chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-101921-24788 (Agency).  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 16Oct2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing); "Myalgic Encephalomyelitis" (unspecified if ongoing); "Chronic fatigue Syndrome" (unspecified if ongoing); "Chronic lyme" (unspecified if ongoing); "Brain injury" (unspecified if ongoing), notes: Brain injury from birth; "Allergy to horse dander" (unspecified if ongoing). Concomitant medication(s) included: NYSTATIN, start date: 11Oct2021; KETOCONAZOLE, start date: 12Oct2021. Past drug history included: Augmentin, reaction(s): "Allergy to augmentin". Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization, reaction(s): "Feel unwell", "Vomit". The following information was reported: HEADACHE (non-serious) with onset 19Oct2021, outcome "not recovered", described as "headache".  Additional information: Patient reported using Cetaphil Gentle Cleansing Bar lot 20014.5 oz size (part of 3 pack) beginning on 17Oct2021 She had ringworm-  it had stopped itching 15Oct2021 and was getting smaller. The rash was getting worse since 18Oct2021 after she had used the product. The rash expanded in size and is more itchy. She had not used the soap directly on the rash. She also noted on 16Oct2021. she had the 3rd Pfizer vaccine. She had a headache today, 19Oct2021 but she believes it is from the vaccine as the second vaccine made her vomit and feel unwell. She discontinued the product for now (last use 18Oct2021) until she speaks to her dermatologist. The events are ongoing. Her medical history was she was immunocompromised-she had Myalgic Encephalomyelitis (chronic fatigue syndrome), chronic Lyme, and a brain injury from birth. She also had an allergy to Augmentin and horse dander. Concomitant products include Nystatin cream since 11Oct2021 Ketoconazole Shampoo since 12Oct2021 and Ketoconazole 2 % cream since 12Oct2021.  No follow up attempts are possible; Information about lot/ batch number cannot be obtained, No further information is expected
Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (Lot Number unknown). The nurse reported that on 23-APR-2007 the female was vaccinated with her second dose of Gardasil (Lot Number 655324/0089U) 0.5mL. On an unspecified date, the patient experienced violent headaches. There was no concomitant medication. Medical attention was sought. Additional information was not provided. Additional information has been requested.
Headache,  fluctuating temperature (normal to 100°), dizziness,  weakness,  nausea, decreased appetite,  pain,  fatigue,  no sign of improvement or worsening over a couple weeks,  recently stated headache comes on suddenly,  symptoms fluctuate throughout the day
Last night my upper arm began to itch at the injection site. I noticed it was red and hot to the touch. Today there is a small hot area around the injection site with a hard, hot, red rash spanning further down my upper arm, about five inches. It is hot and itchy to the touch
This spontaneous report as received from a medical assistant refers to her husband, a male patient of unknown age. Medical assistant reported that her husband received an unspecified pneumococcal vaccine (dose, route and lot number were not reported) about one to two weeks ago, in approximately September 2013. Medical assistant reported that the patient "coming down sick", and he also experienced "slowing of the arm" with a "red streak" down the arm (in 2013). She also stated that the patient was in enough pain that he missed one day of work (in 2013). The outcome of coming down sick, patient was in enough pain that he missed one day of work, red streak down the arm and slowing of the arm was not reported. The relationship between the unspecified pneumococcal vaccine and the events was not reported. Upon internal review patient missed one day of work was considered to be a disabling event. This case is linked to case 1310USA004288 via same reporter link. Additional information has been requested.
Swelling, redness lt arm hurt & felt like a bump; returned on 12DEC no problem; pt phoned in 20DEC c/o arm still sore;
She developed a golf ball sized hardness at the vaccination site. There was warmth, redness and tenderness at the site.
After receiving 2nd dose: Redness, swelling,  pain, itching and "hot to the touch.  Redness injection site  4" diameter 5 days. Fever for 3 days. >than 102 at times Extreme chills, joint ache and muscle aches  Bowel cramping Increased fatigue after day 3
0946 Vaccination. Approximately 5 minutes after sitting in post vaccination area, began feeling shaky. Currenly recovering from chemo. Did not eat breakfast this morning and this is out of routine. Stated line was long. Reports to feeling similarly when she misses meals. 1000am BP 106/72 HR 78 R 18. Offered water and moved patient further away so she could eat the breakfast in her purse. Continued to feel better during the assessment. By 1100, reports feeling better. 1104 BP 114/72 HR 80. No complaints. Released to husband.
Redness Swollen Warm to touch } injection site.  Treatment:  Amox.  POT CLAVULANATE take 8ml BID for 10 days 400-57 mg/5ml  Susp. Received.
Felt fainty; Felt hot; Nauseous; Vomited; Red swollen circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt fainty), FEELING HOT (Felt hot), NAUSEA (Nauseous), VOMITING (Vomited) and INJECTION SITE ERYTHEMA (Red swollen circle at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Felt fainty), FEELING HOT (Felt hot), NAUSEA (Nauseous), VOMITING (Vomited) and INJECTION SITE ERYTHEMA (Red swollen circle at the injection site). At the time of the report, DIZZINESS (Felt fainty), FEELING HOT (Felt hot), NAUSEA (Nauseous), VOMITING (Vomited) and INJECTION SITE ERYTHEMA (Red swollen circle at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported. Treatment details were not provided.
Supraclavicular lymphadenopathy Left side only - same side as injection was administered  Began day after injection  Duration TBD
received the vaccine when she was 13 weeks and 6 days pregnant; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 9HT27, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Tetra 2020-2021 season at day 97 of the pregnancy. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was the patient.  She was a physician resident. The patient received the vaccine when she was 13 weeks and 6 days pregnant which led to vaccine exposure during pregnancy. The reporter consented to follow up.   Follow-up information received on 05th July 2021: After completion of all the follow up attempts the case was considered as pregnancy lost to follow up.
second dose after a year of the first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date one and half years ago).   On 28th September 2021, the patient received the 2nd dose of Shingrix. On 28th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist reported that patient was administered second dose later than the recommended interval, which led to lengthening of vaccine schedule. The pharmacist reported that between first and second dose a year and half was passed. The health care professional did not know the date of administration of first dose. No further events were reported. The reporter consented to follow up.
Fever, Heart Pain  3am: Temperature 99.2. Gave Advil.  11am: Temperature 99.7. Gave Advil.
Patient experienced chills, body aches, low grade fever, and equilibrium imbalance the day after her vaccination.  The side effects lasted approximately 12 hours and then resolved spontaneously.
Still have cough a week after 2nd covid vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 14Aug2021 03:00 PM (at the age of 67-year-old) in left arm as a dose 2, single for covid-19 immunization. The patients medical history included covid-19 prior vaccination from an unknown date. Concomitant medications included Multi-vitamin, fish oil, low dose acetylsalicylic acid (ASPIR), calcium. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 24Jul2021 11:00 AM (at the age of 67-year-old) in left arm as a dose 1, single for covid-19 immunization and experienced coughed so much patient lost his voice for 2 days. Cough was dry then became phlegmy, green phlegm. Patient had not received any other vaccine in four weeks. patient had no known allergies. Patient was tested to COVID post vaccination. On unspecified date in Aug2021 patient had cough a week after 2nd covid vaccine. The patient underwent lab tests and procedures which included Nasal Swab which was negative on 01Aug2021. The outcome of cough was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
No further AE; received an improperly stored dose; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided.  On 12-JAN-2021, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 injection, lot # T024557 was valid with an expiration date of 15-MAR-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The temperature excursion was reported as above 9 degrees Celsius (C) (8.7C) for 25 minutes. There was no previous temperature excursion. A digital data logger was used to capture the temperature. No further adverse event reported. The outcome of the event was unknown.
330PM-430PM vax around 630PM onset something caught in throat coughing-hacking intense pressure in lungs & face;pain in eyes like h/a;chills-fever-took hot tang-sound like terrible cold still raspy throat;severe shaking short 1/2hr achy
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt was waiting for 15 mins after her vaccination and notice the site was swelling and hard to the touch. she said it was painful and wanted us to report this reaction. she will monitor and seek physician visit if necessary
The patient presents with Patient is a 43 year old female presenting for evaluation of abdominal pain. Patient reports the pain began Tuesday and was located in the RLQ. The pain was and remains a sharp discomfort and does not radiate. It is a 10/10 in intensity. This is the first period of pain like this. Movement and palpation have exacerbated the pain. She reports fever, chills, nausea, and vomiting as well. Nothing at home has improved her pain. Given the unremitting pain, the patient presents to the ER for evaluation and was found to have appendicitis on CT scan. Surgery was therefore called. Incidentally, the patient was noted to have COVID infection concurrently. She denies dyspnea or hypoxia while at HOME./PT REMAINS INPATIENT AT THIS TIME.
Initial large hives on the arm of the injection between shoulder and elbow, spreading down to forearm after two days. Extremely itchy and painful. Treated with anti-itch cream and oatmeal paste. Pain radiated up from injection site and into jaw, causing pain similar to toothache. Treated with OTC pain relievers. Fever and chills followed after two or three days of initial onset. Reaction subsided around/after November 18-19th, 2008.
She states that she had a positive COVID test on 26OCT2023.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She states that she had a positive COVID test on 26OCT2023.) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2023, the patient experienced COVID-19 (She states that she had a positive COVID test on 26OCT2023.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 29-Oct-2023 for COVID-19 vaccination, at an unspecified dose and frequency. On 06-Nov-2023, COVID-19 (She states that she had a positive COVID test on 26OCT2023.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2023, SARS-CoV-2 antibody test: Positive. On 03-Nov-2023, SARS-CoV-2 antibody test: Negative. On 06-Nov-2023, SARS-CoV-2 antibody test: Negative. On 09-Nov-2023, SARS-CoV-2 antibody test: Negative. On 12-Nov-2023, SARS-CoV-2 antibody test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient stated that she had a positive for COVID test on 26-Oct-023. She started Paxlovid on 29-Oct-2023 and finished it on 03-Nov-2023. The last shot was administered in 2022.   No concomitant medications was reported.
PNEUMOVAX and Influenza vaccines both given in left deltoid on 10/04/12. Within 24-48 she developed fever to 102.1 as well as myalgias and a large hard red welt at injection site. It is worse after showering. The fever and body aches resolved within 24 hours. The red hard area has improved but is still there as of 11/12/12 visit. (Patient believes is due to PNEUMOVAX).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 29-SEP-2015, the patient was inadvertently vaccinated with an expired dose of pediatric VAQTA 25/0.5, lot # J000366 with exp date on 22-AUG-2015, (route was not provided). The nurse did not specify dose in VAQTA. No adverse effects reported. Additional information has been requested.
2 days after receiving the Moderno Vaccine for Covid-19 I started having a red  rash on my face. It then progressed to my throat and chest. It is very bad under my breasts. It has now broken out in red dots on both of my arms.
Developed Stevens-Johnson syndrome Develops a rash covering the majority of my body, skin became hot and painful to the touch, began to peel, pain in joints, severe chills despite wearing thermal pants, and sweat pants, two pair of wool socks, thermal top, tshirt, sweat shirt, and three blankets. Headache, dizziness, chest pain, and muscle cramps. Was given steroid shots and a prescription for prednisone.
Fever, Tmax 102.7 rash starting with small red bumps that turned to blisters then popped and crusted.
Shortness of breath that started during the night early hours of the next day that progressively worsened throughout the day to the point where I could barely breathe. I developed a deep cough that caused me to vomit. My breath became shallow and strained as well as having chest tightness. I was advised by my primary doctor to go to the ER. I went around 3PM on 8/19/21. My oxygen levels appeared to be normal.  I was given a Covid test and a chest x ray that came back normal. Once I left a few hours later my breathing had returned to somewhat normal and I was told I had an adverse reaction to the vaccine.
On 6/16/21 presented with chest pain, diagnosed with pericarditis, treated with colchicine and aspirin after consult with cardiology. Echocardiogram normal. Troponin negative.
One day post vax, pts arm was red, swollen and sore. Three days post vax, pt seen for PPD results and arm remains red swollen and sore - area approximately 50 mm diameter. Pt reports that previous TD was in 1997.
None reported. Patient was not quite 18 yet and received the first Moderna vaccine on 5/6/21
10/09-flu shot given first time getting a flu shot.  Dull, slight burning, soreness left deltoid.  Hurts when moving the arm a certain way and pain with palpation of the left deltoid.  Left deltoid-normal appearance-no systemic reaction.
Hives located on arms, neck and trunk.  Parents gave oral benadryl and put anti itch cream on hives
Arm subsequently hurt; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm subsequently hurt) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2020, the patient experienced PAIN IN EXTREMITY (Arm subsequently hurt). At the time of the report, PAIN IN EXTREMITY (Arm subsequently hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
01/23/05 pain at site of injection. Throughout that week- developed HA, low grade fever, chills. 01/29/05 blisters inside cheeks/ mouth. 01/30/05 saw MD DX with sinus infection RX amoxicillin 02/02/05 Returned to MD RX Valtrex.
Pentacel was accidentally given without the liquid component, just the HIB part with sterile water, No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a two-months-old male patient who was administered a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ195AAA, Expiry date 12-Mar-2021) without the liquid component, just the Hib part was given with sterile water (product preparation issue), via an unknown route in the right thigh on 09-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL CONJUGATE VACCINE (PCV) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  This was an actual medication error case due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Patient presents to clinic to f/u on c/o LA redness, swelling, and pain s/p PNA injection on 10/08. She reports that since receiving this vaccine she has developed flu like symptoms including sweats/chills (reported highest temp 101) joint pain, sore throat. T: 98.4 (36.9 C) P: 113 R: 18 B/P: 95/60* (sitting) Pulse Oximetry: 96% via room air Pain: 6.
Case number PHEH2012US020890 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and with a follow up information received from the quality assurance department on 02 Jun 2014. This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up information from the quality assurance department, FLUVIRIN (batch number: 1206161) was not a valid batch number. Since the batch number was unknown, a batch specific review could not be performed. Follow up information received from quality assurance department on 02 Jun 2014: Reported batch number was removed.
Severe edema and erythema at injection site of left upper arm within 12 hours of injection. Hives developed on left upper arm within 24 hours. Evaluated at Urgent Care. Treated with Benadryl.
The pt experienced an area the size of a fifty cent piece that was red, swollen, firm and warm to the touch. Pt is bearing weight without difficulty and is extremely active. Does not appear to be in any distress. Mom was instructed to use cool compress and Tylenol.
Patient c/o a reaction to an immunization. Patient had a Flu and Tetanus vaccine on 10-12-07. Patient had localized pt to right arm with erythema and mild edema. ROM is decreased secondary to pain with is some tingling in the right hand. Patient was given Vicodin for pain.
The evening of day of administration the patient c/o pain but nothing seen by mom.  In the AM, the arm looked red and swollen.  The redness and swelling progressed down to forearm.
Completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/02/201pfizer,Lot#EN6205 2nd dose: 03/23/2021Pfizer,Lot# EN6208 Diagnosed covid positive:06/22/2021 Exposure:Unknown Symptoms:Fever,fatigue,muscle aches,nasal congestion.