chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With the first shot he had soreness in his arm but that was basically it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Feb2021 (Lot number: EN6208) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lung blister" (unspecified if ongoing), notes: blister on lung many years ago in his late 20's or early 30's. They stapled it together.; "smoked" (unspecified if ongoing), notes: he was a runner and he smoked. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Feb2021, outcome "unknown", described as "With the first shot he had soreness in his arm but that was basically it". Additional information: No vaccines administered on same date with the Pfizer vaccine. No prior vaccinations within 4 weeks. AE did not required Emergency Room/Physician Office visit.  No follow-up attempts are possible. No further information is expected.
Patient had wheezing, swelling of lips, albuterol nebs, epinephrine 1:1000 0.15 cc, and decadron 6 mg IM given, patient transported to hospital in stable condition via ambulance
minimal side effects:   very sore left arm at shot site + tingling lips that went away quickly + a little tired + no fever + no chills
No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA (lot # S004120 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 11-JAN-2021, but upon internal validation established as 11-FEB-2021) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 1 hour. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Inappropriate schedule of drug administration; Maternal exposure before pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of drug administration) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In April 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On 29-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of drug administration). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. In April 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of drug administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   When tried to enter the doses in the system, the system did not accept the DEC2021 dose as the first dose, so ended up recording it as the second dose and  recorded the FEB2022 dose as a full dose booster.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-476097 (Patient Link).
Patient was given six separate vaccines. After he left the area on the way to check out. He then started to feel faint at that time the mother notified the receptionist. The Receptionist therefore called a code yellow. The patient was pale, he was given juice and crackers. There was several nurses on hand including a N.P.  His blood Pressure and oxygen levels were taken and documented. He was asked to stay seated for about 10 minutes to assure that he was doing better. After he was feeling better he was advised that he may leave but also to inform the nurse about his fainting at the next visit.
No additional AE; received RECOMBIVAXHB "in December" 2022, but is receiving the second dose today, 4/21/2023.; This spontaneous report was received from a pharmacist, regarding a female patient who was a nursing student. Concomitant medications included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The patient's concurrent conditions, pertinent medical history and drug reactions/ allergies were not provided.  In December 2022, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1 ml (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 21-APR-2023, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1 ml (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). No other adverse event occurred (no adverse event).
Patients Inadvertently received additional doses of both Tdap and Menactra.  No adverse reaction
Moderna COVD-19 Vaccine  The morning post second dose of vaccine, I felt nausea like symptoms which followed by fainting spell. In the afternoon had similar nausea like symptoms but felt okay after few minutes without fainting.  Next day, 2 days post second dose of vaccine, felt like little nausea like symptoms but resolved quickly.
Chills; fatigue; stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (stomach upset) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, CHILLS (Chills), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (stomach upset) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
High fever; chills; gastrointestinal upset; nausea; heachache; malaise
Parents report that shortly after leaving the Health Department where injection was given, a red ring formed around the injection site, the next day the child's whole leg turned red and child had red rash and temperature of 101.  Parents stated that they medicated child with Zyrtec (5 mg./5 ml) dose 1.5 ml, prescribed for them by the allergist to treat allergic reactions.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient received GARDASIL 0.5 ml (lot numbers and expiration dates were not reported), intramuscular in her gluteal muscle on the following dates: 11-JAN-2007 (first doe), 15-MAR-2007 (second dose) and 17-SEP-2007 (third dose). The pharmacist reported that the patient was very think and did not want injections in her arm. The pharmacist also reported that in the documentation in the patient's chart had the first two GARDASIL injections documented as "RDL" and the third injection documented as "LVL". No adverse effects were reported. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient said they experienced redness, swelling, and itching of the face, specifically around the eyes, which began the same day as the COVID-19 vaccine administration. The patient said they were "OK" and did not have to go to the hospital, however, they made an appointment to follow up with their doctor.
Pt recvd vax between AUG & SEP92 & exp arthralgia, paresthesia, numbness of fingers, shoulder & knee pain;
Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days.  I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling.  It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)
Narrative: COVID infection following COVID vaccine series 03/08 Janssen, dose #1 08/16 pt cc: chills, cough, fatigue, fever, headache, rhinorrhea, nasal congestion, myalgias, exposure: unknown 08/16 COVID swab, result: detected
Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013N20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Pt developed wheezing and coughing due to wheezing, pt attempted puffs from her personal albuterol inhaler with no relief, an albuterol neb was administered and 50mg benadryl given IM, pts symptoms resolved with this treatment, total time was approximately 15-20 minutes.
On 9/8/99, the pt experienced arm tenderness, low grade fever, injection site redness, and edema 4-6 cm in size. The symptoms lasted 5-6 days.
The day if my vaccination, no adverse reaction. The morning  after, I woke up with a large and painful lump just under the left arm pit, I had received the shot in! It is painful and seems to be getting larger. It is APX.  4" WIDE 6" LONG AND 1 PLUS ".S HIGH!!!
Ran fever of 101 degrees overnight, chills, injection site for 3 days. Fever gone on day 2.
Patient complains that she has pain in the left arm. She described the pain as transient and at times flaring up really bad. This issue started after two weeks since she had gotten the previous covid booster last year. She did not feel like it was a big deal and thought the pain would go away on its own; therefore she never notified the pharmacy or her provider about it.
Rash, swelling and pain at injection site. It was very sensitive to the touch and the area was hot. The rash was 2 inches by 3 inches.
CONFIRMED COVID19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced confirmed covid19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (units unspecified), and COVID-19 rapid POC test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pt recv vax on 11/20/98; on 11/21/98 pt exp urticarial rash
Pt. starting itching approximately 5-10 minutes after receiving FLUZONE .5cc injection. Given BENADRYL 25mg at 11:30 AM. Itching still present at 11:55 AM given second BENADRYL 25 mg.
painful arm extrem pain that i could not move. Develooed rash all over body like hives and small bumps that same night of vaccine got worse net day and third day seems like its the same. Dr gave me steroid shot to see if rash would calm down did not help. Vert fatigue started day 2 of vaccine and diarreah. Day 3 fatigue worsen seems like my airway is forsing to breath. mg face is numb under my eyes like between eyes n  cheek bone and nose seems numb. I feel weak and even dizzy today on day 3. Not feeling myself
Pt had allergic reaction to 1st dose of vaccine the prior month, at which time she was treated with famotidine and diphenhydramine and her symptoms improved. On the date of the 2nd vaccine, she premedicated with 50mg diphenhydramine and 20mg of famotidine. Approximately 15 minutes after receiving the 2nd dose, she felt her lips tingling and developed throat tightness and itching, with some difficulty swallowing. She went to the ED for treatment, where she was given an additional 25mg PO diphenhydramine and 60mg prednisone. She was observed for ~2 hours prior to discharge.
Soreness and swelling at injection site (immediately after - duration 5 days). Fever of 101 (24 hrs after - duration 1 day). Redness (3 days after - duration 3 days).
Received shot too low. The nerve was damaged. A ball was formed on the injection site. Bruising.Two months later there is still swelling and pain.
Head feeling heavy, dizzy when turning head from side to side.  Evaluated by EMS.  BP 142/80, HR 82, O2 97%.  1:45 pm  feeling better.  1:51pm feeling better,  BP 129/74,  HR 70 - discharged home.
Headache, Fever, NauseaVomiting, Extreme fatigue, sweats, swollen arm Narrative:  Extreme fatigue, fever 101.2, sweats, nausea, vomiting, swollen arm, headache; taking ibuprofen, tylenol.  Other Relevant History:
Within a few hours after shots, developed inconsolable crying off and on for 3 days.  No period longer than 3 hours-fever the first day on exam 1 cm SC tender nodule right lateral thigh-inconsolable cry resolved by about 96 hours.
RN administered Moderna 0.5mL when Pfizer 0.3mL was indicated. RN did not closely view the vaccine registry.
I had been at a conference and traveling. The day before I got back or was about to travel back my boss let me know that they had tested positive. I was achy all over and super tired I really had common flu like symptoms. I did develop a cough and was having issues with my respiratory system along with a runny nose. I did take test that Thursday the 12th when my boss told me that they were positive and that was negative. I took more at home tests over the weekend and even went into the pharmacy for a PCR test. Those were all negative. By Monday I was feeling worse and tested again and that positive. I called in and had a virtual appointment and was prescribed PAXLOVID. With-in 12 hours I was feeling so much better without any symptoms.
Mother reports that the child vomited twice within 10 minutes of receiving the vaccine.  Mother further states that the child had a fever of 102 that same night.  On 03/31/2014, mother states that her daughter developed small red bumps, about the size of a quarter on her left cheek.  On 04/01/2014, the red bumps spread over the entire body, including the genital area, causing the child to experience pain on urination.  Mother states she took her daughter to be evaluated by a pediatrician.  Mother further states that the pediatrician stated that the child was having a reaction to the MMR vaccine.
25 yr male with history of Anxiety and near syncope event felt faint after injection. Lying down, water, juice and conversation, self resolved.
patient who was 2 1/2 years old received quadracel yesterday with no reported adverse event; Initial information received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 1/2 years old male patient who received diphtheria-15/ tetanus/ 5 hybrid AC pertussis/ IPV (MRC5) vaccine [Quadracel] yesterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Aug-2023, the 2 1/2 years old patient received 0.5 mL dose of suspect diphtheria-15/ tetanus/ 5 hybrid AC pertussis/ IPV (MRC5) vaccine, suspension for injection (batch number: C6002BA) (expiry date unknown) via intramuscular route in the left thigh for Immunisation with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient who was 2 1/2 years old received quadracel yesterday with no reported 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 the guidelines. 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.
To left thigh, local reaction. Area was red, raised and warm to touch. Instructed to give Tylenol for pain/discomfort. Cool bath, warm/cool compress to area, movement such as walking. Contacted mom on 04/17/18 and mom stated she was doing much better.
09 at recovery station, c/o dizzy. Took about 1/2 hour till admitted feeling better, lacked symptoms - unable to describe dizzy. Resolved on bench with legs elevated. No symptoms. Gave med, H2O drank - back to class.
Patient reported feeling fine after vaccinatoin up until 7 days post Moderna vaccine. She reported her arm started to itch and hurt terribly. She reported a rash that grew to 6 inches long and is starting to show improvement today after 3 days. She reports the itching was much worse than the pain and bothered her so terribly she had difficulty sleeping.
Patient reported violent shivering and 102 degree fever. He states that the shivering was so bad that he thought he might be having a seizure.
He is having swelling in his armpit on the arm where the shot was administered; It's severely sore/swelling in his armpit on the arm where the shot was administered; This is a spontaneous report from contactable consumer (Patient's Parent), reported for a 18-year-old male Patient. An 18-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Aug2021 (Lot number: Unknown) at the age of 18 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE; TRILEPTAL; TRAZODONE. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "He is having swelling in his armpit on the arm where the shot was administered"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "It's severely sore/swelling in his armpit on the arm where the shot was administered".Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain.  Additional information: Reporter stated, "My son went this past Friday to get the COVID Pfizer shot (Pfizer BioNTech COVID-19 Vaccine) and he is having swelling in his armpit on the arm where the shot was administered. How long can we expect this? Because he is in high school and he has weight training and we don't know what to do as far as the class and it's severely sore." Reporter was informed about Pfizer Medical Information Department and offered the number. Reporter was provided with the number of Pfizer Medical Information Department and was requested to select option timings as 8 am to 8 pm on Monday to Friday. Reporter was informed about the role of Pfizer Drug Safety Department and requested to probe Name of the vaccine: Pfizer BioNTech COVID-19 Vaccine. LOT#: Reporter stated, "All I see is his name, his date of birth, Pfizer the date and Pharmacy. When confirmed that there is no LOT#, consumer stated, "No." Reporter Type: Reporter stated, "No, I am not (hence captured as consumer or other non-health professional in tab)."Anatomical site of administration: Reporter stated, "Right Arm." Other medical condition and Concomitant medications: Reporter stated, "Yes, he is taking other medications." Name of medication : Reporter stated, "He is taking Vyvanse, Trileptal, 'Trazodone' that's it (Medicine name not further clarified hence not captured in tab).Treatment : Reporter stated, "Ice and Ibuprofen."  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Weak; arm is very sore; lips and bottom gums are tingling; lips and bottom gums are numb; haven't ate or drank anything; arms and hands itched; Chills; FEVER; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb) and FEEDING DISORDER (haven't ate or drank anything) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb), FEEDING DISORDER (haven't ate or drank anything), PRURITUS (arms and hands itched), CHILLS (Chills), PYREXIA (FEVER) and VOMITING (throwing up). In December 2021, PRURITUS (arms and hands itched) had resolved. At the time of the report, ASTHENIA (Weak), PAIN IN EXTREMITY (arm is very sore), PARAESTHESIA ORAL (lips and bottom gums are tingling), HYPOAESTHESIA ORAL (lips and bottom gums are numb), FEEDING DISORDER (haven't ate or drank anything), CHILLS (Chills), PYREXIA (FEVER) and VOMITING (throwing up) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-408953 (Patient Link).
The pt received a Fluvirin vaccination on 10/23/98 and on 5/29/99 experienced pneumonia and respiratory failure and subsequently died, as a result the adverse event was considered serious. The reporter assessed the causality as possibly related. No more information has been provided.