chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upper back and Right sided neck pain; Upper back and Right sided neck pain; upper back and right sided neck stiffness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Feb2021 13:30 (Lot number: EN6201) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 13Mar2021 09:00, outcome "not recovered" and all described as "Upper back and Right sided neck pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Mar2021 09:00, outcome "not recovered", described as "upper back and right sided neck stiffness". The events "upper back and right sided neck pain", "upper back and right sided neck pain" and "upper back and right sided neck stiffness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, neck pain, musculoskeletal stiffness. Additional Information: The patient had no known allergies to medications, food, or other products.The patient has concomitant medication escitalopram 2.5mg per day. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 09:00, two weeks after vaccination, the patient experienced upper back and right sided neck pain and stiffness. The patient was treated for back pain, neck pain and stiffness with chiropractic care on 22Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021328139 same patient, vaccine, different dose and event
I experienced chest pain, SOB and a swollen back and lung after my second dose vaccine.  I want to notify this for other patients. I lie down on my belly to expand my chest.  Today I still have swollen of my left lung side, I believe it is due to the vaccine since it happened few hours after the vaccine. I also have chest pain that I went to the Emergency Room  where they performed a chest x-ray, they did not find liquid in my lungs and my lungs are clear.  The ER referred me to see a cardiologist.  In April 2021 I had a small stroke, where my lips got numb and had very hard chest pain and my arm got sore.
Developed red spotchy hives in forehead, scalp and face 15 minutes after vaccines administered.  Oral Benadryl given 1 tsp. at 16:50.
no appetite; huge red blotch under vaccination site the size of a mango; which blistered and peeled; left breast red/part of right breast were all red; breasts were real itchy; 2nd dose 08Feb2021/3rd on16Aug; has no energy; On the day after her 3rd shot she woke up with a mild 99.3 fever; felt like freight train ran over her; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like freight train ran over her), DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled) and ERYTHEMA (left breast red/part of right breast were all red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced FEELING ABNORMAL (felt like freight train ran over her) and PYREXIA (On the day after her 3rd shot she woke up with a mild 99.3 fever). On 20-Aug-2021, the patient experienced ASTHENIA (has no energy). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled), ERYTHEMA (left breast red/part of right breast were all red), PRURITUS (breasts were real itchy) and INCORRECT DOSE ADMINISTERED (2nd dose 08Feb2021/3rd on16Aug). At the time of the report, FEELING ABNORMAL (felt like freight train ran over her), DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled), ERYTHEMA (left breast red/part of right breast were all red), PRURITUS (breasts were real itchy) and PYREXIA (On the day after her 3rd shot she woke up with a mild 99.3 fever) was resolving and ASTHENIA (has no energy) and INCORRECT DOSE ADMINISTERED (2nd dose 08Feb2021/3rd on16Aug) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (High) high.         Concomitant medication were not reported. Treatment medication were not reported. Patent was a cancer survivor   This case was linked to MOD-2021-293260 (Patient Link).
Fever, chills, fatigue, nausea, vomiting. Severe vomiting lasting 2  days post vaccine. Recorded temperature at 101 then later at 95.
Information has been received from a 34 year old female consumer, as part of the pregnancy registry for VARIVAX (Merck), with no pertinent medical history and no known drug allergies/drug reactions who on 01-APR-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 665808/1410Y) (site and route not reported). There were no concomitant medications reported. It was reported that the patient was currently 18 weeks pregnant (Last menstrual period on 15-FEB-2011). There was no treatment for the event. A blood work was performed (results not provided). The estimated delivery date was 22-NOV-2011. The patient sought unspecified medical attention. No adverse reactions were reported. Follow up information has been received via initial questionnaire concerning the female patient with no previous pregnancies who on 01-APR-2011 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (Lot # 665808/1410Y). It was reported that on 03-MAY-2011 an ultrasound exam confirmed pregnancy. It was also stated that the patient was not tested for varicella antibodies before vaccination with VARIVAX (Merck). It was reported that the patient had no local reactions at vaccination site and no varicella or herpes zoster symptoms post vaccination. Patient's last menstrual period was on 15-MAR-2011 (previously reported as 15-FEB-2011) and estimated delivery date 20-DEC-2011 (previously reported as 20-NOV-2011). Follow-up information has been received from a registered nurse. She reported that the patient, had delivered a baby full term on 23-DEC-2011 via C-section. The registered nurse reported that the patient had a Cesarean birth due to "failed induction and low amniotic fluid". She stated that there was no delivery record in the medical chart, so did not have any specific health information on the baby. She also stated the patient did not have her 6 week postpartum visit yet. Upon internal review failed induction and low amniotic fluid were considered to be other important medical events. Additional information has been requested.
Experienced swelling in nodes at the base of her neck and had trouble swallowing; Had trouble swallowing; Anxious; This is a spontaneous report from a contactable Pharmacist. A adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown) intramuscular in arm right on 18Jan2021 at 12:00 as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 18Jan2021 at 18:00, the patient experienced swelling in nodes at the base of her neck and had trouble swallowing, had trouble swallowing and anxious. Approximately 6 hours after injection (Patient) experienced swelling in nodes at the base of her neck and had trouble swallowing. She went to the emergency room and was treated with steroids and antihistamines. She was discontinued with Medrol dose Pak, Pepcid and antihistamines. The swelling improved. After completing the steroids, the swelling came back. She went to an allergist who placed her on frequent Claritin and Zyrtec, and hydroxyzine. The swelling goes down with the Claritin but has since come back. She has a history of ALL approximately 20 years ago, no history of reaction to vaccines. She has epipen but is quite anxious. The outcome of the events was not recovered.  Follow up attempts are needed. Further information is expected.   Follow up attempts are needed. Further information is expected.
Staff member had a moderna vaccine and a day later developed a lump under the injection site area. This has been reported many times before. Told her to monitor it and if it stays to contact her provider.
Information has been received from a physician concerning an 11 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported), and the patient did not experience any difficulties after that. On an unspecified date the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) by intramuscular injection (lot number and injection site not reported). The patient also received 2 other vaccines (name not known) minutes prior to GARDASIL vaccine. Within 30 seconds following the vaccination of GARDASIL vaccine, the patient "passed out". Unspecified medical attention was sought. The patient recovered after 30-40 seconds. The patient's mother stated that the patient would not receive the third dose. Additional information has been requested.
Has a big red arm; Itchy arm; Very swollen arm the size of a small egg; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Has a big red arm), PRURITUS (Itchy arm) and PERIPHERAL SWELLING (Very swollen arm the size of a small egg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 029A21A and 031L20A) for COVID-19 vaccination.     Previously administered products included for H1N1 influenza immunisation: Flu shot (Received about 6 to 7 years ago.Patient missed a day of work after the flu shot.Patient still gets the regular flu vaccine in a high dose.). Past adverse reactions to the above products included Vaccination adverse reaction with Flu shot. Concurrent medical conditions included Cold sores, Fibromyalgia and Chronic pain. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Chronic pain, LYSINE for Cold sores, DULOXETINE and GABAPENTIN for Fibromyalgia, MULTIVITAMIN [VITAMINS NOS], CALCIUM, MAGNESIUM and COLISTIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In December 2021, the patient experienced ERYTHEMA (Has a big red arm), PRURITUS (Itchy arm) and PERIPHERAL SWELLING (Very swollen arm the size of a small egg). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Itchy, at a dose of Lotion and Manual therapy (Putting ice on it) for Peripheral swelling. At the time of the report, ERYTHEMA (Has a big red arm), PRURITUS (Itchy arm) and PERIPHERAL SWELLING (Very swollen arm the size of a small egg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Advil P M which the patient took as treatment medication didn't worked for her and the Aveeno lotion helped a little but not for long. The patient stated that She got a mild case of COVID-19 in November so she got monoclonal antibodies and since she got COVID-19 her blood pressure is running higher than usual so she was put on lisinopril. She has been putting ice in the arm where the reaction occurred.   This case was linked to MOD-2021-416077 (Patient Link).
Pt recieved vaccination, in monitoring area felt faint Pale/ diaphoretic, lowered to floor with feet up Vitals: 1105 HR 48, 109/66 (laying) 1108 HR 67, 113/72 1110 HR 69,  128/89 (sitting on floor) 1113 HR 73, 134/80 1117 HR 72, 110/70 (sitting in chair) 1124 HR 58, 120/78  Heart regular, rate and rhythm on auscultation Eating and drinking, conversing easily Ambulated independently, mother to drive home
Approximately 12 hours after vaccine, extreme nausea, vomiting, diarrhea , chills.  Approximately 16 hours after vaccine fever of 101.  Nausea and vomiting lasting continuously for 3 hours, took Emetrol to control nausea.  Fatigue lasting for 20 hours, fever broke after 20 hours.  Stomach continues after 66 hours from vaccine to have diarrhea.  I did get the flu vaccine at the same time. Have never had an adverse reaction to the flu shot.
Headache, Red/Swollen/Warm at the injection site. Temperature of 100.6. Patient was treated with acetaminophen 1 g.
Gave flu 1st, GARDASIL 2nd and MENACTRA 3rd. A few seconds after vaccines, pt became unresponsive, pale and started with generalized jerking movements for a few seconds (15-30)/ Aroused with ammonia ampule. BP 92/38, diaphoretic, no incontinence. Kept pt. for 1 hr. lying down BP improved. Father drove home.
a patient was administered FLUZONE QUADRIVALENT sryinge which were not supposed to be used because of temperature excursion /No AE; shipment of pre-filled syringe FLUZONE QUADRIVALENT arrived late/ No AE; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a Pharmacy technician via consumer via phone via regulatory authority number: 00794935.   This case is linked to case 2021SA310171(CLUSTER).  This case involves a 60 years old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] syringe which were not supposed to be used because of temperature excursion and shipment of these pre-filled syringe arrived late (product storage error and product distribution issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylactic vaccination.  On 30-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Injection lot number: UT7376LA, expiry date: 30-Jun-2022, frequency: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage and product shipment delay (latency: same day).  It was reported "Pharmacy technician called stating they had a shipment of pre-filled syringes FLUZONE QUADRIVALENT arrive late, after a temperature excursion was reported and it was determined that the syringes should not be used, 2 patients were accidentally given these vaccines. She asks if the vaccines were valid or if these patient's should be revaccinated. Caller states they had already reached to Pasteur Company Sanofi to find out if the vaccines were suitable, which they were told they were not and they were set to return them. Upon going to pack and return the shipment, caller realized one of the boxes set aside was incorrect, and the box that was supposed to be returned had been opened and two syringes used on patients."  Product used: Used, first time product used: no, still using product: no and was device used: yes.   No additional adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Warmness, hard around deltoid, swelling, around 10 cm x 5 cm, erythema, swelling, mild warmth and patient has full range of motion and no tenderness.
About 5 minutes after shot, while seated quietly, sudden onset of coughing and difficulty breathing. This is typical of my acute asthma symptoms. It worsened from a few coughs to uncontrollable coughing over about 2 minutes. Took two puffs of albuterol inhaler, coughing and breathing difficulty resolved over another 5 minutes. No further asthma symptoms in week since vaccination. It's unclear if the asthma attack was related to the vaccine. But I often go months without needing to use an inhaler, so timing is suspicious. My usual asthma triggers are environmental allergens (dust, cats), food (hazelnuts), or viral infection.  I had been sick with a cold, but with no lingering asthma symptoms for 4 days prior to the vaccine. I also had more typical moderate side effect symptoms the next day (fatigue, sore arm, muscle aches).
Information has been received from a licensed practical nurse concerning a 17-month-old white female with no known pre-existing allergies, birth defects, or medical conditions who on 19-JUN-2006 was vaccinated SC with the first dose of varicella virus vaccine live (Oka/Merck) (lot # 652629/1031R). There was no illness at the time of the vaccination. Concomitant therapy that day included a first dose of measles-mumps-rubella vaccine (MSD) (Lot # 653338/0216F) administered SC and a forth dose of pneumococcal 4 6B 9V 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Batch # B06641A) administered IM. On 16-NOV-2006 the patient developed a rash with less than 50 lesions. Subsequently, the patient recovered. It was noted that the patient's father had shingles. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.
mild redness (3cm) w/papule around site 5-10min p/vax; resolving when pt left office p/sent home w/DPH
Little pain in the right side of her neck; This is an initial spontaneous report from a Pfizer-sponsored program contactable consumer (patient). A-70-year-old female patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported) second dose via an unspecified route of administration, administered in right arm and first dose administered in right arm as single dose for COVID-19 immunization. First vaccine was administered by a pharmacist and was middle of arm, second dose was by an RN and was administered higher in the same arm, caller states after second vaccine she had a little pain in the right side of her neck, also watches a lot of TV and saw something about vaccinations at a 90 degree angle, relayed PMI number and transferred long hold time, will fax AE to Pfizer.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Maculo-papular, generalized rash, blanches, developed 7 days, post vax.
Fever, rash, irritability, diarrhea beginning w/fever 2 days post vax along w/irritability; Diarrhea & rash on day #8 post vax;
November 6-9: Top of arm red, swollen, warm. November 11: Redness travels down left arm. November 18-21: Tired, no energy, no appetite, developing rash on stomach, back, buttocks, both arms, both legs.. November 24: Body covered in rash, swelling of legs from the knees to both feet.
I tested positive 2 days after my husband. I started with a headache in the afternoon. I also developed severe chills for about 5-6 hours. My fever was 100 degrees. I had a mild cough initially and fits of sneezing. I had some ear pain, and my pulse was racing for 6 to 7 hours. It was averaging around 120's. I felt like I had adrenaline in my chest. I had a moderate sore throat and swollen glands. I tested myself for COVID-19 on February 18 and it was positive. I still had a low-grade fever around 99 degrees. I had COVID-19 PCR completed by the doctor on February 20, 2023, and it was positive as well. I took Tylenol on the 2nd day. All my symptoms are not yet gone. I still have a slight cough with no coughing fits. I'm not yet back to my regular schedule. My oxygen level never dropped below 95% during this process. I completed a 6-day regimen on Prednisone to relieve the coughing fit.
Patient stated that in the evening after receiving the vaccine on 8/28/2020 she was experiencing extreme myalgia of the right shoulder where injection was administered. Later in the evening while watching TV, the patient went to grab remote control and had "dead arm". The patient has continued to struggle with myalgias in her right shoulder for 3 months after obtaining the Shingrix vaccine. The patient does have a past medical history of a musculoskeletal disorder and visits a chiropractor clinic. She has been visiting the chiropractor after the adverse event to the vaccine. At the chiropractor clinic she has been completing physical therapy treatments and exercise to help with the myalgia over the past 3 months. Patient reported the adverse event on 11/20/2020.
At approximately 4:50 pm immediately after flu shot given, patient complained of throat was tightening and was dizzy.  Gave as prescribed CPI injection to left thigh.  Patient stated she felt "completely" normal.  Refused to go with paramedics to ER.  Patient called office 12/6/07 to report no symptoms of anophylaxis.
1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that vaccine was in refrigerator and administered on 01-OCT-2021.  No treatment medications were reported.
Information has been received from a physician's assistant concerning a 31 year old male who in 2003 was vaccianted with a dose of varicella virus vaccine live. On 27-JUN-2006 the patient's titer result was subtheraputic. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
8/8 had immunizations. By evening developed red circle at immunization site, pruritis, then pain in right arm. Now hot and tender to touch 58mm x 82mm tender pink area with mild induration, very tender.