that in Jan2016, he developed pain in left upper arm and shoulder and pain impeded arm movement. Therapeutic measures were taken as a result of these events and the outcome was reported as not recovered. Follow-up (22Mar2016): New information obtained from a contactable pharmacist includes: date of vaccine administration updated, route, dose, lot#, exp date and anatomical location, additional event (persistent left deltoid pain), onset and outcome. Follow-up (21MAY2016): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-JAN-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Became shaky while standing in line 30 to 45 minutes (after vaccination).  Rested on cot for 30 minutes and then able to walk to car.
Physical arm pain, red ring around shot site, swelling, itching - for 1 week and 5 days after
It was reported that pt rec'd pneumococcal polysaccitaride vaccine, 14 hrs after injection fever of 101.2F, weak, could not lift head to drink. 24 hrs after injection fever 103.3F, 45 minutes seizure, bright red swollen upper arm injection site, very painful. 8pm fever 102F, tylenol regular pm meds threw up all fluid. Friday fever 102.0F gave Advil, 12 noon temp 99F, gave Advil and reg meds, 2:45pm temp 96F stomach hurts very weak needs help had to make her drink Gatorade . 4pm to clinic urine test, ear, nose throat check, stomach check, blood checked. Dx: reaction to vaccine 2/1 low grade fever 98-99F, weak and tired started eating lightly, drinking pedialite Gatorade. /arm injection site hot, red and swollen and hurts. 2/2/03 low grade fever, eating better, color back in face, not yellow arm injection site ,red, purple, swollen and hot. 2/3/03 Back to school, injection site pale red, purple rash still warm 99F fever.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 months old female patient who was vaccinated with an expired dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included PREVNAR and ROTATEQ. On 21-Nov-2018, the patient received a dose of each suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (batch number not reported, Exp date: 29-Oct-2018) route, site not reported. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Throat tightness, SOB, trouble getting breath, watery itchy eyes.  Used Albuterol inhaler but continued to have trouble breathing thru the night.  Reports no difficult breathing now, but eyes watery, itchy and red.  Also has runny nose.  Instructed client to go to his physician or clinic to get evaluated.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-JAN-2019, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (strength, dose, route of administration were not reported) (lot # R018135 and expiry date: 02-JAN-2019) for prophylaxis (product storage error). The vaccine was stored in between 74 degrees Fahrenheit (F) for 120 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Nausea, Hives, itching, Blisters to back and back of head.
Patient woke up the following day with for lip slightly swollen and tingling all over her face.  The symptoms did not go away, she called us on 09/19/2015 at 10am for advice.  Patient had problems with Benadryl in the past so she decided to have a doctor visit.  MD prescribed Medrol 4mg dosepak.
8/27: fever, HA, nausea, stiff in joints, throat pain - fever at 102. 8/28: improved. 8/29: evening - altered mental state, not responsive, 3 episodes emesis. 8/30: jerking - to ER - another seizure - transferred to hospital - outpatient (febrile)? 8/31: No trauma; Motrin, Cefataxine. Unknown if related to vaccines at this time.  9/30/08 Reviewed d/c summary of 8/31-9/19/2008. FINAL DX: intraventricular hemorrhage; AV malformation in atrium of right lateral ventricle s/p embolization 9/4/08; seizures; poor oral intake, resolved; pain issues, improving on oxycodone wean. Record reveals patient experienced fever, HA, joint stiffness & nausea approx 2 days s/p vaccination. Night before admit, awoke screaming, crying, inconsolable w/mental status changes, HA, vomiting, jerking movements x 1 min then appeared very sleepy.  Similar episode en route to ER.  In ER had tonic-clonic seizure, responsive to meds.  Transferred from ER to higher level of care.  Continued to have additional seizures.  Abnormal CT & MRI scans as noted in previous records.  Transferred to PICU.  Neurosurg & interventional radiology did embolization of AV malformation & remained intubated s/p procedure w/extubation later same day.  Had ongoing HA pain & oral intake reduced.  Pain management team consulted & parenteral nutrition started.  Improved slowly & d/c to home on tapering steroids, antiseizure meds & pain meds w/neurosurgery, EEG & cerebral angiogram f/u. 9/15/08-records received-patient remains in hospital, admitted 8/31/08 with C/O fever and seizure 36 hours after receipt of vaccines. Disoriented and C/O headache, vomited. C/O stiffness in joints.
No additional AE's and no PQC's were reported.; A nurse reported that an expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a registered nurse concerning a patient of unknown gender and age. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 06-OCT-2022, an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U002528, expiration date 13-SEP-2022; strength, dose, route of administration were not reported) was administered to the patient (expired product administered). No additional adverse events (AEs) were reported.
Within the next week I fell very tired and exhausted. I had bad body aches that they would wake me up in the middle of the night. Needed to have Tylenol and ibuprofen in my system. My skin felt so sensitive when outside. I also had headache, swollen glands, sore throat and cough. First Period after covid shot was for 11 days.
Two days after receiving the vaccine I couldnt lift my arm to touch my bicep to my ear.; My arm was sore for three days; I had mild to moderate headaches on and off throughout the day every day for five days after receiving my vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 22Feb2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to dial original soap. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included guaifenesin/pseudoephedrine hydrochloride (SUDAFED)  and ibuprofen (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, the patient's arm was sore for 3 days, the patient had mild to moderate headaches on and off throughout the day every day for five days after receiving vaccine. On 24Feb2021, two days after receiving the vaccine, the patient could not lift arm to touch her bicep to her ear that went away after one day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm was sore was recovered with sequelae on 26Feb2021; while that of the event mild to moderate headaches was recovered with sequelae on 28Feb2021. The clinical outcome of the event could not lift arm to touch her bicep to her ear was recovered with sequelae on 25Feb2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified number of pediatric patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of pediatric patients were vaccinated with a booster dose of VAQTA (lot number, Expiry date, dose and route were not reported), earlier than 6 months after the previous dose. No adverse experiences were reported. Additional information is not expected as the reporter did not wish to be contacted.
Severe arm pain in the middle of the night - woke me up (the arm pain lasted at least a week); Saturday morning- nausea and headache and I took Motrin. As the day progressed, 4-6pm fever started - went to 102.8 and Motrin lowered to about 101. Very fatigued, body aches, nauseated and headache got worse. I didn't want to keep my eyes open. Fever lasted until Monday and I felt very unwell. I called Clinic Monday morning - Advice nurse -and she suggested I get a COVID test. I felt so miserable - I laid in bed for whole week. It took all my energy to get to the bathroom. I went to work on that Wednesday to deliver my rounds of meds and went back home to bed. Friday, Jan 22nd - Doctor   - redness wrapped all around my arm (from the inch down from shoulder and two inches above elbow)  and it was warm to the touch (it wasn't painful at that point) but it itched like mad and he ordered an anti-nausea medication for me. Arm recovered before second dose. Nausea lasted to the second dose. I was anti-nausea medication  - Andanzitron - 8 mg tablets (Clinic) - to get through my days. Nausea has gotten a little better but still have to take medication from time to time. Second dose received 5th of February.
Tenderness at the injection site; Fever; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2019, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site tenderness, fever, chills and headache. On an unknown date, the outcome of the injection site tenderness, fever, chills and headache were unknown.   It was unknown if the reporter considered the injection site tenderness, fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 24 hours ago from the date of reporting.  At the time of this report, the patient was experiencing fever, chills, headache and tenderness at injection site. The reporter consented to follow up.
Got a rash with blisters all over; This case was reported by a consumer via interactive digital media and described the occurrence of blistery rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was not recovered/not resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and got the rash with blisters all over.  The patient wanted to know was that normal. Additional Supportive Information: The follow up would not possible, as no contact details were available.
1st dose on 9/3/21, 2nd on 11/4/22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd September 2021).   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment:  The reporter stated that he was wondering if someone that had received their two Shingrix vaccines a year apart - do they need to restart series. The patient reported that the 1st dose was administered on 3rd September 2021 and 2nd dose on 4th November 2022. The reporter wanted to know if he needs to get another dose. Additional supportive information: As patient received 2nd dose one year apart rather that 2 to 6 months which led to drug dose administration interval too long.
The employee called on 8/27/18 and left a message re: an adverse reaction. A nurse returned the call and left a message. On 8/28/18, I spoke to the employee who stated about day 4-5 she had a rash near the injection site which now was throughout her body (described as red little dots) She also stated she just felt off and was having intermittent nosebleeds, and bruising. Denied fever, vomiting, diarrhea. She complained of headache and stiff neck as well. When I spoke to her, she stated she called the CDC about the rashes and was told it could be a reaction to the MMR vaccine that occurs 6-14 days after vaccine given and should have her platelets checked and be seen. She also told me she had a difficult time walking and felt terrible, and dehydrated She was seen and evaluated in the ER, on 8/28/18 had lab work done and was placed off of work for 2 days. Her platelet count and all labs were unremarkable. She was given IV fluids as well. The employee knew the vaccine was being reported to VAERS. I also made her a follow up appointment with our Occupational Health physician. She canceled the first one and will be seen on 9/6/18 for follow-up.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose route, frequency, lot number and expiration date were not reported) for prophylaxis. Information regarding concomitant therapies were not reported. The vaccines were stored at 39F degrees during 10 hours. This information was registered in a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (MARRS#1706USA009325). Additional information has been requested. Sender's Comments: US-009507513-1706USA009325.
pt recv vax 8JUL92 & on 12JUL92 pt was seen in ER for febrile sz; dx BOM; ? rxn to MMR:
From initial information received on 2/24/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a nine year old female patient received a Fluzone vaccination, lot number and route and site of administration unknown, on 12/3/03. Two days later, on 12/5/03, the patient experienced constant nausea, lightheadedness when standing, feeling of being cold all the time, ear pain, throat pain, and headaches. At the time of this report, the patient had not recovered from these events.
I experienced swelling in my right arm, fever, chills, lymph node under my right arm and became diagnosed with lymphadenopathy.
about 5 hours post shot, I started to feel ill.....Nausea and ACUTE diarrhea, dizziness....This persisted for 24 hours and then, I just felt a bit dizzy and ICKY!....Then, returned to normal.  This was a rare event that would not have been associated with ingestion of bacterial pathogens/food or other extraneous events....I couldn't figure it out and was laying and bed and noted my sore arm...and thought "OH...the dang Shingrex shot!"
Patient in area of observation refers feeling dizzy, paramedics take action and take her vitals and gets transported to the ambulance. Legs are elevated and put on oxygen. BP 90/50, P92, DXT 110 Sat 98 Doctor is called.
Received Moderna vaccines on 2/16, 3/23/21 COVID-19 positive by PCR on 1/8/22 admitted to hospital on 1/8 due to acute on chronic hypoxic and hypercapnic respiratory failure, pneumonia d/t COVID
Significant illness symptoms started the day following injection of this booster, including sensations of inflamed glands, muscle aches and pains and sensation of fever.   Skin irritation started, with extreme itchy sensations in arms and legs, and then small red welts that developed into scabs or hives with red dots and swelling.   On 6th day after this booster, I developed my first ever asthma attack with difficulty drawing a full breath, pressure on the chest correlated with breathing, and extreme runny nose and mucus discharge.   I have never experienced any symptoms like this from any illness in my lifetime.   On the 6th and 7th day after this booster, illness feeling persisted, including sensation of inflamed glands, muscle aches and sensation of a fever.
08/31/20 @ 1620 employee received flu vaccine. Approximately 2 hours later, employee had c/o red/swollen eyes bilaterally, sinus' that felt like "concrete", and some difficulties breathing. Went to clinic 09/01/20. Symptoms were starting to resolve. MD confirmed diagnosis of allergic reaction and prescribed prednisone. Employee did not take prednisone as his symptoms were improving. Employee Health followed up with the employee on 09/02/20. At this time all symptoms had resolved with no sequela.
My COVID-19 symptoms started on 03/29/2023 in the morning. I had scratchy throat, cough, headaches, and tiredness. I would ran out of breath if I try to do anything. On 03/30/2023 I did a home COVID-19 test which was positive. I called the nurse's  line after testing positive. They prescribe me Paxlovid for 5 days. As of today I've recovered 95% from COVID-19 infection.
This spontaneous report as received from a pharmacist refers to a 61 years old male patient concerning to himself with no known drug reactions or allergies and nothing of importance medical history. On unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously, for shingles prevention (lot number not provided). No other co-suspects were reported. Concomitant medications included losartan potassium, hydrochlorothiazide (manufacturer unknown) and allopurinol. On an unknown date, six to eight months after ZOSTAVAX vaccination, the pharmacist developed a "rash" in his mouth. Both his tongue and roof of mouth were involved and he described it as "being burnt as if he ate something hot". He visited an unspecified primary care physician and was diagnosed with thrush. An unspecified medication was prescribed but did not help. At the time of the report, the pharmacist was still suffering with ulcerative/redness in his mouth. The relatedness for thrush was unknown for ZOSTAVAX. Additional information has been requested.