chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional refers to a 3 unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # K026246; expiry: 28-JAN-2017) (dose #, route and frequency unspecified) (incorrect product storage). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
01/04/22: ST, COUGH, CONGESTION, BODY ACHES, MALAISE, NAUSEA
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PROQUAD (Merck), (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
4-month-old patient was inadvertently administered the Fluzone Quadrivalent with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a consumer/ non-health care professional on 12-Oct-2020.  This case involved a 4-month-old male patient who inadvertently received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UT7065LA, expiration date: 30-Jun-2021, prefilled syringe) via intramuscular route in the left thigh (Product administered to patient of inappropriate age) for prophylactic vaccination on 09-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration. (Latency: Same day).  At the time of reporting, patient had no adverse event.  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.
swollen arm; warm arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and INJECTION SITE WARMTH (warm arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INJECTION SITE WARMTH (warm arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and INJECTION SITE WARMTH (warm arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Chest pain and it went away; This is a spontaneous report from a contactable consumer (patient's daughter in law). This consumer reports similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chest pain and it went away. It was also reported that later on, the patient was okay after the event. Outcome of the event was recovered on an unspecified date.  Information on the lot/batch numbers has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021556550 same reporter and drug, similar events, different patient
adm to ER w/progressive paralysis, back pain, numbness to leg, hx thrombocytopenia & autoimmune insufficiency;
Patient reported fever over 100.8, body ache/pain, cough with clear phlegm, scratchy throat the night after she received the vaccine.
This spontaneous report as received from a pharmacist refers to a 68 year old male patient. On 25-JAN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H018798, expiration date 15-JAN-2014 (reported as 10/2013), 0.65ml, subcutaneous). Concomitant medications were not reported. On an unspecified date in March 2014 the patient developed shingles after receiving ZOSTAVAX. At time of the report, outcome of the event was reported as not improved. The patient sought medical attention by contacting pharmacist. This is one of several reports received from the same reporter. Additional information has been requested.
A week after receiving 2nd Pfizer shot, I was itchy and displayed mosquito bite-like bumps on my body. After another week or so, I developed full urticaria all over my body. I had red welts, hives, rashes and itchy. This was on a daily basis.
Immunization given 8am on 3/28/07 at 7PM on 3/28/07 she c/o severe headache, fever was 102.8. Tylenol and cool compresses used with little relief. 10PM c/o heart racing pulse being 132-140. Taken to local ER - Lab done. Benadryl 100mg PRN given. Lymph glands and right arm swelling of arm noted next day.
Major cramping and pain in the right foot and concentrated pain in right big toe at 30 minutes after shot. At 90 minutes major deep pain started in the right arm, with major pain concentrated at the right elbow. Neck pain started occurring immediately after arm.  After two weeks, toe pain subsided. The elbow pain has not subsided. Neck pain has not subsided.
Cellulitis at injection site. Cephalexin 500mg 1 po BID x 10 days.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: PATIENT CALLED AND COMPLAINED OF REDNESS, ALMOST SCALDING LIKE THE FIRST NIGHT FOLLOWING VACCINATION ON HER NECK AND CHEST, AND RED, BURNING ON THE 12 OF MAY, LIKE SHE HAD BEEN IN THE SUN. ADVISED TO TAKE BENADRYL AND APPLY COOL COMPRESSES TO AREA. PATIENT TRIED NOTIFYING MD
little nauseated; arm hurting; 99.4°F fever; A spontaneous report was received from a Consumer concerning a 80 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, arm hurting, 99.4â°f fever, little nauseated, just doesn't felt good, the side effects didn't lasted more than a day. The patient's medical history was not provided. Concomitant medications reported were Cintroid, Climara, Hemotoplin, Baby aspirin every night, TRN Hydroxine anxiety for drug use for unknown indication. On 7 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 041L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8 Jan 2021, the patient experienced the events, arm hurting. 99.4â°f fever, little nauseated, just doesn't felt good. On an unknown date, the patient experienced the events, the side effects didn't lasted more than a day. Treatment details included Tylenol after the vaccine for the pain. When started with the fever took tylenol. Action taken with mRNA-1273 in response to the events, arm hurting, 99.4â°f fever, little nauseated, just doesn't felt good, the side effects didn't lasted more than a day was not reported.  On 9 Jan 2021 the outcome of events, arm hurting was resolved., 99.4â°f fever was resolved., little nauseated was resolved., just doesn't felt good was resolved. On an unknown date the outcome of events include, the side effects didn't lasted more than a day was not reported.
I was experiencing a sore throat and a dry cough. It was persistent - wouldn't go away. I had some congestion as well. It had taken quite some time - even with salt water gargles etc. I didn't have a fever. I went to Urgent care when it didn't go away. They tested me for Strep and at the time - they said I didn't need a COVID test - they thought it was an acute upper respiratory infection. Mucinex and Ibuprofen - and told me to get rest - it took about three weeks for it to go away. Sore throat started in the upper part of my throat and then moved to the lower part of my throat and so I was concerned that it would shift into my lungs. It never shifted down - it stayed within my throat and sinuses. I had the symptoms for about three weeks.
(7/30/17) Pt complained that later in the day after vaccine she fainted. Did not seek medical attention but called 8/1/17 stating she felt weak with pain worsening and red swollen area of shot stating it was in a square pattern.
Information has been received from a physician concerning two male patients who on unspecified dates were vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, on unspecified dates the patient experienced paralysis from the waist down after receiving ZOSTAVAX (Merck). The patients sought unspecified medical attention. At the time of report, the outcome of the events was unknown. "Paralyzed from the waist down" was considered to be disabling. Additional information has been requested.
Acute diarrhea starting 4 days post injection Copious bloody diarrhea one time only on day 5 post injection ER visit on day 5, prescribed antibiotic which patient did not take upon personal physician advice
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included atopic dermatitis and allergy to feathers. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased, injection site swelling, dizziness, injection site erythema, malaise and nausea. On 28th June 2018, the outcome of the injected limb mobility decreased, injection site swelling, dizziness, injection site erythema and malaise were recovered/resolved. On 30th June 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, injection site swelling, dizziness, injection site erythema, malaise and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving EPIPEN as a concomitant medication. The patient stated after getting the vaccine her arm was in pain and she could hardly lift it. The patient also experienced malaise, dizziness and nausea. Along with swelling and redness at the injection site. The pain lasted for total of three days, and everything else was gone by the next morning post vaccination. The patient had denied permission to contact their physician. No further details were provided.
Approximately 1 - 2 hrs after receiving the 2nd dose of the Moderna vaccine, I started developing a red rash on my left cheek. It started tingling, and slightly itching, and was warm to the touch. A welt had also started on my left cheek approximately 1 inch down from my left eye. I immediately put Benadryl cream on the whole area and it quickly subsided within an hour.  A cold compress helped as well. I also had a severe headache that lasted almost a day and felt extremely weak. I did not have those reactions after the 1st dose. My arm hurt after both doses, but I only felt very tired after the 1st dose.
Employee given Flu shot on 2/11/08 at 3:50/pm and at 4pm she stated she felt flushed and nauseated. Her B/P was up at 162/92 p 110 R 24. Employee stated her tongue felt thick. I gave her a dose of Solu Medrol 125 mg im and called 911 for assistance. She went to ER and received. Solu Medrol Epi Follow-up: It has happened 2x the past 2 years and I don't think drive by flu shots should be permitted.
- Patient got the chills and was unable to get warm. Tried to put on jacket and turn on heater (12/3/08). Was relieved later without any treatment.
Side effects after each dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects after each dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects after each dose). At the time of the report, IMMUNISATION REACTION (Side effects after each dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.   This case was linked to MOD-2023-723945 (Patient Link).
Within about 15 minutes of the vaccination I experienced pain in my stomach that went right up to my throat, I thought I was having a heart attack.
Pt to ED 10/26 for high blood sugar. PT COVID+ 10/26. Patient is non verbal, monitor shows ST, BP is low. 10/27 Pt is lethargic, unable to follow commands, no signs of pain/discomfort. Pt expired 10/28.
hives, red papules on left and right forearm, and under armpits, no redness or rash around injection site
This spontaneous report was received from an office manager refers to a female patient of unknown age. Medical history was reported as none. The Office manager reported that the patient received a first dose of MMR II at about 18 months of age and a second dose at around 4 years of age. On 18-JUN-2013, the patient received a dose 3 of MMR II (lot # expiry not reported) because a recent titer was low for mump. The outcome and causality of recent titer was low for mumps was unknown. Additional information has been requested.
pain, tingling, numbness on left side of face and neck within 2 hour of dose given, tingling started 4 hours later in chest, neck, face, and upper body, 2 days tingling was all over my body including hands and feet, pain  and stiffness in muscles in head/scalp, upper shoulders and neck started 9/27, left eye swelled on 10/2 and lasted a week, now eye is droopy, 9/27 twitching started-ongoing- 10/11-buring skin feeling on left side, temperature dysregulation - either too hot or too cold-no tolerance for temperature change, 10/11-vertigo started-ongoing along with balanced issues, 10/16 weakness in legs started-ongoing, 10/20 depression and anxiety began-ongoing, being seen by psychologist, heart palpitations began in October-ongoing, twitching began in October-ongoing, ringing in ears began in October-ongoing, sensitive to light and sounds began in October, developed food intolerance to all beans, most carbs including white rice, coffee, tea, some meat and fish, major fatigue started in late September-ongoing and debilitating-can barely work and difficulty focusing on work tasks
Injection site Arm pain -started from time of injection- severe during night- could not lay down on arm; icing didn't help much. Muscle/complete body aches- fatigue-started  9pm on day of injection- prevented sleep during most of the night. Vomiting- 3am -7am- 7/19/2018. Very Severe headache- started during the early am hours- lasted through next day. Unable to stand - morning of 7/19/2018- through noon. Reactions were not mild or moderate- unable to feed/ care for the dog- never reacted to anything previously in my life.
Presented with weakness, SOB, cough, dec appetite; CXR:  Patchy bilat airspace opacification, concerning for atypical PNA; dx Type II NSTEMI d/t Covid; Covid PNA;  Labs: D-dimer 0.84, CRP 0.4; Ferritin 1458; remained on baseline 3 LPM NC; Meds: Singulair, Zinc; feeling much better from COVID-19 infection no evidence of significant pneumonia however patient is having a productive cough and therefore will treat him with a short course of steroid and antibiotic due to his underlying interstitial lung disease.
fullyvaccinated 03/01 but then tested (+) 11/29. Case was not interviewed thus no info obtained regarding PMH, symptoms or course of illness.
burning sensation immediately after injection only lasted for a minute. 12 hours after injection my body ached, all my joints and muscles ached and i had a bad headache and my arm was sore from the injection. I felt nauseous 24 hours after injection but it only lasted a couple hours. my joint and muscle ache lasted for about 24 hours.
Patient reports: shock-like sensation in fingers of left hand (only the first evening and following day) dull ache along spine, especially affecting neck and lower back (began the second day and continues in the present). Extreme fatigue, body aching (began the second day and continues in the present). Numbness on the bottom of the left foot (began the second day and continues in the present). Problem with gait-ataxia (began the second day and continues in the present). Dull headache, impeding ability to focus (began the second day and continues in the present). Weakness/feeling of heaviness in limbs. Intermittent feelings of overall weakness (began the second day and continues in the present). Patient's medications include (in addition to the above): Low-dose Naltrexone (see available literature on novel treatment for pain); supplement: Alpha Lipoic Acid. At this point, one cannot fully respond to the question under "Result or Outcome of the Adverse Event" concerning the transience or performance of the patient's symptoms. After twelve days, the patient's symptoms have not resolved or improved.
Patient received second dose on 4/29/2021 after receiving first dose of Moderna covid-19 vaccine on 4/13/2021.
Felt cold, sweaty, chilly - getting confused, felt warm to others. EMT arrived, was delirious, mild headache, mild cough over last few days. Raised lesion at site of immunizations - no smallpox. CXR: increased markings of bronchovesicular area. Dx: Fever, delirium, rash due to immunization.
Heart palpitations, rt leg muscle and foot cramping, left leg twitching, headache, tired, arm tender
Varicella vaccine breakthrough. Had vaccine 2-12-07 at another practice. Diagnosed with varicella in our office on 8-17-08. Had 8-10 lesions. No fever
pt recv vax 9AUG96 & in AUG96 pt devel 12 lesions & a rash;
Pt reported at 3 days after flu shot she developed a rash on her knees and legs.
The patient received a booster dose of the Pfizer Covid-19 vaccine and is not within the age group to receive a booster vaccine.  There were no adverse or negative effects/reactions to booster vaccine.  Patient was discharged home with his mother.
Headache about 24hrs later, no pain killers helped. Temperature about 48hrs later. Both got worse. Went to Dr 6 days later. Said viral must fight off. Continued a full 2 wks after vaccination. Then a wk of severe stomach bloating.  3/9/09 Received PCP medical recods of 07/17/08-1/26/2009. FINAL DX: Low grade squamous intraepithelial lesion, HPV infection Records reveal patient experienced good health on 7/17/08.  RTC 11/10/08 & 11/26/08  w/vaginal discharge.  Colposcopy done 1/12/09.  RTC 1/26/09 & tx w/meds.
Information has been received from a physician concerning a patient who on 03-SEP-2009 was vaccinated with a dose of MMR II (lot # 664658/0679Y). On 03-SEP-2009 the patient experienced unspecified allergic reaction. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Starting later that day I had fatigue and pain at the injection site.  The next day I had severe body aches, mild nausea, more pain at the injection site and now including redness, swelling, and heat.  Fever/chills, sweating, severe fatigue and increased drowsiness, confusion.  Two days after the injection I had all symptoms except nausea.  Sweating was worse but all other remaining symptoms were milder.
This spontaneous report was received from a licensed practical nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9(lot# L006547, expiration date 04-MAR-2017, dose, site and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with VAQTA. Concomitant medications were not reported. On an unknown date the unspecified number of patients received VAQTA doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received VAQTA doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot information was available. This case is linked to 1406USA003227, 1406USA003839, 1406USA003841 and 1406USA003842 (same reporter link). Additional information has been requested.
High fever, rigors, headache, myalgia, confusion that came on suddenly at around 5pm, lasted until 4am the next day and then quickly resolved.  There were no symptoms or any prodrome prior to this, as I was completely in my usual state of health.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (coughing up mucus), COUGH (coughing all through the night), FEELING ABNORMAL (this is not a good feeling) and HEADACHE (been sick with headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 27-Apr-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up mucus), COUGH (coughing all through the night), FEELING ABNORMAL (this is not a good feeling) and HEADACHE (been sick with headache). At the time of the report, PRODUCTIVE COUGH (coughing up mucus), COUGH (coughing all through the night), FEELING ABNORMAL (this is not a good feeling) and HEADACHE (been sick with headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications provided. No treatment information provided.