chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme tenderness and pain when touched at injection site and surounding area within 12 hours of Pneumonia Vacine injection.  High fever 101 Degrees F will full body chills within 24 hours of injection.  Big RED irregular shaped patch (hot to the touch resembling a 2nd degree sunburn) 4" by 4" in size at injection site showed up 48 hours after injection.  72 hours after injection temperature drops to 100 Degrees F and full body chills stop.  Patient took 800 MG of Advil three times a day starting 12 hours after injection.  Patient received a FLU Vacine in the right arm and a Pneumonia Vacine in the left arm.  There was no reaction from the flu shot.  The extremine reaction listed above was from the Pneumonia Vacine and occured in the left arm, e.g., tenderness, pain, red patch all ocured in the left arm (the pneumonia vacine was given in the left arm).  You will have to contact my doctors office to find out the manifacture and lot number for the vacines I received.
This was my booster shot.  I did not have this reaction with my first or second vaccine dose.  A large, red, swollen, warm to the touch lump developed from the day after the booster shot until I had been seen by a NP (today) who diagnosed it as cellulitis.  I was prescribed antibiotics to combat the infection.
immediately p/vax was administered pt devel hive-type rash & exp itching; contacted MD, DPH prescribed & itching relieved; epidose lasted 24 hrs;
blotches on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (blotches on 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 17-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 VACCINATION SITE RASH (blotches on arm). At the time of the report, VACCINATION SITE RASH (blotches on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
1st Dose: only mild pain and swelling at injection site for a few days. 2nd night had heat flash and chills temporarily with constant brain fog for a week coming and going.  2nd Dose: after 4 hours, extreme fatigue throughout body, brain fog, confusion, and lethargic. Extreme brain fog 11 hours after vaccination. The next day strong fever and stronger symptoms from the day before. The 3rd day felt back to normal. 4th day had a mild brain fog moment.
Pt was given vaccine IM route instead of subcutaneous by ancillary staff. Patient had left clinic at time discovered by this provider reviewing chart/ co-sign so not aware of any symptoms or signs at this time.  Called to CDC to verify and per their information the vaccine does not need to be re-administered.
I had a 2.5 in diameter inflamed red sore rash around the injections sign which occurred 2 hours after injection and lasted for 1 week
Administered subcutaneously; Pain in injection site; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program.   A 39-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), subcutaneously on 26Aug2021 (Morning with unknown time) at vaccination age 39 years old (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Vaccination Facility Type Doctor's office. The patient's medical history included asplenic and concomitant medications was not reported. The patient experienced administered subcutaneously as opposed to IM (intramuscularly) (medically significant) on 26Aug2021 with outcome of unknown, pain in injection site (medically significant), having a lot of pain in the arm which patient believed was because of the placement being incorrect in Aug2021 with outcome of not recovered. The events were not requiring emergency room, physician office and hospitalization.  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: A contributory role of PREVNAR 13 with incorrectly subcutaneous administration triggering the onset of vaccination site pain cannot be fully excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Pt recvd vax & lt arm sore & next day arm very swollen lt hand blue & fingernails purple; went to ER & recvd antiinflammatory & ATB;
Client was vaccinated for Covid with Pfizer vaccines on 3/11 and 4/3/2021.  On 9/15 developed Covid symptoms: nasal congestion, sneezing, cough, temp 102 x 1 day, loss of taste and smell.  Tested + with rapid test on 9/19/2021.  Reported as a case of breakthrough Covid in a fully vaccinated person.
Pt. received vaccine on 8/17/09 11:28.  Pt. returned to clinic (where she received vaccine) @ 7:30pm 8/17/09.  THe following is note left in chart by FNP at that time on 8/18/09 :"pt. returned at 7:30 on 8/17/09 with a  itchy blotchy rash that had started 3 hours before- pt had taken no antihistamines at that time.  Diffuse, blothchy rash noted on arms and abd, no hives, no SOB or difficulty breathing.  Suggested that pt. take Zyrtec or benadryl - pt stated that she had zyrtec at home.  Told pt if she worsened to go to ER or call 911 if any hives or SOB.  I called pt this am - she stated that she took zyrtec last night and the rash was gone in one hour.  No further problems at this time." I am entering this data on 9/8/09 because pt is here today to receive flu shot and questioning whether she should get flu vaccine since she had this reaction to pneumovax.
Left upper arm edematous, erythematous, warm to the touch.  Parents stated no fever, but children's Tylenol given and ice applied to arm 9-9-08/9-11-08 reported to RN.  Asked mom and dad to take to family MD and ER if condition persists after Tylenol and ice packs.
Headache Narrative:  c/o headache/migraine starting one day post vaccination spanning to 4 days post vaccination. migraine resolved on day 5.
This spontaneous report was received from a physician concerning a 60 year old patient of unknown gender. On 28-OCT-2013, the patient was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously instead of ZOSTAVAX. This was due to staff error and not product confusion. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Bad headache one day after first dose, third day after first dose experienced hay fever type symptoms, fourth day after first dose experienced pain in chest under right rib and cough
splashed to nurse's eye; splashed to nurse's eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product and exposure via eye contact were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter reported that while giving Shingrix to the patient, the shingrix solution accidentally burst out and splashed to their nurse's eye, which led to the occupational exposure while administering product and exposure via eye contact. The reporter asked that they want to know if there were any effects from this incident. No further details provided via web form.  The reporter submitted all available information. The reporter consented to follow-up.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 77-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. Treatment information was not provided.
Fever/chills, decreased apetite, chest congestion, coughing up white congestion. Patient Wheelchair bound and has COPD and reports he gets pneumonia frequently. No Dr visit was done by patient.
Dr. gave me a verbal to give pt his Dtap that was due, he is VFC so I went to get and we did not have any just Dtap but had Dtap and IVP combo.  I asked co-worker if it was ok but she did not ask the age and also let Dr. know that was the only Dtap we had available in VFC, she stated ok to give unsure if she knew about the age recommendation.  I gave the injection and let the parent know that it was the combo.  When I was getting ready to input info I looked under the Dtap/IVP part and it stated Kinrix and I knew that second that I gave the dose that is recommended only for 4 yr old.  I emailed our VFC contact without knowing that she was not at the HD any longer. Made my variance at work and let our VFC contact know what happened and waited until I heard from the HD, I was reminded about by our admin that variance I put in was still opened and so I am now reporting incident
Blurry near and far vision.  This was still occurring when I received my second dose on 03/31/2021 at same location. (Lot EP 6955)  I continue to have issues with blurry vision. I did not have this issue prior to the vaccination.
Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml. The children (age 5-11) received 0.3 ml x 41.9 mcg/ml = 12.6 mcg. Pfizer Case #:
Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated the second 0.5ml dose with PNEUMOVAX 23 (lot# not reported). A couple years ago, the patient developed a reaction to PNEUMOVAX 23 and was admitted to an unspecified hospital for an unspecified length of time. The nurse did not specify what the reaction was. At the time of this report, the patient's outcome was not reported. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose, lot number, date of event, recovery status and hospital name. This is a corrected report. The AE coding "vaccination adverse reaction" has been changed to "adverse event". Additional information has been requested.
First:  Site swelling & pain (about a week - 03/04 to about 03/10/21) Second: Headache, muscle pain, joint pain, tired (started day after - 03/05 to 03/06/21 - about 1-2 days) Third: Serious pain in left arm (mid-upper arm & lower arm down to the hand). Bones hurt, muscles hurt, and joints hurt. Rash on upper and lower left arm. Sensitive to touch and slightly red. Serious diarrhea just after arm started to hurt. (started 03/17/21). Still on-going.
Pain along a nerve line on side under the arm in which shot was given.  Saw my physician. Said it could have been shot or shingles. Pain went away in about two weeks. Shoulder became weak and sore about the same time. Saw my orthopedic physician. Recommended exercise. Still not completely back to normal but is better.
Severe intermittent shoulder pain; unable to fully lift arm; that lasted for 7-10 days. Exacerbated by certain motions. Pain has lessened but discomfort is always present and pain is exacerbated by multiple routine motions. Hand/lower arm occasionally feel tingly/asleep. This has persisted for the last few weeks.
Leg swollen, rash-circular 10cm x 12cm around injection site, warm to touch.
I have an Itchy rash on my back still there not as bad as it was but I am handling it
Headache  Chills/Feeling warm Fatigue  Feeling of ?fogginess?/?out of it?
This is a spontaneous report from a contactable consumer via a non-clinical study program. A 21-year old female patient (weight was between 166 pounds to 170 pounds) received first dose of TRUMENBA on 04MAR2015 at single dose in arm after an outbreak of meningitis. Medical history included ongoing seasonal allergy. Concomitant medications were not reported. On 04MAR2015, after receiving the vaccine, she felt a little tired and nauseated and her arm started feeling really weak; initially her arm was sore where shot was received (on 04MAR2015), then the soreness spread on unspecified date in MAR2015. She could not sleep on the side she received the vaccine because it was sore and kept her awake. On 05MAR2015 she could not lift her arm very far, she could not lift her wrist, elbow or shoulder for about a week after getting the vaccine. On 06MAR2015 she did not have enough strength in her arm to move it around. She stated she did not remember if her arm felt heavy and if it did, it was not very much. On an unknown date all limbs were weak, she could move fingers but they were weak. She could not clinch her hand to hold stuff.  No hospitalization was required. She was treated with acetaminophen for soreness on the site of vaccination which helped a little bit. No treatment was received for the other events. Fatigue resolved on 07MAR2015, felt nauseated resolved on 05MAR2015. The other reported events resolved on an unspecified date. She did not receive her second dose of TRUMENBA which was scheduled in MAY2015. Follow-up attempts completed. No further information expected. Follow up (30JUN2015). This is a follow up spontaneous report from a contactable consumer. The same contactable consumer reported in response to the telephone follow-up activities that included: events outcomes and details. Follow-up attempts completed. No further information expected.
pt recv vax 9SEP96 & 22SEP96 pt devel chronic neutrophilic meningitis;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Patient lost consciousness, unable to respond. -Severe, Additional Details: Within 5 minutes of dose, patient lost consciousness, unable to respond. Lowered to the ground. Pulse and breathing checked as positive. BP checked 113/70, HR 78. 911 emergency services called. However, within 1 minute, patient regained consciousness and was able to converse. She reported exercising prior to dose and being slightly dehydrated. She reported passing out after a prior Hep B vaccine which was not reported on her initial screening. She was able to sit up within 5 minutes, drank water
pt recvd vax;devel rash around inject site & three lesions on body;
8JUL93 shot @ 10AM nap from 1130-12 woke up screaming fever 104, shaking, crying, refuses to eat & drink; given APAP; t102 1hr p/APAP; 3 hrs later temp goes up to 104; restless noc of sleep; sleeps 1-1 1/2 hrs then awake for 15mins crying ;
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old male patient. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On an unspecified date in September 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided)) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. He was treated by a physician for the event. The outcome of the event of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Associate gave me your information to contact you regarding several issues I have been experiencing since my flu shot was administered on October 3rd. On Friday, October 4th I began to feel fatigued and experienced some discomfort in my throat. On Saturday the throat discomfort, not exactly a sore throat but generally feeling like something was going on. This continued on Sunday the 6th and worsened on Monday the 7th. I continued feeling fatigued and having some discomfort in my throat through the remainder of the week including a fever and went home early on Tuesday, was off sick on Wednesday and then worked through Thursday and Friday. By Monday the 14th whatever was causing the issues in my throat moved to my chest turning into an upper respiratory infection and fever. I was off work two days that week and on vacation Thursday and Friday but remained very ill with fever, chills, coughing, but with no congestion I have had some issues catching my breath during coughing fits to the point where my husband was ready to call 911 in the middle of the night. About a week ago I noticed tenderness in the upper quadrant of my right arm. I thought that maybe I had strained a muscle. It got to the point where it hurt to press down to write something. A couple of days ago my husband noticed a bruise in the area where the tenderness is and it was then I realized that it was right below the area where the flu shot was given. It appears that what I am dealing with is indeed muscle pain and deep tissue bruising. Today I still have a terrible cough and have all but lost my voice. While I am susceptible to upper respiratory infections, bronchitis, and pneumonia none of the symptoms I've experienced in the last month are similar to those that I have experienced with any of the conditions I've had with those illness. In addition the fatigue is unbearable at times. I just haven't felt well since before getting the flu shot. I hope I provided what you might need so that the lot can be reported. I know several other people who are having same issues as I am however they're not here where I work so I'm not sure what's causing the similarities. Let me know if you have any questions.  Handwritten notes 11/7/19, RPh, Severe coughing spells, Arm bruise, tender to touch. Mild vertigo after flu. Under Tx. 5 days of work missed. Has had Rxn in the past, ill for an different.
Woke the next morning, felt like she was going to pass out, dizzy, wheezing, pulse ox 83. BP 100/60, pale and diaphoretic. TO ED Next day felt aches, chills, diaphoretic, tired.
On 12/8/00, pt had clumsiness; dropping tools. On 12/9/00, had difficulty with balance and swallowing. On 12/10/00, could not move without assistance and had slurred speech. "Miller-Fisher variant of Guillain-Barre". Still hospitalization. 60 day follow-up states the pt was discharged from the hospital on 5/7/01.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with vaccine that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient administered with vaccine that have undergone temperature excursion) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with vaccine that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient administered with vaccine that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered with vaccine that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient administered with vaccine that have undergone temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No patients have reported any adverse events to date. Vaccines were thawed on 28-Jan-2022. It was reported that 2 vials with lot number 059H21A had expiration date of 27-Mar-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. Treatment information was not reported. This case was linked to MOD-2022-539812 (Patient Link).
Pins and needles sensation over both arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles sensation over both arms and legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PARAESTHESIA (Pins and needles sensation over both arms and legs). At the time of the report, PARAESTHESIA (Pins and needles sensation over both arms and legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided