chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day felt a little sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Next day felt a little sore) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Next day felt a little sore). At the time of the report, MYALGIA (Next day felt a little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.   No treatment information was provided.   This case was linked to MOD-2021-035031 (Linked Report).; Sender's Comments:  MOD-2021-035031:
Mild body ache; Pressure at the back of neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild body ache) and NECK PAIN (Pressure at the back of neck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (Mild body ache) and NECK PAIN (Pressure at the back of neck). At the time of the report, PAIN (Mild body ache) and NECK PAIN (Pressure at the back of neck) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Mother states at 4pm child started to have red raised rash on both lower extremities. Child was covered with rash by 9pm and somewhat lifeless. Child eat and drink most of day. Mother took child to ER and was treated with Prefone and responded within 1/2 hour and to continue with Prelone x 3 days. Child also cried when touched below legs by 9pm
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious.  No follow-up attempts are possible. No further information is expected.
Over a week after the vaccine, the upper arm is sore and tender at vaccination site again. Patient is feeling fatigue and lightheadedness.
heart palpitations; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and DIZZINESS (dizziness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PALPITATIONS (heart palpitations) and DIZZINESS (dizziness). On 07-Mar-2021, PALPITATIONS (heart palpitations) and DIZZINESS (dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Cellulitis developed at injection site 2d later. Infant placed on abx and followed up.
Injection site pain; leg muscle soreness; This is a spontaneous report from a contactable Other-HCP. A 41-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number Ek5730), via an intramuscular route of administration on 18Dec2020 at 07:35(at the age of 41-years-old) into Arm Left as a single dose for COVID-19 immunisation at hospital. Medical history included asthma from 09Jan1981 and ongoing, polycystic ovaries from 15Aug2016 and ongoing, Allergies from an unknown date and unknown if ongoing, High Blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included mometasone furoate (MOMETASONE FUROATE) taken for Allergies from 15Jul2010 to an unspecified stop date; cetirizine hydrochloride taken for Allergies from 30Aug2013 to an unspecified stop date; lisinopril taken for High Blood pressure from 15Jul2016 to an unspecified stop date. On an unspecified date, the patient experienced Injection site pain,8-10 hours after injection leg muscle soreness. Treatment included Magnesium 400mg, Electrolyte water, Ibuprofen for the events. No culture was performed. The events did not require visits to the emergency room or the physician's office. The patient received acetaminophen 400 mg (2x200 mg) by mouth on 08Jan2021 for fever,30 hours after injection fever over 100.3. The patient underwent lab tests and procedures which included body temperature: 99.0-101.6 on an unknown date, body temperature: fever over 100.3 on 08Jan2021.The outcome of the events was recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "79 YO female that presented to the ED with c/o right leg pain. Patient reports she has been dealing with a leg wound since the holiday. She went to her primary doctor and was given abx. Unable to recall which abx. She finished the course last week but has been having increasing swelling and pain in the right leg. Making it difficult for her to get around at home. She reports yesterday she could barely walk. She took some tylenol at home which seem to help for some time. Pain is throbbing and goes down to her foot. She has been using a walker to get around lately due to pain in leg. She reports pain is much better now and is able to walk. Patient was found to have Covid. She tested on the 15th. She reports nonproductive cough, congestion and intermittent wheezing . Patient is not sure of hx of COPD or CHF. Reports albuterol inhaler use at home. She admits to smoking a cigarrete to half a pack depending on the activities of the day. She denies fever, chills, malaise. She denies chest pain, nausea, vomiting.   Hospital Course: No notes on file patient is a 79yr old female with a history of HTN, HLD, CKD, Anxiety who presented with Right leg pain and swelling.She says symptoms started since the holiday when part of her crockpot fell and pierced her leg causing a wound.    Sepsis secondary to RLE Wound Cellulitis - Wound non-healing since the holiday, apparently failed outpatient abx. Blood culture no growth 2 days, wound culture growing staph epidermidis and pseudomonas aureginosa. Wound care on board. She received IV Vancomycin and IV cefepime day#2. MRSA nares negative. Will discharge on keflex to complete 7 days of treatment.    Right lateral leg: Cleanse with normal saline. Apply Therahoney to wound bed. Cut Maxorb II (calcium alginate) to size of wound bed and place over Therahoney. Secure with Optifoam Gentle. Change Monday, Wednesday, Friday, and as needed.   Active Problem: Incidental Covid finding - No overt sign of respiratory distress or xray findings suggestive of covid so no indication for covid directed treatment. Will continue to monitor."
Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative:  Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2009, the patient was inoculated with ZOSTAVAX by the healthcare facility/clinic (by unspecified healthcare professional), as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by the healthcare facility/clinic (by unspecified healthcare professional), for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  The reporter considered the events as related to ZOSTAVAX. Additional information has been requested.
Myalgias, chills, vomiting, shivering. Went to emergency room and was given IV fluids and discharged.  Later, developed headache, subjective fever, cough. Still symptomatic as of 5/16/2012; further evaluation pending.
pt recv vax 15APR97 & to clinic 15APR97 w/t104 R-was fine earlier evaluated for infect;urine cult contamination staph;
A few minutes after her vaccination, the infant became nonresponsive with blank stares, initially was limp with pallor, she cried intermittently with sensation, oxygen given. Episode lasted about 45 minutes with infant lethargic. After episode infant was alert and smiling.
Nausea; Vomiting; Dizziness; This is a spontaneous report from contactable consumer (on behalf of his wife) via Medical Information Team. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered on an unspecified date for COVID-19 immunization. Second dose was administered on Tuesday (09Mar2021), on Thursday (11Mar2021) experienced nausea/vomiting, was prescribed Zofran/Antivert. Saturday night hospital given IV Ativan/Antivert/Zofran. She still maintains dizziness. She took a lot of medications. The outcome of dizziness was not recovered and for other events was unknown.    Information on the lot/batch number has been requested.
1-2 days after receiving vaccination in left deltoid, she developed redness, pain in the upper arm, also nausea and diarrhea.
Extreme painful lower back body inflammation. And other parts of my body suffer from inflammation. I Never had this before I had this extremely harmful vaccine. It felt as though I had a semi short circuit in my nervous system. Related to my lower back and legs. Which is now evolved into an inflammatory syndrome when it occurs someone  who is sick. I become painfully inflamed. As though my immune system is attacking me. And I have complained to many doctors and anybody who would listen to me the whole time. Including the facility. I had the moderna shots. Two shots. They have the records In clinic. Of which shots I took in which arm. I feel as though I'm a victim of fraud because of their lies. I would of never taken any of these shots if they didn't say it had 95% of protection. And you would not get the virus after taking the shots. And now I feel I'm going to suffer a long lifetime of pain and imflammation because of the lies.
With in five hours of vaccination child developed fever lethargy, and diarrhea. Pt also developed eczema. Lasted 5 days in duration
A quarter-sized lump appeared in the area of vaccination on 10/10/2014 which spread to cover the entire upper arm within 3 days. High fever, nausea and vomiting, severe back pain followed. Fever, nausea and vomiting, and pain resolved in 48 hours. Lump in arm slowly resolved in 4 weeks. Took prednisone taper for 13 days.
Extremely large (4-5 inch in diameter), warm, red-hard area around DTaP injection site. Treated with Augmentin ES600 1 1/2 tsp bid x 10 day-warm packs prn.
7 Days after injection, at the injection area my arm became very red and itchy.  within 24 hours the area was swollen, sensitive to touch, very itch, the area was hot and about 3 inches in diameter.--after 7 more days, still slightly itchy but no longer red or sensitive.
Migraines (1/13/2021-Present), Nausea (1/13/2021-Present), Fatigue (1/13/2021-Present)  Redness, Itching, and Swelling of injection area (1/13/2021-Present) Soreness spread from injection area to chest and back (1/13/2021-Present)  All treatment has been hot compresses on injection site and other irritated areas as well as Naproxen OTC.
aches, pain, dizziness, light-headed, cramping in bowels, diarrhea, nausea; started 5 hours post shot & lasted ~ 16 hrs. On Thu 5/30, states she was mostly just tired & weak and feeling almost normal today 5/31/19
Arm pain-swollen-very itchy-red. Couldn't lift. 10 pm fainted/like seizure.
Approximately 6 hours after vaccine, began to have stomach upset and then later that evening began to have muscle and bone pain. Later that evening felt that heart rate was "low" and that "I couldn't get air", meaning was having some SOB. Also began to have rib cage pain and felt weak.
6 cm x 7.5 cm erythema with induration; non-tender to palpation; no warmth at site. Imm. administered 4/12/11; seen in office r/t reaction 4/14/11. Tx: ice pack to arm & Ibuprofen.
Flu like symptoms; cough, chllls, fever 102.5; dizzy.
About 30 minutes after vaccines administered patient was in pharmacy waiting with parent.  Mom noted patient to start to have tremors, seem to breath more rapidly, look like she was going to faint and became pale. Did not have Loss of consciousness.  Patient was brought back to clinic and noted to look weak and pale.  Blood pressure, respirations and Pulse Ox were WNL. Blood glucose checked and was 56. Oral glucose gel 15 gm administered. EMS contacted to transport patient to emergency room. Blood glucose rechecked 15 minutes later and was 60. Another 15 gm of oral glucose administered.  EMS arrived and rechecked blood glucose prior to leaving which was 79. Patient taken to emergency room for further evaluation.  Per Emergency Room note patient was back to baseline with stable vital signes by the time she arrived in Emergency Room.  Did not think episode was related to seizure thought was a presyncopal episode. Observed for 1 hour and continued to be stable and had normal EKG. Discharged with follow up with PCP and Neurology.
Patient displayed signs and symptoms of vaso vagal reaction 5-7 mins post vaccine : dizziness, nausea, vomiting, no rash present. Pt  was given an ice pack, water and started feeling better about 20 to 30 minutes later. No medical treatment was necessary
63yr old female called into call center, stated she received J&J vaccine Friday 4/16 (external site; not with county), and today noticed swelling on her left calf, and 4/10pain above her left knee. Pt denied emergency symptoms at the time of call. Stated sunday night she felt her throat ""a little tight."" Drank water and felt better. Denied swelling of face, lip and throat at time of call.  Pt denied SOB, pain/tenderness on calf, petechiae, new/easy bruising, abdominal cramping, backache or headache. Pt stated only other symptom she felt was on Friday 4/16 evening, a slight headache after the vaccine. did not experience any other symptoms. Pt Advised to call 911  or arrange for immediate transport to the closest ED. Pt verbalized understanding and agreed.
This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 including PF-07321332/ritonavir (PAXLOVID). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
approx 5 or 6 days p/vax pt devel gen red raised rash;following day papules appeared & were present @ the date of this report;
It first Bbgan with soreness at injection sight. The next day, I experienced nausea, shooting pains I various parts of my body, and chills. Then there was a lot of redness and swelling for several days, and I was unable to lift my arm above shoulder height or carry anything or even touch the arm without a significant amount of pain. A week in a half later, I still have some mild swelling and redness.
apneic episode 24 hr p/vax; to ER by 911 code;
The pt developed red, swollen upper arm from top of shoulder down for 5 inches area, hot to touch. Treated with Tylenol or Ibuprofen and cold compresses.
Bleeding from his stomach, from his anus, seriously; Bleeding from his stomach, from his anus, seriously; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) at single dose for an unspecified indication.  The patient medical history and concomitant medications were not reported.  The patient experienced having some adverse reaction on an unspecified date: He is bleeding from his stomach, from his anus, seriously. Inquiry regarding bleeding from his stomach, from his anus, seriously relative to the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
Low-grade fever; Extreme chills; Feeling cold; Switching off with hot flashes; Nausea; Dry heaving; Back became extremely sore and painful; Back became extremely sore and painful / have a disc herniation at the L5-S1 level.; Left arm (place of injection) remain sore; Tired; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 which was confirmed via positive antibody test as blood test performed on 23Dec2020, disc herniation at the L5-S1 level and penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lisdexamfetamine mesilate (VYVANSE); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, after the vaccination, the patient became tired. After 9 hours, the patient started developing a low-grade fever. Over the course of the following six hours, the patient's body was experiencing extreme chills, feeling cold and switching off with hot flashes that came along with nausea and dry heaving. The patient's back became extremely sore and painful. The morning after, the patient's body had returned to a normal temperature but her back and left arm (place of injection) remain sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events tired, low-grade fever, extreme chills, feeling cold, switching off with hot flashes, nausea, dry heaving, back became extremely sore and painful / have a disc herniation at the L5-S1 level and left arm (place of injection) remain sore was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the ED for suicide attempt by drug ingestion and was subsequently hospitalized within 6 weeks of receiving COVID vaccination.
Patient got first shot of shingrix on 12/02/20/20. On 02/02/2021 she came in for her second shingrix shot and reported that the only reaction she got from the first shot was  a slight irritation on the injection site.  The only allergy she reported on her questionnaire was to clindamycin. She was fine after she got the shot and actually waited for her husband to get his shot..  A few minutes after, she fainted and became unresponsive. I administered epinephrine which revived her, and called 911. She said she was okay but very weak. She was taken to the emergency room, and later discharged after a few hours.