chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes (mild swelling) in left armpit; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Arm Left in May2021 at 10:45 AM (Batch/Lot Number: ER8736) (at age of the 14-year-old) as 1st dose, SINGLE for covid-19 immunisation. Medical history included precocious puberty, attention deficit hyperactivity disorder, anxiety and the patient had known allergy to animal: Pet dander. The patient received methylphenidate hydrochloride (CONCERTA), guanfacine (GUANFACINE), vitamin c [ascorbic acid], melatonin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  In May2021, the patient experienced swollen lymph nodes (mild swelling) in left armpit. The patient did not receive any treatment of the event. The outcome of the event was not recovered.
This spontaneous report was received from a healthcare professional and refers to a currently 5 year old, female patient. The patient's medical history and concurrent conditions were not reported. On 28-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Information has been received from a certified medical assistant referring to a 14 year old male patient with no drug allergies or pertinent medical history. On 05-APR-2016 the patient was vaccinated with a dose of 0.5 ml GARDASIL 9 (lot # L037339 and expiration date: 09-FEB-2018) intramuscular in the right arm. There was no concomitant therapy. On 06-APR-2016, the patient developed cellulitis of right arm. The patient sought unspecified medical attention and was treated with KEFLEX. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering from cellulitis. Additional information has been requested.
diarrhea shortly after second moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea shortly after second moderna vaccine) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea shortly after second moderna vaccine). At the time of the report, DIARRHOEA (diarrhea shortly after second moderna vaccine) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant and treatment product was reported
Throat itchy, heart racing, feeling sensation throughout my body  and feeling very faint within 5 mins from injection.  The Dr on call and nurse or PA gave me benadryl and checked my vitals twice. The itchy feeling went away after about 15/20 mins.  My vitals were normal both times. I  have had anxiety/panic attacks in the past, but this felt different.  I stayed total 45 mins to make sure no other reaction occurred.
This case was reported by a consumer via call center representative and described the occurrence of heart racing in a 80-year-old male patient who received SHINGRIX (batch number 4492P, expiry date April 2019) for prophylaxis. Concurrent medical conditions included heartbeats irregular. Concomitant products included acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), famotidine, magnesium hydrogen aspartate dihydrate (Magnesium), tamsulosin hydrochloride (Tamsulosin), triamterene, alprazolam, hydrocodone, methocarbamol (Metocarbamol), metoprolol and nicotinamide (Vitamin B3). On 1st May 2018 12:30, the patient received the 1st dose of SHINGRIX. On 1st May 2018 22:00, 9 hrs 30 min after receiving SHINGRIX, the patient experienced heart racing and heartbeats irregular. On 1st May 2018, the outcome of the heart racing and heartbeats irregular were recovered/resolved. It was unknown if the reporter considered the heart racing and heartbeats irregular to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, he received SHINGRIX during daytime. At about 10 pm, the patient's heart started racing and he experienced irregular heartbeats which went away after about 30 to 45 minutes.
2 days after vaccine pt. reports breaking out in a bad rash between her breasts and in genitals, also reports severe migraine
On 9/27/2017, we administered both PNEUMOVAX 23 and FLUZONE HD to the patient's left arm. She left the pharmacy feeling fine. On 9/29/2017, she came by the pharmacy, and complained of swollen and painful site of injection, and she could hardly raise her arm. We gave her 2 tabs of 25mg BENADRYL. On 10/1/2017, we called and found out her symptoms had gotten worse. Her armpit area had become tender, and she also felt her entire left arm down to her left thumb was tender. We urged her to seek medical care. A few days later, she came by the pharmacy, and reported that her symptoms had improved.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently the patient developed small bumps all over her body about a week after vaccination. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Presented to ED w/myalgia x 2 days; admitted for COVID pna, acute resp failure w/hypoxia; tx w/abx, remdesivir, steroids, zinc, magnesium, pepcid, O2. Pt deteroriated & expired.
Shingles; itching around the nipple area at that time.; a pain under her arm and on her back; 2 bouts of diarrhea; palpating and fluttering; felt like she got hit by a truck/was feeling miserable; sore arm; stuffy nose; sweating really bad; chest was fluttering on and off; hearing was muffled; headache; restless night.; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0165; Expiration Date: 31Aug2021), via an unspecified route of administration on 05May2021 (at the age of 64-years) as 1st, single dose for COVID-19 immunization. Medical history included unspecified allergies. The patient concomitant medications were not reported. On 05May2021 (same day after vaccination), patient developed a headache within the first 15 minutes. She stayed 30 minutes after the COVID vaccine because she has a history of allergies and then she went home and took Tylenol. She was resting that whole day and then she had a restless night. On 06May2021 (one day after vaccination), when woke up, patient felt like she got hit by a truck and had a headache, sore arm, stuffy nose, she was sweating really bad but there was no fever, and her chest was fluttering on and off. Patient ears felt like they were blocked because her hearing was muffled. On 07May2021, patient woke up with a really bad headache, worse than the day before, she had heavy sweating, her hearing was muffled, she had a stuffy nose, and she had the palpating and fluttering that continued. She had no fever. On 08May2021, she woke up with no sweating finally, but she had a real bad headache, her nose still felt congested, her hearing was still muffled, and she was feeling miserable. She had 2 bouts of diarrhea. She was basically nursing with Tylenol at that time. On 09May2021, patient had a slight headache, no sweating and she felt a little bit better in the morning but not 100%. Then she developed a pain under her arm and on her back and she could not lay on her left side. The pain was radiating from the front to the back. She took Tylenol and that did not help, and she could not sleep. On 10May2021, patient had a doctor appointment that was already scheduled so she went to see the doctor. Before she went, when she woke up her ears were still blocked, she had pain on her left side and itching around the nipple area at that time. When she saw the doctor, she was diagnosed with shingles and gave her medicine. Patient received unspecified treatment for the event Shingles and before that patient took Tylenol. The Tylenol she took was only 325 mg because she was sensitive to chemicals in medicines. The lowest dose was usually all she has taken, and it will be enough to relax her to fall asleep, but it did not touch the pain on Sunday night. Patient was worried about the second shot. The outcome of all the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Patient presented with redness and swelling on (L) Deltoid measuring 4.5 in length & 3.5 inches in width. The area is hot and tender.
pt became nauseated, diaphoretic, faint, unconscious for 1min, vomited, had BP 118/70;was sleepy rest of day;
diffuse erythematous papular blanching rash 0.5 - 1.0 mm from mid calves to top of chest sparing skin folds occurring 5 days p/vax;t98.5 R
sleepy; she still feels bad; chills; fever; shaking like a leaf; a little cough/she is swallowing phlegm; muscles are aching all over/aches in her knees but mostly the shoulders and lower arms; headache; she has a pain that goes down the right side of her headache to her shoulder, arm and back; eyes are burning all the time noting it is hard to open her right eye; eyes are burning all the time noting it is hard to open her right eye; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had the second dose of BNT162B2 on 16Mar2021. Patient was still getting symptoms she did not like. Caller stated her symptoms started four days after the vaccine (20Mar2021) and had continued for four weeks. Caller stated she was sleepy as she could possibly be. Caller stated she had chills, fever, shaking like a leaf and a little cough. Caller stated that her muscles were aching all over. She ached in her knees but mostly the shoulders and lower arms. She had a headache at the back of her head on the top. She had a pain that goes down the right side of her headache to her shoulder, arm and back. Her eyes were burning all the time noting it was hard to open her right eye. She was swallowing phlegm. She still felt bad. Caller asked if it is normal to feel this way after four weeks and how long should it be. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426400 same reporter/drug, different patient/AE
9/26/2022 patient contacted to inquire if it was normal to have pain in the arm where vaccine was received a week after injection.  Pt. was advised as per form, typically the pain will last 2-3 days and resolve on its own.  Patient was advised that Acetaminophen or Ibuprofen for the pain and if the pain continued to worsen to contact her PCP or go to Emergency Department for evaluation.  On 9/19/2022, pt. reported going to local Emergency Room for evaluation due to the swelling and extreme pain in her arm. Pt. did have Ultrasound of her left arm, resulting in diagnosis of blood clots (thrombosis) from shoulder to wrist.   Pt. was referred to local oncologist.  Per patient, "I was informed that it was extremely unusual to have clotting in the arm."  Patient was started on Xarelto.  Pt. was scheduled to see another provider the day after reporting this reaction to have additional blood work complete  Pt. also reported that the plan of care is for her to remain on the medication for 3 months and then see doctor.
I got a severe fever, chills, and body aches (so badly I couldn't move) 24 hours after having received the 1st dose. Then my lymph swelled up for 3 days. From my collar bone to my shoulder blade and under my arm, it was extremely swollen and painful. I thought I had a rib out! When the swelling subsided (day 4 or 5), my heart started fluttering, palpitating, and I felt extreme anxiety.  I also felt achy in my entire body for the following month. Pain in all my joints. A LOT of inflammation. I was worried.  I got a dr. appt and had an EKG.  Nothing was found and nothing was suggested. Upon seeing a second doctor, he suggested I take aspirin. This has helped A TON! I am still having a lot of heart fluttering. This is NOT NORMAL it happened within a week of getting the shot and it is scary.
High fever 102; Fully body aches; Cold sweats; Vomiting; No appetite for 24 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15(at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8737) via an unspecified route of administration in the arm left on 05Apr2021 at 10:30(at the age of 24-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 27Apr2021 at 20:15, the patient experienced high fever 102, fully body aches, cold sweats, vomiting and no appetite for 24 hours after vaccine, started about 8 hours after her shot. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 27Apr2021, the patient underwent body temperature test and the result was 102 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event high fever 102, fully body aches, cold sweats, vomiting was recovered on an unknown date in Apr2021 and no appetite for 24 hours after vaccine was recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.
Pericardial effusion, shortness of breath, started within 2 weeks after 2nd vaccine
IMMS 3/21/03 Returned with blotchy erythema of left anterior thigh, swollen, tender to touch. No temp
Began to notice a rash of raised, itchy bumps on bilateral thighs, by that evening the rash became worse on my legs extending behind the knees and down the calf & both arms. My heart rate was fast & my throat felt 'tight'.  No difficulty breathing, I took 50 mg of Benadryl which relieved some of the symptoms.  The next day, I still have a slight rash on all extremities & itching all over my body.
Sudden vertigo, confusion, and drowsiness. Pain in left arm and tingling in arms when dizzy. Usually after eating. Almost constant head fog. Slight nausea from dizziness.
Blisters (fluid filled) appeared on thigh area where shot was given & on chest during the evening after receiving flu shot that day at approx. 2 P.M. No fever or difficulty breathing noted, but child was cranky. Blisters disappeared within 4 days. No treatment necessary.
Patient was not eligible to receive Moderna vaccine since it is approved for 18 yrs and older population. Patient was 17 yrs old when she received two doses of Moderna Covid 19 vaccine.
Patient had shortness of breath, slight  throat swelling, arm swelling, and increased heart rate
racing heartbeat; dizziness; lightheaded; weakness; esophageal restriction; swelling in roof of mouth; bronchial irritation; muscle pain; This is a spontaneous case from a contactable consumer (Patient) reported that: A 78-years-old non-pregnant female patient received BNT162B2 (Pfizer BioNTech solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 09:45 (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 78 years). The patient past medical history included Allergy (drug hypersensitivity) from an unknown date and unknown if ongoing highly sensitive to all medications. Concomitant medication included calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported and Vitamin d (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. the patient was not diagnosed with COVID-19. On 16Apr2021 After 4 hours the patient experienced racing heartbeat, dizziness, lightheaded and weakness. After 9 hours experienced esophageal restriction, swelling in roof of mouth and bronchial irritation and after 20 hours reported muscle pain all over body. No treatment was received. The event outcome was Recovering.  No follow-up attempts are possible. No further information is expected.
Admitted to hospital on 7/23/2021. Intubated on 8/1. Expired 8/12
This case was reported by a pharmacist via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included post herpetic neuralgia (had pain relief from post herpetic neuralgia after receiving SHINGRIX). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient had pain relief from post herpetic neuralgia after receiving SHINGRIX and it was an unexpected positive result of vaccine.
pt took first dose 6PM on 27JUL94 & became very nauseated 1 hr later; 2nd dose taken 29JUL94 6PM exp nausea, abdo pain & cramping & diarrhea;
Information has been received from a nurse practitioner concerning a female who was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  Subsequently the patient had a Pap test that resulted in an abnormal result.  The patient had a biopsy which came back negative.  The patient had not decided if she will continue with the dosing schedule.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Headaches started a little over one week post second shot. Not relieved with ibuprofen, Tylenol or water.  Increased skin sensitivity again with intense itching at times causing open sores on face.
Patient came in today with overt shingles rash few days after vaccination for shingles.
04/21/07 pt c/o H.A., 4/22/07 pt woke around 8am with Fever 102.6, 4-24 worked at school - had fever off and on. 4/23 fever 101-103 alternated Tylenol with Motrin.
I got on my periods and I usually have really bad pain but this time it is like 10 times worse than really bad that I usually have; I have really bad abdominal pain; This is a spontaneous report from a contactable consumer (patient).  A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization, at the age at vaccination of 27 years old.  The patient's medical history and concomitant medications were not reported. The patient experienced she had really bad abdominal pain (non-serious) on 20Apr2021 with outcome of unknown, she got on her periods and she usually had really bad pain but this time it was like 10 times worse than really bad that she usually have (non-serious) on an unspecified date with outcome of unknown.  Consumer stated, "On Monday I got the Pfizer covid vaccine and I got it like yesterday and situation was pretty bad but it likes lot worse and it is like has been stopped being like really bad. I don't know if this is like something, that was adverse side effect or what?" It was the 1st shot." Consumer stated, "Yes but that's not the concern about it is the fact that I got on my periods and I usually have really bad pain but this time it is like 10 times worse than really bad that I usually have. I don't know if I be concerned or not. I have really bad abdominal pain. It is worse than usual that I have in my period."  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Bell's Palsy symptoms showed up on 7/2/2021.  Diagnosed on 7/7/2021 at Urgent Care.   Note: Moderna shot #1 was on 3/20/2021 at the same urgent care, and the lot number was 037A21B.    The symptoms include a slightly droopy right eyelid, slightly droopy right side of mouth, partly paralyzed tongue causing a speech impediment and difficulty swallowing, an ache in the neck and shoulders, dry eye, and less saliva.  The mouth improved quickly.  The other symptoms appeared and got worse over the next two months.  After three months the ache in the shoulders is less, the tongue and speech is still bad.  Have relied on rest, sunglasses and a blindfold, massages, a heatpad, and Biofreeze cream.