chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse reaction or side effect: none; every 5 years since 2005; This spontaneous report was received from a consumer, lawyer and a physician referring a female patient of unknown age. The pt's concomitant medications included spironolactone (ALDACTONE). The patient's concurrent conditions included failure congestive, orthostatic hypotension, osteoporosis, gastrooesophageal reflux disease (GERD), hypothyroidism, arteriosclerosis coronary artery, depression, anxiety and hypertension. The patient's historical conditions included chicken pox. The patient was an ex-tobacco user.   Since an unspecified date 2005, the patient has been vaccinated by a physician with pneumococcal vaccine (manufacturer unknown) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis every 5 years (inappropriate schedule of product administration) without experiencing any adverse reactions or side effects.  On an unspecified date in 2013, the pt experienced blindness, fall and vaccination failure; on 27-AUG-2013, the pt experienced injury corneal and herpes zoster; and on an unspecified day in October 2013, the pt experienced post herpetic neuralgia (captured in MARRS# 1812USA008155).; Sender's Comments:  US-009507513-1812USA008155:
2 weeks after vaccination developed lymphadenopathy in neck which resolved in a few weeks.  Also developed dermatographism and chronic urticaria which is on going.
36 hours after my shot I experience a mild frontal headache; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EER8730) via an unspecified route of administration in the right arm on 25Apr2021 at 12:30 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. On 26Apr2021 at 00:00, 36 hours after shot, the patient experienced mild frontal headache which lasted most of the day until after dinner. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild frontal headache was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This report concerns twin patients that received DTaP, IPV, and MMR vaccines and developed swelling arm from elbow to axilla and fever of 102 deg F. They were admitted to hospital. History of "infections, boils, etc." No other patients experienced this reaction. A follow up report received 6/6/2002 adds: Diagnosis was cellulitis.
Rash began under upper left arm (same arm as injection) several hours  after injection, then spread to other arm, low back, buttocks, legs. RASH - pinpoint, red,  like sandpaper, ITCHY, seems to be worse medially.
Patient reported experiencing right arm soreness ever since she got her flu shot. Per patient, doctor said she might develop tendonitis. Patient suspected that the pharmacist who administered the vaccine might have injected a little high up on the deltoid area but she admitted she had been carrying her twins which might have worsen the symptom.
Lightheaded, hypotensive, Tingling  / cold feeling up the side of my neck, into my face and down the other side of my neck. Feeling of impending doom.
minimal pain in left ear and throat.  A lot of pain, 7/10, in my right axillary area (lymph node pain)
Client received a 5-11 Pfizer immunization instead of Pfizer 12+ vaccine. Medical director and department do not recommend a revaccination only completion of series.
At 1555 patient was administered AFLURIA in (R) arm. Patient tolerated vaccine well and was advised to wait 15 min in waiting area. At 1608 patient was not feeling well developed rash in arms and chest and tongue was swollen; Staff administered epi at 1610, ZYRTEC at 1614 and BENADRYL at 1616 then transported to urgent care.
Sudden sharp pain in the back of my leg when walking went to the doctor and got a steroid shot, next time a sudden sharp pain to where I could not walk. A Ct was performed diagnosis was sciatica. MRI was done as well.
Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
Client received the 1st COVID vaccine Pfizer Lot#EW0185 on 05/22/21 at 3:29 PM. The client presents to the vaccination site today for her 2nd COVID Pfizer vaccine. The following information was obtained with use of a Spanish-English interpreter. The client alerted RN that she "felt like she couldn't breath in a mask" 24 hours after receiving the vaccine while the client was at work. The client states she works in a nursery, where the temperature is usually increased. One RN alerted another RN who responded. The client states she left work, removed her mask, and her symptoms resolved. She states she had eaten and consumed water on the day the symptoms began. The client denied any other signs of anaphylaxis at the time of the initial incident. No medication was administered at the time of the incident. They did not follow up with any medical care providers after developing the symptoms. The client denies any chronic conditions, or current medications. The client has no known allergies. She denies a history of anxiety or shortness of breath while wearing a mask. Vitals obtained by EMT on 06/12/21 at 3:42 were as follows: BP 128/82, HR 62, RR 16. RN submitted a consult to the medical team via text message. Approval was received from PHN via text message. RN provided education regarding s/s of anaphylaxis, to report any symptoms during observation to EMT, to follow up with PCP if the client develops any symptoms post vaccination, when to seek EMS, to consume water prior to vaccination and after, and V-safe. The client was also instructed to wait 30 minutes in the observation period. The client voiced understanding of this. Client received the 2nd COVID vaccine Pfizer Lot#EW0187 on 06/12/21 at approximately 3:55 PM. The client waited in the observation area for 15 minutes and left the premises AMA. The client received the vaccination area without complication and did not alert the EMTs of any symptoms during her observation period.
Moderna vaccines that were expired past the 30 days and given to 24 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccines that were expired past the 30 days and given to 24 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011d21a exp11-27-2021.) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccines that were expired past the 30 days and given to 24 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccines that were expired past the 30 days and given to 24 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Information has been received from a nurse concerning a 12 month old male who on 24-APR-2007 was vaccinated with ProQuad (Lot #657264/0294U). On 03-MAY-2007 the patient experienced a fever over 101F. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Dosing series of PENTACEL was skipped and another MEDICINE was given with no reported AE; Initial information received on 18-Apr-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 15 months old and unknown gender patient who had dosing series of pentacel was skipped and another medicine was given with no reported ae after receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection (strength, expiration date and lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event dosing series of pentacel was skipped and another medicine was given with no reported ae (inappropriate schedule of product administration) (unknown latency).  Action taken was not applicable.  Outcome: Unknown for the event dosing series of pentacel was skipped and another medicine was given with no reported ae.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
heart rate had plummeted to 38 BPM; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (heart rate had plummeted to 38 BPM) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031321A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and VITAMIN COMPLEX for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-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 HEART RATE DECREASED (heart rate had plummeted to 38 BPM). At the time of the report, HEART RATE DECREASED (heart rate had plummeted to 38 BPM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 38 (Low) Decreased to 38 BPM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported   This case was linked to MOD-2021-418614 (Patient Link).
pain in his left hip radiating down the leg; The pain started on Sunday and got worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse). At the time of the report, ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Reddened, painful, itchy area at injection site the size of a hockey puck.
First evening, weak, no appetite, unable to move, fatigue for full 48 hours. Day 7 - rash, diagnosed as contact dermatitis, showed up on arms, stomach, legs, weeping wounds. Still experiencing fatigue at day 10.
Patient abducted left arm up above head, turned head to left with eyes to left deviation, and start shaking in a tonic clonic fashion.  The entire episode lasted about 2 minutes.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, since 17-SEP-2014, unspecified number of GARDASIL doses (dose, route and lot number not provided) had been administered to patients. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 27 February 2014. A female patient (no information was provided regarding the patient) had received a dose of FLUZONE HD during pregnancy on an unspecified and no adverse event was reported, i.e. wrong vaccine administered. List of documents held by sender: none.
This spontaneous report as received from a physician refers to a 18 year old female patient. Patient's pertinent medical history included, Herpes Type 1 positive, Genital Type 1 outbreaks recurrent, Bipolar and Migraine which were diagnosed on December 2016. Drug reactions/ allergies were reported as none. On 18-APR-2017 the patient was vaccinated with first dose of GARDASIL 9 (lot # M011117, expiry date 07-DEC -2017) intramuscularly in the right deltoid for the indication of age and risk. Concomitant therapies included ABILIFY, clonidine and vitamin d (unspecified). On 18-APR-2017, the patient developed very bad chest rash. On 21-APR-2017 the patient experienced nausea, diarrhoea and vomiting. The second dose of GARDASIL 9 was never received. Patient received an unspecified treatment for the events. No medical attention was sought for the events. Lab tests were reported as none. The outcome of rash, diarrhoea, vomiting and nausea was reported as recovered/resolved. Causality assessment was not provided. No product quality complaint was filed. This is one of the several reports received from the same reporter.
Immediate ache and stiffness at injection site that is getting worse after 3 days. After 3 days all muscles in both arms and in my torso are aching. Impossible to turn over in bed due to stiffness.
pt was treated for OM on 29APR93 w/Amoxicillin; was having loose BM's & evening vomiting on 10MAY93; nl exam; immun given; about 33 hrs later was found to be pale & sweaty, poorly responsive, eye rolling about, was taken to hosp ER;
Employee states she started to experience fatigue, positional vertigo within 24 hours of vaccination. Continued to feel dizzy and was seen by her PMD. Employee states doctor feels that the "flu vaccine exacerbated previous condition of vertigo." Employee was diagnosed with HTN (consistant with finding in exam by NP in employee health office: see section 9 of this form) and was given a Rx for Hydrochlorothiazide.
Injection site redness and soreness. Original injection site was fine after vaccine was administered but became red and sore a few weeks ago.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 26-NOV-2014, the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03K20A?) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Received vaccine around 8am. At 10am noticed very minor aches. By noon noticed aches progressing but still minor. By 4pm noticed aches and fatigue. By 8pm had body aches, malaise, headache, and pain at injection site. Middle of the night had fever of 101F and body aches/muscle pain, chills, headache. Fever was gone by morning (99F at 9:40am on 01/29/2021). Body aches are slowly going away.
Pt was given FLULAVAL on 10/14/2010 on 10/15/2010 started w. hives around vaccine site on right deltoid, hives then spread to rest of body.
muscles tigthened up; joints tightened up; could barely walk and get up from bed; bumps/welts under her skin where the veins are; in serious pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain). At the time of the report, MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD-2021-273412 (Patient Link).; 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.
This spontaneous report was received from a nurse and refers to a 11 year old female patient. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. On 31-AUG-2017, the patient was vaccinated with M-M-R II for prophylaxis (dose, frequency, route of administration, lot #, expiration date were not reported). And then, on 14-SEP-2017, the patient was vaccinated with VARIVAX for prophylaxis (dose, frequency, route of administration, lot #, expiration date were not reported). The vaccines was administered separately within 30 days (4 weeks). No adverse effects were reported.
pt recv vax & devel swelling & tenderness of entire rt shoulder;a knot was noted @ the inj site;the swelling, tenderness & knot resolved p/3-4 days;1DEC97 (32 days post vax) rt shoulder became painful & warm;dx sterile abscess;
Bruise on back formed, hard to bend over, spinal pain.. chills, muscle aches
Increased blood pressure,  Right sided weakness, Confusion,  Patient complains of weakness.  Patient still in Hospital
Case number PHEH2014US007740 is an initial spontaneous report received from a nurse on 16 Apr 2014 with a follow up information received from a nurse on 05 Jun 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. Her vaccination history included administration of MENVEO (batch number: not reported) on unknown dates which were well tolerated. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: M12094), reconstituted with a sterile diluent instead of MenCYW 135 liquid component intramuscularly at a dose of 1 cc on 16 Apr 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution). Follow up information received from a nurse on 05 Jun 2014: Patient demographics (height and weight) and vaccination history updated.
Blister at injection site.  Still scabbed over 1 month later.  Soreness in arm muscle.
presented to ED with c/o SOB, cough, fever, chills, abdominal pain; on O2 @ 4LPM @ baseline for COPD; placed on nonrebreather; tested positive for COVID; pt's condition declined; was intubated; condition continued to decline and pt expired in the hospital
Rash over (R) shoulder x1 day, erythematous, urticarial. No fever.
On day 7 after the vaccine, I experienced a large knot in my arm near the injection and itching around the area about 1 inch in diameter.  some raised skin around the injection was also noticed, like hives.  No other side effects were noticed with this development.
RESIDENT UNABLE TO SIT UPRIGHT IN CHAIR, NOTED FACIAL DROOP, SLURRING OF WORDS AND MUBBLING, POA ELECTED HOSPICE SERVICES AND REQUESTED NO FURTHER TREATMENT