chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurts; arm is swollen; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and her/his arm hurts and swollen, but still better than getting shingles. The follow up would not be possible as no contact details were available.
Headache, Diarrhea, NauseaVomiting, fatigue, sore throat,chills Narrative:
Fever, fussiness and episode of difficulty breathing (unclear whether stridor or wheezing) while asleep prompting mom to bring child to local ER. Good stats, no wheezing or stridor noted on ER encounter visit. Temp 102.1
Pt noticed red area on LA last night 4/15/09. School nurse (called 4/16/09). 3/4" wheel - 2" flare -red-hot; dermis itching - no rash- no resp. problems (Lower (L) deltoid are at injection site) - cold compress applied- Sch - nurse will observe 4/23 child is fine; spoke with mom 4/15/09. Nurse to mom 4/20 and 4/21 for flu - TAN - no response
Pt received Hep A vaccine, dose #2, on 4/23/13. Started with a rash on arms on 4/25/13. Mom states he has an allergy to Neomycin, component in Hep A vaccine (Havrix). No reaction to first dose of Hep A. Pt seen in office on 4/29/13, treated with hydroxizine and ranitidine. School nurse also put Neosporin in an open wound same week as vaccine, she was not aware of allergy.
Patient was given MMR at 11 mos instead of after 12 mos.  Will need to repeat at 12-15 mos.
This spontaneous report as received from a now 64 years old female patient with azithromycin allergy and cimetidine allergy refers to herself. The patient's medical history included really bad reaction to an unspecified flu shot when she was twelve years of age. The patient was vaccinated with live ZOSTAVAX on 26-DEC-2012. Route and lot# unspecified. Concomitant medications included: EVISTA. On an unknown date the patient experienced small, red bump on her arm at the injection-site after receiving live ZOSTAVAX. The patient stated that the swelling had gone down since she initially noticed it, but the area was still red. No treatment was given. No lab test was done. The patient was recovering. This report was linked with 1301USA012938 as refers to the same patient. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 52 year old female patient. No medical history or concurrent conditions were reported. On 29-NOV-2014, the patient was vaccinated with ZOSTAVAX vial, 0.65 ml dose, subcutaneous route (SQ) in the right arm, (lot # K003602, Exp. Date: 20-MAR-2015). Diluent with lot # K014246; Exp. Date: 11-JUN-2017 was used to reconstitute the ZOSTAVAX. Co-suspect or concomitant therapies were not provided. On 30-NOV-2014, the patient developed pain, swelling and an itchy red rash on her arm at the injection site after receiving ZOSTAVAX. Patient returned to pharmacy for medical attention. No treatment was given for the event. At the time of the report, the outcome of the events was reported as not recovered/not resolved. The causal relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
My armpit to be swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (My armpit to be swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (My armpit to be swollen). At the time of the report, SWELLING (My armpit to be swollen) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Large red swelling and itching in arm where injection was given.  lasted about 3 days
I didn't have any side effects from the vaccine except a little tenderness around the injection site. In August 2021 I got really sick. I had muscle aches, joint aches, pain, shortness of breath, loss of taste and smell, bad headache, loss of appetite, and lack of energy. That lasted about 20 days. I had also lost 25 lbs. because of my loss of appetite. I went to the ER on August 14, 2021 where they did a COVID test that came back positive. My lungs have also been affected by COVID. I was taking a nebulizer but my doctor changed it to Advair. Then the Advair started to lose it's effectiveness by the end of the month so my doctor changed the medication again. Now I am on a BREO inhaler.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (route, dose and lot were not reported) that was improperly stored. No adverse symptoms reported. The outcome of patient received improperly stored VARIVAX (Merck) was unknown. This is one of several reports from the same source. Additional information has been requested.
Felt not myself 100%; Trembling on whole arm; A shock in the arm, like an electric thing; Felt "hot", had a temperature about 100.6F; Warm sensation on vaccination site; Stinging sensation on wrist; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt not myself 100%), PAIN (Stinging sensation on wrist), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and VACCINATION SITE WARMTH (Warm sensation on vaccination site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Mental disorder NOS (mental health condition).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PAIN (Stinging sensation on wrist) and VACCINATION SITE WARMTH (Warm sensation on vaccination site). On 30-Apr-2021, the patient experienced FEELING ABNORMAL (Felt not myself 100%), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and PYREXIA (Felt "hot", had a temperature about 100.6F). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 30-Apr-2021, FEELING ABNORMAL (Felt not myself 100%), TREMOR (Trembling on whole arm), ELECTRIC SHOCK SENSATION (A shock in the arm, like an electric thing) and PYREXIA (Felt "hot", had a temperature about 100.6F) had resolved, PAIN (Stinging sensation on wrist) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Warm sensation on vaccination site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100.6 (High) 100.6F.         Concomitant medication reported included a product for mental health condition (unspecified).   This case was linked to MOD-2021-101567 (Patient Link).
No adverse effect. Patient received monovalent Moderna as booster dose instead of bivalent Moderna.
dizziness; weakness; feeling unwell; headache; nausea; tired; pain at the injection; A spontaneous report was received from a consumer concerning a female patient of 89 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced headache, pain at the injection site, nausea,tiredness,weakness,dizziness and felt unwell. The patients medical history,as provided by the reporter,included blood pressure,heart disease,blood clotting.No relevant Concomitant medications were reported. On 20 feb 2021,prior to the onset of events, the Patient received their second of two planned dose of Mrna-1273(Lot number: unknown ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 20 feb 2021,couple of hours later patient experienced headache, pain at the injection site, nausea,tiredness,weakness,dizziness and felt unwell.  No Treatment information for the event was provided. The outcome for the event headache, pain at the injection site, nausea,tiredness,weakness,felt unwell and dizziness was not reported.
Patient experienced dermatographia: she broke up in constant hives; Muscle aches after Booster dose; Headache after booster dose; Fatigue after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose), FATIGUE (Fatigue after booster dose) and MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose) and FATIGUE (Fatigue after booster dose). On 09-Nov-2021, the patient experienced MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Antihistamine therapy and Dermatographia, at an unspecified dose and frequency. On 31-Oct-2021, MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose) and FATIGUE (Fatigue after booster dose) had resolved. At the time of the report, MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives) had not resolved.            Concomitant medication of the patient was not reported .   This case was linked to MOD-2022-468796, MOD-2022-468718 (Patient Link).
PATIENT FELT LIGHT HEADED. MOTHER WAS PRESENT WITH HIM. SHE CAME UP TO THE COUNTER TO LET US KNOW BUT THEN HE IMMEDIATELY FAINTED AND FELL TO THE GROUND FROM HIS CHAIR. 911 WAS IMMEDIATELY CALLED. PATIENT GAINED CONSCIOUSNESS WITHIN NO MORE THAN 1 MINUTES. HE WAS AWARE, ALERT, AND ORIENTED (PATIENT CONFIRMED HE DID HAVE BREAKFAST THAT MORNING). HE WAS CLAMMY AND SWEATY. HE EXPLAINED THAT HE USUALLY EXPERIENCES THIS TYPE OF FAINTING EVENT WITH NEEDLES. PARAMEDICS ARRIVED ON THE SCENE AND EVALUATED PATIENT'S CONDITION. PATIENT'S BP AND EKG WERE WNL. PATIENT REFUSED BLOOD SUGAR TEST D/T NEEDLE PHOBIA (HE SAID HE DID NOT WANT TO PASS OUT AGAIN), AND HE DECLINED GOING TO THE ER.
Information has been received from a registered nurse concerning a 26 year old female with a fish allergy and a history of brain surgery who on 09-AUG-2007 and also reported as 09-SEP-2007 was vaccinated intramuscularly in the arm with a first dose of GARDASIL vaccine (yeast) (Lot #658100/0525U). Concomitant therapy included lamotrigine (LAMICTAL). Subsequently the patient experienced a delay in her menstrual period at the time of the report the patient was three weeks late for the second menstrual period. The patient's urine pregnancy test was negative. The patient was seen for a follow-up exam. At the time of the report the patient had not recovered. Additional information has been requested.
TOOK MACROBID 48 HOUR BEFORE STARTING VIVOTIF; This spontaneous case (PVX2019-1529) was received from a consumer on 12-Jun-2019. It describes a 21-year-old female consumer who "took Macrobid 48 hour before starting Vivotif". The consumer was receiving Vivotif capsule for an unknown indication and Macrobid (nitrofurantoin) for urinary tract infection (UTI) prevention.  Case report: The consumer took Macrobid 48 hour before taking the first dose of Vivotif. She completed full course of Vivotif.  Action taken with Vivotif and Macrobid was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Macrobid 48 hour before starting Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Macrobid 48 hour before starting Vivotif" was considered as not applicable.
Body ache; fever; congestion; cough; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced general body pain, fever, nasal congestion and cough. On an unknown date, the outcome of the general body pain, fever, nasal congestion and cough were unknown.   It was unknown if the reporter considered the general body pain, fever, nasal congestion and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 78 or 79 years old. Post vaccination with Shingrix the patient had body ache, fever, congestion and cough. The reporter consented to follow up.
arm is bruised, black and blue in the injection site; pain is worse in sensitivity areas from surgery; headaches; fatigue; back pain; arm pain; numbness and tingling in hands and feet.; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), PAIN IN EXTREMITY (arm pain), HYPOAESTHESIA (numbness and tingling in hands and feet.), INJECTION SITE BRUISING (arm is bruised, black and blue in the injection site) and PAIN (pain is worse in sensitivity areas from surgery) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Orthopedic procedure (6 surgeries on 2020 but mostly orthopedic ones). Concomitant products included CIPROFLOXACIN, TRIAMTERENE, QUINAPRIL, ATENOLOL and ALFUZOSIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced BACK PAIN (back pain), PAIN IN EXTREMITY (arm pain), HYPOAESTHESIA (numbness and tingling in hands and feet.), PAIN (pain is worse in sensitivity areas from surgery), HEADACHE (headaches) and FATIGUE (fatigue). On an unknown date, the patient experienced INJECTION SITE BRUISING (arm is bruised, black and blue in the injection site). At the time of the report, BACK PAIN (back pain), PAIN IN EXTREMITY (arm pain), HYPOAESTHESIA (numbness and tingling in hands and feet.), INJECTION SITE BRUISING (arm is bruised, black and blue in the injection site), PAIN (pain is worse in sensitivity areas from surgery), HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Felt slightly lightheaded approximately 10 minutes after receiving FLUMIST - lasting approx. 15 minutes. BP = 118/76. BP after feeling better = 110/72.
The patient watched the shot being given, saw a tiny drop of blood, then  fainted. We laid the patient on the floor and elevated her legs for 5 minutes. Her dad then sat with her and brought her some water. She walked out with him 10 minutes later and seemed fine but a little shaky.
Patient was waiting in the lobby for observation for any adverse reactions. Patient walked up to the front office receptionist and disclosed that her upper was swelling  for approximately 10 minutes.  Patient was brought back into a room at 12:14 pm and was given Benadryl at 12:18pm. We assured she had a driver to take her home. Patient tolerated Benadryl well after 15 minutes of observation patients upper lip swelling has gone down.
Moderna COVID-19 Vaccine Around 13 minutes following injection, I developed a rapid heart rate and dizziness.  After 25 minutes or so, the heart rate decreased.  The dizziness lasted several hours longer.  At this time, 7 hours following vaccination, there is still mild dizziness but heart rate is normal.
Hard-raised lump @ inject site; 2-3CM size noted 8FEB91 minimal reddness 18FEB91 less sore sm amt of swelling - 1cm
I am dying I have never felt that; if it gets worse I will just write it out or I will go ahead and die or whatever; Sweating real bad; I am doing everything in slow motion; Sleepy but could not sleep; Every joint on me ached; Where the shot was, that was sore it was first time that I have been getting these side effects; Slight headache; I don't feel like getting up. I don't even want to get out of bed, I ache so bad. I don't want to do anything else; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734) at single dose, on 05Apr2021 at 02:15, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 12Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. On 05Apr2021, the patient experienced feeling abnormal ("I am dying I have never felt that; if it gets worse I will just write it out or I will go ahead and die or whatever"), sweating ("Sweating real bad"), mobility decreased ("I am doing everything in slow motion"), Sleep difficult ("Sleepy but could not sleep"), joint ache ("Every joint on me ached"), pain in extremity ("Where the shot was, that was sore it was first time that I have been getting these side effects"), slight headache and patient was feeling unwell ("I don't feel like getting up. I don't even want to get out of bed, I ache so bad. I don't want to do anything else"). The patient did not have fever. Clinical outcome of the events was unknown at time of this report.
Patient is a 68-year-old female with history of COPD, HFpEF, and other problems who presented from home with shortness of breath, cough, and fever.  She was found to have COVID-19 and likely concomitant upper respiratory tract infection.  She improved with oral steroids, but developed signs of URI/bronchitis and was placed on empiric antibiotics with further improvement in all of her symptoms.  She qualified for home oxygen likely on the basis of COVID-19 and her chronic bronchitis with acute component.  She improved and was clinically ready for discharge on Thursday, January 5.  She was released home in stable condition on oxygen.  She will complete a total 10-day course of dexamethasone for COVID, and a total 5-day course of antibiotics (p.o. azithromycin) for URI/bronchitis.  She will follow-up with her primary care physician in 1-2 weeks.   Acute hypoxemic respiratory failure COVID-19 infection URI/bronchitis  COPD exacerbation HFpEF, chronic -Hypoxic likely related to COVID, COPD and underlying heart failure with URI/bronchitis  - likely with superimposed upper respiratory tract infection URI - repeat CXR 1/3 with nonspecific hazy and linear opacities in the lung bases - COVID positive 12/31 (symptoms started 12/30); developed purulent sputum 1/2 - clinically improved, afebrile - received Rocephin/Azithro in the hospital, plan Azithromycin PO to complete total 5-day course of antibiotics at discharge -Complete 10-day course of dexamethasone 6 mg daily for COVID --Continue albuterol MDI, singulair, symbicort for COPD -Home oxygen was arranged, recommend 2 L around-the-clock and at nighttime while sleeping until she sees PCP for further follow-up.  Also follows with Dr. (OP pulm)    Unilateral RLE edema -Chronic per patient, noted per chart review since 6/2020. Unclear etiology, consider impaired RLE lymphatic drainage. -Prior RLE duplex 7/2020 without evidence of DVT. -Negative duplex this admission   Elevated creatinine, resolved - BUN 35 sCr 1.28 1/4; likely dehydration, acute illness -Creatinine 1.12 on 1/5.   Hypertension -Home regimen: coreg 25 mg BID,  - BP mostly acceptable here with some elevations in the setting of acute illness -Okay to resume home meds at discharge discharge today   Hyperlipidemia -Home lipitor 20 mg daily   Obesity -BMI 35.15, weight loss to be recommended
a Metallic Taste in Mouth; Arm Pain; "Tingling" Sensation of Tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (a Metallic Taste in Mouth), PAIN IN EXTREMITY (Arm Pain) and PARAESTHESIA ORAL ("Tingling" Sensation of Tongue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) and VITAMIN D NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (a Metallic Taste in Mouth), PAIN IN EXTREMITY (Arm Pain) and PARAESTHESIA ORAL ("Tingling" Sensation of Tongue). At the time of the report, DYSGEUSIA (a Metallic Taste in Mouth), PAIN IN EXTREMITY (Arm Pain) and PARAESTHESIA ORAL ("Tingling" Sensation of Tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Within 24hrs after the vaccine I developed chills, shaking and a headache.  I also developed nausea, diarreah and just did not feel well for over a week after the vaccine.
This spontaneous report as received from a physician refers to a 14 year old female patient. On an unknown date when she was 12 years old the patient was vaccinated with GARDASIL dose 1 and dose 2 (dose, route, lot number and expiration date was not provided) with no issues. On an unknown date the patient was vaccinated with GARDASIL dose 3 (dose, route, lot number and expiration date was not provided). On an unknown date, after receiving the third dose of GARDASIL when the patient turn 14 years of age she experienced headache, chronic constipation, severe abdominal pain, urinary tract infection. Also reported that the patient experienced several seizures and was hospitalized. At the time of the report, the outcome of the events was not recovered/not resolved. The patient sought medical attention. Upon internal reviewed several seizures were considered medically significant. Additional information has been requested.