chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a erythema multiform rash to the torso only on right side of body. red macular,  also has a purple/blue/ red bruisng with rash to the crease of the elbow on the right side as well as a rash on the wrist similar to the one on abdomen, Noted some spreading of rash up her neck as well. Patient was given Prednisone taper for 15 days to see if that helps clear, informed to go to the ER if no improvement in 48-72 hours or if she experienced other symptoms
Pt experienced extreme pain in left arm shortly after receiving vaccination. Could not lift arm. Complained of swelling to "bicep" the following day, butno improvement.
4 X 4 IN HARD ITCHY LUMP AT SITE OF INJECTION
Fatigue; Pain at site of injection; Swollen lymph nodes in lower right of neck; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 27Mar2021 at 13:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included primary lymphedema in lower extremities. Concomitant medication included allergy medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 06Mar2021 at 13:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 16:00, the patient experienced fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for events fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck. The clinical outcomes of the events fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a 63 year old female patient with no drug reactions/allergies, refers to herself. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, dose was not reported (lot# and expiration date were not provided). The patient reported that after receiving ZOSTAVAX, on an unspecified date in December 2014 (reported as 'week before 25-DEC-2014'), she developed chicken pox. She stated, she has been "miserable" with itchy rash. The patient also reported an "intolerable itching in front part of body, and now it has started on the back of body." She has not been able to sleep good because of the itching. In weeks prior to developing rash the patient experienced headaches, chills, and felt lethargic. The patient sought medical attention by visiting the office. Skin culture was performed on an unknown date (results were not provided). For the treatment the patient was given LOTRIMIN lotion, cortisone cream and a drug reported as 'ACYLIV'. The outcome of chicken pox and 'she has not been able to sleep good' was reported as recovering/resolving. Relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Information has been received from a medical assistant referring to a currently 71 year old female patient. The patient had no relevant medical history or concomitant medications. Information about concurrent condition was not reported. On an unknown date (reported as "April"), the patient was vaccinated with PNEUMOVAX 23 (lot# M036728, expiration date: 20-MAY-2018; dose, route were not reported) for prophylaxis. Other suspect therapies included PREVNAR 13 (dose, frequency, route , lot # and expiration date were not reported) for prophylaxis. On 14-DEC-2017, the patient came into the office again. When they looked at her chart, they were not able to tell if she had gotten the PNEUMOVAX 23 that was ordered or if she received PREVNAR 13 inadvertently (Wrong drug administered). It was unknown if there was relevant lab work. As of 14-DEC-2017, it's unknown if the patient would receive PNEUMOVAX 23 again and the outcome of possibly getting PREVNAR 13 inadvertently was unknown.
About 4 hours after receiving the pneumonia vaccine (PPSV), the arm in which the vaccine was given began to throb with pain, not only at the site of the injection but, under the arm. I began to have chills and fever. The muscles  and joints in my legs began to ache. The discomfort was so great that Tylenol had no effect. At 2:00 AM on 10/25/2016 my temperature  spiked to 101.5. I continued to have chills and such intense muscle and joint pain in my legs and pain in my arm that I could not sleep. During the day of 10/25/2016, my temperature fluctuated between 98.6 and 101.8. Finally, around 7:00 PM my fever broke and the muscle/joint pain subsided. My arm continued to be sore on 10/26/2016, but as of today 10/27/2016 the pain is minor. I have never had such a harsh reaction to a vaccine before.
Almost immediately after injection my heart started to race , heart rate increased, could feel myself get shaky for a few minutes.  Also, felt like it was more difficult to breath but could breath, again took a few minutes to return to normal.  It took a few minutes before starting to feel my heart rate slow down.  I remained seated for approx. 25 minutes after shot.
After a few hours after my vaccination I had issues with my right knee and debilitating pain that would not allow me to walk. And the next day I was unable to walk due to this pain. These issues continued to persist for a week until today where they continue to persist however the pain is starting to slowly dissipate. I tried to take Aleve and ice my right knee symptoms however that did not help. I did contact my orthopedic specialist at the HCF. As of now I am not in debilitating pain, however there is still symptoms continuing. X-ray and blood work have been ordered to see what is causing these symptoms.
Myocarditis - treated with hospital confinement, monitoring, Motrin. Overnight stay in the hospital.
Extreme and Prolonged Exhaustion with Inflammation throughout body.  Inflammation mostly in right and left legs, knee and ankle area.  nodules on top of both knees and right forearm.  Dry skin spots on legs.
That evening I had developed a pretty bad headache by that evening but it didn't go away. I went in to ER on April 19 for migraine because my that time news had come out to seek medical help and nothing was helping my migraine. They gave me via IV - migraine cocktail -  Pregnancy - I think I became pregnant right after the vaccine but I'm not sure. I didn't know but at the time I was pregnant - and I'm not pregnant anymore. I had a miscarriage about two weeks ago.  Now my headaches are gone. I've also been put on between my pregnancy doctor and the two doctors at the hospital - steriod pack pills; Migraine cocktail at first ER; anti-inflammatories at second ER and then Primary Care Dr put me on Prescription nasal antihistamine/steroids  nasal spray and headaches have slowly stopped happening. (My allergies flared up majorly after getting the vaccine. I have) Follow up is still needed on both the head pain - need an MRI and follow up is still needed on the miscarriage - I may still need further medical intervention.   I have had two previous pregnancies - were abortions - both were confirmed to be fine before that. I was scheduled for my first sonogram for my pregnancy - I'm estimating I was probably about 5 weeks.
Patient stated her heart was running away.  Nurse checked her heart rate 90/min & regular.  Medic arrived and checked client's B/P  140/104. Client denied SOB.  No facial swelling noted.  911 called & arrived and checked client out.  B/P 147/90.  Cardiac monitor applied by ambulance staff.  HR was regular.  Client was released home per ambulance staff.  Instructed to call 911 if s/s returns and et her PCP know if reaction occur.  Will contact is her PCP.
neuropathy; Information has been received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or around February 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of neuropathy to be related to zoster vaccine live (ZOSTAVAX).  The event of neuropathy was considered to be disabling.  Upon internal review, the event of neuropathy was determined to be medically significant.
Pt developed a 3 - 4 inch red ring around her arm about 1 -2 inches below injection site. She came in 2 days after vaccine to show me. It was red and warm to the touch. Pt stated it was getting better and that it was much worse day before.
Vaginal bleeding 24 hours later. Swollen, itchy, red, hot to the touch in injection site. 3 days after vaccine, woke up to heart beating out of chest, nausea and chills. Honestly thought I was dying. Just noticed a month later, injection site has lost feeling and is also discolored.
Patient was given Pfizer as 2nd dose. Later, it was shown by patient that he received Moderna as his first dose.
Prolonged seizure 2 hrs approx 12 hrs post DTP;neuro status now seem good;
Not doing good, In bed all morning; A spontaneous report was received from a wife, concerning an 80-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and is not doing well, and was in bed all morning.   The patient's medical history was not provided. Concomitant medications reported was apixaban, metoprolol tartrate, losartan potassium, atorvastatin and acetylsalicylic acid.   On 30 Dec 2020, the patient received his  first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 30 Dec 2020, several hours after the administration of the vaccine, the patient received a positive result from her covid test taken on 21 Dec 2020.   The patient stated she is not doing well, and he is in bed all morning. Treatment information was not reported.   Action taken with mRNA-1273 vaccine was not reported.  The outcome of event, not doing well, in bed all morning, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
itchy break out by corner of her eye; itchy; Bumps on both areas that are raised; Warm injection site; Within the last 3 weeks have what appears to be "insect bites"; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy break out by corner of her eye), PRURITUS (itchy), INFLAMMATION (Bumps on both areas that are raised), VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Within the last 3 weeks have what appears to be "insect bites") in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 02A21A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration. Concomitant products included VITAMINS NOS for Vitamin supplementation.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE PRURITUS (itchy break out by corner of her eye), PRURITUS (itchy), INFLAMMATION (Bumps on both areas that are raised), VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Within the last 3 weeks have what appears to be "insect bites"). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, EYE PRURITUS (itchy break out by corner of her eye), PRURITUS (itchy), INFLAMMATION (Bumps on both areas that are raised), VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Within the last 3 weeks have what appears to be "insect bites") outcome was unknown.            Patient took blood thinner and injection for macular degeneration as concomitant medications and doesn't know whether insect bites are related to vaccine or if antibodies are wearing off.   This case was linked to MOD-2021-297651 (Patient Link).
Client's stated date of birth on paperwork was 05/01/2009 and age stated was 12. Nurse asked client how old she was while talking over paperwork with client. Client stated she was 12 years old. First dose of Pfizer vaccine was given. Mother went to the vehicle while client waited the 15 minutes required after vaccination. began to input vaccine into OSIIS and noticed date of birth was actually 05/01/2010 making client 11 years old instead of 12. AA confirmed date of birth. All dates showed the client's birthday and 11 years old. The client was asked to get her mother from the car and the mother was then asked to provide proof of age/birthdate for the client. She stated she did not have anything on her and that she had just recently moved so she would go and try to find something and bring it back. She never came back.
pt recv vax; bumpy red rash around inject bite; itching; rxn happened w/ both hep B vax;
I am very sensitive to everything and typically get a reaction to the flu shot for a day or two.  With this shot, I woke up burning up and then ran fever.  I had diarrhea.  But, the illness only lasted 24 hours from onset.
Patient was scheduled for an appointment on 4/7/21 which was a second dose Pfizer Covid 19 vaccine clinic. Patient was checked in and given Pfizer vaccine. Afterward noted that patients first dose of vaccine had been Moderna given on 3/19/21. Therefore patient should have been scheduled for and received a second Moderna vaccine on or after 4/16/21, Reported to  team leader,  who spoke with patient and will follow up re: further actions.
06/20/02 Pt presents to clinic with right leg, 3 x3 cm area, redness, swelling & 101 .9 rectal fever. Diagnosis: Local reaction of DTaP right leg with fever. Treatment: Keflex x 7 days: Benadryl
Within 3hrs of having the Moderna shot, my left arm began swelling from the injection site. It is currently an inflamed swollen area 3 inches across and 2 inches from top to bottom. It has continued to swell and grow since I received my shot despite taking antihistamines and icing the area.
SIRVA diagnosis for ongoing nerve and muscle pain, inflammation in left shoulder and arm since injection of 8-May-2023
Patient fainted briefly for 5 seconds immediately after vaccine administration and later reported headache/nausea.
This spontaneous report was received from a male patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported. On an unknown date, the patient received a second dose of therapy with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, lot number, expiry date, anatomical location and route of administration were not provided); and he had problems (unevaluable event). The outcome of unevaluable event and the causal relationship between zoster vaccine live (ZOSTAVAX) and the aforementioned event were not reported.
Patient had a flu shot on 10-29-14 and the next day he noticed a fluid filled blister at the injection site. He states the blister burst the next day causing a small open area at site. He states the area itches and all over his body as well. He states he washed the area with warm soapy water and placed a Band-Aid at the site.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 01-JAN-2009, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-FEB-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed prednisone and valacyclovir for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
booster; it hurts to move my arm; Slight headache; Nausea; My shoulders been red and swollen; My shoulders been red and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FE3592) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for hypertension; MONTELUKAST; SYMBICORT. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 12Nov2021, outcome "unknown", described as "it hurts to move my arm"; HEADACHE (non-serious) with onset 12Nov2021, outcome "unknown", described as "Slight headache"; NAUSEA (non-serious) with onset 12Nov2021, outcome "unknown", described as "Nausea"; JOINT SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "unknown" and all described as "My shoulders been red and swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, headache, nausea, joint swelling, erythema.  Additional information: The patient stated she was reading her paper work and it said if she had any reactions she should call Pfizer Drug Safety. She got her shot about 09:30 on Friday morning at her medical Center and her shoulders been red and swollen since then, sometime it hurts to move her arm. She had a slight headache and little bit of nausea. Treatment, she stated she put some ice on it and took an allergy pill.  Follow-up attempts are completed. No further information is expected.
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document was received. Reporter details and patient details was updated. On 08-Jun-2022: Upon internal review on 15-Jun-2022, significant correction was performed. On 08-Jun-2022 case became valid but missed to tick the significant check box. Hence correction was performed to tick the significant check box for report submission.
Three days post vax, the pt experienced a high fever that lasted two days and then subsided. Eleven days post vax, the pt developed a maculopapular rash over most of her body. The pt sought medical attention and was treated with Zithromax.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 27-NOV-2013 the patient was vaccinated with VARIVAX (Merck). Nurse practitioner reports that a patient was inadvertently given VARIVAX (Merck) instead of ZOSTAVAX today. The patient will be given a dose of ZOSTAVAX today. No adverse effect was reported. No other information provided. Additional information has been requested.