chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm to touch; 10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION; RED RASH SPREADS FROM SHOULDER TO ELBOW; SWOLLEN AND GETTING BIGGER; SORE ARM FOR 2 DAYS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM FOR 2 DAYS), INJECTION SITE WARMTH (warm to touch), RASH (10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION), VACCINATION SITE RASH (RED RASH SPREADS FROM SHOULDER TO ELBOW) and VACCINATION SITE SWELLING (SWOLLEN AND GETTING BIGGER) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Colitis and Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, BUDESONIDE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ESTRADIOL, VITAMIN D3, VITAMIN B12 NOS, BIOTIN and LIFITEGRAST (XIIDRA) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM FOR 2 DAYS). On 30-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm to touch), RASH (10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION), VACCINATION SITE RASH (RED RASH SPREADS FROM SHOULDER TO ELBOW) and VACCINATION SITE SWELLING (SWOLLEN AND GETTING BIGGER). On 22-Jan-2021, PAIN IN EXTREMITY (SORE ARM FOR 2 DAYS) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to touch), RASH (10 DAYS LATER DEVELOPED RED OVAL SHAPE PATCH ITCHY RASH AT THE SITE OF THE INJECTION), VACCINATION SITE RASH (RED RASH SPREADS FROM SHOULDER TO ELBOW) and VACCINATION SITE SWELLING (SWOLLEN AND GETTING BIGGER) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Email ID added On 08-Jul-2021: Follow-up information contains reporter details updated, medical history and concomitant medications were added.
3/15/18 New onset this AM. Suspect this is related to the varicella vaccine that she got 10 days ago. She is without fever and only slight change to her baseline activity. I have educated mother about this and precautions for those who are older, immunocompromised and very young who have not been vaccinated. Will f/u closely in office tomorrow. Counselled to just use calamine lotion prn if needed. All questions answered. Skin: many small macular erythematous rash to extremities, trunk and face - NO PUSTULES. 3/16/18Grossly unchanged presentation from yesterday. Continue to wait/watch. Precautions discussed again with mother. Will call us next week with update. 3/19/18 Mother reports patient is doing much better, rash is almost gone(rash has disappeared/no scabbing).
approx 1hr p/vax pt reported severe pain shooting down left arm. instructed to go to urgent care 2 days later pt came to clinic for PPD reading & reported had applied ice & pain lasted 12hr;
I feel a very slight sore throat; slight cough; Slight diarrhea; mild headache; body temperature 97.2; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 18Feb2021 (at the age of 74-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) 10 mg; losartan 25mg; rosuvastatin 10mg. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021, the patient reported 'I feel a very slight sore throat, slight cough, mild headache, slight diarrhea, body temperature 97.2, was this a normal reaction 2 weeks after first covid vaccine'. The patient did not receive any treatment.  The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.
Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare professional. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included urinary tract infection (UTI). Patient stated she was on an antibiotic for a UTI before having the vaccine. No other vaccine in four weeks. No COVID prior vaccination.  The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Patient stated that she broke out with a rash across chest and legs approximately 24 hours (on 11Jan2021) after having the vaccine. Patient states she had a low grade fever and chills 4 days post covid-19 vaccination (on 14Jan2021).  The events resulted in doctor or other healthcare professional office/clinic visit  The patient received treatment for the events. The patient was given a steroid shot by dermatologist. Patient was tested for COVID test post vaccination (covid test type: Nasal Swab) which showed negative result. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Severe sore arm where shot was given. Area red, raised hot to touch. Painful to move.  Severe body and joint aches  Frontal headache  Fatigue  Fever of 100 Fahrenheit for 48 hours  Body shakes/chills
Nausea (felt like I was going to vomit, but did not) and dizziness within 10 minutes of receiving vaccine Headache and arm pain came later
Narrative: She reports having about an hour of nausea, which started 2x hours after the vaccination. It was not associated with vomiting or abdominal cramping. She denied other common adverse effects from vaccination. The nausea spontaneously resolved without need for intervention.
Insomnia, unable to stay asleep for more than 2 hours at a time since receiving booster; This is a spontaneous report from two contactable reporter (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Mar2022 at 17:30 (Lot number: FR9895) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FY0584), administration date: 06Aug2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FC3184), administration date: 27Aug2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: INSOMNIA (non-serious) with onset 07Mar2022, outcome "not recovered", described as "Insomnia, unable to stay asleep for more than 2 hours at a time since receiving booster". Therapeutic measures were not taken as a result of insomnia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
developed a 2"x1" oval-shaped, raised pinkish-red area at the Menveo injection site. First noticed area 10.21.2020. Patient complains of continuous, achy pain, worsened by use of arm, especially when lifting objects. Has tried applying ice on two different occasions with no relief.
Information has been received from a physician concerning a 75 year old female with no pertinent medical history who on 14-MAY-2007 was vaccinated with Zostavax (Oka/Merck) SQ.  Concomitant therapy included unspecified concomitant medications (physician could not provide list).  On 15-MAY-2007 the patient went to the emergency room and presented with shingles on same side as the vaccine (right side).  The patient did not have a rash of greater than 50 lesions and the patient was not admitted to the hospital.  As of 04-JUN-2007 the patient was recovering from the shingles.  Additional information has been requested.
My period is now 11 days late; This is a spontaneous report from a contactable consumer (Patient). A 29-years-old Non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0181 and Expiry date was not reported), via an unspecified route of administration on 08Jul2021 15:00 (at the age of 29-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The patient other medical history was none, The concomitant medications was not reported. The patient previously took tramadol and experienced allergies. (Known Allergies: Tramadol). Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0191 and Expiry date was not reported), via an unspecified route of administration on 15Jun2021 12:00, (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0191 and Expiry date was not reported), via an unspecified route of administration on 15Jun2021 12:00, (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. The patient did not received other medications in two weeks. The patient was not pregnant. The patient had not received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had not tested for COVID-19 since the vaccination. On 08Jul2021, the patient experienced her period was now 11 days late, she have had a regular period before this (within the same 1-2 day cycle) and there was no way this was stress-related from life because she was not feeling stressed from life. This was definitely from the vaccine. The patient had not received treatment for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Ipol was injection to a patient one week apart instead of the month that is recommended; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old patient who was injected with a 0.5ml dose of IPV (VERO) [IPOL] one week apart instead of the month that is recommended lot PLE701M via intramuscular route in the right deltoid on 14-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate schedule of vaccine administered.  Adverse event was not reported.  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 document held by sender: none.
PATIENT DID RECEIVE BOTH DOSES, BUT THEY WERE 2 YEARS APART; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: PATIENT DID RECEIVE BOTH DOSES, BUT THEY WERE 2 YEARS APART).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 26-AUG-2023 and 27-AUG-2023 The patient did receive both doses, but they were 2 years apart which led to lengthening of vaccination schedule. Asked does he need to get a 3rd dose. The reporter consented to follow up. No further details provided on form. Specialist submitting all available details.
Hospitalization for fatigue likely partly due to COVID-19 on dates 10/17/22-10/19/22. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
30JAN93 pt has elevated temp 99.4 ear lobe; on lt arm from elbow up to inject site was red w/whelp; arm was warm to touch & sore; pt seen by MD on 30JAN93; dx cellulitis; given ATB; mild erythema @ inject site & inflammation @ DTP site;
Hives - received vaccination 9-5-08, broke out in hives 9-7-08.  Hives continued through 9-15-08.
Hives, erythema all over body. 19  x5 on side of stomach, 12x6  right thigh.
On 10/21 patient received flu shot and on 10/23 developed (L) side swelling of the throat with no other symptoms. Pt took BENADRYL 25 mg po and sx subsided.
Pain in arm/arm pit that is shooting down side of body. Nausea/ vomiting. Chills, Dizziness
Patient received an undiluted Pfizer COVID-19 vaccination for his 1st dose in the 2-dose series of Pfizer COVID-19 Vaccinations. Provider and patient were contacted to make aware that patient received undiluted dose of COVID-19 vaccine and the potential for local side effects. The patient was instructed to proceed with the 2nd dose in the series as originally planned, 21 days after the 1st dose was administered.
This spontaneous report as received from a registered nurse refers to a 50 year old male patient. On unspecified dates the patient was vaccinated with three doses of GARDASIL (lot numbers, doses and routes not reported). No adverse effect was noted. Additional information is not expected.
Case previously recorded as MA2009-4806. A girl was vaccinated with Novartis H1N1 vaccine. Reported vaccination date is 17NOV2008-this must be a mistake, because no H1N1 vaccine was licensed in this country in 2008.
This spontaneous report was received from a licensed practical nurse referring to a 54 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-JUN-2017, the patient was vaccinated with an expired dose of VAQTA intramuscularly, for prophylaxis (dose not provided; lot # M034893, expiration date 26-MAY-2017). The vaccine had been properly stored. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
having difficulty to communicate.; Arms are heavy; She sounds very ill; headache; NAUSEA; Fever 101F; vomiting; chills; severe Body Aches on movement; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache) and NAUSEA (NAUSEA) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040G21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Apr-2021, the patient experienced COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache), NAUSEA (NAUSEA), PYREXIA (Fever 101F), VOMITING (vomiting), CHILLS (chills), MYALGIA (severe Body Aches on movement) and INJECTION SITE PAIN (Sore Injection Site). At the time of the report, COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache), NAUSEA (NAUSEA), PYREXIA (Fever 101F), VOMITING (vomiting), CHILLS (chills), MYALGIA (severe Body Aches on movement) and INJECTION SITE PAIN (Sore Injection Site) outcome was unknown.
On 12/28/2020 around 9 PM she started feeling fatigued.  Also noticed L arm tenderness at this time. This has continued since this time..  She knew it has been sore, hurting and swollen. Yesterday 1/5/2021, she had her daughter look at site and take pictures, she was able to see redness and she could feel heat radiating from this. She went to urgent care.
This spontaneous prospective pregnancy report was received from a 30 year old female patient regarding herself. On 16-SEP-2013, the patient who is seven-months pregnant was vaccinated with a dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly in error at her physician office. No concomitant therapy was reported. The patient was scheduled to receive a Rhogam (unspecified) injection but was administered with GARDASIL. Gestational age was reported as 7 months. Due date was reported as 09-DEC-2013. The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. No adverse effect was reported at the time of report. Additional information has been requested.
PATIENT STATES THAT WITHIN THE LAST WEEK OR SO THAT SHE FEELS LIKE HER HEART IS FLUTTERING AND FEELS EXCITED SOME OF THE TIME. SHE SAYS THIS CAN HAPPEN SEVERAL TIMES A DAY.
Cold sweats, fever, diarrhea. Persisted for about a week. COVID Swab was negative.
Injection site pain starting evening of 1/8/20. Mild swelling and severe pain at injection site morning of 1/9/20. Moderate progressing to severe headache, and intermittent chills all day; no fever. Reduced appetite. Mild muscle pain/stiffness.
Fevers of 105, rash, swelling of hands and feet. Seizures with high Fevers.
TDaP was drawn up from stock but should have been drawn up from private stock. Vaccine was not used and error did not reach pt.
A non-serious spontaneous report of Flu-like symptoms has been received from a consumer concerning her husband, a 38-year-old male, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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 not reported, batch number: 1802072, and batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On 18-MAY-2011, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In 2013, the patient was treated by a healthcare provider at an urgent care for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
I walked back during watching TV heart skipped a beat. Then a couple hours later felt like it was coming back, but it didn't come full on. Also, a lot of discharge of mucus also was coming out of my vagina. Only had a mild fever, aching including joints. Also felt constipated. Also felt that my sinuses weren't as intense. Also, had ear ringing during Dose 2.
Temp. of 102.7 at 1:00am on Friday 11/15/02 area of injecion (left thigh) was red and swollen. Parents took child to emergency room at 2:00am. Patient's parents left ER due to unsatisfaction. Phoned Dr.  at 3:00am. Dr. told parents to start patient on Tylenol 40mg every 4 hours and to apply ice to injection site and observe patient and call Dr.  if symptoms persist.
Right after shot as patient was at car; patient experienced transient chest ache which went away. Next morning upon awakening, severe chest ache/tightness took place x 1/2 day.
Information has been received from a registered school nurse concerning a child in her school between the ages of 6 and 9 years old with an unknown medical history who was vaccinated with a dose of varicella virus vaccine live. It was uknown if the child was on concomitant medication. On 20MAY2003, it was reported that within the last 3 weeks the child developed a fairly severe case of chickenpox with a fever, vomiting a lots of pox. It was unknown if diagnositics studies were performed. Unspecified medical attention was sought and it was unknown if any treatment was required. No product quality complaint was involved. It was also reported that 7 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. Additional information has been requested.