chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out with shingles / I have broken out again; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the shingles vaccine 2 months ago and broke out with shingles.  The reporter wanted to know It's time to take the second shot and had broken out again. Should the second shingle shot be taken.
pain in my right lung; Pleurisy; blood clot; difficulty breathing; body aches; chills; low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Supraventricular tachycardia on 04-Apr-2017 and AFib since 04-Apr-2017. Concomitant products included VERAPAMIL from 04-May-2017 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN BAYER) from 07-Jan-2003 to an unknown date and TAMSULOSIN HYDROCHLORIDE (FLOWMAX) from 14-Oct-2012 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever). On 02-May-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-May-2021, the patient experienced PLEURISY (Pleurisy), COAGULOPATHY (blood clot) and PULMONARY PAIN (pain in my right lung). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) for Pleurisy, at a dose of 875 mg twice a day. On 15-May-2021, PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4 degree (High) 100.4 degree F. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-May-2021, Blood test: abnormal (abnormal) D-dimer was elevated to 3600, Possible blood clot. On 05-May-2021, Computerised tomogram: abnormal (abnormal) Developed Pleurisy.         Symptoms: Patient reported that he had spiked fever and Difficulty breathing after vaccination.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-103195, MOD-2021-103270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains Significant information: Added Patient Demographics, Medical History, Lab Data, Suspect Drug Information, Concomitant medications, Treatment Medication, New Events added, Event outcome added.
The day after IZ's, pt was seen in ER X 2 for right swollen, red arm and shoulder. He was dx'd with cellulitis. Put on po antibiotics. Seen in office 2 days, post vax, given antibiotics and discharged. Next day pt was much more normal.
Headache; temperature, temperature of 100 ºF now, and that was around 102-103 ºF; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (temperature, temperature of 100 ºF now, and that was around 102-103 ºF) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (temperature, temperature of 100 ºF now, and that was around 102-103 ºF). At the time of the report, HEADACHE (Headache) and PYREXIA (temperature, temperature of 100 ºF now, and that was around 102-103 ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 ºf (High) 102 - 103 ºF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The same day of vaccination, the infant developed a fever and experienced a seizure. She was hospitalized where the reporter noted that the child was "sedated".
Patient received second dose of Pfizer COVID-19 vaccine. Dose given 1122. She complained of periorbital swelling. She was given two doses of Benadryl 25 mg and sent to Urgent Care.
Vertigo; I start to get a little dizzy on the right side of my ear specially when I lay down; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 72 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 09Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single and administration date 02Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset Feb2021, outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "I start to get a little dizzy on the right side of my ear specially when I lay down".  Additional information: The patient noticed that after she got the first one, may be a week later she thought it was vertigo. She said that "the first one, may be after 2 weeks I start to get a little dizzy on the right side of my ear specially when I lay down and it's like vertigo because I had this before in the year of the beginning in January. About 2 weeks after February, I started feeling of little dizziness when I was lying down." The patient added that when she took the second vaccine in March, she still has it when she lay down on the bed when turning on right side and it lasted about 5 seconds.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
aches; high fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (aches) and PYREXIA (high fever) 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 PAIN (aches) and PYREXIA (high fever). At the time of the report, PAIN (aches) and PYREXIA (high fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that  got 3rd moderna shot on 10-DEC-2021 also stated that  had no adverse reactions with the first dose,but did have a strong reaction to the second dose  No concomitant medications were reported   No treatment information was provided
3MAY95 ER visit T99.1, had lt delotid erythemai & warmth of 4.5 x 10cm; dx cellulitis; given Ancel & Dynapen; 7MAY95 t99.2 lt deltoid erythemia 54mm x 18mm; no adenopathy;dx UTI;
The vaccine laid me out for at least 48 hours. I had fever and fatigue. I had a fever of 100 degrees or more for a couple of days. I was very fatigued like I had the flu. I was really fatigued. I was scared to take anything, so I remained in bed until the symptoms. All symptoms were gone after 2 days.
Swollen face; Swollen neck; Concentration is off; Headaches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen face), SWELLING (Swollen neck), DISTURBANCE IN ATTENTION (Concentration is off), HEADACHE (Headaches) and FATIGUE (Tiredness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic eosinophilia (Highly eosinophilic and very allergic. ). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (CETRIZINE), MOMETASONE FUROATE (NASONEX), OMEPRAZOLE and VITAMIN D NOS for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swollen face), SWELLING (Swollen neck), DISTURBANCE IN ATTENTION (Concentration is off), HEADACHE (Headaches) and FATIGUE (Tiredness). At the time of the report, SWELLING FACE (Swollen face), SWELLING (Swollen neck), DISTURBANCE IN ATTENTION (Concentration is off), HEADACHE (Headaches) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Noticed rash & extreme redness on top of both feet developed into burning & itching - severe burning more at night (not too bad during day). Only redness was on top of feet. Few spots on upper thighs but no where else, gradually got better over next week, Dr gave Rx for mupirocin, very small pimple like spots which dried up but never scabbed over condition continues to improve at this time.
upper eyelid was starting to swell/more swollen than yesterday; stiff neck; something hurts in my neck when I turn it a certain way; Her face felt tighter around the right eye; eye started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye started to hurt), SWELLING OF EYELID (upper eyelid was starting to swell/more swollen than yesterday), MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (something hurts in my neck when I turn it a certain way) and MUSCLE TIGHTNESS (Her face felt tighter around the right eye) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     Concurrent medical conditions included Perfume sensitivity (Allergic to a whole slew of things, like fragrances, was reported.).    On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced EYE PAIN (eye started to hurt), MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (something hurts in my neck when I turn it a certain way) and MUSCLE TIGHTNESS (Her face felt tighter around the right eye). On 28-Dec-2021, the patient experienced SWELLING OF EYELID (upper eyelid was starting to swell/more swollen than yesterday). At the time of the report, EYE PAIN (eye started to hurt), SWELLING OF EYELID (upper eyelid was starting to swell/more swollen than yesterday) and MUSCLE TIGHTNESS (Her face felt tighter around the right eye) had not resolved and MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (something hurts in my neck when I turn it a certain way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported  Getting brown around the eyes like somebody socked her in the eye, was reported.
No fever, only swelling occured two days after then redness spread with red streak lining towards the back of leg and itching. Brought him in and pediatrician prescribed abx. He suspects bacteria may have imbedded with shot.
Patient is a 56yr old female presented today for her 1st Moderna vaccination. Patient educated on side effects, need and to wait 15 min before she could leave the waiting area. Patient was on her way out the door when she started to feel a "wet sensation on the right side of her face" and pain like a needle in the back of her eye. Dr. came to evaluate her and did not think she was having an allergic reaction. She denied any shortness of breath, swelling of the lips, tongue, throat or eye. Patient felt like the pain was not high enough to warrant even taking tylenol and felt well enough to return to work. She is schedule for a wellness exam with medical provider tomorrow and will follow up with her.
I had a pretty bad cough with a little bit of sinus pressure. I had a sore throat for the first couple of days. It wasn't too bad.
I had a raised heart rate and I went to the emergency room on 9/27/2021. All I can tell you is that I now have to go for a stress test and a sleep study to see what caused A-fib too now. I followed up with my PCP and heart DR and I am not on blood thinners as well.
5-10 minutes after receiving 2 vaccines, pt developed an erythematous, blanching rash on his trunk and legs that he said itched somewhat. No respiratory symptoms; itching improved.
Information has been received from a pharmacist referring to a 62 year old female patient with high cholesterol. The patient was allergic to PERCOCET. On 18-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L006381, expiration date 25-MAY-2015, 0.65 ml, subcutaneously in the left arm. Concomitant therapies included LIPITOR. On an unspecified date in July 2015 the patient experienced redness, itchy, swollen and rash around the injection site of left arm. She also experienced redness and itchiness of her lips and around her jaw line on an unknown date in July 2015. A physician had written a prescription of famciclovir 500 mg three times daily by mouth for treatment. On 20-JUL-2015 (today), the patient came in to the pharmacy to seek medical attention, and the pharmacist stated that although the patient said she had rash around the injection site, but the pharmacist just saw swelling and redness. The outcome of the events was reported as not recovered. Additional information is not expected as the physician was asked not to be contacted.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Patient said that she feels like she has shingles again where she had them in January started this morning.
HEADACHE (NON FEBRILE), BODY ACHES, VERY LOW ENERGY, GENERAL MALAISE.
Initial report received from healthcare professional on 16 January 2013. A 61-year-old female patient, who had medical history of sulfa allergies, GERD (Gastroesophageal reflux disease), osteopenia and dermatitis and concomitant medication included CENTRUM SILVER, Vitamin D3, Vitamin E and fish oil, had received an intradermal dose of FLUZONE ID (lot number: UT4473AA) in left deltoid on 22 October 2012. On 22 October 2012, the patient experienced redness and swelling at the injection site. On 16 January 2013, patient claimed of a flat lesion with a slight white scale at the injection site. The patient had not received any corrective treatment by physician and laboratory details were not reported. At the time of this report, the patient's outcome of the event was unknown. Follow up information received from a healthcare professional on 24 January 2013. The reporter's (physician) address was changed. Follow-up information received from a healthcare professional on 05 April 2013. The patient had developed permanent scar. Documents held by sender: Photo of the affected site. Follow-up information received on 05 June 2013 and 06 June 2013 from a healthcare professional. On an unspecified date, the patient had round erythematous area approximately of 1 cm in diameter consistent with post-inflammatory erythema. The patient also had a flat lesion with slight white scale at the vaccination site. It was reported that this post-inflammatory erythema will take some time to resolve. The physician advised the patient to refer to the dermatology for evaluation and management of lesion. The adverse event permanent scar was no longer reported, so this event was deleted from database. The patient was evaluated but didn't receive any treatment.
On July 4, 2022 when I caught COVID-19 I had a slight sore throat that evening. On July 5th I had slight nasal congestion, sneezing, and diarrhea. On July 6th and July 7th the same symptoms continued. During the time of having COVID-19 I had also been running a fever at the maximum of  100.6 degrees. On July 8th it felt like my fever had broke because my temperature had went down a little bit. I was improving on July 9th. I had no fever, my congestion was pretty much gone, and i felt recovered on July 10th. I had some fatigue for a few days after that.
Within a few minutes of receiving the Menactra vaccine, felt light-headed, sat down, then suddenly arched his back, fell backwards on his chair, lost consciousness. Denied feeling tightness in chest or throat. Became diaphoretic, vomiting x2. BP 124/60. Remained diaphoretic, nauseated, weak for less than 45 minutes in office, then observed by parent at home - had gradual recovery. Seen back in office at 5:30 PM, still feeling al little tired and weak.
On 1/26/00, the pt experienced a grapefruit sized welt at the injection site. On 1/27/00, the pt developed a 101 fever that the reporter felt may be due to influenza virus vaccine. The pt was treated with Benadryl by mouth and cream and ice packs were applied to the welt. Follow-up information from a registered pharmacist indicated that approximately 2 weeks post onset the pt recovered. The pt had been in a 6 week rehab program and the welt at the site of injection did not prolong his stay. The pharmacist stated that the main obstacle in determining what caused the reaction was that the pt had received both the pneumococcal and influenza vax in the same arm.
Exaggerated local rxn @ Varivax site with 8 cm redness, swelling pain induration dx 2d after vaccine No systemic s/s
Feeling of throat scratchiness and difficulty swallowing when eating.  Symptoms felt similar to how I feel if there is something with corn in my food or medicines.  I treated with OTC Benadryl 25mg with resolution of symptoms in 2 hours.  Recommended dose of 50mg was not taken due to need to drive vehicle.
Anaphylactic reaction, 1st signs noted 10mins p/shot recvd; pt given Epi & adm for Solumendrol & DPH; rxn did not progress;
On 9/14/2023, my client was inadvertently given an expired dose (Exp. 9/4/2023) of MMR. When the error was discovered, the remaining box of vaccine was removed from inventory and expired. Since the client was leaving the country and unable to return to the clinic at 28 days to repeat the dose, a decision made between both the client and I was to administer another UNexpired dose of MMR immediately. This was done,  tolerated well, and there were no adverse effects following a 15 minute wait time.
Restless sleep first night, slight arm soreness. Beginning the next morning, skin hypersensitivity, particularly arms and legs. Took two tablets 500mg Advil, this relieved the issue. Most notable reaction has been tinnitus, noticed some time that morning. Consistent background 'buzz' which has not abated. Annoying.
Arm pain immediately after shot for 2 days Low grade fever 8 am morning day after until 9 PM day after Extreme Fatigue day after beginning 24 hours after shot Muscle aches starting morning after shot for 18 hours  Joint pain morning after shot for 18 hours Intense back pain/muscle pain 24 hours after
The patient reported dizziness, lightheaded, and felt like he was about to pass out. He also said he had some stomach upset and diarrhea.  He later reported chest pain. He went to the ER, and we are awaiting further information.
After receiving the second COVID Moderna vaccine, Patient reports that she is dizzy and her tongue feels thick. She is having trouble coming up with words, having difficulty focusing eyes, and feels like she is in a brain fog. She denies any issues with first vaccine. She consents to Benadryl administration. She would like to stay here to be monitored rather than call an ambulance at this time. She has no facial droop, no weakness or unequal grips.    After about 10-15 minutes, she reports her dizziness and thick tongue feeling is improving.    After another 5 minutes, symptoms have not fully resolved. She still feels like her mentation is abnormal, and her tongue is still feeling "sticky."    After another 5 minutes, patient continues to be mildly dizzy, and still reports difficulty finding words, difficulty thinking, and persistent visual disturbance. I discussed with patient that she needs to be seen in the ER. She declines an ambulance, states she would like her husband to drive her.    Patient left.
The day after the vaccine I had full body aches, nausea, chills and swollen lymph nodes (left axillary & inguinal area). Everything except for swollen lymph nodes was gone in 4 days. The biggest complication is the swollen lymph nodes and an ache in my arm. The ache feels like a tourniquet is on my arm. I just had an ultrasound for my swollen lymph nodes. I saw my primary doctor on 6/23/21. I saw my gynecologist on 6/18/21.
This spontaneous report was received from a licensed practical nurse and refers to a 48-year-old-female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with an improperly store dose of PNEUMOVAX 23 (dose and route of administration were not reported) lot # N011305 and expiration date: 20-JAN-2019. PNEUMOVAX 23 was stored between 32 Fahrenheit degrees (°F) and 35°F for 1 hour and 57 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No causality assessment was provided by the reporter.
Developed sudden onset of chills + muscle tightness. Got up + covered up.  Chills improved after 1 hour but still had muscle tightness.  Didn't sleep well + developed a HA.  Took Aleve @ 8:30 AM which helped improve HA + muscle tightness.