chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large area of cellulitis around the injection site.; redness at the injection site; alot of pain at the injection site; Shingrix administered subcutaneously, instead of intramuscularly; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site cellulitis, injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site cellulitis was not recovered/not resolved and the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient believed that, the shingrix was administered subcutaneously, instead of intramuscularly which led to intramuscular formulation administered by other route. The patient experienced redness and a lot of pain at the injection site, as well as a large area of cellulitis around the injection site. The reporter did not consent to follow-up.
Arthralgia, NauseaVomiting, FATIGUE, CHILLS, PAIN/DISCOMFORT AT INJECTION SITE Narrative:
Information has been received from a certified medical assistant (C.M.A) referring to a child patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 28-APR-2015 the patient was vaccinated with 2 ml ROTATEQ (lot # J007436, expiration date 05-MAR-2015, oral) (expired product administered). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
At 1555, RRT was called on a 41 y/o F with c/o lightheadedness, dizziness, and ?feeling cold?. Vaccinated at 1543 on the R arm. She states that some of her symptoms she is experiencing may also be because she has a condition called Chiari malformation. She stated feeling hot and then feeling extremely cold is her baseline and feels dizziness with temperature changes. Head-to-toe assessment completed. Client was cool and clammy. Baseline skin color is pale. BP: 108/62, RR: 21, 0/0 pain.  Hx of anemia, asthma, emphysema, and scoliosis. Allergies to NSAIDS, bee stings, PCN, and cipro. Took Megace in the AM.  Client stated she wanted to lay down on the floor. Nurses laid a drape on the floor and nurses assisted client to lay on the floor. Client stated she felt better doing that. Throughout monitoring period, client?s condition improved. Client did not want ambulance assistance. At the end of monitoring period, client stated she felt better and opted to go home with her husband. Client left vaccination clinic @ 1620 in stable condition, ambulatory, accompanied by her husband. Husband drove client home.
10/6/10:  weakness of upper and lower extremities.  10/7/10 weak cough, trouble breathing but good pulse ox readings.  Noted to have ataxia by neurologist and transferred to PICU for probable Guillian-Barre Syndrome.  Intubated and treated with IVIG (5 doses, each with 400 mg/kg).    Extubated 10/14/2010).  Transferred from ICU to rehab inpatient unit.
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with a dose of Rotateq. Subsequently the patient turned blue and was administered oxygen. Additional information has been requested.
Patient developed acute left upper quadrant severe abdominal pain several days after his second COVID-19 Moderna vaccine shot. Admitted 7/30/21 for CT Abdomen findings that showed diffuse splenic infarcts. Treated with parenteral blood thinner and transitioned to Eliquis (which he is on as of 8/26/21).
Chills Muscle aches Joint pain, specifically lower back and right hand long finger headache photophobia redness at injection site itching at injection site hard lump at injection site slight nausea fatigue
None with J&J. Moderna booster: extreme body aches, upset stomach, fever, chills, swollen arm?red hot and itchy no energy,and No appetite  for 48 hrs with some symptoms lingering on.
mom reports child devel a bump @ inj site & arm became warm 2 days p/vax;pt referred to PMD for eval & f/u;
cant be heard well because of the Moderna COVID-19 vaccination; sick as a dog; This spontaneous case was reported by a patient and describes the occurrence of HYPOACUSIS (cant be heard well because of the Moderna COVID-19 vaccination) and ILLNESS (sick as a dog) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Patient not had Allergies. Not tested covid positive or diagnosed covid infection.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first Pfizer COVID-19 vaccine) on 14-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Lot number of the second Pfizer COVID-19 vaccine was EN6206) on 17-Mar-2021 and Pfizer COVID-19 vaccination (Lot number of the first Pfizer COVID-19 booster vaccine was FE3590) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Pfizer COVID-19 vaccination.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced HYPOACUSIS (cant be heard well because of the Moderna COVID-19 vaccination) and ILLNESS (sick as a dog). At the time of the report, HYPOACUSIS (cant be heard well because of the Moderna COVID-19 vaccination) and ILLNESS (sick as a dog) outcome was unknown.            No concomitant medication was reported. Patient got the second Moderna COVID-19 booster vaccine on 30-Jun-2022. Patient informed that if she stayed with Pfizer she wouldn't have gotten sick.  No treatment drug details was reported.   Reporter did not allow further contact
Initial Left leg weakness followed by weakness bilaterally in hip flexion.  Loss of two point discrimination of the lower extremities below the knees with urinary retention.  MRI showed mild enhancement throughout the nerve roots in the lumbar spinal canal involving the cauda equina and surface of the conus medullaris.  Started IVIG and treated as Guillain Barre.
The pain she had was so intense that by the 2nd day she wanted her arm to be amputated; The pain she had was so intense that by the 2nd day she wanted her arm to be amputated ans she lost 9 days of work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "The pain she had was so intense that by the 2nd day she wanted her arm to be amputated"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2021, outcome "unknown", described as "The pain she had was so intense that by the 2nd day she wanted her arm to be amputated ans she lost 9 days of work".  Additional information: A contactable consumer reported different events for 2 patients. This is 2 of 2 reports. the reporter is not related to a study or programme. patient is the (Privacy) for the reporter. Reporter seriousness for the pain she had was so intense that by the 2nd day she wanted her arm to be amputated and she lost 9 days of work: Unspecified. the reporter stated that his (Privacy) got her 2nd dose of the Pfizer COVID Vaccine at a different location on the same day and told him the pain she had was so intense that by the 2nd day she wanted her arm to be amputated and she lost 9 days of work; reporter states he does not know if she reported this and he has no other information to provide including the lot, expiry date or NDC of her vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a midwife referring to a 20 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 20-FEB-2015, the patient was vaccinated the 1st dose of GARDASIL lot# K009482 with expiration date 06-MAR-2017, (strength, dose and route were not reported) for prophylaxis. On 21-APR-2015, the patient was vaccinated the 2nd dose of GARDASIL, lot # K008931 with expiration date 04-MAR-2017, (strength, dose and route were not reported) for prophylaxis. On 18-JUL-2017, the patient was in the office in order to receive the 3rd dose of series and would be receiving GARDASIL 9 as the 3rd dose (interchange of vaccine products and inappropriate schedule of drug administration); this was outside the recommendations per the GARDASIL prescribing information. No adverse events reported.
This spontaneous report as received from a health care worker refers to a patient of 15 months old. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 30-JUN-2014 the patient was vaccinated with PROQUAD, dose 0.5 ml, route subcutaneous and VARIVAX (route, dose was not reported). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from an unspecified reporter via a company representative, and refers to a female patient possibly in her 50s. The patient's vaccination history included an unspecified Influenza vaccine and other unspecified vaccines with which she had unspecified reactions. Other historical vaccines also included PREVNAR 13. Information regarding the patient's concurrent conditions was not reported. On either 01-MAY-2018 or 02-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 in the left arm (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. In May 2018, immediately after vaccination, the patient started to have bad swelling at the injection site, so much pain in her left arm that she could barely lift her arm. She also had a high fever, felt nauseous, and had chills. The patient called to her doctor's office for medical attention and received an unspecified treatment for the adverse events. At the reporting time, the patient had not recovered from the adverse events. Causality assessment was not provided.
Contracted covid after both doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted covid after both doses) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced COVID-19 (Contracted covid after both doses). At the time of the report, COVID-19 (Contracted covid after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive..         No concomitant medications were reported. No treatment medications were reported.
I woke up with stroke symptoms (right side facial drooping, speech deficit) in the morning on 4/30/2021. I went to the ER where I had many tests, including a MRI that confirmed the stroke. The doctors also discovered that I have a PFO in my heart which was closed on 7/9/3032. I had a TIA on 6/6/2021. I am taking Plavix, Asprin 81mg, atorvastatin, and immediately stopped use of microgestin.
Hard, fast, shot, which bled n saturated the pad on my bandaid. Arm hurt n bruised with lump right away. First shot easy didn?t hurt at all till that night.  Headache on way home. Developed 101.7 temperature, chills, muscle and joint aches n bouts of nausea around 11p.  Lasted till about 4pm the next day. Today, just a sore arm.  Did not take anything,  Thought it best to let it run its course. Just rested, drank fluids till I felt better.
On Oct 15, 2021 (the next morning after 2nd vaccine dose) woke up with severe diarrhea.  (I do not get diarrhea ever except if I get the flu).  For the last 100 days STRAIGHT daily diarrhea!  The first 5 weeks 3 to 5 times/day. From Nov 26th to Dec 5, 2021, 6 to 11 times diarrhea every day.  Doctor started me on Colestipol Hydrocholide Tab 1 gram each day on Dec 1st, 2021.  Daily episodes 3 to 5 times a day still, despite on medicine. I thought I thought I was improving in mid December and went off the medicine for 2 days and was back immediately to 11 times a day of diarrhea, on the 3rd day I got back on medicine.
Developed epistaxis on 3/11 after second dose of vaccine on 2/25 (1st dose 1/28).  On 3/12 noted petechiae then on 3/13 awoke with spontaneous periorbital hematoma.  Evaluated on 3/16, platelets 8.
4-26-16, 7:40 pm Patient said his left arm was itchy and swollen, redness 3 inches by 4 inches. 4/27/16 4:45 pm Mom reports area is now pink 3" diameter, skin color at injection site. Slightly itchy. BENADRYL 2 tsps. given 4-26-16. Ice pack with good effect.
Initial report received from a consumer on 21 October 2014. A patient, whose gender, age at the time of event and concomitant medications were not reported, had received a dose of influenza vaccine (batch number, dose number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. It was reported that, the patient had migraine headache in the past and didn't have for the past 7 or 8 years. It was reported that on an unspecified date, immediately after receiving Influenza vaccine, the patient experienced severe headache. It was reported that, headache continued for two days. Headache was severe and after taking ADVIL also as a corrective treatment it was coming back within few hours which were continued in the night also. As per reporter, influenza vaccination triggered migraine as it was as severe as patient's migraine headache. The patient's laboratory investigations were not reported. At the time of this reporter, the outcome was not recovered. Documents held by sender: none. Follow-up information received from a consumer on 24 December 2014. On 01-Oct-2014, a female patient was vaccinated with influenza vaccine and patient details were updated. List of documents held by sender: None. Follow up information received from a consumer on 27-Mar-2015. The patent demographics (age and date of birth were provided). A 63 year old patient had received first dose of influenza vaccine. On 01-Oct-2014 the vaccine was administered to all employees. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions included "heart bypass" and history of migraines in childhood. There was no illness at the time of vaccination. Concomitant medications included LIPITOR, metoprolol and aspirin (81 mg). There was no other vaccine administered 4 weeks prior to the vaccination date. There was no adverse event prior to the vaccination. It was reported that the patient was doing well and there were no other problems after few days. There were no laboratory investigations performed. At the time of this report, the patient had recovered from the event of severe headache on an unspecified date. Follow-up information received from a Nurse on 11 May 2015. Reporter stated that she could not confirm the case based on the information provided. It was possible that the above - named individual was a temporary contact at the site, but they were not current or past employee. List of the documents held by sender: none.
Redness, swelling, local induration left thigh 11cm x 12 cm.
A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection) dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced that her top eyelid got swollen, placed hot compress but did not resolved it. She will be getting her second shot on 22Apr2021 and queried what she should do if her swollen eyelid will get worse on the second shot. The outcome of the event was not recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Severe pain at time of shot, arm would not move for weeks. Went to physician- family gave pain meds. I have throbbing and numbness in both arms. Neurologist found lesions in brain and spinal fluid. Can't figure out. Getting 2nd opinion.
Patient was administered 2nd dose of Pfizer vaccine after 2 weeks, which is 1 week too early
Swollen eyes and then hard, red, purple lumps in tear troughs .  Still not resolved.  GP prescribed corticosteroid.
Initial site reaction of redness and swelling that resolved within 1-2 days. She also developed a rash/hives on her right arm and bilateral thighs that has been present for 6 days.
Faint, wooly cottony head. Client reports that she feels "drunk". Client was taken to MD who diagnosed her conditon to be: Migraine. Dr. gave the client Rx and advised her to go home.
Within hours my arm was sore, I was commuting and unable to eat. I ran a fever that did not exceed 102 for 24 hours. It was difficult to keep balance while walking or standing. I could not keep fluids down and had extreme muscle aches. The headache lasted a full 48 hours and might have been the worst part.  I was for the vaccine until I had this occur.  It was a definite horrible experience.
Patient became light headed and nearly passed out.  Patient also vomitted twice.  Patient was weak and feeling warm and clammy for about 15 minutes.
flu like symptoms.  Greatly reduced energy.  Fever.  Lassitude.  Lack of appetite.  Feeling of general malaise.   Too early to tell how long it will last.    My wife had the same vaccine at  the same location a couple days earlier and was fine.
With in five minutes of administration complaint of headache, then felt faint.  I had my daughter sit down in the waiting room with her head down before we walked out.  Not thinking this had anything to do with the vaccine.  We walked out the door and she began have difficlty walking, weaving, I asked her if she was okay and she could only respond yes.  I took her arm and tried to turn her back to the Doctor's office and she collapsed on the ground.  Though, she remainded conscious her eyes were glazed and was disoriented.  It happened that another lady was leaving the office and I asked for her assitance to walk her back inside.  The nurse immediately had us put her on an exam table.  I do not think she was able to hear a blood pressure.  At this point, my daughter was extremely pale, clammy, shallow rapid breathing, weak pulse, able to anwser questions.  She stated her ears were ringing and that she had tingling in her feet.  The doctor naturally examined her as well.  They treated her with oral fluids, rest and some sugar cookies(the only thing they had). I am not sure the exact time the vaccine was administered. I believe it was around 5pm.  When we left the doctors office, it was 5:45, my daughter felt weak and was shaky (visible).  On the drive home she experienced visible muscle contractions in her arms and legs.  Legs and arms were involuntarily jerking.  This lasted approximately 10 minutes.  By 6:00pm she felt "normal".
LITTLE BIT SORE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in MAY-2021 for prophylactic vaccination. The patient had zero symptoms following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little bit sore after receiving his booster dose (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little bit sore was not reported. This report was non-serious.
a consumer got an expired dose of ACTHIB with no reported adverse event; Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 15 months old male patient who got an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Aug-2023, the patient received an expired dose of 0.5 ml dose 4 of suspect of standard strength HIB (PRP/T) vaccine [ACT-HIB] Powder and solvent for solution for injection (lot: UJ803AA, Expiry date: 13-Aug-2023) via intramuscular route in the right vastus lateralis for Immunisation with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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.
Severe Lymph node pain and pain radiating into my breasts. Under my breasts. Sides of breasts. Subsided after a week but still have a bit of pain nearly 3 weeks later. Went into doctor for manual breast exam. No lumps. This is almost certainly from the vaccine. The pain in both breasts was shifting through all the lymph drainage areas. I expect it to completely be gone by the time I get a mammogram in a month. It has improved a lot. I also had a headache and fatigue.
Bowel movement containing significant amount of dark green mucus and black, string-like blood. Also vomit containing pinkish, dark brown blood.
(R) upper arm with a 3cm area with mild erythema 2-3 days. (L) upper arm with a 3cm area with redness and induration 2-3 days.
exhausted; Low grade fever; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient were exhausted after their second vaccine and had a low grade fever. Outcome was unknown.  Information on the lot/batch number has been requested.