chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unknown route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if diarrhea was a side effect of the vaccine and for the efficacy after one dose, if there was a certain percentage. The patient had received the vaccine on 15Jan2021. On the 17Jan2021 or 18Jan2021 she started having diarrhea that had been off and on. She was scheduled for the second vaccine on 05Feb2021. The clinical outcome of the diarrhea was reported as recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
2nd dose given days before 6 months; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given days before 6 months). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The nurse called in to ask for the definition of 6 months between doses of Havrix. After reviewing recommendations for calculating intervals between doses the healthcare professional realized that the second dose of Havrix was administered a few days before the minimum 6 months interval described in the Product information.  The reporter asked if the dose given was counted as valid. The reporter mentioned that several patients were involved in this situation. However, the reporter did not provided patients information nor data about the vaccine administered (Lot number, expiry date, date of administration).  The reporter consented to follow up. The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Fever, flu like syndrome. Erythema left arm over PNEUMOVAX administration site.
Vasovagal response immediately after vaccination. Dizzy, pale, lightheaded, diaphoretic, hypotensive.  B.P. 64/25 @10:25 and @10:35 B.P. 110/60.  Laid down in medical screening with good rebound Blood pressure. Remains for 30 minutes observation. Left in stable condition at 10:53.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On AUG-2017 the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On AUG-2017 the patient experienced incorrect dose administered and drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of incorrect dose administered, no adverse event and drug administered to patient of inappropriate age is unknown. The reporter considered incorrect dose administered, drug administered to patient of inappropriate age and no adverse event to be not related to RECOMBIVAX HB.
CURRENTLY 27 WEEKS 3 DAYS PREGNANT. EDD: 2/7/2023.  RECEIVID INITIAL FLU VACCINE ON 9/30/2022.  RECEIVED UNINTENTIONAL SECOND FLU VACCINE ON 11/11/2022.
low platelet count . Patieint had no previous history of low platelets  until 4/15/21. No current symptoms
trigeminal neuralgia pain returned; 1st dose Jan2021, 2nd  Feb2022; This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included trigeminal neuralgia (trigeminal neuralgia, that she suffered with for years, was completely pain free). Previously administered products included Shingrix (received 0.5 ml 1st dose on 1st January 2021 into unknown arm).   On 1st February 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th September 2022, the patient experienced trigeminal neuralgia. On an unknown date, the outcome of the trigeminal neuralgia was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the trigeminal neuralgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The case was reported by the patient. The patient received second dose of Shingrix (Inappropriate schedule of vaccine) and the patient had trigeminal neuralgia, that patient suffered with for years, was completely pain free until today (the day of reporting) and pain returned.  The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
This is a spontaneous case initially received from other health professional (nurse) on 29-Oct-2018, concerning a 3-year-old, female child patient. On 26-Oct-2018, the patient (underage of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252228 and expiry date: 31-May-2019]. No adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 27-Nov-2018: Reporter stated that, the patient had no medical history and ICD I73 was provided in error. Narrative was amended accordingly.
No adverse event; improperly stored dose of ROTATEQ was administered to the patient; This spontaneous report was received from other non-health professional reporter and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 24-MAY-2022, the patient was vaccinated improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #U026666, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Administered dose of vaccine experienced the temperature excursion of 54.5 degrees Fahrenheit for 11 hours. There was no adverse event or product quality complaint reported.
Flu vaccine given L deltoid at 0950; client says could feel it going down her arm.  At 1030 she reported feeling a choking feeling and at 1045 returned ambulatory to the vaccine site.  Her B/P was 130/76, pulse 68.  She denied difficulty breathing and did not appear in distress.  At 1050, she reported the choking feeling was no better, so Benadryl 50 mg was given IM Right deltoid.  At 1102, her B/P was 112/80.  She was observed and did not seem in more distress but said that the feeling was not subsiding, so a call was made to the emergency room with the PA there advising giving Epinephrine.  Epinephrine 1:1000 1mg/1ml 0.5 ml given SQ right arm per standing order.  B/P at 1132 was 112/76, pulse 72.  Patient was transported per car to the ER.
Area turned red and swelled.  I had night sweating and cold chills at night for 3 nights.  During the first 2 days I had soreness at injection site and felt tired.  On the 3rd day I had some nausea and headache.   By the 4th  day and night , I felt fine.
TACHYCARDIA; LOW GRADE FEVER; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the subject experienced tachycardia. On 31-JUL-2021, the subject experienced low grade fever. On 31-JUL-2021, the subject experienced injection site soreness. Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) greater than 110 beats per minute (BPM). On 01-AUG-2021 14:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, and had not recovered from low grade fever, and tachycardia. This report was non-serious.
Information has been received from a physician concerning a 7 year old female with no medical history who on 22-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 13-MAR-2007 the patient experienced a rash on her abdominal area and back. The physician reported that it looked like a case of moderate wild chicken pox. No labs were performed. Unspecified medical attention was sought. The patient has not recovered. Additional information has been requested.
:  Approximately 5 minutes after administration of first Moderna COVID vaccine, patient lost consciousness while sitting in chair for approximate 15 seconds. Fell onto floor, denies hitting head. Patient was placed prone on mat with feet flat. Given orange juice, wet cloth to head. Appears pale, cold, clammy skin initially. Improved quickly. Denies vomiting, nausea, difficulty breathing or headache. Girlfriend states he has passed out in the past, cause has frequently been due to anticipation of medical procedures, such as dental work or discussions of medical procedures. Witnesses included patients girlfriend and clinic staff. VAERS report to be submitted due to syncope with loss of consciousness
Pt. was seen in ER on 6/15/11 at 1632 with hoarseness, elevated temp, chest tightness, muscle aches today. Pt states she has been taking live typhoid vaccines. Took last dose 6/14 - AM.
moderate to severe pain left arm and left side body muscles and joints,- 2 days duration, swelling and redness at injection site up through 3 days+ duration, chills, low grade fever, nausea, fatigue, headache, lethargy - 2 days duration.  Side effects significantly affected ability to function for 2 days. No treatment other than bed rest and sleep.  Redness, swelling and pain still present in left deltoid area and pain under left armpit when palpating lymph nodes through day 3.  Day 3 recovered from all other side effects.
Patient received 3rd dose (booster) about 2 months too early. Patient received second dose of Pfizer vaccine on 6/19/2021 and third dose on 10/28/2021. Patient was contacted on 10/29/2021 but patient did not answer. Was able to contact patient on 11/1/2021 and counseled patient on common side effects, no need to repeat the dose, and that there is minimal information regarding adverse reactions with giving the vaccine early. Patient stated that they were fine and working at the time of the call.
Started with just sore injection site. After about 5 hours, pain started in shoulder and neck and sick to my stomach. Day 2 shoulder burning sensation and nausea all day. By the evening was feverish with chills. Went to bed immediately after work. Slept until following morning. Woke up as if nothing ever happened. felt great. No shoulder pain or nausea or fever/chills. The only thing that remains is swelling and soreness at injection site.
Fever 101 F, severe body aches and pains, nausea, headache, vertigo and loss of appetite. Symptoms persisted for two days. Severe enough to call in sick to work for two days. Treatment: Tylenol ES 500 mg X 2 doses (not effective); Benadryl 50mg X 1 dose (not effective).
pt had rxn to vax redness 1 1/2" x 2 1/4" & warmth
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporin, reaction(s): "Known allergies: Cephalosporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 22Aug2023 to 27Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291068 Same patient, different drug/AE;
PSVT with syncope morning of 1/19,  10 episodes of SVT lasting about 5 seconds, followed by syncome then return of NSR, spontaneous resolution. Hospital admission 1/19 with telemetry,  normal electrophysiology study, loop recorder placement. discharged 1/21 with no recurrence.
pt devel a swollen, hot, red arm approx 1 hr p/receiving vax; required ER/MD visit; treatment included oral DPH & pred; pt recovered;
Pt developed a red blister over area of injection the next day. Pt states it popped and left a gaping hole. On exam today, area of slight erosion & scarring. Mild tenderness at site of injection. No treatment.
Pt reports having a rash and itching develop at the injection site 10 days after receiving the vaccine.  It was reported to have spread to the arm.
Generalized flushing onset 45 min to 1 hour post vaccination. Took Benadryl 25mg at onset, symptoms improved after 20-30 minutes. Denies difficulty breathing, throat or lip swelling, or chest tightness.
I was warm and sweaty after shot  around 10am for and about hour .  Then at 11:30am my arm , armpit and neck started hurting . Next every part of my body became achy at different times starting with lower back then shoulders and moved to other areas  last was my inner legs .  Finally I had chills ..... woke up next day feeling good but arm where I was injected hurt only
In the beginning of August 2022, I noticed that my clothing was a little bit bigger on me. I didn't pay too much attention to that. I did look at the scale and noticed I had lost 4 lbs. It was summer time and I don't eat too much when it's hot. I went to my cardiologist at the end of the month that was a routine visit. I got on his scale and I was down from 183 to 167 lbs. I didn't think too much of it. Suddenly it was not until September or so where I noticed I was just losing weight. I was losing 3lbs every 3 days maybe, around a pound a day. All of a sudden, I found that I was unable to swallow certain things. When eating breakfast with my favorite foods, and I would try to eat them and I cannot get myself to swallow it because it disgusts me. I would spit it out and try again with other foods. The same thing happened a week later with eggs. The same instance happened with potatoes. I threw it away with disgust. I tried different foods and nothing was working and I continued to lose weight. I lost interest in food because they didn't taste right. In January 2023, I finally decided I couldn't do this and I had lost 48lbs. I was also very hungry. I went to see my PCP. I made the mistake of saying I had trouble swallowing foods. Mechanically I had no problems swallowing, I just couldn't stand to swallow specific foods because they did not taste good to me. For example, I love chocolate and I could no longer stand the taste of the chocolate. The doctor sent me to get a barium swallow test, and it was completely negative which I knew it was going to be. I went to see a speech pathologist as well, and she determined I did not have a swallowing problem. Both of these I knew. The doctor wanted me to see an ENT, and I said I didn't think I had ENT problems. She mentioned a neurologist as well, and I noted I didn't want to do that either. I declined those two tests. I'm still losing weight. It has been since August 2022 and now we're into April 2023. I'm still losing weight, not at the same rate I was in the beginning, but I am now at 131. I'm eating much better now. I've been taking meal supplements by Pro Caps and Ensure as supplements. For these supplements, they are bigger pills, but I do not have trouble swallowing them.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00512996) and transmitted to Sanofi on 10-Mar-2021.  This case involves a 26-year-old female patient who received an expired 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]( Oral solution, lot C5585BA and expiry date: 06-Mar-2021) via an intramuscular route in the left deltoid for prophylactic vaccination on 06-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, 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 holders 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.
A sore arm after all doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm after all doses) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-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 PAIN IN EXTREMITY (A sore arm after all doses). At the time of the report, PAIN IN EXTREMITY (A sore arm after all doses) outcome was unknown.            No concomitant medications were reported. Treatment medication was reported as unknown.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Dec-2021: Follow up received includes treatment medication information (Unknown).
Swollen face (eyes), shortness of breath, tightness/pressure in chest area, cough. Took Cetirizine 10mg; reduced swelling in the face and eyes.
Flu like symptoms.   Chills, achy, 101 fever, nauseous.
pt recvd vax;was fussy/cranky but ok until 5pm;t 102,at 5am 23sep t105 R;mom called MD;pt given APAP which lower t to 99 p/ 2 doses;could be consoled;got a rash 25sep,was checked 26sep by MD;was given DT 17nov;has fully recovered;
I actually ended up calling the PCP doctor on the 25th. I had muscle aches, fever and headaches. The headache and arm pain still had not gone away. I missed work due to the headaches from the 21st through the 27th.  I also experienced nausea due to the severity of the pain. It felt like a sinus headache that throbbed. I took ibuprofen 400mg before calling the doctor but it didn't do much at all. I was also taking Tylenol 500mg 3 times a day. It wasn't until this past Monday that I saw my doctor. My shoulder and upper arm are in constant pain and it gets worse whenever I try to use my arms or move.
This report is being submitted by the guidance of the DOH. 1 patient was affected by storage and handling excursions.
Patient is seen today in triage room for vaccine reaction. Fifteen minutes into the 30 min observation time (due to past hx of chemo reaction), patient reported having a "scratchy throat" and being flushed.    Patient had flushing over cheeks, sitting up in recliner, aaox 3, in no acute distress. Vital signs were stable, Blood sugar level was 252. Patient then became warm and clammy. She denied shortness of breath, chest tightness or difficulty swallowing. She was given Benadryl 25 mg oral solution and Famotidine 20 mg tablet. Upon ascultation, heart rhythm was irregular, in monitor by pulse oximeter HR fluctuated in the low 40's, to 90's, 50's, 130's then back to 40's. Patient denied chest pain or palpitation, denied past cardiac history.Patient also denied dehydration symptoms, diarrhea, nausea or vomiting. She did report to RN she was taking 3 different types of herbal supplements; and daily vitamins. Patient verbalized feeling resolution of throat itching. Patient remained calm and cooperative. Of note, patient has history of endometrial cancer,last chemotherapy was 4 years ago.   @ 1513 BP 137/69 , HR 55 , Sat 99% on RA      @ 1518 BP 134/71 , HR 43, Sat 98% sat on RA   Plan:  - 911 was called to send patient for further evaluation. EMS arrived, handoff report given. EKG on their portable monitor showed PVCs. Patient left with EMS to Hospital (Other Hospital Emergency was at capacity).    - Patient's father was called by RN to inform of transfer. Patient spoke with father as well.
pt recvd vax 25OCT93 sl pink area rt upper arm; 27OCT93 swelling & redness elbow to shoulder, raised red splotches upper rt arm; APAP given;
inconsolable & fever to 103+ on day of vax 14OCT96 cont to 16OCT96;mom stated intervals of at least 2 1/2hr;vomiting 16OCT96;
p/vax pt started w/fever;red rash on body w/vesicles;
This spontaneous report was received from a nurse, concerning a 16 year-old male patient. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 09-MAY-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 injection (dose, frequency and route were not reported) lot # reported as K010215 with expiration date of 05-MAY-2017, for prophylaxis. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
I received a full dose (100ug) third dose as the half dose booster was not yet approved and I was traveling abroad. I had had little response (8 hours of chills) to the first 2 doses of Moderna. The third dose only gave me a sore arm.  Then 2 and aa half weeks later I developed unrelenting dermatographia- redness, itching, red lines, hives- which moved from place to place all over the body - resolving in one place after 30 min and then moving to another. I have been diagnosed by my GP and a dermatologist and placed on daily Zyrtec for 3 months which treats the symptoms effectively.  If however I am late on my dose, all of the symptoms return. I thought I was alone and then found a case study and saw that there were hundreds of folks like me who had added comments to the article  We are all suffering from this same condition post mRNA Covid 19 vaccine treatment. No one's condition has yet resolved.
Behavior changes. Rage, screaming, kicking walls, hitting. Previously very mellow child with no history of such behavior.