chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had major swelling in my armpit. Hurts and is lumpy; had major swelling in my armpit. Hurts and is lumpy; had major swelling in my armpit. Hurts and is lumpy; This is a spontaneous report from a contactable other healthcare professional. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 30Apr2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and allergy to penicillin  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:00, the patient experienced major swelling in armpit, hurts and was lumpy. 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 the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event major swelling in armpit, hurts and was lumpy was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
upper part of arm became red & swollen the evening p/inject given; this lasted approx 4 days; pt recvd no tx; pt is better now; no swelling or redness but still has a knot & some discomfort;
skin was red/ Skin was angry; swelling is way more pronounced and expanded; Elbow pain, Shoulder pain, 6 out of 10 pain scale; Skin was hot; arm hurts (where she received the vaccine); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Skin was hot), VACCINATION SITE PAIN (arm hurts (where she received the vaccine)), VACCINATION SITE ERYTHEMA (skin was red/ Skin was angry), VACCINATION SITE SWELLING (swelling is way more pronounced and expanded) and ARTHRALGIA (Elbow pain, Shoulder pain, 6 out of 10 pain scale) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Anxiety, Depression NOS and Allergic reaction to analgesics (causes itchiness and nauseous). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety and Depression NOS, METOPROLOL for Blood pressure management.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PAIN (arm hurts (where she received the vaccine)). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Skin was hot). On 05-May-2021, the patient experienced VACCINATION SITE SWELLING (swelling is way more pronounced and expanded) and ARTHRALGIA (Elbow pain, Shoulder pain, 6 out of 10 pain scale). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (skin was red/ Skin was angry). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 4 tablets in the past 18 hours. At the time of the report, VACCINATION SITE WARMTH (Skin was hot), VACCINATION SITE PAIN (arm hurts (where she received the vaccine)), VACCINATION SITE ERYTHEMA (skin was red/ Skin was angry), VACCINATION SITE SWELLING (swelling is way more pronounced and expanded) and ARTHRALGIA (Elbow pain, Shoulder pain, 6 out of 10 pain scale) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MODERNATX, INC.-MOD-2021-110576 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-110576:for 1st dose
pt recvd vax & lost hair assoc w/ black dots; form of diffuse alopecia areata;
3 x 4 swollen/warm to touch/erythematous site tender, very itchy spot left upper arm (site of DTAP).
This spontaneous report as received from a nurse refers to a 7 year old patient of unknown gender. On 23-JUN-2014 a dose of GARDASIL (dose, route of administration, LOT# and expiration date were not provided) was inadvertently administered to the patient (who was younger that the age that is indicated for GARDASIL). No adverse effects were observed. Additional information has been requested.
Sx for 2-3 days after vaccine; dizzy, not feeling right; clammy; increased thirst.
Information has been received from a healthcare worker concerning a 20 year old female who on 14-MAR-2007 was vaccinated with the first dose of Gardasil (lot #653938/0954F). There was no concomitant medication. On an unspecified date, "a couple of weeks after" vaccination, the patient developed pancreatitis. On 16-MAY-2007, the patient was vaccinated with the second dose of Gardasil (lot #656050/0245U) and on 20-SEP-2007, the patient was vaccinated with the third dose of Gardasil (lot #658560/1062U). The healthcare worker reported that before the second and third vaccinations, the patient's pancreatitis would "slowly get better," however, after each vaccination the patient's pancreatitis worsened. The patient was hospitalized on more than one occasion (dates and number of hospitalizations unspecified). At the time of this report, the patient's outcome was unknown. Additional information has been requested.  3/16/09 Received vaccine records  & GYN records which indicate patient experienced HSIL prior to initial vaccine & pt had colposcopy w/biopsy & ECC.
Initial case was retrieved from the scientific literature on 12 June 2012. The following is verbatim from the article: "A 32-year-old male developed myocarditis after immunisation with smallpox vaccine. The man received the smallpox vaccine [dosage and route not stated] 14 days before presenting with chest pain. He had been diagnosed with erythema surrounding the deltoid site of vaccination 3 days earlier. He reported gradual onset of mid-sternal chest pressure, radiating to his right arm and neck, with intermittent nausea, 12 hours before presentation. ECG showed ST elevation, while cardiac enzyme assay showed elevated creatine kinase. The man was initially treated with aspirin, morphine and nitroglycerine for acute coronary syndrome. He was hospitalised and received heparin, a B-adrenergic receptor antagonist and a platelet glycoprotein GPIIb IIIa complex inhibitor. His pain continued and repeat ECG showed persistent ST elevation. Coronary angiography found no evidence of coronary artery disease. He was diagnosed with myopericarditis temporally associated with smallpox vaccination. He was discharged receiving NSAIDS on hospital day 3. Author comment: In assessing patients presenting with chest pain and a history of vaccination, particularly smallpox vaccination within 30 days, myocarditis should be considered in the differential diagnosis.". The patient's outcome was not reported. Documents held by sender: None.
disorientation; High fever/fever 101F; substantial chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) Dose 2 intramuscular, administered in the left arm on 29Jun2021 at 14:00 (at the age of 56 years-old)  as a single dose for COVID-19 immunisation. Medical history included ongoing hypothyroidism, and ongoing blood cholesterol increased High CHL. Concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism from an unspecified start date and ongoing; atorvastatin for blood cholesterol increased from an unspecified start date and ongoing. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 on 08Jun2021 at 14:00 (Lot Number: EW0191) via intramuscular in the left arm for COVID-19 immunisation. The patient experienced substantial chills (disability) on 29Jun2021 at 22:00, disorientation (medically significant) on 30Jun2021, and high fever /fever 101F (non-serious) on 29Jun2021 at 22:00.  No adverse event until 12 hours after Dose 2 of bnt162b2, which included significant chills. Need to place pillow between knees to prevent injury. Fever is 101 F for 20 hrs. Disorientation was significant. The patient underwent lab tests and procedures which included body temperature: 101F on 29Jun2021.  The patient recovered from the event, High fever/fever 101F on 30Jun2021, and from substantial chills on an unknown date. The outcome of the event, disorientation was unknown.
This spontaneous report as received from a pharmacist refers to 78 years old female patient. Patient had no medical history and other previous drug allergic reactions. On 22-SEP-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, (dose number, frequency strength, lot number and expiry date unknown) subcutaneous. No concomitant therapies were reported. On an unknown date in 2014 the patient experienced unspecified condition. Patient received an electronic prescription written from her physician. Physician prescribed unspecified steroidal treatment for unspecified condition. Action taken with ZOSTAVAX was not applicable. The outcome of unspecified condition was unknown. The causality of unspecified condition was unknown to ZOSTAVAX was unknown. No further information was reported. Additional information has been requested.
Annual flu shot. Severe pain in injection site. Can't move arm without pain 5 weeks after injection.
During observation after receiving dose 2 of the COVID vaccine, she developed dizziness, visual sensation (spots) and complained of some chest pain.  She remained stable and seen by EMS.  She declined transport to ER.  She left with her husband.
Elevated Blood pressure, Face and eye swelling, shortness of breath and chest pain went to the emergency department and is currently admited at Medical Center. Now experienceing new onset atrial fibrillation which is still occurring. Patient still in hospital presently. 4/29/09-records received for DOS 3/24-3/28/09-new onset atrial fibrillation and anaphylactoid reaction to vaccine. Became reddened and itchy with some chest pressure
Disorientation, SOB, lightheadedness, throat tightness. Evaluated by EMS, cleared.
Patient had a local reaction to left thigh no fevers, leg warm to touch, red inflamed and painful, size 10 x 10. Has been going on for four days. No evidence of infection will watch may need antibiotics if not improving.
Patient had ED visit and/or hospitalization within 6 weeks of receiving COVID-19 vaccine.
Swelling; Pain; Redness; This is a spontaneous report from a contactable Physician via Pfizer sales representative.  An adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on an unspecified date at single dose for immunization, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), both via an unspecified route of administration at unknown dose for immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date after use of product the patient experienced a moderate reaction of swelling, pain and redness that spread up towards the neck area. The events were non-serious with outcome of unknown. The information on the batch number has been requested.
I noticed later in the evening on the day of the vaccine that my heart rate was racing. The next morning I felt tightness in my chest and my resting heart rate was averaging 130-155. If I walked from the living room to the bathroom it would increase to 155 BPM. After several hours with no change I had to go to the ER for treatment. I was given an EKG and they found that my hear rate was elevated. I was eventually discharged after a series of tests and told to monitor for increases in heart rate.
Administered Heplisav-B Two Days Past the Expiry Date; Initial Report Received on 09-SEP-2022  This is a spontaneous report received from an immunization program specialist regarding a 37-year-old patient who received HEPLISAV-B for hepatitis B immunisation.   Medical history and concomitant medications were reported as unknown.   On 19-Sep-2022, of the first dose of HEPLISAV B (Lot # 935841, expiration date 17-Sep-2022, NDC # not reported), route and site not specified, was administered for hepatitis B immunization.   It was reported that the dose was administered two days past the expiration date. The patient has not reported any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Delayed response at the injection site.  Initial muscles soreness at the injection site in the first 24 hours but then no other immediate side effects. Day 7 some let arm swelling and heat at the injection site appear.  Contacted my primary care and was informed what to look for and if it gets worse contact again or if it last more than 2 weeks post vaccine.
About 10 mins after vaccines administered pt began to have trouble breathing, tongue swelling, wheezing.
* My left arm hurt for over a month, I could feel it every time I was at the gym * pain in my upper lungs * Ive had headaches quite often and I rarely get them * Dizzy spells that are on and off (never had that before) * My joints burned when i was working out for a good two months after the shot * the left side of my head hurt... almost like my teeth hurt but not one specific tooth.
After patient received first dose of Covid vaccine patient experienced a reaction as described "feel fuzzy" and lack of self awareness five minutes after dose. That evening patient contacted her primary care provider and has not spoken until then. Patient still complains of not feeling herself and currently has not received her second dose and is worried of lack of self awareness.
2/16/2021:  Telephone call to PCP/DR: I.  This is all a little strange. Especially with the fever. I would like him seen by NP if we can get him in with fever. I am OK with office visit since we likely have a source in his wrist and he has had first Covid shot.  We need to worry about shingles or gout or cellulitis. If no sign of infection, he may benefit from some prednisone unless shingles.   2/16/21 11:08 AM You routed this conversation to, MD    2/16/21 11:08 AM Note:Saw Dr on Friday.  He was told to go back on Mycophenolate which he started on Friday. Left hand pain from palm to wrist on Saturday.  Some shoulder pain on the left and right side.  Sunday pain got worse.  Went to the ER at hospital yesterday.  Dx'd with carpal tunnell syndrome and gave him a wrist brace. He is taking tylenol/ibuprofen (200mg two tabs q 8 hours) as directed. Temp was 99.8 yesterday.  Temp is 99.5 this morning altho he is taking ibu/tylenol as directed. His wife reports he has traveling pain.  Today is pain is in the Right hand and right shoulder.  No left sided pain today.  Today he is able to hold a spoon in the left hand. He had a "real rough night last night", didn't sleep much. She has called Rheum but hasn't heard from them. Okay to put him in with NP? For ER follow up?  Or should something else be done? 2/19/2021: Call to office PCP/DR. His wife called saying that he went to the emergency room for severe pain in his left hand and swelling he could not hang on to anything.   The pain started on Friday and kept getting worse all weekend . The er told him that it was carpel tunnel and gave him a wrist splint.  His wife says that she call his rheumatologist and they started him on prednisone 40 X 3 days, 30 X3 days, 20 X 3 days, 10 for 3 days then stop.  She states that now he is having traveling pain it went into his left shoulder and arm. Now it is in his right shoulder and hand the right hand is very swollen can not make a fist. This am she states that he is limping on the right leg the cord in the back is very painful,  She then states that now that she thinks about it over a week ago in the evening he told her several nights that he was having difficulty swallowing first it was on the left side then the right side of his throat he did salt water gargles and was fine in the morning but it has continued to come back every night she states now he is saying that it fells like there is something in his throat.  Since yesterday it is on the left side of his throat.  She is call the rheumatologist but wonders what you think. 2/19/2021: OV with PCP see previous.
On 1/3/2022, Clinic staff notified health department staff of documentation found in system that patient received J&J vaccine while under 18years old. Health department staff member confirmed in system documentation system this 16 year old patient did receive J&J vaccine on 5/18/2021. Patient?s mother was contacted by health department nurse. Patient?s mother indicated she was already aware of the error and patient had not been revaccinated. Patient?s mother denied any adverse events related to vaccine however patient did experience 2 to 3days of body aches, headaches, and fever. All symptoms resolved after 3 days.
Left deltoid muscle erythema, warmth, swelling-approximately 3" in circumference.
lt arm w/large swollen reddened area;vax given 1wk ago;did not react until 1wk p/vax
giving two IPOL doses with no adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old female patient who received two poliomyelitis vaccine (inactivated) [IPOL] doses with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received 0.5 ml (dose 4) of suspect poliomyelitis vaccine (inactivated), suspension for injection (lot U1C571M, expiry date: 02-Feb-2024) (With unknown strength) via intramuscular route in the left gluteus medius for immunization.  On 22-Mar-2023, patient was giving two ipol doses with no adverse event (extra dose administered) (latency: same day) following the administration of poliomyelitis vaccine (Inactivated).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  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.
I received the Moderna Bivalent COVID-19 booster on 10/8/2022. Sometime in mid-November 2022, I began to experience symptoms similar to those of a UTI; namely, I felt a burning sensation whenever I urinated. One day, I decided to go to an urgent care clinic to see if they could help me. When they took my vitals, my blood pressure was extremely elevated. It was 180/113. I was put on ciprofloxacin for my UTI, and I was told to closely monitor my BP for the next several days. If it didn't go down, I was to see my PCP. After that, my BP alternated slightly, but it remained elevated, so I went to see my PCP. He prescribed me metoprolol XR (25 mg). He suspected that my elevated BP was caused by stress and told me to take the medication for so many days, monitor my BP, and to call him to report my BP readings. My BP did not get any lower, so he changed the dosage from 25 mg a day to 50 mg a day. He then again told me to monitor my BP and to call him back after so many days to report on the results. By the time I called him back, my BP had still not decreased a significant amount. The PCP then put me on 75 mg of metoprolol a day, and it is now my current dosage. At the time of this writing, the BP has come down slightly, but it is still in the elevated range.
Lightheaded and dizziness post vaccination.  Patient denies any medical conditions to cause dizziness. EMT called, pt refused going to hospital.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-DEC-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 208 hours. The lowest recorded temperature was 34 Fahrenheit degrees (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
3/15/12 Pt. received MENACTRA and ADACEL at (R) deltoid. Started to develop pain/redness/swelling 1-2 days after. Seen in ED. Started on oral Clindamycin. Redness/pain continued and spread downward/distally. Clinda was changed to oral BACTRIM and Prednisone was started 1+ week. Redness spread down to wrist. Symptoms started to improve day 13 and completely resolved by day 17. CBC/CRP x 2 normal.