chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the second dose of the vaccine 17 days later vs. 28 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose of the vaccine 17 days later vs. 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose of the vaccine 17 days later vs. 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose of the vaccine 17 days later vs. 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with the mRNA-1273, is considered as not applicable Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Localized area (5 cm (around)) of redness, swelling, and tenderness to left arm, upper deltoid area - Approx 11 days duration - 6/22/10 -> 7/2/10.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter reported that the vaccines were stored in freezer and they take out one to two vials and placed in fridge each day as needed.  No treatment medications were provided.
About an hour after the flu shot, I felt like a lump in my throat, it felt more like air was closing off down there, my eyes were burning and running a lot of water. This went away after about 30 mins or so. I went to sleep, after waking up, I notice my face was swollen.
Left side of face swollen and numb. Under the care of a neurologist and attending physical therapy. Diagnosed with Bells Parsey about 8 days after receiving first dose.
Elevated heart rate, blood pressure remained high at minimum of 165/110 chest tighten.. tingling/swelling in left hand and feet.. became weak speech slurred felt moments of wanting to pass out.
Fever 103F Chills Body ache Headache Nausea Red itchy rash around the site of the vaccine
Mother is very concerned that child has developed autism since the last vaccinations, given on 9/12/2000. She said that on 9/22/00 her husband thought the child was in a world of her own. She started crawling backwards and also starting to rub her head against people. On 9/18/00, I had already noticed she was very mopey. Not interested in playing, she seemed to be running a slight fever, has stopped talking and chattering. She doesn't want to eat. I asked her to say "up" when she put her arms up and she looked confused and walked away. On 9/19, still drinking her morning bottle, waking up cranky instead of happy. She zones out but I can say her name and touch her face and get nothing but a blank stare. On 9/20/00, I called the MD to see if they thought her behavior could be related to her shots. She points and says "kick" to everything. She wants to pet the black and white stuffed dog, doesn't dance to music or spin in circles and won't engage in game with her sister as she used to do. She won't take her chewable vitamins which she used to come running for and she also has puffiness under her eyes. Instead of talking, she points and says "uh uh" frustratedly. She still has a fever, very attached to her blanket. She wanted on my lap then off, then on, etc., still crying. This is very unusual behavior for her. After her doctors visit on 9/22/00, I gave her 1st dose of CLO-1 teaspoon. She doesn't run like she used to and still unsteady and she is not as fast. I noticed that around 17:00 or 18:00 she is more herself. I noticed a rash on her back, at the waistline and then making a triangular shape on her buttock. I called her MD and described it and she said it sounded like yeast. Rash, red, definite edges, raised and swollen area and feverish. Took to the doctor on 9/21/00 and told to give Motrin. Nose was congested, dark circles her eyes and several teeth coming in and felt the glands in her neck and said her eyes looked fine. She rubs her head and sometimes bangs her forehead on our coffee table or doors or walls. She is excited when daddy comes home. She is also stumbling and walking unsteadily. Her urine smells salty and stools were a little hard but looser now. She has had a decreased appetite and lost 1 lb in 2 weeks. We gave her Nu-Thera with P5P dietary supplement powder. On 9/26, I gave her 1 tsp of CLO. With her speech, it is like she has started over with the baby talk. Playing with the farm animals and the stuffed animals causes her anxiety and frustration for her. FU from physician indicates child is not autistic and her symptoms are improving.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. No demographic information was available. On 23-OCT-2014 the patients were vaccinated with doses of expired PNEUMOVAX 23 lot # J010654, expiration date: 17-OCT-2014, route of administration was not provided. The vaccines were also exposed to temperatures outside of the proper storage range. No adverse event was reported. Additional information has been requested.
little uncomfortable feeling, like having a cold; little uncomfortable feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 13Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jan2021, outcome "unknown", described as "little uncomfortable feeling, like having a cold"; DISCOMFORT (non-serious) with onset Jan2021, outcome "unknown", described as "little uncomfortable feeling".  Additional Information: Patient has taken second dose on 03Feb2021 and had no issues at all.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis left thigh post vaccination Keflex 250mg PO TID x 1 week. Tylenol warm compress.
I contracted COVID-19 on 06/27/2022 with symptoms of sore throat, cough, and fever. I was prescribed PAXLOVID on 07/02/2022. I was ill for 9 to 10 days before my symptoms began to resolve. I still have a lingering cough.
skin reaction on chest, upper stomach, looks like rosacea, not painful, not itchy.   Other reactions after the Modern booster were light fever, chills, headache, nausea, fatigue, feeling better now. Rosacea still there.
Postherpetic Neuralgia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His medical history, concurrent conditions and concomitant medications were not provided. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, the patient was treated by a physician at a medical office for postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, he had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The postherpetic neuralgia injury was considered to be ongoing.
Redness at injection site approx. 5" in diameter. Sore to the touch. Patient was given Benadryl 1 time every 6 hours
The pt experienced an urticarial rash noted on second day post vax on trunk and extremities.
3hr p/vax T106 & shaky sent to ER told it was probably from tetramune shot irritable;
Itchy all over; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over) and HEADACHE (Really bad headache) 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy all over) and HEADACHE (Really bad headache). At the time of the report, PRURITUS (Itchy all over) had resolved and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-073015 (Patient Link).
After the first dose, fast heart beats up to over 130; high blood pressure, fatigue, could not perform evening's exericses; skin itchiness around neck and right arm (still itchy now from time to time) ; after second dose, a fever till 102F, then took Telynol 500mg twice and one Motrin 200mg. Two months after felt better, seemed to regain the strength, was able to power walk daily;  Since the first dose, got often red face with burning sensation around the sides of the neck, hot blood flow around left leg/ankle;  skin easily got irritated and broke when scatching;  the worst is since Sept. high blood pressure, am now put on Propranolol 60 mg on Sept. 25, a week later switched to 10mg; I am taking it 3 times a day every 8 hrs, but as soon as it gets the time to take the next dose, BP is very high 175/115 this moring); it seems to me that it is completely out of control for unknown reason. I am not axious about anything...
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2017, the patient was vaccinated with an improperly stored GARDASIL 9 (lot: M041990: expiry date: 28-JUN-2019) (incorrect product storage). The vaccine was stored at 0C for 16 hours 10 minutes. The call was due to a data logger. No adverse effects were reported.  There was no prior temperature excursions. Additional information has been requested.
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 11 years old male patient who was vaccinated with a 1.0 ml dose of vaccine FLUZONE (lot number and Exp. Date not reported) via intramuscular route in the left deltoid on 01-Feb-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to overdose. It was unknown whether the patient experienced any adverse event. 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. List of documents held by sender: none.
On April 7 and and 9, day 11 and 13 of my menstrual cycle I experienced spotting. That cycle ended up being only 26 days with me beginning to bleed on April 23rd, and during my menses I had a headache for 3 days in a row and greater moodiness. My next cycle was 36 days, then 30, the 26, and currently waiting for my period and on day 34. So it is unclear whether my cycle has re regulated.
Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
COVID-19 VACCINATION MADE FELT ACHY ALL OVER; Sniffles; Postnasal drip; COVID-19; Cold like symptoms; Muscle spasm in chest; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19), NASOPHARYNGITIS (Cold like symptoms), MUSCLE SPASMS (Muscle spasm in chest) and FATIGUE (TIRED). At the time of the report, PAIN (COVID-19 VACCINATION MADE FELT ACHY ALL OVER), RHINORRHOEA (Sniffles), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), COVID-19 (COVID-19), NASOPHARYNGITIS (Cold like symptoms), MUSCLE SPASMS (Muscle spasm in chest) and FATIGUE (TIRED) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter. On unknown dates, the patient experienced sniffles, covid-19 vaccination made felt achy all over and tired, postnasal drip, covid-19, cold like symptoms and muscle spasm in chest. No treatment information was provided. The reporter's causality of Humira for the events PAIN, RHINORRHOEA, UPPER-AIRWAY COUGH SYNDROME, COVID-19, NASOPHARYNGITIS, MUSCLE SPASMS and FATIGUE was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2022: Live follow up received: New event added.
pt recvd vax 25AUG93 & devel following sx pruritus, urticaria worst on abdo area-welts protruded 2", swollen eye lids & scratchy eye lids;
lump under lymph arm/Swollen lymph node (left); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lump under lymph arm/Swollen lymph node (left)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced LYMPHADENOPATHY (lump under lymph arm/Swollen lymph node (left)). The patient was treated with IBUPROFEN ongoing from 14-Jan-2021 at a dose of UNK UNK, qd. At the time of the report, LYMPHADENOPATHY (lump under lymph arm/Swollen lymph node (left)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI: Patient's email address updated.
Large local reaction at site of DTAP and IPV injections. 8.5x10.5cm raised red indurated, slightly tender. No SOB, swelling of lips or eyes.
Hives; Numbness and tingling; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives) and HYPOAESTHESIA (Numbness and tingling) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and HYPOAESTHESIA (Numbness and tingling). At the time of the report, URTICARIA (Hives) and HYPOAESTHESIA (Numbness and tingling) was resolving. Not Provided      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.   This case was linked to MOD21-049553 (E2B Linked Report).; Sender's Comments:  MOD21-049553:
Breakthrough Case admission 1/7/21 Pfizer Lot#3 el1283 1/28/21 Pfizer Lot# EL3247 1/14/22 Pfizer Lot# FJ5682
First day  1 .Arm pain  2.Neck pain  3.headache  Second day  4.chest Pain  5.Armpit pain  6.strong pain in the arm 7. some difficulty to breath 8. Swelling face  The rest of the days until today 6/30/2021 Armpit pain  chest pain  chest pressure some difficult to breath leg and feet pain
Woke up feeling Ill. He was mentally distant & fatigued. He staggered into the living room and collapsed in the recliner.  Was unresponsive to verbal commands.  His eyes rolled back into his head.  Felt he was doing fine and collapsed to the floor as he stood up the second time. Wife called paramedics - they came and checked him out. BP was 132/86, sugar was ok, pulse ox 98, as time went by we became more responsive.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient did not have any adverse events post injection. It was reported that the storage condition at the time of the excursion was at refrigerator. Maximum temperature reached was 64-degree Fahrenheit, and excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. Temperature excursion occurred on 10 Mar 2022. As per source document the Tran date was reported as 15-Mar-2022. No treatment medication information was given.
Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
48 hours of muscle and joint aches similar to those with a flu. Very mild nausea.  Exhaustion. Skin was stinging.  Intermittent pains in head. Not headache.  Followed by mild dizziness and continued fatigue from the 48 hour mark until today.  I have recovered from the worst of the symptoms but continue to feel some fatigue and upper left arm injection site still red, swollen, sore and itchy.
Within 10-15 minutes experienced full body pruritus, worse on the upper extremities and chest.  Experienced throat tightness sensation 24 hours after vaccination that resolved 1 hour after taking more loratadine.  Also experienced extreme right arm soreness 24 hours after injection, which lasted for about 3 days.
Child began with rash 3 days post MMR vaccination.  Mom took to Dr. who associated rash with vaccine.  Mom took child home, rash worsened and acquired fever of 103 degrees F, responsive but lethargic.  Admitted to hospital.  Child quarantined with rash and encephalitis per mom. Hospitalized for approximately 2 days.
Covid symptoms started on 03/28/2022. I had a home test come back positive on March 30, and a PCR test return positive on April 7. The symptoms were congestion, productive cough, muscle aches, and fatigue. Symptoms lasted about 10 days. I did reach out to my PCP and Oncologist because I wanted to understand what my options might be, and I was put on antivirals that was prescribed over telephone. I have no lasting symptoms, and I had a negative PCR last week.