chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone Quad was administered to a patient instead of the Fluzone HD with no AE; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong product administered [Latency: on the same day].  It was reported "caller stated that a nurse was supposed to administer FLUZONE HD to a patient, but instead administered FLUZONE QUAD".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
Runny nose; Tired and Achy; Can't stay out of bathroom; Developed chills galore; Very cold; Arm was sore; Very tired; Had some Chills; Had a Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), FEELING COLD (Very cold), RHINORRHOEA (Runny nose), PAIN (Tired and Achy) and FATIGUE (Very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), FATIGUE (Very tired), CHILLS (Had some Chills), HEADACHE (Had a Headache) and NAUSEA (Nausea). On 09-Jan-2021, the patient experienced FEELING COLD (Very cold) and CHILLS (Developed chills galore). On 15-Jan-2021, the patient experienced PAIN (Tired and Achy) and FATIGUE (Can't stay out of bathroom). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, PAIN IN EXTREMITY (Arm was sore), FEELING COLD (Very cold), RHINORRHOEA (Runny nose), PAIN (Tired and Achy), FATIGUE (Very tired), CHILLS (Had some Chills), HEADACHE (Had a Headache), NAUSEA (Nausea), CHILLS (Developed chills galore) and FATIGUE (Can't stay out of bathroom) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
I received my vaccine in the afternoon.  The initial injection wasn't painful.  Three hours later, my arm was a 10/10 pain from shoulder to elbow.  I took pain medication and a heating pad to relieve the pain which was unsuccessful.  I later continued with medication.  The pain finally subsided by Thursday midday.  Beginning on Wednesday I have had fatigue lasting until Sunday.  Monday while at work I developed a severe bilateral temporal headache.
pt recv vax 7OCT97 & 20OCT97 pt devel a chickenpox-like rash on upper body, accompanied by a sore throat & mild fever;
Significant pain (and swelling) in right armpit; (Significant pain) and swelling in right armpit; This is a spontaneous case, initially received from other health professional via Med Communications (reference number: SEQ19-04339) on 10-Oct-2019, concerning an 51-year-old male patient.   The patient's relevant medical history and concomitant medications were not provided.  On 08-Oct-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: right deltoid, batch number reported as 260204 (Seqirus batch number: 261204), expiration date: 26-Jun-2020] for influenza prophylaxis.  On the same date, after vaccination, the patient developed significant pain and swelling in right armpit.  The outcome of the event significant pain and swelling in right armpit was unknown, at the time of report.  The reporter assessed the case as non-serious, but did not provide causality.; Sender's Comments: The patient developed axillary pain and axillary mass, on the same date after administration of the suspect vaccine, Flucelvax QIV. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.
felt sick; vaccine hurt; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date refer case US2019AMR131615).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that he felt sick for a couple days after receiving Shingrix. He also said that the vaccine hurt and he would like us to make it hurt less.
tingling over the entire body, slight dizziness feeling off balance, gave H2O and rested, discharged in no distress
Not feeling well; Arm was sore ,body aches; Temperature; Sweats; Body was burning hot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore ,body aches), PYREXIA (Temperature), HYPERHIDROSIS (Sweats), BURNING SENSATION (Body was burning hot) and MALAISE (Not feeling well) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced MYALGIA (Arm was sore ,body aches), PYREXIA (Temperature), HYPERHIDROSIS (Sweats) and BURNING SENSATION (Body was burning hot). On an unknown date, the patient experienced MALAISE (Not feeling well). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Arm was sore ,body aches), PYREXIA (Temperature), HYPERHIDROSIS (Sweats), BURNING SENSATION (Body was burning hot) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Temporal temperature on right aide was 102.2 and on left side was 102.3. No concomitant medications were reported.
This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, fatigue and weakness generalized. On an unknown date, the outcome of the fever, fatigue and weakness generalized were unknown. It was unknown if the reporter considered the fever, fatigue and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
pt says her throat started burning immediately after taking the vax and she had some difficulty swallowing.  her PCP came and checked her vitals.  She was observed for about 30 minutes and was able to leave.  About 4 or 5 days later she noticed her vision declining.  She already has poor vision but seemed to be getting worse.  She has a varicose vein on her right leg and her upper right leg is swollen.  She will contact her doctors.
Every joint aches -started 4/9 @11 pm  and still happening.  Gastrointestinal distress, excessive gas, colon cramping- started 4/10 @ 1am Loss of appetite- am 4/10
Patient became presyncopal shortly after vaccination.  She was placed in supine position, with legs elevated. Vitals WNL, symptoms completely resolved with position changes.  No other symptoms reported.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 13-JUL-2016 and 13-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
No adverse effects immediately. However, a week later the injection site started to itch a lot. By the end of the day there was a large patch of red on the arm - looked like rash. Today it is smaller but has welts. It does not itch any more.
5 DOSES OF EXPIRED VACCINE ADMINISTERED TO PATIENTS; OFF-LABEL USE; This spontaneous report received from a health care professional concerned 5 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patients experienced medication error: 5 doses of expired vaccine administered to subjects. On 23-SEP-2021, the patients experienced off-label use. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error: 5 doses of expired vaccine administered to patients and off-label use was not reported. This report was non-serious.
patient has been pregnant or breastfeeding the whole time, so she only has an OB; Headache; This is a spontaneous report from a contactable consumer (patient husband). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in right arm on 20Mar2021 at 10:30-11:30 at single dose for covid-19 immunisation. Reportedly, patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in right arm on 10Apr2021at 10:30-11:30 at single dose for covid-19 immunisation. The patient medical history included chronic stress, reporter stated other than going through a pretty lengthy season of chronic stress. Reportedly, they have had a bunch of crap happen. It was reported place where they live, they had massive outages and they also were going through a transition period professionally with some things. Patient had no other relevant medical or family history. On an unspecified date in Apr2021 after first dose of vaccination patient experienced headache. The patient experienced pretty bad headache after the first dose, and it was for a few days, it got pretty bad then it began to improve then it came back somewhat, and it was not as bad. Reporter stated either unknown or persistent. Reporter stated patient also experienced headaches semi-regularly before the vaccine. Reporter stated her headache is ongoing. Reporter stated he remembers it was being pretty persistent, bad, and it peaked probably around 3-5 days after getting the first dose. Reporter verified it started sometime in Apr2021. It was also reported that patient did not have a primary care doctor and patient has not established one yet. Reporter stated patient has been pregnant or breastfeeding the whole time, so she only has an OB. Reporter stated the patient was taking acetaminophen or ibuprofen for headaches. No investigation assessment. No relevant tests were done. The outcome of event was not recovered for headache and unknown for maternal exposure timing unspecified.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives on back of both hands, more on left hand.  Appeared when woke up Sunday, April 4. Still here monday evening,  April 5.
IMMUNE THROMBOCYTOPENIC PURPURA; This solicited report received from a physician: concerned a 78 year old male. 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: Unknown) dose was not reported,1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 4 days after vaccination the patient was diagnosed with immune thrombocytopenic purpura (ITP). His platelet count were significantly lowered. He was treated with immunoglobulin human normal (IVIG), 2 units of platelets, and decadron (dexamethasone). He visited physician's office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune thrombocytopenic purpura was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura as related. Company causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220110559 -covid-19 vaccine ad26.cov2.s-immune thrombocytopenic purpura. This event(s) is labeled per RA and is therefore considered potentially related.
I contracted COVID-19 on 07/06/2022 with symptoms of cough, low grade fever, phlegm, and congestion. I was prescribed Paxlovid on 07/08/2022 and I also took Mucinex. I began to improve on day 4 of my illness, but I am still experiencing symptoms of cough and phlegm.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint  This case, from the same reporter is linked to 20221262240.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (via oral route of administration; dose, lot# and exp. date were not reported). No adverse effects were reported. The outcome of the event was unknown. This is one of the two reports received from the same source. Additional information has been requested.
Began losing all previously developed language and showing signs of PDD/ASD.  Undergoing speech and occupational therapy.
she had to stop what she was doing at the time.; She began to experience waves of nausea; She said she got dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EW0150) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood Pressure" (unspecified if ongoing), notes: Patient taking blood pressure medicine, and her blood pressure was controlled. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 04Apr2021, outcome "not recovered", described as "She began to experience waves of nausea"; DIZZINESS (non-serious) with onset 04Apr2021, outcome "not recovered", described as "She said she got dizzy"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she had to stop what she was doing at the time.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient received first dose on 30Mar2021 between 13:00-13:30. On Sunday, 04Apr2021, she began to experience waves of nausea and dizziness that are ongoing and, were "actually even worse today".  The symptoms come and go. The patient had not checked BP because she was at home, didn't have a fever. On Sunday morning (04Apr2021), she had 4 cups of coffee, and started cleaning her son's bathroom. She said she got dizzy and had nausea, clarifying she had to stop what she was doing at the time. She said she couldn't go out to dinner with her children on Sunday because the dizziness and nausea kept waving in and out. She had been on the blood pressure medicine for a while. Additional Vaccines Administered on Same Date of the Pfizer Suspect were None. Prior Vaccinations (within 4 weeks) were None.  No follow-up attempts are needed. No further information is expected.
On 10/8/18, 81-y/o woman got her flu shot at the pharmacy. Pharmacist told her based on the  database, she was also eligible to get her PREVNAR 23 booster, so she agreed; they were both administered in the same arm. She could not remember when she got the previous PNEUMOVAX, but it had been awhile. She has a tendency for vagus reactions to pain (passing out), but did fine with the vaccines at the time of injection. However overnight she had some significant reaction: pain, warmth and swelling in her arm and lapse of consciousness. We scheduled an urgent care appt the next day and she ended up in the ER after she passed out several times during the exam. On Weds. 10/10/18, she had a follow-up with her regular physician, who looked on the website/registry and determined that she had already had the PREVNAR 13 in 2016, the PREVNAR 23 booster in 12/17, and had now gotten a third dose of vaccine and was suffering from a significant arthus response. Not life-threatening, but certainly dangerous for a woman with no threshold for pain. This may have been an oversight by the Pharmacist who didn't know how to check the registry correctly, or it may have been intentional because these retail pharmacies appear to be incentivized to administer as many vaccines as they can. She will no longer receive vaccines outside of her physician's office. I've been advised that I can file a complaint with Agency regarding my concern about financial gain.
Admitted to PICU for monophasic V. Tach with pulse up to 220
Pt. received first dose Pfizer COVID vaccine at 1415 and shortly developed throat itching, swollen tongue, and swollen left lower eyelid.  Baseline VS at 1418 was BP 126/82, RR 16, HR 122, O2sats 95% on RA.  States throat felt tighter and epipen was administered to left thigh at 1419.  She was examined   Lungs CTA, no stridor, CV RRR and did not appear to be in distress with breathing.  She was placed on oxygen at 2 liters.  Code blue called at 1427.  VS-BP 128/73, RR 18 HR 132 O2sats 99% on 2L post-epipen administration.  States she felt better after epipen was administered and 2 puffs albuterol.  Transported to local ER and discharged same evening.
Tingling in her feet and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling in her feet and legs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L012034 and expiration date 07-APR-2017) (dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Dizziness occurred 5-10 min after dose administration. Lasted about 30-45 min. Mild nausea occurred around the same time.
I woke on 09MAR2023 feeling very ill my symptoms were very bad. I had a headache, diarrhea, stomach ache, loss of taste and smell and body aches. I was extremely weak. I had a fever. I called my Doctor and Paxlovid was prescribed within two days I was feeling much better.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-23.
27 August 2008- received smallpox vaccine- constant itching, rash, small postules around injection site. One week later still itching and arm is swollen around injection site. Two weeks later, extremly tender around injection site-painful and lymphnodes on left side of body are swollen-mainly under left arm and groin lymphnodes. Additionally, I had a rather large amount of my hair fall out in the shower on 3 September. Also got anthrax shots 1 and 2 on 15 August and 3 September and have had a constant cough and sore throat since the shots. Not sure which vaccine these adverse events are from. 5 September Dr. put me on quarters and directed me to take Motrin for the pain and use a warm wash cloth on the injection site.