chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his tonsils are still swollen and he went back to urgent care because his tonsils are so swollen that he can barely swallow.; his tonsils are still swollen and he went back to urgent care because his tonsils are so swollen that he can barely swallow.; This is a spontaneous report from a contactable consumer (patient's mother).  A 18-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) on 09Apr2021 for covid-19 Vaccination. Caller states she is not sure if her son is having a reaction to the Pfizer COVID vaccine. Caller states he received the first dose on 09Apr2021 and then on 10Apr2021 she took him to urgent care because his tonsils were swollen, enlarged, he couldn't swallow and his tonsils were touching each other. Caller states urgent care did a strep test and it was positive so they prescribed him Amoxicillin and he finished the course of antibiotics and then on 04May his tonsils were swollen again and he went to convenient care and he was prescribed Zithromycin and Methylprednisolone. Caller states he finished the course of those antibiotics and medications as well. Caller states he received his second dose of the vaccine on 07May2021 four weeks apart instead of three weeks at . Caller states now he is saying that his tonsils are still swollen and he went back to urgent care because his tonsils are so swollen that he can barely swallow. Caller states her son does not have a primary care doctor and it would be until June before he can be seen there. Caller states he has been to urgent care three times and they don't know what to do to treat her son. Caller states he has not had any other symptoms such as a cough, fever, or tiredness. Caller states he is a healthy student athlete with no underlying conditions and no history of having tonsillitis or strep. Caller would like to know if the Pfizer COVID vaccine could have caused her sons symptoms and what treatment recommendations are there for him. Caller would like to know if it is possible for her son to already have had strep prior to receiving the Pfizer COVID vaccine and then the vaccine caused an immune response to make his symptoms worse after the vaccine. Caller states this issue has been going on for a month. Caller states I have not provided her any information that can help him and hopefully he doesn't die she will just have to figure it out. Caller disconnected call unable to offer survey. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Localized edema to area, erythema within 2 minutes of injection, ice pack applied to area.
Headache; Nausea; Vomiting; Low grade fever; Fatigue; muscle ache; Swollen lymph node near the injection site (armpit); general pain at site of injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (muscle ache), LYMPHADENOPATHY (Swollen lymph node near the injection site (armpit)) and VACCINATION SITE PAIN (general pain at site of injection site). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (muscle ache), LYMPHADENOPATHY (Swollen lymph node near the injection site (armpit)) and VACCINATION SITE PAIN (general pain at site of injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant products were reported.No treatment drugs were reported.
Initially there was typical soreness in the injection sight, but the soreness subsided and now I am experiencing shoulder stiffness and pain that wakes me up at night and causes pain when I lift my arm. It is painful to dress, shower, etc. in the shoulder where the shot was given. I have never had shoulder pain before this flu shot.
Post vax, on the same day and into the next day, pt had redness at injection site or right arm and left arm, fast heart rate and pale in color. He had increased temperature. He couldn't sleep. Rash appeared around trunk area on 1/2/01 through 1/4/01. A seizure occurred on 1/8/01. He was listed as serious and in ICU. Will be on Tegretol for a few years for febrile seizure disorder.
Pt became pale, diaphoretic, and nauseous. Vomited undigested food once and complained of dizziness.  Pt was laid down on the floor with his feet up on a chair. His color immediately came back, and he felt better and went home.
the plunger was able to go down after removal of the needled from the skin; that the vaccine spilled out on arm when the plunger was pressed, that the pharmacy still has syringe with no AE; the plunger of a Fluzone High-Dose syringe becoming jammed after the needle was inserted into the consumer with no AE; Initial information regarding this unsolicited valid non-serious case received from Pharmacist and transmitted to Sanofi on 11-Nov-2019 and follow-up information was received on 12-Nov-2019.  This case involves a 67 year old male patient for whom the plunger was able to go down after removal of the needled from the skin; that the vaccine spilled out on arm when the plunger was pressed, that the pharmacy still has syringe [exposure via skin contact] and the plunger of a fluzone high-dose syringe becoming jammed after the needle was inserted into the consumer with no ae [Device connection issue ] was reported, while she received vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Nov-2019, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine [lot UJ301AA and Exp. Date 24-Jun-2020] via intravenous NOS route for prophylactic vaccination.  It was a case of actual medication error due to exposure via skin contact and also a case of Syringe connection issue .  The patient was injected with a another syringe to get his dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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
48 hours post vax, the pt developed shortness of breath. He was taken to the ER and hospitalized overnight. He was treated with antibiotics.
No pain during injection. Aproximately 3-4 hours later significant discomfort and pain in the area of arm. Then later when took shirt off the upper arm was very swollen from top of arm almost down to elbow. It was significant and could be easily seen by spouse. It was quite sore to touch, and very swollen. I called primary doctor and was told it was very unsually and to put ice on it. The ice seem to help.
Pain in arm muscle and shoulder joint. Worse symptoms after 1 1/2 weeks, by third week is improving. Some fatigue and skin sensitivity.
sudden onset of forceful scream & sudden cessation of activity, becoming limp, responsive;asleep for quite a while w/profuse head diaphoresis;thrush,diaper rash;turned purple;clammy;severe breath holding episode;dx HHE, anaphylaxis;
I have had uncontrollable leg tremors, loss of balance, split and blurred vision, loss of coordination, loss of thoughts, unbearable pain in both legs, numbness in both legs and hands,
Weakness in dorsiflexion of right ankle--causing unstable gait. Patient stated this began the morning after he received 3 immunizations from the Health Dept. No other injuries or illnesses noted.   Neurology consult being scheduled.
The pt experienced a fever, achy limbs, aching eyes, fatigue for 4-5 days.
This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a patient who was vaccinated with a second dose of ROTATEQ vaccine live (human-bovine). Concomitant therapy included TYLENOL. The child was given the second dose of vaccine and spit up. The child had a reaction around the mouth that looked like "hives" after vaccine administration. BENADRYL INJECTION was administered to the child and the child recovered. The third dose of ROTATEQ vaccine live (human-bovine) will not be given. No product quality complaint was involved. Additional information has been received from a physician concerning a 4 month old female who on 05-MAY-2008 was vaccinated with the first oral dose of ROTATEQ (lot # 659917/0017X) at 10:08. On 05-MAY-2008, the patient developed hives on chin and neck. The patient recovered date of recovery unknown.  Additional information is not expected.
caught COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (caught COVID-19) in a 40-year-old male patient 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, the patient experienced COVID-19 (caught COVID-19). At the time of the report, COVID-19 (caught COVID-19) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.; Sender's Comments: This case concerns a 40-year-old male patient with no relevant medical history reported, who experienced non-serious unexpected event of COVID-19. The event occurred on an unknown date after the first dose of Spikevax. Rechallenge was unknown since information regarding second dose was not provided. The benefit-risk relationship of drug is not affected by this report
SUFFERING SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced suffering side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering side effects was not reported. This report was non-serious.
Chest pain developed about 24 hours after the vaccine was delivered and increased in intensity over the next 8 hours.  Patient was taken to the ER for further evaluation.
rash not all over the body just on the site of injection; redness on site of injection and itchiness; redness on site of injection and itchiness; arm pain; 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.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Jan2023, outcome "recovered" (27Jan2023), described as "arm pain"; VACCINATION SITE RASH (non-serious) with onset 26Jan2023, outcome "not recovered", described as "rash not all over the body just on the site of injection"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 26Jan2023, outcome "not recovered" and all described as "redness on site of injection and itchiness".  Additional information: Caller was a patient. Caller stated that she received Pfizer covid-19 vaccine yesterday and now experiencing rash, itchiness and arm pain. Caller wanted to know if these were normal. Caller clarified that rash was not all over the body but  just on the site of injection, no pain in her arm 4 hours after (maybe after receiving the vaccine), redness on site of injection and itchiness. Consumer stated that she just have a question about the side effect on the fourth one. The fourth Pfizer vaccine for covid. She got the shot yesterday at (Withheld). That is where they got to tell her to go with the Pfizer one and they did not tell her anything about side effects. After a few hours, little pain in her arm that was gone this morning, but she did have like a rash that itches. Caller was querying if that was normal.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
ON 1/12 got covid vaccine, moderna. Few days later got red and since then its larger. Painful to touch and sl warm. No fever. . NO fever.
Patient states her left arm became red, hard and swollen at the injection site.  About 5 weeks after getting 2nd covid shot she developed diarrhea and skin rashes that are intermittently located on her arm, chest, scalp, neck, elbow, left breast and left leg. The skin on the rashes have became hard and raised. Some of the skin on the rashes can be removed but some cannot.  Some of these rashes are itchy and are in patches. She has had these symptoms since last year and has been treated by multiple physicians. She continues treatment today. She is using Lotion for minor itching. Also using Mupirocin, Triamcinolone actinide.
- Fever for approximately 6 hours - Chills, headache, fatigue, nausea, loss of appetite, muscle aches for 24 hours - Soreness at site of injection for 72 hours
PERICARDITIS  Onset of chest pain and shortness of breath accompanied by fever, chills and myalgias on 23 July 2003.  Initially seen in the ER on 25 July 2003.  Pain was imnproved by leaning forward and splinting. Was treated in the ER with Toradol and sent home with Indomethacin.  He slowly improved was asymptomatic at follow-up on 3 Aug 2003.
Shingrix vaccine was inadvertently administered to 12 year old female; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received Herpes zoster (Shingrix) (batch number 34YF7, expiry date 23rd January 2023) for prophylaxis.   On 20th July 2021 11:30, the patient received the 1st dose of Shingrix (intramuscular). On 20th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided are as follows: The reporter was a Clinic supervisor. The reporter reported that Shingrix vaccine was inadvertently administered intramuscularly in left deltoid muscle to 12 years old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Menstruation abnormally long after 1st dose of vaccination.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 at 15:00 (age at vaccination: 47 years) as dose 1 single for covid-19 immunisation. Patient's medical history included hypothyroidism.Patient did not receive any other vaccine in 4 weeks. Concomitant medication included varenicline tartrate (CHANTIX) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication, ethinylestradiol, norgestimate (TRI LO MILI) taken for an unspecified indication. No known allergies were reported. Patient did not have Covid prior to vaccination. Patient was not tested COVID post vaccination. On 19Apr2021 at 03:00 pm, the patient experienced menstruation abnormally long after 1st dose of vaccination. Therapeutic measures change in birth control were taken as a result of menstruation abnormally long after 1st dose of vaccination. At the time of this report, the outcome of event was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: pt states tested positive for covid 6 days after booster vaccination-Severe
No symptoms other than significant pain in arm during the daytime after the injections. Took ibuprofen at 5pm for arm pain.  By 10 PM feeling general achiness, including headache and stomach ache. Fever rose to 101.9F (baseline norm is 97.1-97.4F) by 2AM.  With regular ibuprofen, the fever remained in the 98-100 range over the next 2 days.  Temperature returned to normal 97.4 on 06/28 about 72 hours after the injection Significant pain in arm continued for 4+ days. Never was significant swelling or any sign of bruise.
Wheezing, coughing, congestion in her chest and feels like she has a chest cold.; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT CONGESTION (Wheezing, coughing, congestion in her chest and feels like she has a chest cold.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal asthma (She always has seasonal asthma this time of the year.).    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 LOWER RESPIRATORY TRACT CONGESTION (Wheezing, coughing, congestion in her chest and feels like she has a chest cold.). At the time of the report, LOWER RESPIRATORY TRACT CONGESTION (Wheezing, coughing, congestion in her chest and feels like she has a chest cold.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  Patient said that it was usual for her and she  didn't want to provide any further information about it, so consent for safety follow-up was not given.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Developed infraclavicular lymphadenopathy three days after receipt of smallpox vaccination.  History of Present Illness:    CC:  "Pain and swelling near my left shoulder x 2 days." Service member received SPV (re-vaccinee) on 22 April 2004 (5 days ago).  She had previously received SPV in 1959 and reports no known problems with that vaccine.  She had no complaints on the day of the vaccination.  She attended the Smallpox Briefing and received the educational brochures.  She does report that her arm was sore the afternoon after the vaccination.  Everyone in her unit was given "down-time" after the vaccinations, and she returned to her room for a nap.   Two days later (24 April 2004), she noticed that she felt a little tired and lightheaded.  The next day (25 April 2004), she reports that she felt even more tired and "spacey and lightheaded."  She also had a slight headache but no vision changes or stiff neck.  No fever, shortness of breath, chest pain, palpitations, or rash.  On 26 April 2004 (Day 4 after SPV), she reported to the Medical Center Emergency Dept. because she had noted a "swollen, tender lump" near her left shoulder.  She was told that it was likely an inflamed lymph node from the SPV and told to follow-up with the Healthcare Center. Member reported to the Vaccine Healthcare Center on 27 April 2004.  She reports that she already feels much better and that the "lump" has decreased drastically in size.  She denies any chest pain, shortness of breath, cough, fever, or rash.  Her headache and lightheadedness have resolved.  She also reports some irritation from the band-aids.  She denies any injury to the arm but has been carrying a heavy pack.  She denies any recent URI, asthma episodes, or seasonal allergic rhinitis symptoms.  Treatment Plan/ Recommendations:  1.  Provided reassurance her symptoms of lymphadenopathy, generalized malaise, and lightheadedness are common after smallpox vaccination, although the lymphadenopathy is typically seen in axillary area and neck/cervical region.  Would expect the lymph node to continue to decrease in size and tenderness over the next 1-2 weeks.  If lymph node remains inflamed, instructed patient that she would need further evaluation.  Unable to schedule follow-up appointment as she is scheduled to deploy within one week.  She verbalizes understanding and states that she will follow-up with her local unit medical staff and has VHC contact information, if needed. 2. Instructed patient that she also is having irritation from the band-aids.  Changed the dressing to non-adherent gauze and paper tape.  Supplies provided to patient. 3. Reinforced education on methods to prevent autoinoculation from SPV site and proper care of site and disposal of bandages. 4. Referred patient to PCP for follow-up of elevated blood pressure.  She states that her blood pressure usually runs 120-130/80. 5. Meds:  Motrin 800 mg po q 8 hours with food prn discomfort.  #30 with 1 RF.   6. Avoid strenuous activity with left arm x 48-72 hours.
4/16 sporadic fever up to 103, irritated eyes. 4/17 sporadic fever up to 103, irritated eyes, coughing. 4/18 sporadic fever up to 103; faint rash on face, coughing. 4/19 faint rash covering entire body, coughing. 4/20 full blown measles rash covering entire body, coughing; visited pediatrician - diagnosed as '99% certain it is a measles like rash caused by an adverse reaction to the MMR vaccine'. 4/21 rash covering entire body, lessened redness, coughing.
The same day she got all she shots she had a seizure and was hospitalized for 3 days. She is now developmental delayed.