chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fever of 100/mild fever 99.5; fatigue; non productive cough; tested Covid 19 positive; tested Covid 19 positive; This is a spontaneous report from contactable consumer. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient was a 23 years old nurse and received the Covid 29 vaccine on Saturday morning. Sunday she developed a headache fever of 100 and fatigue. Monday she developed a non productive cough as well as mild fever 99.5, fatigue, and the headache was reduced. It was also reported that the patient was tested Covid 19 positive on 22Dec2020. The outcome of the events were unknown. Information on the lot/batch number has been requested.
48 year old  pediatric dose; 48 year old  pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Registered Nurse reported that, the patient received pediatric dose of Engerix- B, which led to underdose and adult use of a child product. The reporter confirmed formulation of Engerix- B via batch number look up. The reporter consented to follow-up.
Menveo - Use of sterile water for reconstitution.; Menveo - Use of sterile water for reconstitution.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo - Use of sterile water for reconstitution.) and inappropriate dose of vaccine administered (Verbatim: Menveo - Use of sterile water for reconstitution.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-JUL-2023 A CMA called in to asked for information regarding a patient who received a dose of Menveo reconstituted with sterile water instead of the (MenCYW-135) liquid component. The HCP asked for any side effects. The reporter declined to share information regarding the patient. Data about the Menveo dose was not provided (lot number, expiry date). Due to the nature of the call permission for follow up was not requested.
The pt developed permanent chronic diarrhea, arersion to eye contact, change in hearing and stopped speaking. Diarrhea and loss of speech were immediate others were gradual onset approximately 1 month.
Fever 102 -103. Headache behind eyes.  Sensitivity to light.  Nausea.  Constipation. Loss of appetite.  Lightheaded/dizzy and weak.
Patient reports twitching in the periorbital area of the left eye (under the eye and above the cheek) beginning on Friday 10/23/09. States that the twitching was visible to others and very noticeable on 10/23 and has become less frequent each day after vaccination.
Patient was able to receive all 3 series of COVID-19 vaccinations.  The first series was provided by MCHS (incident discovered during a NURSELINE call when the patient called reporting symptoms requiring triage). Reporter contacted pharmacy - administrator of Pfizer Series and was informed that at the time of the 2nd series vaccination, they were not checking the Immunization Registry for vaccination history.  They have since changed their practice. At the time of the report, still awaiting response from Public Health to understand their vaccination process.
Back pain; cold; Experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), NASOPHARYNGITIS (cold) and CHILLS (Experienced chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IRBESARTAN, ATORVASTATIN, FEBUXOSTAT, CALCITRIOL and LEVOTHYROXINE for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BACK PAIN (Back pain), NASOPHARYNGITIS (cold) and CHILLS (Experienced chills). At the time of the report, BACK PAIN (Back pain), NASOPHARYNGITIS (cold) and CHILLS (Experienced chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Febrile Seizure X 3 (10:35am, 3:55pm, 8:30pm). Seizure again 5/29 3:30pm without fever. Seizures continued 6/1 twice daily since. Currently in diagnosis process for seizures.
Splotches, rash around right IM leg area.  Follow up: treated with benadryl.
From initial information received on 05Aug04 from a RN regarding an adverse event occurring, it was reported that a 26 year old male pt received a dose of Menomune A/C/Y/W-135, lot number UE123AA, administered SC in the right upper arm; a dose of YF-Vax, lot number UE180AA, administered SC in the left upper arm and a second dose of Hep B vaccine, lot number 0628N, administered IM in the left deltoid on 03Aug04 at 11:00AM. Twelve hours later, at 11:00PM on 03Aug04, the pt developed vomiting and diarrhea, which stopped on 04Aug04. The pt also experienced sweating on 04Aug04 and 05Aug04. Reportedly, the pt recovered from these events. From additional information received on 18Nov04 from the initial reporter, it was reported that this case was reviewed and there is no additional information at this time. No further information is anticipated, this case is considered closed.
Got half the dose, medicine dripped down the arm; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Got half the dose, medicine dripped down the arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 07-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Got half the dose, medicine dripped down the arm). On 07-Apr-2021, ACCIDENTAL UNDERDOSE (Got half the dose, medicine dripped down the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.
p/vax pt had recurrent breakouts/rash; seen again @clinic; bumps  all over body/grew in size; reddish-brown in color; scaly over body;pelvic region diffusely;Dx @ that time c/ringworm infect; oval shaped raised lesions all over;dry skin
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
Father stated child became febrile on Sat. 12/5/09 through Thursday 12/10/09 with cough and body aches. Fri. 12/11/09 - Father states child has recovered, is afebrile and feeling better. Child's MD was contacted by parent.
Fatigue; Neck was super swollen on one side; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's wife).    A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8734 or EK8734) via an unspecified route of administration, administered in Arm Right on 10Apr2021 12:00 (at the age of 37 years) as dose 1, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Family Medical History included the main concern was that her husband's mother had a heart attack in her 50s and his paternal grandpa died of hardening of arteries when he was 32 years old, so that is why the doctors did a full work up on the heart attack to make sure her husband was completely good there. On an unspecified date in Apr2021 after receiving first dose of vaccine the patient experienced fatigue which lasted for 3 to 4 days, neck was super swollen on one side which lasted for a week and alter ended to visit emergency room and physician visit. Reporter stated the lot number for the first dose of the vaccine is either ER8734 or EK8734, she can't read the person's handwriting on the vaccine record card. Reporter stated the only thing she wanted to note was back in Feb2021 her husband thought he could have had COVID, he wasn't sure so he went to get tested. However, his COVID test results were lost so he never got the test results. She wanted to add that in because she knows if her husband had COVID that could effect things, but he has been feeling fine ever since February. Reporter stated after the first COVID 19 vaccine, her husband was pretty much out of it, like completely out of it. She was concerned and was like "are you going to wake up today?". The fatigue was very real and then his neck was super swollen on one side. That was the only side effects from the first one, it was nothing horrible. She confirms the fatigue was either 2 or 3 days after her husband received the first dose of the vaccine and it lasted a good 3 to 4 days where he was beyond fatigued. His neck being super swollen started pretty soon after the first dose, either the next day or 2 days later and lasted for a week or so. She knows it was really sore when he touched it. The patient underwent lab tests and procedures which included blood clot test was normal on an unknown date, COVID-19: test results were lost on Feb2021. Therapeutic measures were taken as a result of fatigue, neck was super swollen on one side. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503792 same patient and reporter, different dose and event.
miscarriage late August-early Sept 2021 (seen at Hospital ER). COVID symptoms: sore throat, headache, cough, having abdominal pain, she is 11 weeks pregnant. starting 12/3/21
Started feeling some dizziness and nausea.  Also reported "swimming in front of eyes" while working on the computer.  He then went home and laid down. Is feeling better now.
This case was reported by a physician via call center representative and described the occurrence of erythema induratum in a 68-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (injection received years before). On 29th April 2019, the patient received SHINGRIX. On 29th April 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema. On 1st May 2019, the patient experienced erythema induratum (serious criteria GSK medically significant), genital eruption male and rash. On an unknown date, the outcome of the erythema induratum, injection site erythema, genital eruption male and rash were unknown. It was unknown if the reporter considered the erythema induratum, injection site erythema, genital eruption male and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on left arm. The patient experienced redness at the injection site. On 1st May 2019, the physician noted that the patient has a 10 cm area of indurate erythema on the left lower tricep where it meets the deltoid. The physician also reports the patient had edematous areas about 1.5 cm in area around the right cheek and area of the penis. The reporter consented to follow up. The physician gave permission to contact him for any further specifics. The patient was not given the injection of SHINGRIX at this physician's office.
Per phone message on 8/31/12 @ 12:51PM: (Patient says) 24 hrs after the vaccine she had a 102 fever, a funny cough, and her chest felt heavy. Went to bed the entire day. The right arm is warm to touch. hard and bruised. Fever is gone and feels better. Denies itching at the site.  On 9/4/12 @ 9:38AM  Patient says vaccine site is now just tender to touch.
Soreness of both breast got worse after second shot; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Soreness of both breast got worse after second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Soreness of both breast got worse after second shot). At the time of the report, BREAST PAIN (Soreness of both breast got worse after second shot) was resolving. Not Provided          The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-082956 (E2B Linked Report).; Sender's Comments:  MOD-2021-082956:First Dose
Information has been received from physician concerning an 8-week-old female who on 16-MAR-2007 was vaccinated with a dose of Rotateq. The physician reported that on 18-MAR-2007, the patient developed vaccine induced rotavirus characterized by vomiting along with diarrhea which started on the morning 19-MAR-2007. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
p/vax pt began exp pain & swelling in rt armpit area approx 24hr post vax;pt saw MD the following day who felt was r/t tetanus shot;prescribed warm compresses;was resolving @ time report was made;
Initial and follow-up information has been received from a nurse practitioner concerning a 4 year old white male who was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck) (lot# 657754/0782U) in the right ventralis lateralis. The patient developed 7 lesions on his torso 7 days after vaccination. No medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of three reports from the same source. Additional information has been requested.
A 3RD DOSE OF MODERNA WAS INADVERTENTLY ADMINISTERED ON 04/12/2021. 1ST DOSE WAS GIVEN ON 01/27/2021, AND THE 2ND DOSE WAS GIVEN ON 02/24/2021.
w/in 15min pt c/o severe SOB, gen itching;exhibited facial swelling;taken to hosp given DPH;pt recv yellow fever & meningococcal per PMD;
Very sleepy, lack of nursing, large hard red lump at injection site lasting 6 weeks, patches of eczema behind knee that soon spread to other knee, thighs, stomach, and chest.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age who on 06-JUL-2012, was vaccinated with a dose of ZOSTAVAX (Dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient developed a cellulitis infection on their arm which was hard and warm to the touch. CIPRO was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient developed a cellulitis infection on their arm which was hard and warm to the touch was unknown for ZOSTAVAX. Additional information has been requested.
Sore arm with significant pain. Could not lift arm above shoulder or lay on the arm.  Redness and swelling where I got the shot. Significant tiredness, full body muscle pain, headache, dizziness, low grade fever-like shivering and nausea. Soreness at injection still present at time of this adverse event entry. Other symptoms resolved 24 hours after they began.
Fast heart rate, fever for 2+ days ranging from 100-102, body aches. Right arm inflamed, lymph in right armpit inflamed
Patient was provided vaccine at age 11, three months prior to turning 12.  Staff contacted clients mother and explained to her that she had submitted paperwork signed to have her daughter vaccinated and that we provided it, but that it was too soon.  Mother stated she was happy her daughter received the vaccine.  Mother was explained that the childs second dose can not be given until after the child is 12years old, or if new authorization comes out that lowers the age limit, as long as there is 21 days between dose 1 and 2.  Mother expressed understanding and again stressed she is happy her child received the vaccine regardless.  Staff asked mother how the child was doing and it was reported to us that no problems or side effects were occurring.
Severe soreness  and swelling in arm returned 8 days after initial soreness from shot. Soreness is traveling up my arm, into my neck and down my back muscle. Feeling very tired today (6-24-21) .
pt had a 15sec gen sz about 9 hr p/vax; pt slept briefly then returned to nl behavior
Severe headache and eye pain - 3 weeks. Oxycodone - did not relieve pain at all.  Used ice packs for head and eyes - made eye pain less. Could not work  Fever, chills, exhaustion, nausea, severe flu-like symptoms. Brain fog. Could not get out of bed. Needed help. Could not work. 72 hours. Took extra strength Tylenol - fever reduced, did not help other symptoms.
Patient contracted COVID after being fully vaccinated.  No booster. chills, headache, dizziness, weakness, cough, body aches, fatigue, anorexia.
45 min after injection, rash and later hives. Was seen and treated by PCP, BENADRYL IM, XYCAL 5mg BID and PREDNISONE dose pack.
c/o headache, nausea, dizziness.  BP 126/64, P-76, R-18.  Denied SOB.  Felt extremely weak and sleepy. Transported to ER.  Treated at ER for Cystitis. Advised had "Adverse Drug Reaction."
delayed onset of erythema, swelling, itching, pain at injection site followed by spreading redness in 24 hrs but decreased swelling and itching
I received my first dose of the Moderna COVID-19 vaccine at approximately 10:25AM on 2/2/21. By about 6PM that evening, I was running a low grade fever of 100.8F, had a headache, and my neck was abnormally stiff and painful on the left side. Throughout the night, my fever increased to 101.6F, my body aches and headache intensified, and my neck pain became so intense that I could no turn my head fully to the left. My throat was also very sore to the point where I could no longer speak normally. On 2/3/21, I was so ill that I missed work and slept most of the day, taking Tylenol and drinking water to ease my symptoms. Later in the afternoon of 2/3/21, I developed a productive cough with very thick, dark colored mucus discharge. By the morning of 2/4/21, I felt mostly better. The cough is still present along with the mucus, but the fever, body aches, headache, neck pain, and sore throat have stopped. The extreme fatigue I was feeling on 2/3/21 has also subsided.
Clinical Lead contacted Pfizer Safety Data program to discuss stability of Pfizer product in refrigerator past 10 weeks Use By Date. Pfizer representatives confirmed this product is no longer stable. Guidelines indicate child should be revaccinated immediately, with no waiting period. Administering RN was informed of Pfizer safety data results on 6/10/22. The client's parents speak predominantly another language. Administering RN made 6 attempts to connect with a interpreter through contracted Language Line and was unsuccessful with these attempts to create a secure and working connection with a speaking interpreter. On 6/13/22, administering RN contacted Language Line and secured a working connection with a interpreter and contacted FOC to discuss. RN explained that the dose the child received on 6/2/22 was considered invalid and advised FOC to bring child back to clinic to be revaccinated. Administering RN answered FOC's questions and FOC indicated he would return to the clinic during normal hours to revaccinate the child.                                   Signed: 6/13/22
Patient came back to my store on 11-8-2019 and said she had range of motion issues and pain since her vaccination.  She went to a walk in clinic on 11-15-2019 and was referred to Hospital.   The patient told me that at hospital they did an ultrasound exam that did not uncover any issues.  There was no bone chip.  There was no hematoma.  She was told to take Motrin and apply a heating pad.  She felt better for 2 days after doing that, but the pain and range of motion issues came back.  She now has an appointment with a specialist on 11-11-2019
Patient received Booster dose of Pfizer vaccine lot #FG3527 and expiration date 02/2022 on 12/13/2021 and the vaccine vial stored in the fridge should have been used until 12/12/2021 and the vaccine was administered on 12/13/2021 which made the vaccine to be expired for one day , however the patient did not experience any side effect .
Injection was in left arm.  Severe pain in left upper, back started on the day after vaccine.  Severe pain was constant in upper left shoulder with shooting pain up neck, down arm.  Swollen arm pit.  Red welt at site of injection.  Left breast pain.  The severe pain lasted 36 hours.  So severe all I could do was lay still.  Tried heat, and  cold.  Took Tylenol and ibuprofen.  Nothing helped.  Could not move neck.  Intense pain subsided 3 days after vaccine.  I am at 5 days out and still have some a pain, swollen arm pit, sore arm, busing at injection site.
inadvertently received a dose of VAXELIS instead of the ordered FLUZONE HIGH DOSE QIV; Vaccine administered to a 73yr old; This non serious spontaneous safety report with reference #2022SA461540 was received by the partner on 08-NOV-2022 and forwarded on 09-NOV-2022 from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  Further information is expected.  Case is linked to MCM-004263 (same reporter link)  SIGNIFICANT FOLLOW-UP INFORMATION was received on 23-NOV-2022 from a health care professional.  The reporter confirmed that the patient did not experience any adverse event. Patient history, dose, batch number and expiration date of Vaxelis dose were provided.  The causal relationship between Vaxelis and the reported events were not applicable.  The case is maintained as non-serious.  No further information is expected