chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not feeling good; Has lot of mucus; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good) and RHINORRHOEA (Has lot of mucus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced MALAISE (Not feeling good) and RHINORRHOEA (Has lot of mucus). At the time of the report, MALAISE (Not feeling good) and RHINORRHOEA (Has lot of mucus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
2nd COVID dose: Pt has slightly raised red strip (approx. 3" wide x 1' high) across arm UNDER location of injection sight. Looked a bit like a spider bite. Reporting, as it appeared 2 days after vaccination and on same arm. Does not itch, but hurts when touched by pt. Otherwise, she feels fine. No reaction to first dose.
Tinnitus started within 12 hours.  Has been constant 24/7 since 1/21/21. It feels like it is mostly on the left side of my head.
Initial and follow-up information has been received from a registered nurse concerning a 48 year old female licensed practical nurse who on an unspecified date "squirted" Zostavax in her eye when she was drawing it up. The patient's eye was washed out. The patient's only reaction was redness. There was no product quality complaint involved. No further information was available. Additional information is not expected.
Sugar levels went quite high and then would go low.  It was hard to keep the level steady for almost 10 days after the vaccine administered.  Now keeping better pace.
Patient was diagnosed with COVID-19 on 6/13/2021 and subsequently died on 6/17/2021. Patient was considered to be fully vaccinated as of 3/24/2021 having received both doses of Pfizer.
Patient reports of redness and inflammation of the site of injection.  Says that the right upper arm up to shoulder was swollen.  She contacted primary care physician and pharmacy to have them aware.  Took benadryl and applied cold compress to reaction.  Dr. says he still recommends getting the second dose with caution with benadryl for she may have a sensitivity to the vaccine.  The reaction went away later that day or the next day.  She states it did take a while for it to go down on its own but the benadryl helped.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Headache-Medium
lumps all over my body- chest, arms, thighs, legs, breasts, burning sensation, chest pain and palpitation
pain in her shoulder; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in her shoulder on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-MAR-2018, 31-MAY-2018 and 31-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# M022173 and expiration date 15-MAR-2019; lot# N028258 and expiration date 30-MAY-2019; lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis, respectively. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
On February 6, 2021, my arm was extremely itchy, how to the touch and very swollen. I placed cold compresses on it to help subside the itchiness and swelling. This lasted approximately 4 days of extreme itchiness and swelling. I did not go to a doctor I just was very deligent about not scratching and applying cold compresses.
Narrative:  Patient with hx of colon cancer with mets tot lung in treatment. Received First Moderna vaccine on 3/17/2021. Pt went to ER 3/30/2021 after approx 2 weeks of shortness of breath with exertion. He was diagnosed with CHF and Right Pleural effusion. On 4/28/2021 he got the 2nd Moderna Vaccine, on 5/1/2021 he returned to ER in worsening heart failure. Died on 5/2/2021
break out in shingles; Initial information regarding an unsolicited valid non-serious case from a consumer (patient) via social media on 07-Dec-2020.  This case involves an unknown demography patient who got INFLUENZA VACCINE and broke out in shingles (Herpes zoster).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) following vaccination patient broke out in shingles (Herpes zoster).  Case details- every time patient get the flu shot the patient broke out in Shingles, would rather had flu.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was Unknown for Herpes zoster.  There will be no information available regarding batch number for the case.
10OCT91 mom called today stating pt had rxn to MMR 2 hrs p/receiving vax; mom states pt had generalized swelling & redness & also restricted breathing; sx left p/2 doses of DPH;
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011220A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-407136 (Patient Link).
BAD STOMACH CRAMPS; This spontaneous case report was received from a consumer (PVX2019-324) on 05-Feb-2019. The report describes a 34-year-old female consumer who experienced bad stomach cramps following the intake of Vivotif for an unknown indication.  The consumer's concurrent medical condition includes hypothyroid.  The consumer's concomitant medication included Vitamin B12 (cobalamin), Vitamin B2 (riboflavin), Vitamin D (ergocalciferol), magnesium oxide, and other medication for hypothyroid.  It was reported that the consumer took the first dose of Vivotif on Saturday (02-Feb-2019) and started having stomach cramps 14 to 15 hours later for the rest of the day. She took second dose on 04-Feb-2019. She did not have diarrhea but felt like she had to go to the bathroom every 20 to 30 minutes. She was not exposed to any atypical food or chemicals and had no relevant medical conditions.   The action taken with Vivotif with respect to the event bad stomach cramps was unknown.  The clinical outcome of the event bad stomach cramps was unknown.  Company's Comment: in this case, a 34-year-old female consumer who had bad stomach cramps following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: in this case, a 34-year-old female consumer who had bad stomach cramps following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then radiated across her shoulders.  Pt has wheezing which she reports is normal for her.  BP is elevated, pt reporting not taking her meds this a.m.  MD ordered breathing treatment of albuterol and metoprolol 50mg po for BP of 175/101.  HR 68 SR 100%SpO2/RA,RR=21, No Respiratory Distress Noted
I had to get on steroid medroln dose pack and hydrocodone because I was having excrutiating pain in my back. I was referred to an orthopedic doctor.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 1:35 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.  The patient did not have any adverse events and did not require any medical attention. No problems reported from the patient.
Discussion with patient about booster doses and she revealed that after her 2nd Moderna vaccine on 4/2/21 she developed a fever of 99-100', felt "woozy", was short of breath, and her BP was very high. She presented to the  Medical Center-  ER at approximately 2pm on 04/04/21 where she was seen by Dr.   She had a CT Scan and EKG.  They found 2 upper lobe pulmonary embolisms.  She reports she does have Factor V.  She is now on Coumadin.
Not sure when it began but 24 hours later looked at arm because had ache at site of injection. It hurt like if vax went into armpit. Line of hives, size of a quarter, went from vax site to lymph node in armpit. It was swollen but not itchy. Put cold compress and took BENADRYL. On 10/9 went to doctor who asked her to come back if did not get better. Got better by Saturday, hives were gone but armpit still ached. Since then also has redness and inflammation of gums. Went to dentist but she was not sure if related. Her last Pneumonia vax was on 2008 with no problems.
Swollen lymph node under armpit area..redness around site of vaccination, pain to touch on arm of injection, fatigue
Patient received the Flu vaccine for the previous season 2020-2021 by mistake. Patient was contacted to come back to the pharmacy to receive the vaccine for the current season 2021-2022. No adverse events reported.
Headache, Sedation, Myalgia, Fever, Skin Rash and Chills.
30 min after admin of vaxs, pt began coughing, broke out in urticarial rash all over body, severe pruritus.
Patient reported a red, itchy rash about 6 inches in diameter around the injection site starting the day after patient received vaccination. Patient reported adverse event to the pharmacy. Pharmacist recommended patient take BENADRYL if needed, but it is unclear if patient took BENADRYL or not. Six days following the vaccination, pharmacy contacted the patient and patient reported that the rash was receding and improving.
Developed pruritic scalp few hours after vaccine. Next day rash on chest and back. Rash is pruritic. Described as salmon colored, scaly, papules and patches on chest and back.
onsite swelling and redness; hot and cold sweats; Malaise/not feeling well; Dizziness; onsite swelling and redness; cold sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ZW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose:lot unknown/expiration date: unknown, No reaction with 1st shot.), administration date: 03Mar2021, when the patient was 86 years old, for covid-19 immunization, reaction(s): "no adverse event". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "onsite swelling and redness"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "hot and cold sweats"; MALAISE (non-serious), outcome "unknown", described as "Malaise/not feeling well"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; COLD SWEAT (non-serious), outcome "unknown", described as "cold sweat".  Additional information: Reporter wanted to know if the reported adverse reactions of the vaccine. Investigation Assessment: Not Provided.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a 71 year old retired white male with no known allergies or pertinent medical history who on 17-AUG-2007 was vaccinated in the left deltoid with a first dose of Zostavax (Lot# 656413/01477F). There was no illness at the time of vaccination. Subsequently on 24-AUG-07, the patient developed a couple lesions at the injection site after the vaccination. The pharmacist received a call from the patient's physician who had diagnosed the lesions as shingles. The patient's shingles persisted as of 27-AUG-2007. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the vaccine VZV strain. The sample of the lesion was collected on 28-AUG-2007. The sample was taken from a vesicle on the patient's left arm. PCR results were provided: the isolated virus was wild type VZV strain. An office visit on 29-AUG-07 indicated that the left arm shingles had more crusting and some pain. The physician prescribed 7 days of LYRICA. Follow up information from the physician indicated on 04-SEP-07 the patient had finished treatment with VALTREX and LYRICA. There was some pain and numbness. Additional information from the physician indicated that the lesions were pretty well healed. Some still crusted on the left arm, and pain if he hit his elbow on a hard surface, and some numbness. The patient declined more LYRICA. According to the reporter the patient recovered on 18-SEP-07. No further information was provided. On the initial office visit on 27-AUG-2007 there was on the left arm a rash consistent with shingles. Manufacturer and I.D. recommended treatment with VALTREX 1 gm three times a day by mouth for 7 days. On 29-AUG-2007 in the office it was noted the left arm shingles more crusting some pain. The treatment of 7 days of LYRICA was added. On 04-SEP-2007 after finishing treatment with VALTREX and LYRICA the patient complained of some pain and numbness. At the office visit of 18-SEP-2007 the lesions were pretty well healed, some still crusted on the left arm. There was pain if he hit his elbow on a hard surface and some numbness. More pregabalin was declined. Additional information is not expected. This is a consolidation of 2 reports concerning the same patient. It has been determined that WAES # 0708USA04950 is a duplicate of WAES # 0708USA04938. Therefore, WAES # 0708USA04938 is being deleted from our files and the reports consolidated into WAES # 0708USA04950.
Next morning 1/24/21 headache, malaise, nausea, some abdominal cramps, muscle pain, low grade fever 99.4, lasted all day and evening, symptoms less and resolving the next day 1/25/2021
pt devel hives on face, arms, & legs approx 2hr p/vax;mom took pt to MD who prescribed DPH;hives gone by 24JUL96;pt father has allergy to eggs;MD suggests pt see an allergist a/receiving the 2nd MMR;
(L) arm still hurts at site of Tdap (ADACEL) injection, 1 1/2 months later. Has not been using analgesics PO, but has been using topical lavender essential oil and "DEEP BLUE" liniment, to which she denies a reaction. Pain (L) shoulder 5-5/10 w/ lifting.
mild fever (101-102), chills, intermittent chest pain (she said it was likely related to muscle contractions due to chills), pulse ox 91-92, pulse 110,  finger bone ache. the following morning, vomited water, diarrhea  symptoms resolved over the next 2-3 days.
pt recvd vax & devel hives on abdo, sides of breast & huge patches on upper front thighs; lt side most bothered w/itchy hives gone @ 2300-2400; then returned in morning for breast; rash completely gone now;
24 hours after vaccination had intense headache which necessitated Advil. Also extreme fatigue.  48-72 hours later had continuous tachycardia with resting heart rate ~125-130 bpm. Also had recurring intense headaches during this time that lasted a couple of days.
COPD; anxiety is high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "disabled", start date: 1991 (ongoing), notes: disabled; "high blood pressure" (ongoing); "COPD" (ongoing); "she has started smoking again" (unspecified if ongoing), notes: she has started smoking again; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: NEURIVAS; OXYCODONE taken for anxiety. Past drug history included: Chantix, notes: starting Chantix in the "90s", has "used it many times" and it "worked". She specified taking Chantix and stopping it because of the way she felt when taking her coffee in the morning. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; ANXIETY (non-serious), outcome "unknown", described as "anxiety is high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety.  Additional Information: she mentioned she got the Pfizer virus shot and did not get the virus, states she has COPD. States her anxiety is high.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache; Light fever after 10 hours; This is a spontaneous report from a contactable consumer. This consumer reported for a 30-year-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine) via an unspecified route of administration on Mar2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 in Feb2021 for covid-19 immunization. The patient experienced headache on Mar2021 with outcome of unknown, light fever after 10 hours on Mar2021 with outcome of recovered.  Facility where the most recent COVID-19 vaccine was administered was unknown. It is unknown that the patient was receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Flu shot given 10/24 about 2 PM. No unusual sx noted until 8:30 AM after intense yoga. Pt felt over exerted, achy, fatigue, mild malaise. Sxs continued, not worsening, until 10/27/03. On 10/26, pt noted "burning" on left side of neck, "superficial". Pt noted a pain and ache from left neck down to injection site on left arm. Pt did not examine himself until 10/27/03 at 6 PM, he saw a scattered groupings of pin like pustules, raised. No bleeding. No discharge. More itching, less heat. Discussed case with MD, ruled out shingles.
Patient notes having diffuse itchiness shortly after receiving vaccine. No sensation of throat closure, chest pain, palpitations or SOB.  She was given 50mg IM Benadryl and monitored for an hour. Patient states symptoms have almost completely resolved.
Flutters of heart couple times day of vaccine Following day one or two By Friday woke w flutters and continued throughout day in Saturday  Had beef flutter free up until time of vaccine
03/25/03 PM: Child seen at ER for vaccine injection site complaints: left deltoid - large painful area of redness, swelling and vesicular type rash. Rx - Keflex. 03/27/03: Mild erythema and mild induration 3 1/4" x 2 1/2" area of dry, superficial layer of skin ready to flake off. No vesicles, no pustules, no ulcers. Resolving very well. Completed the 3 day course of Keflex 3/26/03-3/28/03. Recheck 04/01/03: only mild superficial peeling of left deltoid area.
Came into office 08/08/02, Left leg swollen  red, warm to touch, very hard warm  induration - 5 inches, Swelling started on day after immunizations @ 6 pm started (?)  QID x 1 week, warm compresses
Tremor of hands; Aching in knees; Fever; Headache; This spontaneous case was reported by a physician and describes the occurrence of TREMOR (Tremor of hands), ARTHRALGIA (Aching in knees), PYREXIA (Fever) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Smoker (Tobacco use/cigarettes  one packet daily) since 1973.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremor of hands), ARTHRALGIA (Aching in knees), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, TREMOR (Tremor of hands), ARTHRALGIA (Aching in knees), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information was received on 24 May 2021 contains non significant information.