chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. On an unspecified date the patients were vaccinated with ROTATEQ which was improperly stored at various temperatures. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. No adverse reaction reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
pt became pale, limp, very lethatgic, eyes rolling back, breathing became very irregular, t101;
Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves 36-year-old male patient who received vaccine IMOVAX RABIES. The patients past medical history, concomitant medication and family history were not provided. On 04-Feb-2019, the patient received injection of first dose of suspect IMOVAX RABIES lot number not reported via unknown route in unknown administration site. It was an actual medication error due to Inappropriate schedule of vaccine administered. It was reported that patient was bitten on the tip of his finger by a stray cat several days before the first dose but given but he did not think anything about it until the finger started to get infected. First dose given 04-Feb-2019, but the product was not available to give the dose for day 3 but will be given today. IMOGAM was not administered but they plan on giving it today. It was unknown whether patients experienced any adverse reaction after the injection. 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 and Module VI of the 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. List of documents held by sender- none.
the patient not going to be able to come in for her 2nd vaccine on day 7; Case reference number US-BN-2021-001649  is a spontaneous case report initially received from nurse on 26-Apr-2021, and concerns a 22 years-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 21-Apr-2021, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. ARBA8018) at unknown dosage regimen for pre exposure vaccination. After the patient was administered with first dose of RabaVert, she experienced COVID-19 infection (reported as not related to vaccination), and she was not able to come for her second vaccine on day 7. The vaccination on day 14 was questioned, because that would have been when her 10 days would be up. (Inappropriate schedule of vaccine administered)  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was scheduled due to COVID-19 infection, which is considered to be inappropriate schedule of product administration. No adverse events were reported. Inappropriate schedule of product administration is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient did not receive the second dose of RabAvert on the day when it was scheduled due to COVID-19 infection, which is considered to be inappropriate schedule of product administration. No adverse events were reported. Inappropriate schedule of product administration is not related to the vaccine itself, but to human action.
Symptoms were chills, fatigue, body aches, headache, fever, tachycardia that started about 12 hours after receiving the vaccine and lasted for about 3 days.
Several days after the vaccine I noticed that when I tried to exercise, like riding a bike with my husband, I would have a lot of exertion. At the same time, whenever I would go up a hill on my bike, or something that required a little bit of extra exertion, my heard would beat extra and it would feel as though I was having a run of IHPs. During that time, it was about two to three weeks, I felt very weak when I tried to do any exercise. I was fine going to work and walking around all day, I was fine when doing that. I had to apologize to my husband when we would go on our regular bike rides, because I just could not do it as I would previously. After that period I was able to regain my exercise tolerance, however, I continued to have what I felt was ectopy, more so when I was exercise but also happening all the time/randomly/when sitting and doing nothing. So I decided to quit caffeine and also went to see my DR. The DR did an EKG. They also had me wear a monitor, but the PVCs had wore down at that time. I cut down on caffeine and started taking magnesium as well. But I just wanted to say I did not correlate what was going on with the vaccine, I did not share because I did not want to seem whiny about it when other people could not get the vaccine and I had had it but now I am scared of there being a possible booster because of what I went through. The irregular heart palpitations probably haven't happened in about 4 weeks, approximately.
Experienced extreme bad headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that someone in the building got the Pfizer coviid-19 vaccine and experienced extreme bad headache. She used that excuse from doctor to not get the second dose. I know so many people dying after received the Pfizer. The woman in her building who had the first dose awful headaches and could not move from the bed and she did not do the second dose. It was stated they gave her a strong dose of antihistamine before the vaccine. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
8 days after I had the shot my upper arm got red,swollen,hot and very itchy and sore
A LOSS OF MY TASTEBUDS, MOSTLY SWEET AND SALT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced a loss of my tastebuds, mostly sweet and salt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a loss of my tastebuds, mostly sweet and salt. This report was non-serious.
Patient developed urinary retention the morning after receiving the vaccine. Inability to void without valsalva, small void w valsalva, post void urinary residual, bladder distension (mild). No dysuria or hematuria. No hx similar.
Hardness - Near Injection site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness - Near Injection site) and VACCINATION SITE RASH (Rash - Near Injection Site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness - Near Injection site) and VACCINATION SITE RASH (Rash - Near Injection Site). At the time of the report, VACCINATION SITE INDURATION (Hardness - Near Injection site) and VACCINATION SITE RASH (Rash - Near Injection Site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were  reported. Treatment for the events not provided.   Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a certified medical assistant concerning a 21 week male patient with no known drug allergies who on 13-JUL-2011 was vaccinated with a first dose of ROTATEQ, PO (dose and lot # not reported) and on 14-SEP-2011 was vaccinated with a dose of ROTATEQ (Lot # 669529/0548AA, Expiry date 20-SEP-2012), PO (dose and route not reported). Secondary suspect therapy included PEDIARIX, ACTHIB and PREVNAR. There were no concomitant medications. The certified medical assistant reported that on 15-SEP-2011 the patient experienced hives (red raised bumps) on his legs, coughing and difficulty breathing after his second dose of ROTATEQ. The certified medical assistant also reported that the patient was examined in the emergency room but was not hospitalized. A complete blood cell count (CBC) was performed (no results provided). Ibuprofen was given as a treatment for the events. At the time of the report, the patient's outcome was unknown. Information received from medical records concerning a 5 month old male with a history of neonatal jaundice who on 14-Sep-2011 at 17:00 was vaccinated with a second dose of ROTATEQ (Lot # 669529/0548AA). At the same time the patient received a second dose of the following vaccinations: ACTHIB and PREVNAR. On 15-Sep-2011 at 11:04 the patient was seen in the emergency room for hives on his legs. The patient's mother reported that the patient had a choking episode and could not catch his breath. The patient also had a decreased appetite and experienced nausea and vomiting x two during the previous night. It was noted that the patient was being breast fed. The patient's mother reported that at 0730 the patient received 1.3 ml of TYLENOL. The patient's vital signs in the emergency room were: temperature of 100.2 rectally, pulse of 160 and respirations of 24. His oxygen saturation was 99% on room air. The patient was alert, appeared well nourished with no respiratory distress noted. At 13:28 the patient received 4 cc of ibuprofen. At 14:26 a repeat temperature was 100 temporarily. At 14:36 the patient was sleeping. The following laboratory results were obtained: blood count with differential was within normal range except for a mean corpuscular hemoglobin concentration (MCHC) of 35, mean platelet volume (MPV) of 6.5, platelet of 405, neutrophils of 58 and lymphocytes of 34. The absolute cell count was within normal range with the exception of absolute neutrophils of 9.3. The patient was discharged at 15:00 with a diagnosis of acute allergic reaction. Discharge instructions given to the patient's mother included: TYLENOL or ibuprofen for fever and follow up with their physician. It was reported that the patient was recovered on 15-Jul-2011. 15Sep2011 abnormal laboratory results received included: absolute neutrophils of 9.3 x1000/uL, mean corpuscular hemoglobin concentration(MCHC) of 35g/dL, mean platelet volume (MPV) of 6.5fL and platelet count of 405x1000/uL. Upon receipt of medical records the following adverse events were removed as they were considered symptoms of an acute allergic reaction: difficulty breathing, coughing and hives on legs. Additional information has been requested.
LOW GRADE FEVER SCRATCHING COUGH SLEPT 34 HOURS AFTER SHOT TASTE AND SMELL AFFECTED STUFFY NOSE HEADACHE
Arm is a little sore, left arm/her arm hurts after she took the 1st dose; my body hasn't built antibodies, yet from the vaccine; This is a spontaneous report from a Pfizer-sponsored program (NCSP: 159558) from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 as a single dose for COVID-19 immunization. Patient medical history included patient went to the doctors 2 days before the vaccination because of kidney stone, woke up with feeling sick yesterday (24Feb2021) before the vaccination like having cold, sore throat, runny nose, sinus and went to get the vaccine. The patient believed that was a cold, not virus. No fever, she really did not believe it was covid. She had colds twice and been tested twice. She said it was not Covid since he had not gone out for a month. Concomitant medication included homeopathy medication Oscillococcinum; they were all antiviral or immune boosters. The patient previously took elderberry gummies before the patient went to get the vaccine. On 25Feb2021, patient was feeling better today, and her arm was a little sore, left arm, with no pain, no redness after she took the 1st dose, but it's not swollen or no redness at all and it's not her main concern. The patient had no antibodies when she came back. Her body had not built antibodies yet from the vaccine. The patient wanted to know whether it was okay to take herbal antiviral, ginger tea, tumeric, zinc, elderberry gummies and licorice; whether it was interfered with vaccine. The patient knew she could take antipyretics drugs. The patient underwent lab test which included drug specific antibody: absent on an unspecified date and covid test twice: unknown as she really did not believe it was covid. She had cold twice and been tested twice. The clinical outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Possibly 3 doses adminstered to 1 patient; A spontaneous report was received from a HCP concerning about a 74 old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of received 3 doses of Moderna COVID-19 vaccine.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 29 Oct 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection.  On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection.  On 23 Feb 2020, prior to the onset of the events, the patient received their third of two doses of mRNA-1273 (Batch number: 043L20A) via an unknown route for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced received 3 dose of Moderna COVID-19 vaccine.  Laboratory tests was not reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event are unknown.  The outcome of event was considered as recovered on 23 Feb 2021.; Reporter's Comments: This report refers to a case of Extra dose administered for mRNA-1273, lot # 043L20A, with no associated AEs.
Erythema and pruritus around injection site (immediate, approx. 2" diameter), headache, diaphoresis. No orthostasis. Patient's baseline condition includes wheeze, SOB, so hard to determine worsening.
Red painful spot on injection site, roughly 2 inches in diameter, noticed next day, redness and soreness has faded some as of 4 day mark, but random itching and random small pangs / pains have started. Sore arm started night of and lasted about 3 days.Fever started next morning and lasted 2 days. That was joined by aches, chills, headache, and worse fatigue than usual.
Received my covid shot Wednesday, March 31st. Experienced a headache afterwards which was tolerable but lasted all day. Had a headache the next day as well, all day. Since receiving the vaccine, I have been experiencing headaches from what appear to be daily, I had experienced headaches before but not this often. It tends to be throbing pain on the right side of my head only.
Experienced flu-like sx w/nausea, transient "scleric changes" & an ulcer under her tongue; Seen in ER; Was vaccinated w/second dose of HepatitisB (Recomb);
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 19 years old male patient who experienced soreness at injection site/ left arm is sore at injection site while he received vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TENIVAC for Immunisation; and HEPATITIS A VACCINE for Immunisation in the right arm on an unknown date. On 26-Sep-2018, the patient received a 2.5 ml dose of suspect IPV (VERO) (lot number: B1G51 and expiry date: 02-Aug-2019) in the left deltoid (route of administration were not reported). On an unknown date, the patient developed a non-serious soreness at injection site/ left arm is sore at injection site following the administration of IPV (VERO). It was also a case of actual medication error due to overdose because 2.5 ml total to a patient and the patient was given an excessive dose. No Lab data was reported. Final diagnosis was gave an excessive dose/ just gave 5 times the normal dose of ipol, gave 2.5 ml total to a patient and does have soreness at injection site/ left arm is sore at injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for does have soreness at injection site/ left arm is sore at injection site. 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. Documents held by sender: none.
itchy rash like redness & tenderness near & around injection site approximately 8 to 9 days after initial immunization date.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On an unknown date, the patient missed a dose of VAQTA because the vial was under filled (product quality issue). No adverse effect was reported. A Product quality complaint (PQC) was reported because the VAQTA vial was under filled. Additional information has been requested.
Pt has developed fluid retention after COVID booster, >10lb weight gain in 48 hours. she is currently undergoing cardiac testing. she has no history of fluid retention or heart disease
Patient was fearful coming to vaccine event.  Said she could "hardly enter room". "Anxious".  Has had anxiety issues.  Talked about mother's recent death.  Asked to have BP checked after injection.  Apears nervous.  Discussed heart attack and surgery in 2019.  Currently without insurance.  Lost hotel job during Covid.  Recently started new employment, but missed enrollment.  Has had elevated BP in past, but not taking BP med.  Discussed normal vaccine reactionq and gave literature.  After talking with the monitor for about 20 minutes seemed relaxed an said she felt fine.  Directed patient to a Health Care Representative for resources to insurance and health care during this insurance group.  Symptoms: Sweating.  Vitals 12:30p : bp 142/82, p 72 strong; 12:42: bp 142/80, p 70 strong, r 16;  Left monitoring area feeling better, was given bottled water to drink.  Will rest and take fluids.  Able to call PCP and Heart Specialist if concerning symptoms.  Seemed relaxed and smiling.  Encourage special program enrollment.
2 shingrix doses, then shingles; Shingles under right and left  breasts; rash began as little pustules; itchy pustules, ruptured pustules leaving  itchy area; ruptured pustules leaving red area; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression and crohn's disease. Concomitant products included infliximab (Remicade).   On 29th March 2022, the patient received the 2nd dose of Shingrix. On 18th January 2022, the patient received the 1st dose of Shingrix. In November 2022, between 6 and 7 months after receiving Shingrix and between 10 and 11 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pustular rash, pruritus and erythema. On an unknown date, the outcome of the vaccination failure, pustular rash, pruritus and erythema were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pustular rash, pruritus and erythema to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-Dec-2022 Reporter's Comments:  This case was self-reported by the patient.  The patient received first dose and the second dose of Shingrix.  The patient reported being unaware of which arm they received doses in, but stated they typically received vaccinations in the left arm.  The patient experienced Shingles outbreak, which began approximately a week and half ago.  The patient reported Shingles outbreak began on the right side, under the right breast along the bra line before spreading the left side, under the left breast two days later. The patient reported rash began as little pustules, which were itchy.  The patient reported pustules have now ruptured, leaving the area red and itchy.  The patient reported being immunosuppressed, due to taking Remicade for treatment of Crohn's disease.  The reporter did not consent to follow up. Additional supportive information: This case considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported.
swollen glands/high fever x 1 1/2 days; 9 days p/vax, then rash x 2 days, then stiff joints; all resolved;
Sore arm, swollen shoulder on the side where the shot was injected ,  flu like symptoms, no taste.
Pain, swelling, itching at injection site. Pt self-treating with hydrocortisone cream. Visited her PCP to have them look at it.
Rash developed around injection site approx. 4" in diameter. Patient was seen at walk in and treated for possible cellulitis.