chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difference in vein struture in left arm after second dose; left arm had different color of skin than right arm; left arm area had a sharp stinging effect like a bee sting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (left arm area had a sharp stinging effect like a bee sting), SKIN DISCOLOURATION (left arm had different color of skin than right arm) and PHLEBITIS SUPERFICIAL (difference in vein struture in left arm after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN OF SKIN (left arm area had a sharp stinging effect like a bee sting). On 16-Apr-2021, the patient experienced SKIN DISCOLOURATION (left arm had different color of skin than right arm). On an unknown date, the patient experienced PHLEBITIS SUPERFICIAL (difference in vein struture in left arm after second dose). At the time of the report, PAIN OF SKIN (left arm area had a sharp stinging effect like a bee sting), SKIN DISCOLOURATION (left arm had different color of skin than right arm) and PHLEBITIS SUPERFICIAL (difference in vein struture in left arm after second dose) outcome was unknown.            no concomitant medications are provided.  no treatment medications are provided.   This case was linked to MOD-2021-079466 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received on 19 Apr 2021, contains both the doses details. On 18-May-2021: Additional information received on 18 May 2021 contains No New Information On 27-Jul-2021: Additional information received on 27 Jul 2021, patient needs help for filling AE form; Sender's Comments:  MOD-2021-079466:First dose of vaccine case
itchiness; white raised bumps; redness in her injection arm; swelling in her injection arm; injection site was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was warm to the touch), PRURITUS (itchiness), RASH PAPULAR (white raised bumps), VACCINATION SITE ERYTHEMA (redness in her injection arm) and VACCINATION SITE SWELLING (swelling in her injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm to the touch), VACCINATION SITE ERYTHEMA (redness in her injection arm) and VACCINATION SITE SWELLING (swelling in her injection arm). On 03-May-2021, the patient experienced PRURITUS (itchiness) and RASH PAPULAR (white raised bumps). At the time of the report, VACCINATION SITE WARMTH (injection site was warm to the touch), PRURITUS (itchiness), RASH PAPULAR (white raised bumps), VACCINATION SITE ERYTHEMA (redness in her injection arm) and VACCINATION SITE SWELLING (swelling in her injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
pt rcvd vax; mom noticed swelling on lt side of face & jaw following day; pt taken to MD; MD dx this on mumps based on CBC results;
little bit tired in the arm; tongue was numb; glass of water felt peppery/couldn't taste the candy; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue was numb), TASTE DISORDER (glass of water felt peppery/couldn't taste the candy) and MYALGIA (little bit tired in the arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021 at 5:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced HYPOAESTHESIA ORAL (tongue was numb) and TASTE DISORDER (glass of water felt peppery/couldn't taste the candy). On an unknown date, the patient experienced MYALGIA (little bit tired in the arm). At the time of the report, HYPOAESTHESIA ORAL (tongue was numb), TASTE DISORDER (glass of water felt peppery/couldn't taste the candy) and MYALGIA (little bit tired in the arm) outcome was unknown.            no concomitant and treatment medications are provided by the reporter. After the booster shot, everything was fine right away,Consent denied for Safety to contact HCP.
Initial report received from a health care professional on 22 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 1013274P) on 22 Dec 2009. The vaccine was administered via intranasal route instead of intravenous route. No adverse event was reported.
Pt developed a few pox; a total of 12 lesions, but did not blister and scab. The pt sought unspecified medical attention. Follow-up information from a LPN indicated that the pt fully recovered.
ActHib was mixed with sterile water instead of the saline/No Ae; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 months old female patient  who received 0.5 mL first dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date not reported) via intramuscular route in one of legs for prophylactic vaccination which was mixed with sterile water instead of the saline on 25-Aug-2020 (product preparation error).   The patient's past vaccination(s) included Pentacel (child has received Pentacel series previously). The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution.  Case details: Reporter stated that another nurse reconstituted ActHIB for patient to administer and it was later discovered that it was erroneously reconstituted. Reporting nurse administered dose after preparation by another HCP.   At the time of report, 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.  There will be no information available on the batch number for this case.
Within 12 hours, developed total body urticaria that lasted for approximately 1 week. Child was very uncomfortable and required an ER visit, multiple doses of BENADRYL throughout the week and visits to our office along with an evaluation by an allergist.
Temperature range 6°F to 14°F Time frame 80 hours; This spontaneous report was received from an office manager, referring to a 5-year-old patient of unknown gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.    On 08-SEP-2020, at the age of 5-year-old, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S027464 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) as prophylaxis. The vaccine administered, experienced a temperature range from 6 degrees Fahrenheit (F) to 14F, for 80 hours, as recorded by a data logger (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007316:
This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 02-JUL-2015 the patient was inadvertently administered with improperly stored M-M-R II vaccine, rHA therapy type, lot # K007107, expire date 16-MAY-2016 (dose, route therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received form the same source. Additional information was been requested.
1 day after shot ran a fever, weak, and achy. Left arm red, hot, very hard and very painful . Could not touch my arm where I was vaccinated. 2nd day after shot no fever but weak. Arm still hot, hard, and sore. 3rd day after shot a lot of pressure in my head, no energy and then vomiting. Arm continued to be red and sore.
Presented after OOH arrest; recent covid infection; + covid in ED, unknown onset of symptoms Dx: Covid PNA, sepsis; Labs: D-dimer 4.18; CRP 4.9; Ferritn 412; Procal 1.27 Tx: Intubated on arrival; extubated on 1/26; 1/27 resp arrest;  reintubated; 2/4 extubated; 2/11 reintubated; 2/15 trach/peg  Meds: Decadron, antibiotics, heparin, vasopressors intially  Discharged to LTAC
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/18/21 2nd dose Diagnosed covid positive:09/09/21 Symptom onset:09/0721 Exposure: Symptoms:fever, HA
Hives around neck, left arm, and upper torso. Complaint of burning and itching in throat and swallowing alot.
Redness & swelling on arm at site of DTaP administration.  Swelling started within 1 hour of vaccine & has been stable for 2 days.
Information has been received from a registered nurse concerning a 15-month-old male with no drug reactions/allergies and with a history of croup who on 10-MAR-2004 was vaccinated with a first dose of MMR II. There was no concomitant medication. On 19-MAR-2004, nine days post vaccination, the patient had a fever, and subsequently experienced a febrile seizure. Unspecified medical attention was sought. Subsequently, the patient recovered. The office reported being cautious of giving the child his second dose for his 4-5 year old vaccination visit. There was no product quality complaint. The event was considered to be an other important medical event. Additional information has been requested.
When I woke up this morning I was lethargic, on the way to work, I started getting tired.  Mid way through the day I started getting chills
Approximately 30 hour after 2nd dose vaccine given, patient noted boggy swelling below his axilla on the external chest wall on R side of body, same side vaccine had been given the morning prior. It's felt slightly uncomfortable in the area, no palpable lymph nodes in axilla or elsewhere, earlier today felt somewhat numb in R arm but resolved. No weakness, numbness, tingling now in clinic. No arm swelling. No redness or bruising noted on the skin.
AFTER RECEIVING HER VACCINE SHE COMPLAINED OF A HEADACHE. ON SITE EMS RESPONDED. VITALS ARE BELOW.  SHE REFUSED FURTHER EVALUATION AND LEFT.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 11 November 2013. The 11-months-old patient had received second dose of FLUZONE 0.5 ml dose instead of 0.25 ml. It was an overdose. No adverse event was reported. List of documents held by sender: none.
14 yr slender female with history of fainting with needles(told staff after event) with ALOC of 45 seconds in chair supported by very observant LVN; self resolved, departed with mother who reports: this "happens all the time".
3cmx3cm warmth and erythema. Febrile 99-101. Slept a lot. Decreased appetite. Emesis one time.
A healthcare professional reported that her 27 year old son received an injection of flu shield on 10/31/2001. Concomitant therapy included Propecia and Flovent. approximately two weeks post-vaccination, the pt developed a cold. Sometime in November 2001, the pt travelled twice by air, and after air travel experienced some transient hearing loss and dizziness. The pt was seen by a physician who made a diagnosis of vertigo. He was treated with Bonine and exercises. The reporter indicated that as of the date of this report, the dizziness had not improved. No further info was available at the time of this report.
Extreme left shoulder joint pain, went to ER 10/25/12 3:00 pm pain unbearable. Given ULTRAM, and NAPROSYN. Sling for left arm. Continued left shoulder pain 11/7 Dr gave Rx for more ULTRAM and NAPROSYN if pain persist appt. with orthopedics.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on medication like nasal spray and allergy shot.
The next day after I experienced shortness of breathe that is currently ongoing. I've been having colon issues and was put on a high dose Prednisone. I have also been taking over the counter Iron pills for the shortness of breathe.
muscle spasms; burning; tingling; She has not been able to work outside because of her symptoms; received 2 doses of the Moderna COVID-19 vaccines by injection on 13MAR2021 and 02APR2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She has not been able to work outside because of her symptoms), BURNING SENSATION (burning), PARAESTHESIA (tingling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses of the Moderna COVID-19 vaccines by injection on 13MAR2021 and 02APR2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and DIOMZOA) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses of the Moderna COVID-19 vaccines by injection on 13MAR2021 and 02APR2021). On 23-Jun-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She has not been able to work outside because of her symptoms). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms), BURNING SENSATION (burning) and PARAESTHESIA (tingling). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency; GABAPENTIN at a dose of 300 milligram three times a day; CITALOPRAM at a dose of 40 milligram once a day; LOSARTAN at a dose of 50 milligram once a day; LORAZEPAM at a dose of 5 milligram twice a day and BUSPIRONE at a dose of 15 milligram twice a day. At the time of the report, MUSCLE SPASMS (muscle spasms), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She has not been able to work outside because of her symptoms), BURNING SENSATION (burning), PARAESTHESIA (tingling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses of the Moderna COVID-19 vaccines by injection on 13MAR2021 and 02APR2021) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that She had spoken to her primary care doctor and a dermatologist. She had been taking multiple medications for this including oral steroids and the strongest creams. She last saw her dermatologist two weeks ago, and is due to see them again on the 17th. it was reported could not go outside for any amount of time without itching and burning more.   This case was linked to US-MODERNATX, INC.-MOD-2022-670478 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2022: Live-Follow-up received and additional narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670478:Dose 1
Tachycardia 124- 132 started 10 minutes after vaccine.  Resolved spontaneously about 2 minutes later
Redness and induration measuring 8" X 7" on left tricep. Treated with Benadryl and clobetasol topical ointment.
A few weeks after receiving 1st dose of shingles vaccine, I began to have extreme pain in lower legs, 80% left, 20% right. Visits to back Dr. did not help. Visits to e.r. every 3 days for extreme pain. Finally ended up at neurologist. who diagnosed me with guillian-barr. By this time I was mostly in a wheelchair and ended up bedridden for 2-1/2 months. Dr  said he believed it was from shingles shot, and not to get the second shot. I currently take gabapentin 800mg 1-2 times a day for pain.
Patient received first dose of COVID-19 vaccine, Moderna, on Monday April 19 2021. After vaccine patient reports having a headache for 2 days. On Wednesday April 21, 2021 the patient reports having a rash on chest and stomach.
cdizziness and lightheadedness, worse with head movements. She mentions having a heaviness sensation in her upper chest and shoulders region. Denies any lip swelling, tongue swelling, shortness of breath, rash, or difficulty swallowing.   lightheadedness, bilateral upper eyelids red and swollen,
My wife and I were both vaccinated at the same time for two doses of the Moderna. Only muscle soreness with the first vaccine. The day following the second injection we both felt fatigued for the day and through the night. I experienced chills during the night. Felt much better during the day. The next day I started sneezing similar to having seasonal allergies that I had 10 years ago. No antihistamines relieved the symptoms. Those symptoms remained for 4 days. 6 days following my wife's second injection of Moderna, same lot number, she is experiencing similar allergy symptoms. No relief from over the counter meds either.
two bumps in her armpit/and they are really swollen; her breast and they are really swollen; burning sensations there; has a really strong pain if she breathes really deep; has a little pain in her arm; She states that she feels like she cannot breath; she feels like she has tachycardia; This is a spontaneous report from a contactable consumer (Patient). A 44-years-old female patient received bnt162b2 (COMIRNATY, Formulation:Solution for injection, Batch/Lot Number: FD8448) dose 2 via an unspecified route of administration on 26Aug2021 10:00 as dose 2, single (At the age of 44-years) for covid-19 immunisation. Medical history included blood cholesterol and hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. The patient previously took bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EC3100) dose 1 via an unspecified route of administration on 05Aug2021 (At the age of 44-years) for covid-19 immunisation. Patient has not taking any medications and has a lot of allergy but all of that she has and maybe some or a bit of cholesterol and triglycerides but that was already under control and states she had no other diseases; states the allergy, cholesterol and triglycerides began prior to the Pfizer Covid vaccine. On 26Aug2021 16:00 the patient experienced two bumps in her armpit/and they are really swollen, her breast and they are really swollen, burning sensations there, has a really strong pain if she breathes really deep, has a little pain in her arm, she states that she feels like she cannot breath, she feels like she has tachycardia. After 2nd dose Symptoms started at 4:00 pm and her symptoms are worse. Therapeutic measures were taken as a result of two bumps in her armpit/and they are really swollen, her breast and they are really swollen, burning sensations there, has a little pain in her arm, she states that she feels like she cannot breath. She states that someone told her to take 800 mg of Tylenol after getting the shot, but the Tylenol didn't even take away 5 percent of the pain. Lot number F200557 and expiration date Feb2022. Symptoms started at 4:00 pm and her symptoms are worse. Caller was given the following information. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. The outcome of the events was not recovered.   Follow up(27Aug2021): This is a spontaneous report included. Event onset dates and some clinically relevant information provided.
Subsequent to receiving one dose of varicella virus vaccine live, 11/97, On 4/14/99, the pt experienced a mild, atypical rash concentrated on the neck, head, and upper arms. The rash was atypical in regard to shape and duration. The rash came in crops that concentrated to form one large rash site and were bigger in comparison to chickenpox. Hives were still erupting at the time of the report. The rash sites has a slight watery center, had no crusting over and itched. No further information is available.
persistent fatigue and myalgia since 2/10 which acutely worsened after 3/10/2021 vaccination.
Polyarthritis involving the proximal interphalangeal  joints of the 5th and 4th fingers and distal joint of the 3rd finger of the left hand.  Swollen and painful and still persisting.
pt recv vax & less than 10mins-c/o nausea,dizziness,diaphoretic,cyanotic,SOB;sent stat to hosp
From initial information received on 01/29/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 45 year old female patient received a second dose of Menomune A/C/Y/W-135, lot number UE110AA, administered subcutaneously in the left arm at 1:05 PM on 01/22/04. Approximately five hours later, at 6:00 PM, the patient developed redness, itching and swelling at the injection site. The patient was treated initially with Benadryl and was also given intravenous and or antibiotics, as well as Percocet for pain. Reportedly the patient recovered from this experience. The patient had previously experienced injection site redness at the age of 42 years following the receipt of Menomune, TD and Pnemo.