chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt weak; fever; muscle aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (felt weak), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (Chills). On 04-Mar-2021, ASTHENIA (felt weak), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   This case was linked to MOD21-045015 (Patient Link).
Same day fever associated with chest pain that was positional. Admitted to the hospital, diagnosed with Myopericarditis based on elevated troponin, CRP, clinical history, and cardiac MRI.
No adverse effects or symptoms as a result of administration. No other AE/no PQC.; dose of PNEUMOVAX23 was given to a patient who was 1 year and 11 days old; This spontaneous report was received from a licensed practical nurse and refers to an 1-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-APR-2022, the was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, lot #T039322, expiration date: 09-SEP-2022 (strength, site and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported (No adverse event).
Information has been received from a physician concerning a female who on 09-OCT-2007 was vaccinated with Gardasil vaccine (lot number was not reported). On 09-OCT-2007, the patient experienced fainting while walking out to the waiting area. Subsequently, the patient recovered from fainting while walking out to the waiting area. The physician had used "smelling salt" to wake the patient. No product quality complaint was involved. Additional information has been requested.
We accidently gave this patient a third dose. He received his first dose on 2/28/21, second on 3/25/21 and we gave him another dose on 8/6/21
Genital herpes sores; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Genital herpes sores) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FAMOTIDINE, CITALOPRAM, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GENITAL HERPES (Genital herpes sores). At the time of the report, GENITAL HERPES (Genital herpes sores) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event was none. Caller reported that they presented with genital herpes sores 2 days after receiving dose 1 and dose 2 in the left arm of the Moderna vaccine. With dose 1, it cleared after 2 days and with dose 2 it cleared after 1 day. It's been 20 years since their last outbreak.   This case was linked to MOD-2021-031963, MOD-2021-031963 (Patient Link).
2 x 3 1/2 redness, swollen, hot to touch. Rx: Cephalexin.
Flat dark red rash on both legs below the knees. No other symptoms, rash does not itch, no discomfort. Pt states his dermatologist is not concerned, no treatment needed at this time.
Symptoms started 9 hours after vaccine given. She had slight fever of 99-100, wheezing, hoarseness, trouble breathing as if she had a lot of mucus and her heart was racing. He stated the symptoms had lasted all night until 5 or 6 PM the following day. Difficulty breathing lasted until bedtime. they gave her infant Tylenol for 4-6 hors through the night. Father reported a few minutes after above report that child has wakened from nap with wheezing. Instructed to go to ER.
The mother of this patient states the child had redness, warmth, pain, and swelling the size of the mom's hand at the injection site of the Hep A on the child's leg. The mother noticed this Am. The mother states treating child's pain with Tylenol every 4 hours.
Two weeks after shot i got an Acanthoma on right leg and shingles on right thigh. Also developed gum infection which required surgery.
Urticarial lesion, swelling - frst on the left upper arm at the injection side, spreading distally and also seen on the right upper arm Lesions are erythematous, maculo-papular, circumscribed. No fever. No other skin lesions noted on the trunk, legs. Initially treated with Benadryl. Here in the office today, given Solumedrol 125mg IM followed by 4 mg Medrol dosepak, Levocetirlzine.
18 mo rec'd DTAP, Flu and HEP A 10/20/09. Seizure < 24 hrs later. GTC x 3.  10/29/09 Medical records received for DOS 10/22/09. CC: FIrst time afebrile seizure.  PICU admit. Genralized tonic-clonic seizure x4, each 45 secs in length.   Vaccines the day before.  99.1F. Irritable, lip pursing noted (automatism), stares for 1-5 secs. Glassy eyes. fell from seated postion x1 but nortmally stable. Small bruise on forehead. Screamed all night except when sedated.  EEG no focal findings,  with slowing due to AED given. CT, LP and WBC's WNL. Seizures idiopathic.  ICD: Codez: 780.39
sore muscle at injection site (both doses)  Rash behind right knee (second dose)
Patient got very sick by 3oclok tje day after getting shot. She was so dizzy She couldn't stand she was nauseated and was not able to focus. She went to urgent care. Was told ahe should have come sooner and she was having a reaction to the vaccine.  She was given medication to help with vertigo symptoms.  Then on 10/26/21 patient symptoms continued and was having difficulty walking standing and would get so dizzy She needed assistance to walk. She went to Emergency Department Patient as of 11/2 is still unable to focus she gets extremely dizzy. She is due for second dose and
Anxiety, BP 130/75 HR85 RR16, patient stabilized and was released from vaccination site
Headache, Myalgia, REPORTS "FLUSHE NECK AND CHEEKS"  Narrative:
The pt experienced a 3 1/2 cm x 4cm are of erythema and a  2 x 2 cm area of induration surrounding the injection site.
Got injection Monday.   Arm soreness starting about an hour after the shot, and worse arm pain the next day (Tuesday). Arm pain mostly gone by the 4th day after the shot (Thursday). Body aches throughout the second day after the shot (Wednesday). No fever, but felt the body aches that are usually associated with fever. Also contributed to fatigue. The body aches increased throughout the day, leading me to take one acetaminophen pill before bed. Chills were gone by the next morning (Thursday).
no adverse event; improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, historical drugs and drug reactions/ allergies were not reported.   On 15-JUL-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S000132 and expiry date 02-JAN-2021 (dose number, route of administration and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent which was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly.   The storage temperature and time frame was reported as 15 degree Fahrenheit to 46 degree Fahrenheit (29.1 degree Fahrenheit) for 3 hours. There was no previous temperature excursion. No adverse effect was reported. Digital data logger was not involved. No Product Quality Complaint (PQC) was present.
I have been having severe dizziness since getting my second dose .  I am still currently very dizzy. Haven?t been able to stand to long unassisted
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-JUL-2015, the patient was treated at a medical center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
the patient was given Pentacel in the left thigh and a other Hib vaccination in the right thigh on the same office visit/ NO AE; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15-months-old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB VACCINE [HIB VACCINE] on the same visit (extra dose administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant vaccination included a dose of hepatitis A vaccine on 21-Aug-2020 (on same visit).  On 21-Aug-2020, the patient received a dose of 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ214AAA and expiry date: 02-May-2021) in the left thigh and a dose of HIB VACCINE [HIB VACCINE] in the right thigh on the same visit for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  Reporter wanted to know if extra dose administration would hurt the patient and recommendations.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
SHIVERING AND CHILLS; This spontaneous report received from a parent concerned a 24 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced shivering and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering and chills. This report was non-serious.
Rapid heartbeat, shortness of breath, chills, vomiting, diarrhea
upper respiratory sickness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736), via intramuscular, administered in right arm on 26Apr2021 at 13:00 (age at vaccination 63-year-old) as 1st dose, single for COVID-19 immunization. Medical history included covid-19 in early December for 3 weeks. The patient's concomitant medications were not reported. Patient had no prior vaccinations within 4 weeks and had no adverse event following prior vaccinations. Patient had no additional vaccines administered on same date of the pfizer suspect. Patient had no history of all previous immunization with the pfizer vaccine considered as suspect. On 08May2021 the patient experienced upper respiratory sickness. Patient did not have any reaction, but 2 weeks later, she got a upper respiratory sickness and hasn't gotten better. She was nearing the 6 week mark but her infection was still lingering. She was told not to get the second vaccine until she was feeling better. She said that she knows you are supposed to get the second dose within 6 weeks, but with having Covid, she was advised to have a antibody test to see how many antibodies she has. Patient enquired, should she have take antibody test and how long she can go between getting the first and second dose. Patient does not know if her upper respiratory sickness was related to the vaccine or not, but does not think it was, she was just concerned that it was lingering so long. She has not really felt well since she had Covid. She said that she had no side effects or anything, but was hesitant on the 2nd vaccine because she has not felt good. Patient was coughing while reporting. As therapeutic measure patient was taking a Z-Pac, it has not helped, she said that she guess it has, but not great. The event resulted patient to visit physician office. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Pt came in for the Jansen COVID shot around 11:00, after receiving it he went to the waiting area and a few minutes later seemed to momentarily pass out in his chair, his wife called us over and Pt described feeling warm and dizzy. He drank some water and ate a candy bar over the next few minutes.  Pt continued to feel dizzy and was sweating. After a few minutes Pt appeared to continue having extreme syncope and we called 911. Paramedics arrived a few minutes later.
3/16/04 received vaccine that evening swelling with pain, deltoid swollen and red with pain
not feeling good; Feelings of weakness; skin was burning; felt like someone was sitting on her throat and she couldn't breath; left arm tingly-all  body tingly; lip quivering; ache; fever; chills; head hurt; bone were hurting; sore arm; both arms blotchy; both arms red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness) and RASH MACULAR (both arms blotchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE, ALPRAZOLAM (XANAX) and Duexis                                                         for her stomach as needed for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Apr-2021, the patient experienced BONE PAIN (bone were hurting), CHILLS (chills) and HEADACHE (head hurt). On an unknown date, the patient experienced SKIN BURNING SENSATION (skin was burning), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Apr-2021, RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red) had resolved. At the time of the report, SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), BONE PAIN (bone were hurting), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache), CHILLS (chills), HEADACHE (head hurt) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a registered pharmacist concerning a 72 year old female patient with diabetes, penicillin and "quinolones" allergy and a history of shingles who on 08-OCT-2010, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). It was reported that approximately on 09-OCT-2010 "over the weekend" the patient had elevated blood sugar. The patient did tell the pharmacist that she needed a new machine because she was having high readings previous to ZOSTAVAX (Merck). The patient after receiving ZOSTAVAX (Merck) was having even higher readings. The patient also stated that she did not want to get shingles again. At the time of the report, the patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
This spontaneous report as received from a registered nurse via a field representative refers to a 65 year old female patient. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported) and PNEUMOVAX23 (dose, route and lot# not reported) at the same time, on the same date, both injections in the right arm. After receiving these two vaccines, on an unknown date in November 2013, the patient developed swelling, redness, rash and bruising. The patient was using unspecified antibiotics (name, dose, frequency, and manufacture unknown) as treatment for this adverse event. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was recovering. Additional information has been requested.
PATIENT STATES THAT IMMEDIATELY AFTER SHE RECEIVED VACCINE SHE NOTICED ARM PAIN, REDNESS, AND SWELLING AROUND INJECTION SITE. AT THIS TIME, 3 DAYS LATER, THE AREA IS ABOUT THE SIZE OF A BASEBALL AND IS RED, INFLAMED, AND SWOLLEN ON HER LEFT ARM. SHE INITIALLY REPORTED THE REACTION TO A RADIOLOGY TECHNICIAN YESTERDAY AT A ROUTINE SCAN AND THEY DREW A LINE AROUND THE AREA TO MONITOR GROWTH, IT APPEARED TO BE GROWING SLIGHTLY THIS MORNING WHEN SHE REPORTED TO PHARMACY.
Headache, Myalgia, NauseaVomiting, sore arm, chills Narrative:  Received 2nd dose of Pfizer vaccine 1/12 at 1500 1900 - Arm was slightly sore and nausea 2115 - Very cold with slight headache 1/13 0230 - Extreme body aches and slight headache (took Ibuprofen and Tylenol) 0730 - Headache and body aches 1800 - Slight headache and no body aches 1/14 - symptoms resolved
Skin redness, rash, hives ( raised spots - medium to large size distributed over both arms , thighs, abdomen, back but none on face)  began on Sunday late night  to Monday early AM .
Immediately after shot, pain and soreness in the arm. Next morning, 2 inches around injection site is painful to touch. Woke up with throbbing headache, hurts worse when I move. Constant throbbing headache and felt slightly nauseous. Has not even been 24 hours since vaccinated.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial, 1 subcutaneous injection, lot number, expiration date and dosage were not reported. Concomitant therapy was not reported. The nurse practitioner informed that on an unknown date the patient presented with shingles two weeks after being administered ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Pain and stiffness in right scapula, shoulder and right side of neck for 96 hours post injection. Treated with Tylenol to reduce symptoms until end of recovery period.
It looks like patient received 3 doses of Moderna. 1st dose listed - 12/30/20. 2nd dose listed - 1/27/21. 3rd dose given 4/13/21.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient experienced soreness in forearm. The reporter declined providing details of the patient. The reporter did not consent to follow-up. This case has been linked with case US2019028258 (patient's wife), reported by same reporter.
48hr p/vax pt exp severe joint pain in rt ankle, rt shoulder, rt wrist for 3 days, resolved p/3rd day;
This spontaneous report was received from a medical assistant referring to a 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX Lot#: M009769, expiration date on 25-FEB-2018 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. No product quality complaint was involved. The vaccines experienced the following temperature excursions during 20 minutes: 32°F (Fahrenheit), 36°F and 46°F; during 41 minutes: 77°F; during 1 hour and 20 minutes: freezer 5°F and 14°F. The aforementioned ones were identified due to a data logger. There was no previous temperature excursion. It was reported that the vaccines were supported. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA012391: US-009507513-1701USA012289:
Injection site (deltoid) erythema, edema and pain. A follow up report received 10/20/2003 adds: Right deltoid (injection site) (caused by Pneumo shot). Rx ice, Benadryl, elevation, Motrin.
Patient received Fluad instead of afluria. He is not 65 or older, which means he is not indicated for this vaccine. Patient reports some fatigue and low grade fever of 99, 24 hours after vaccination.
erythematous, blanching, macular rash on trunk/face 10 days p/vax;
p/ pt recv vax 1st & 2nd dose pt failed to seroconvert