chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflamed Injection Site; Hot Flashes; quite large hard knot at the vaccine area; Red Injection Site; Swollen Injection Site (> Golf Ball); Sore Injection Site; Joint Aches and Pain; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE MASS (quite large hard knot at the vaccine area), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE MASS (quite large hard knot at the vaccine area), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)), VACCINATION SITE PAIN (Sore Injection Site), ARTHRALGIA (Joint Aches and Pain), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)), VACCINATION SITE PAIN (Sore Injection Site), ARTHRALGIA (Joint Aches and Pain), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved and VACCINATION SITE MASS (quite large hard knot at the vaccine area) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No Concomitant medication was reported. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional information was added on 22-Jun-2021. Reporter address, contact  information added, patient details was added, Information about 2 doses  along with other events like Sore at injection site,joint aches and pain, hot flashes, chills, Headache, fatigue were added.
Information has been received from a registered nurse concerning a 17 week old infant who was vaccinated on 05-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
BILATERAL UPPER EYELIDS ERYTHEMA AND SWELLING FIRST NOTED AT 10:30 PM 09/03/08, WORSENED UPON WAKING THE AM OF 09/04/08. PATIENT EXAMINED BY DOCTOR AND ADVISED TO USE OTC BENADRYL 25 MG Q 6 HOURS PO AND COLD COMPRESSES TO EYES.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received flu injection recently from the time of reporting. He did not know the brand of the vaccine, but the site of injection after that flu vaccine is also sore. For tolerance to SHINGRIX, refer case US2018190928. This case is also linked to case US2018190930 (wife's case), reported by same reporter.
7 and 1/2 hours after injections, patient experienced a rapid heartbeat, dizziness, weakness, and blurry vision which lasted about 45 minutes. The following evening of 12-6-17, she noticed a rash on her forehead. The following day 12-7-17 she called our pharmacy to let us know what happened. At that point, she still had the rash on her forehead. I told her to take oral BENADRYL and call her MD. I followed up with a call to her on 12-8-17. Her doctor did have her come in. The MD thought the rash was a separate issue because it was localized. Otherwise, as of 5:20PM 12-9-17 the rash had subsided and she was feeling fine.
This spontaneous report was received from a pharmacist via company representative regarding multiple unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date the patients experienced local reactions. The outcome of local reactions was unknown. Causality was unknown. Additional information has been requested.
I woke up at 2 am with severe body aches, a headache, fever of 101.2 and chills that lasted for 24 hours.
moved date of second shot to a later date to be safe; two days of pain of the injected arm; one day of mild headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (two days of pain of the injected arm), HEADACHE (one day of mild headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (moved date of second shot to a later date to be safe) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (two days of pain of the injected arm), HEADACHE (one day of mild headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (moved date of second shot to a later date to be safe). At the time of the report, VACCINATION SITE PAIN (two days of pain of the injected arm) and HEADACHE (one day of mild headache) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (moved date of second shot to a later date to be safe) outcome was unknown.            The patient underwent tooth extraction which  caused a severe infection and swelling due to which the patient underwent two oral surgeries and was taking high doses of antibiotics, so moved the date of second shot to a later date for a safer side.   This case was linked to MOD-2021-054492 (Patient Link).
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 04-Dec-2013. It was reported that four patients were inadvertently administered expired FLUMIST quadrivalent which started on 04-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to four patients is unknown. The report was considered to be non-serious.
11/12/21 presents to EC ED for "fever, cough, chest pain, shortness of breath". PMHx "DVT, PE on Eliquis, HTN".
This spontaneous prospective pregnancy report as received from a physician refers to a 28 year old female patient. The patient's pertinent medical history was not reported. On 03-DEC-2014, a 6 months pregnant (Approximately 26 weeks and second trimester) the patient was vaccinated with M-M-R II (dose, route not reported). The patient's last menstrual period (LMP) was approximately 04-JUN-2014 and Estimated date of delivery (EDD) was 11-MAR-2015. No adverse effects were reported. The patient did not sought medical attention. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Shakes; Chills; Fever; Body aches; Back aches; Sweating; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0178) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced shakes, chills, fever, body aches, back aches and sweating. The clinical outcome of the events of shakes, chills, fever, body aches, back aches and sweating were unknown at the time of this report.   No follow-up attempts are possible; No further information is expected.
Swollen left armpit/lymph node; Headache; Low grade fever; Sore throat; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 07Apr2021 at 15:30(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 17Mar2021 at 15:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation and took Morphine on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 03:00 the patient experienced swollen left armpit/lymph node, headache, low grade fever, sore throat and body aches. 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. The clinical outcome of the event swollen left armpit/lymph node, headache, low grade fever, sore throat and  body aches was recovering.  No follow-up attempts are needed. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA I woke on the 18th with extreme fatigue and nausea, fell asleep twice during the day while sitting on the couch.  Lessened and became just tired by Sunday Dec 19.
Child seen in doctor's office today for red and swollen right thigh. Had DTAP in right thigh, 2 days ago. No fever, not tender and walks ok. Thigh is red and swollen from hip to knee and around leg. Told to apply ice and to give Benadryl and ibuprofen.
Received DTaP IM on left deltoid and MMR and IPV on left tricep fold area on 9/4/02. Noted redness arm of 9/6/02 on left deltoid. Size was 13x9 cm; no fever, no tenderness.Follow-up report received 10/16/02 stated, "Redness disappeared after 2 days."
R deltoid swollen 9.5 x 9cm approximately 4 hrs after injection, painful.
A 42 year old female patient had a Td injection on 08-31-2004. On 09-03-2004 the patient had swelling, redness and warmth over the injection site. The patient states that she had a fever and pain at the injection site
Systemic: Shakiness-Medium, Additional Details: Patient reported feeling "extremely nervous" and "faint" within 5 minutes of receiving the COVID vaccine. No trouble breathing, no rash, no lasting pain, and no fainting occurred. Patient reported history of anxiety attacks, and was smelling hand sanitizer to calm down. After several minutes with no relief from anxiety and constant feelings of faintness, patient requested emergency services. Fire dept determined all vitals were normal. Didn't take patient to hospital as only experiencing anxiety
Chills; Arm ache; Vivid dream; Body aches; Head ache; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 (at the age of 52-year-old) (Lot Number: EN6203) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and known allergies were none, and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 25Febr2021 16:00 (at the age of 52-year-old) (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 19Mar2021 01:00, the patient experienced chills, arm ache, vivid dream, body aches, head ache, joint pain. The patient did not receive treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
itching has gone down a little bit today 03Mar2021; face was comletely swollen; rashes on both sides of my face; face felt funny; eyes were so swollen; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face felt funny), EYE SWELLING (eyes were so swollen), PRURITUS (itching has gone down a little bit today 03Mar2021), SWELLING FACE (face was comletely swollen) and RASH (rashes on both sides of my face) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included SLE.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FACIAL DISCOMFORT (face felt funny), EYE SWELLING (eyes were so swollen), SWELLING FACE (face was comletely swollen) and RASH (rashes on both sides of my face). On 03-Mar-2021, the patient experienced PRURITUS (itching has gone down a little bit today 03Mar2021). The patient was treated with PARACETAMOL (TYLENOL) 02-Mar-2021 at a dose of 1 dosage form. At the time of the report, FACIAL DISCOMFORT (face felt funny), EYE SWELLING (eyes were so swollen), PRURITUS (itching has gone down a little bit today 03Mar2021), SWELLING FACE (face was comletely swollen) and RASH (rashes on both sides of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported  taking 2 Tylenol last night 02Mar2021. She used a cream on the rash. No concomitant medications were reported.
Next day I had a little sore arm and fatigue. 11Dec, I got a cough. 12Dec, cough got worse and a headache and got tested on 12dec2021 and was positive. This AM I felt a bit better. Headache is gone and have a bit of cough and no achiness. I can still taste and smell.
Pt developed large area of erythema, edema, induration at injection site, same day hours later. Day 3 post injection pt developed rash on arm and at one week pt had diffuse body rash. Pt received telephone triage on day 3 and reported to RN and MD at PCP 4-3-13.
Info has been received from a consumer concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644218/1027M). Subsequently the pt developed a rash. The reporter had no other info to provide. Unspecified medical attention was sought. Follow up info from the physician indicated that the pt developed pain and swelling in the deltoid and shoulder area following vaccination. The reporter noted that the pt could not lie down on that side and could not lift the arm because of the pain. The reporter indicated that 2 other pts developed a rash after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644218/1027M) (WAES #0302USA02959 and 0302USA02882). Additional info has been requested.
p/vax 2-3 days pt devel fever 101.7;had to be readmitted to hosp, labored breathing- 7 day course of Gentamycin;
Joint pain that began after second dose of COVID shot the end of January.  Required visit to PCP in April, treated with steroids and pain medication.  Continued pain that required visit to specialist (Rheumatologist) in July.  Final diagnosis of Rheumatoid Arthritis by Rheumatologist in July.
Patient received TDAP vaccine to right arm and Zoster vaccine to left arm. Patient had a redness and golf ball size welt to  arm TDAP was given on.  Patient also had redness to the arm that the Zoster vaccine was given on.
Moderna COVID-19 Vaccine EUA Starting 2/12/21 around 10:30am (while at dr's office) injection site became itchy, red and warm continues off and on through today 2/13/21, unclear if it has permanently subsided Previous mild symptoms for a day or two after injection were reported via VSafe and included pain at site of injection and mild nausea
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 10 weeks old female patient who had received liquid component of the first dose of PENTACEL (lot number: C5439A, expiry date: 29-Oct-2018) via intramuscular route in right thigh on 20-Aug-2018. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown if any adverse event was occurred. 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 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. Documents held by sender: none.
Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). The nurse reported that doses of improperly stored (Merck) PROQUAD had been administered to an unspecified number of patients on unspecified dates (dosages and route of administration not provided). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
SLEPT ALL DAY; MORE TIRED THAN USUAL; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced slept all day. On 08-APR-2021, the patient experienced more tired than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more tired than usual and slept all day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818227.
01/14/2021 evening sever chills could not get warm flu like symptoms, wet sweat, too hot, too cold, that lasted two days better for two days with chills, fatigue, body ache and muscle ache, and no fever. On going with the hot cold and the fatigue for a couple of days then sick again.
old Pfizer was drawn instead of the new bivalent Pfizer vaccine. no adverse reactions reported but meant to give pt the new bivalent vaccine. spoke with pt and recommended to come back after 2 months to receive the bivalent pzifer.
Patient presents to the ED on 01/22/2022 with a Chief Complaint of Abdominal Pain after receiving covid vaccine on 01/19/2022. Per guidelines, all hospitalization are reported.
Pt received a bivalent vaccine instead of a monovalent no reaction was noted or reported.
6 patients were given Pfizer vaccine that was diluted with bacteriostatic normal saline.  Issue was discovered and remaining vaccine was discarded.  We are unable to identify which 6 people were given the wrong diluent but able to identify the timeframe and narrow it down.
For over a week, patient's head was itching. When I investigated, I did see some red places on her scalp. I worried it might be lice since she is school aged and in Elementary school but it was not. We washed her hair with a new shampoo (Head and Shoulders) to see if it might be something on her scalp but that did not remove the itch. Finally after several days, her discomfort, as well as, the spread of the red marks to her neck, I called a telehealth DR because all immediate care centers and pediatrician were closed. They agreed it was not lice and prescribed a prednisone liquid, zyrtec liquid to take several days. If not better, follow up with Dr. I had a well visit appointment with Dr 1 week later so we visit the Dr 1-8-22 at 8 AM
I had my arm swell Up And get really hot. Big circle for about 5 days. I have tingling face and still Do with a little Red like A sun burn. I was achy for About 5-6 days. 7 days past the day of Injection I got another red circle by injection site and was it hot with bumps. It?s still there but not itchy it?s achy.
Woke up on the 18th of April feeling sick. A lot of pressure in my head. I called the doctor's office to make an appointment. They gave me an appointment for the following day. In the meantime, my cousin called me to tell me that she tested positive for Covid and I had seen her on Saturday. I went the the doctor on Tuesday, was tested for Covid, and tested negative. She felt that I had a sinus infection and treated me with azithromycin. I continued to feel bad with a lot of pressure in my face like sinus infection. I felt fatigues and almost felt like I had the flu. I tested myself with the government Covid test on Thursday, the 21st of April and tested positive for Covid.
One day after, the site was red and warm, two days after, it was swollen, hot, painful with chills, Third day, swollen but bigger area, hot, painful, with fever.  Went to primary doctor and got prescriptions for keflex and ibuprofen and tylenol.  On the fourth day, the swelling is less and no ever.  O n the fifth day, swelling is almost gone.  One week after, patient is good, with not syptoms.
Case received 2 MRNA vaccines for Covid, then was hospitalized for Covid pneumonia several months later.  Hospitalized at Hospital. 65-year-old gentleman with history of type 2 diabetes, hypertension, chronic kidney disease who was vaccinated for COVID-19 who presented with Covid pneumonia requiring 2 to 3 L of supplemental oxygen. He was treated with dexamethasone and remdesivir and within 48 hours was able to be weaned to room air. Despite the addition of corticosteroids and reduction in his Lantus he had some hypoglycemia episodes and his Lantus was scaled back significantly to 50 units nightly at time of discharge. Anticipate that he may have fluctuating requirements in the immediate post hospital. As he completes a course of Decadron and returns to eating his normal home diet. Thus we will have him follow-up with his primary care for any necessary adjustments. The patient was stable on room air at time of discharge and appointment was made for him to follow-up with his PCP in about 2 weeks