chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt got PNEUMOVAX 23 on 6/26. Been sore on her right arm and starting a swelling redness with a stripe of 2 inches.
pain arm in the injection arm (lasted 2 days); swollen and pain armpit just started today
Patient received the 2nd dose five weeks after the 1st dose, instead of waiting the 2 to 6 month period.
Uveitis; pain around my left eye and the eye ball; eye ball was also red; Sore arm; A spontaneous report (United States) was received from a consumer who was also a 69-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  a sore arm, pain around her left eye and eye ball, eye red, and uveitis.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, escitalopram oxalate and omeprazole.  On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm shoulder deltoid muscle for prophylaxis of COVID-19 infection.   On date 16 Feb 2021, the patient had a sore arm, pain around her left eye and eye ball and eye was red. The patient experienced a condition called uveitis. Treatment for the event included Pred-Forte eye drops.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events is unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
pt had alot of crying immed p/DTP/HIB for about 3 hrs; sometime holding would help temporarily;
Dyspnea with throat-clearing and frequent cough, present all day long and when she wakes from sleep for other reasons (e.g. to use the bathroom), but not interfering with sleep.  Also, missed menses (at time of reporting, menses are 10 days late) in a patient who is normally "like clockwork" and not at risk of pregnancy.
Developed rash on body extending from chest down to ankles two days after vaccination, along with body ache and low fever. Rash is scaly, moderately itchy and is in round patches. Initial diagnosis from dermatologist is pityriasis rosea for some areas of the rash. Skin biopsy performed on 11/07/2019. Differentials ordered were to rule out tinea, PLEVA, ID (autoimmune eczema), and psoriasis. Biopsy results will be available to reporter on 11/15/2019.
He got the vaccine and within an hour of the vaccine he got this headache behind the bone on his forehead he is getting spasms of some sort, perhaps in the sinus cavity.   The headache is fairly constant, but the spasms come about every 10 minutes and are still continuing today, 4/8/21.   No reaction at the injection site itself.   He had also lightheadedness similar to the reaction from the first injection, but the spasms are bothersome and have not gone away.
5 days prior to hosp, pt tested positive for COVID; admitted with increasing SOB; taking Medrol Dosepak and antibiotic; O2 @ 6L via NC initially; progressed to BiPAP and eventually required intubation; experienced hypotension and A Fib; pt was extubated in palliative manner; she died in the hosp
Heaviness on her chest; Neck is itchy; Random joint pain; Sore joint; Sore knees; Sore ankles; Irregular "splatches" or patches of discoloration on both of her upper arms, but definitely more so on her left arm, where the vaccine was injected; Sore throat; Redness on her neck; Redness on her chest; Rash on her neck / neck is slightly rashy; Rash on her chest; Lightly numb tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Lightly numb tongue), VACCINATION SITE DISCOLOURATION (Irregular "splatches" or patches of discoloration on both of her upper arms, but definitely more so on her left arm, where the vaccine was injected), OROPHARYNGEAL PAIN (Sore throat), CHEST DISCOMFORT (Heaviness on her chest) and ERYTHEMA (Redness on her neck) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter and concomitant drugs are provided.  Concomitant products included PROGESTERONE for Birth control pill.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Lightly numb tongue), OROPHARYNGEAL PAIN (Sore throat) and ERYTHEMA (Redness on her chest). 25-Jan-2021, the patient experienced ERYTHEMA (Redness on her neck), RASH (Rash on her neck / neck is slightly rashy) and RASH (Rash on her chest). On 26-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Irregular "splatches" or patches of discoloration on both of her upper arms, but definitely more so on her left arm, where the vaccine was injected), ARTHRALGIA (Sore joint), ARTHRALGIA (Sore knees) and ARTHRALGIA (Sore ankles). On an unknown date, the patient experienced CHEST DISCOMFORT (Heaviness on her chest), PRURITUS (Neck is itchy) and ARTHRALGIA (Random joint pain). At the time of the report, HYPOAESTHESIA ORAL (Lightly numb tongue), VACCINATION SITE DISCOLOURATION (Irregular "splatches" or patches of discoloration on both of her upper arms, but definitely more so on her left arm, where the vaccine was injected), OROPHARYNGEAL PAIN (Sore throat), CHEST DISCOMFORT (Heaviness on her chest), ERYTHEMA (Redness on her neck), ERYTHEMA (Redness on her chest), PRURITUS (Neck is itchy), ARTHRALGIA (Sore joint), ARTHRALGIA (Sore knees), ARTHRALGIA (Sore ankles), ARTHRALGIA (Random joint pain), RASH (Rash on her neck / neck is slightly rashy) and RASH (Rash on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included diphenhydramine (Benadryl)
Received PHEUMOVAX on 9/21/10 declined fever, body ache with red area around and swelling at injection site on 9/23/10. Seen on 9/23/10. Temp 100 degrees F. 8 x 7 cm area of erythema with induration and tenderness on (L) arm
22MAR96 tiny maculopapular rash that started @ waist & inc to chest;25MAR96 hive-like rash on neck, back, behind knees appears @ noc only;tx DPH, calamine lotion, baking soda baths;27MAR96 face flushed & raised/blotchy red, itchy patches;
Every time I have received the vaccine I have started my period shortly after. I do not take the placebos for my birth control as my periods are very painful. Both times I had not missed a day on my birth control.  I just thought this was information that may be useful for you.
supraclavicular lymph node swelling/tenderness to L supraclavicular lymph node; watchful waiting and taking NSAIDs OTC recommended for now. if no improvement, will proceed w/ CBC and u/s of neck and consider possible abd xray
Pt called today stating her arm has been swelling, itching, red (size of softball) and warm to touch. No temp taken. Since receiving shot. Dr advised BENADRYL as nothing tried at this point. Sores on lips but gone now.
swelling to head; swelling to left back knee; swelling to left hip; swelling to left foot; hit  head; bump on back of the head; fainted; sleepiness; left arm pain; acute body aches; fatigue; flu like symptoms; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip.  The patient's medical history was not provided. Concomitant medications included warfarin (5mg, 7.5mg).   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the right arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient experienced flu like symptoms which lasted 8 hours. On 02 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient reported experiencing acute body aches, sleepiness, fatigue, and left arm pain.  On 03 Feb 2021, approximately at 3am, the patient fainted and was out for 10-15 mins. She is on blood thinner and is concerned about a cerebral bleed because she hit her head.   On an unspecified date, the patient was experiencing swelling of left back knee, swelling of left foot, swelling of left hip and swelling of head. Treatment included paracetamol and ondansetron.  Action taken with mRNA-1273 was not applicable as the subject had already received both scheduled doses.  The events flu like symptom was resolved on 05 Feb 2021.    The outcome for the events, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip were unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported event of swelling of the head and mRNA-1273 use ids assessed as not related as swelling was due to subject hitting her head. Based on temporal association between the other reported events and mRNA-1273 use, a causal relationship cannot be excluded.
Had rt. arm swollen, itchy and red. It happened after she got Tdap vaccine 5 days ago. Started at the injection site then getting worse. No fever. Treatment: Hydroxyzine long TID PRN x 3 day ice compress to wound.
This spontaneous report was received from a registered Nurse refers to a patient of unknown age and gender. Since 02-JUN-2014, one dose of PROQUAD (Merck) was not stored properly. On an unknown date in 2014, the patient was vaccinated with PROQUAD (Merck) (dose, duration and indication were not reported). No adverse effects were noted. Additional information has been requested.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown. Not Provided          No concomitant medications were provided.  On an unknown date, the patient administered the solution of injection of Skyrizi (risankizumab) with dose of 150 milligram by subcutaneous route. The patient had reported the liquid was cloudy of Skyrizi.  No treatment medications were provided.
FEVER OF 104 RECTAL WITH COUGH, NASAL DISCHARGE, VOMITING.  BROUGHT CHILD TO ER.  WAS SEEN BY PCM NEXT MORNING, WITH TEMP DOWN TO 99 AXILLARY.  NO FURTHER TREATMENT NECESSARY.
pt recv vax & exp induration, erythema & itching;ER or MD visit was required;pt sx were treated w/ice & antihistamines PRN;sx resolved as of 29APR96;
Very dry/sore throat, intermittent lose of voice, low-grade fever, body shivering/chills, pressure/tension headache, hard spot at injection site, joint pain/stiffness, ringing of ears; all for around 40 hours and slowly clearing up. *Tylenol, ibuprofen, cold/flu meds had minimal effect.
Sleeping problems; head congestion and mild nasal drippage; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeping problems), NASAL CONGESTION (head congestion and mild nasal drippage) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (Sleeping problems), NASAL CONGESTION (head congestion and mild nasal drippage) and FATIGUE (Fatigue). At the time of the report, INSOMNIA (Sleeping problems) had resolved and NASAL CONGESTION (head congestion and mild nasal drippage) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant medications or treatment details were reported.  Action taken with mRNA-1273 vaccine with the events was not applicable  Patient reported that it was a chronic problem, although the head congestion was more severe than normal, and the nasal drippage couldn't have been related to the vaccine.  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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Reporter's causality for the events were updated. Severity of the event (head congestion and mild nasal drippage) was updated.; 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.
p/immun pt felt dizzy & was some what pale; pt continued to feel dizzy & upset about the vax; pt out of school 1245PM went to ER on the evening 31MAR92 for anxiety rxn to vax;
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, one intramuscular dose, for prophylaxis (with either lot # N014464, expiry date: 31-JAN-2020; lot# N020352, expiry date: 10-APR-2020; or N014464, expiry date: 19-DEC-2019). The vaccines underwent a temperature of 47 Fahrenheit degrees (°F) to 77°F (50.7°F), by a time frame of 1 hour 30 minutes, with no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA008096: US-009507513-1801USA008097:
Complaints of numbness in both arms (vax given in left deltoid), nausea, numbness in mouth, tightness in chest, not sure if he has a fever but feels hot. On 3/16, seen in ER and referred to family MD.
got sick; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media along with live follow up on 07-Dec-2020 (both processed together).  This case involves an adult patient with an unknown demographics, who got sick (illness), while being vaccinated with INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2019 (reported as last year) (latency: unknown) after starting the suspect vaccine therapy, the patient got sick (illness) that week.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, headache, pain at injection site, fatigue, nausea and dizziness. Retired early and got up during night with GI distress. Before getting back to bed passed out hitting my head and lower back on a metal door frame. I did not recall this but found myself back in bed partially dressed.  Husband found a hallway Persian rug (heavy) displaced in AM.  Slept  until 3PM following day and awoke with lg. bump on head and pain in sacral area. Self treated with ice to painful areas plus Tylenol 500 mg. After 6 days with no relief saw orthopedist who took x-rays and diagnosed bruise to sacrum and post-concussive syndrome. Offered visit to neurologist which was declined as cognitive ability seemed intact,  Treated with ice to sacrum 20 min. x 5 daily, Tylenol 1000 mg. and Aleve 1 q 12h x 5 days. Sx continued for 8 days requiring Tylenol, Aleve, iceand/or heat. Feeling less pain by Day 20 post vaccine.
Moderna COVID-19 Vaccine EUA Saturday night 1/30, one week after receiving the vaccine, I noticed the site of the injection felt warm to the touch. The next morning, 1/31, I noticed the area around the injection site was red, warm to the touch, and hurt when pressure was applied. The next morning, 2/1, the size of the red area increased slightly and it was still warm and hurt when pressure was applied. This afternoon, 2/1, I'm noticing feeling warmer and sweating more than usual. I'm not sure if that is related but I don't have another explanation for it.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 29-OCT-2009, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-NOV-2015, the patient was treated at a medical office, for the onset of a rash, which was diagnosed as shingles. The patient was prescribed VALTREX and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Tachycardia. Febrile seizure day 7 after vaccination. Temperature >101 for 4 days, beginning on day 4 from vaccination.
Rash on left arm, close to injection site.  However, this happened one week after receiving the Modern vaccine.
This spontaneous report was received from a nurse referring to a male patient of unknown age who on 28-JUL-2014, was vaccinated with a dose of improperly stored M-M-R II (lot# not reported). No adverse effects reported. No further details provided. Additional information is not expected.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4261477-00 (RA). A 45-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1139577) at unknown (citrate free) and second regimen (Lot number: 1157581), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BENIGN BREAST NEOPLASM (medically significant) with onset Jan2022, outcome "unknown", described as "two benign lumps in the right breast"; VACCINATION SITE PAIN (non-serious), outcome "unknown". The action taken for adalimumab was unknown. Clinical course: In Jan2022. Patient had two benign lumps in right breast. On 04Feb2022, Surgery was performed to remove lump which were benign. She had sore arm after Covid vaccine. It was the unknown if the patient was enrolled in a Covid-19 vaccine trial. Regulatory Authority opinion is that the events of two benign lumps in right breast is not assessable. Regulatory Authority opinion is that there is no reasonable possibility that the event of sore arm after vaccines is related Humira (Adalimumab). The reporter's assessment of the causal relationship of "two benign lumps in the right breast" and "vaccination site pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for Humira(Adalimumab): The reporter's causality for the event(s) of two benign lumps in right breast and sore arm after vaccines was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the events benign breast neoplasm, vaccination site pain and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
25 mins. after injection sore right gland, an hour and half later a slight headache and left shoulder/middle of back slight pain . By evening bilateral kidney pain back pain, gland still sore and some chills without fever.  after midnight bad back discomfort, skin sensation and have had weird dreams since first vaccine and increased with the second which im still having as of last night  By Tuesday-day two the pain and discomfort was all on my left side of chest and back from the side of my body to the center of my back -which is the side of my injection, skin was so sensitive to touch even my breast hurt and right gland pain,  chills returned that night, Wednesday was the same that evening had the worse chills ever but no fever and then by Thursday most everything subsided except for the arm and shoulder  pain from the injection which lasted 7 days
Information has been received from a nurse concerning a "70 - 80 year old" female with "unknown allergies" and is a patient in a rehabilitation hospital, who on 13-JUN-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (Lot # 657145/1226U; site unreported). It is unknown if this was the patient's first vaccination with PNUEMOVAX. On an unspecified date, the patient developed an injection site reaction. The reaction was bright red, raised, warm to touch area of 3 - 6 cm at the injection site. The patient sought medical treatment by seeing the nurse and the injection site reaction was being treated with ice. The patient outcome was not reported. No additional information was provided. This is one of three reports from the same reporter. Additional information has been requested.
Stomach pain, severe injection site soreness, orange urine, constant diarrhea, general malaise x12 days.
headache on day 2 with low energy and felt lethargic   Also felt hot all night like I couldn?t cool off.   Woke up with rash all over body. Mostly around neck and right chest/armpit area. Also speed to arms and legs but to a lesser degree.
Dizzy, near syncopal episode. Became Bradycardic, hypotensive, diaphoretic. Symptoms resolved.