chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid; she just had allergies; lost her taste and smell; lost her taste and smell; mild fever of 99; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program . A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 05Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that both she and her husband received their first vaccine doses on 5Mar2021. On 11Mar2021, the patient thought she just had allergies but then lost her taste and smell and tested positive for covid on March 11th (she reports that her test results came back and confirmed covid on 16Mar2021) and she also reports having a mild fever of 99. They were scheduled to get their second vaccine dose on 26Mar2021 but patient's husband (was tested since they live together) tested positive on 20Mar2021 even though he only had some mild sinus congestion. Caller reported that she was told by the health department to wait 90 days to get the second dose and her doctor told her 14 days. And she was also told that she would have to start the whole series over again. Seriousness of event Covid-19 was medically significant. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379323 same reporter/drug, different patient/AE
Child had an extra dose of PCV13 due to records being sent. Pediatric office that sent us records sent two different records that did not match, and the nurse that completed immunizations reviewed the record that did not have the appropriate amount of PCV13 listed.
pentacel administered today expired on 09/11/2022, with no reported adverse event; Initial information received on 15-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 months old female patient and it was reported that  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered today expired on 09/11/2022, with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , once (lot : UJ571AAA; expiry date: 11-Sep-2022)  via intramuscular route in unknown administration site for immunization.  t was reported that Pentacel administered was administered on 15-Sep-2022 and it expired on 09/11/2022, with no reported adverse event" (expired product administered) (latency: same day)   Action taken : not applicable.  Outcome: 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 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.
I was initially getting mild pain on my left rib, on and off pain, increasing pain with the days, went from to left rib to my back. I went to see a doctor when I got a very strong pain (#10), I could not walk, got tired and was very difficult for me to breathe; the pain was going and off. I went to see the doctor and they did scan but doctor did not find anything and just gave me a prescription of Gabapentin 3 times a day.
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant medications were reported.  It was reported that 113 Bivalent doses were administered after the BUD to patients 12 and up. 51 doses were administered from Lot AS7140C, and 60 doses from Lot AS7148B.  No treatment medications were reported.
About 10-12 hours after receiving my second dose of the Moderna COVID19 vaccine, I began experiencing chills and body aches. This continued throughout the next day, and lasted about 24 hours. Pain was especially acute at the vaccine site.
6/17 Rash on hands and sore throat  6/18-6/20 rash on hands, sore throat, headache, body aches, tiredness, brief high heart rate, slight cough
Initially, patient had redness and swelling at the injection site. The day following administration of the vaccine the patient experienced a blotchy rash on her torso spanning from just under her breast area to her groin.
Splenic Infarct Patient is a 74 y.o. female presenting with left sided chest pain. She became very ill after receiving her second Pfizer COVID booster on 4/28 - an hour later, she developed fevers/chills, body aches, diarrhea, and fatigue. By 5/1, she began to develop a pain under her left rib that continued worsen and became unbearable tonight. This pain is worse especially with deep breathing.
pt recv vax 1MAY96 & 18MAY96 pt devel parotitis, accompanied by a swollen lt cheek & pain when chewing;
This spontaneous report was received from a medical assistant and refers to a 21 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-DEC-2016, the patient was vaccinated with a first dose of VAQTA 25/0.5 unit not reported, intramuscularly (site of administration were not reported) lot #M022924 and expiration date: 24-JAN-2018. On 14-FEB-2017, the patient was vaccinated with a second dose of VAQTA, intramuscularly injections (site of administration was not reported) lot # M036458 and expiration date: 02-MAR-2018. The patient did not experience any adverse effect. Additional information has been requested.
A nurse reported that an unidentified adult subject did not seroconvert after receiving 3 injections of Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On unspecified dates, the subject received injections of Engerix-B at 0, 1, and 6 months. 2 months following the 3rd dose, the subject's "titer" (NOS) was less than two indicating that the subject did not seroconvert. The reporting nurse stated that she has investigated the "Lab" to see if there was a problem there. (Outcome not specified.) Treatment and outcome were not provided. Comment: The reporter indicated that four subjects have experienced this event, however, identifiers were not provided. Therefore, this report is considered not reportable.
Information has been received from a company representative concerning a child (gender not reported) who at about one year of age in 1998 was vaccinated with a dose of MMR II (lot not given). Subsequently, the child developed an "MMR type rash and seizures," which required hospitalization. The pt's mother stated that the child has regressed after having the seizure, has had to relearn walking and talking and now has attention deficit disorder. Upon internal review, has regressed after having the seizure, has had to relearn walking, has had to relearn talking and attention deficit disorder were determined to be other important medical events. Additional info has been requested.
Patient requested the Pfizer Bivalent vaccine and was administered in error an empty syringe.
Pt who was vaccinated with varicella virus vaccine live, subsequently tested negative for varicella antibodies. Additional information has been requested.
Patient reported onset of mild/moderate tinnitus starting the evening of 10/17.   Patient called to report to pharmacy at 5:45PM on 10/21 and reports that symptoms have not resolved.  Patient was advised to follow up with health care professional for evaluation as soon as possible.
SLIGHT ARM ACHE; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced slight arm ache, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and slight arm ache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210440719, 20210439367 and 20210439312.
Severe pain deep to injection site right deltoid shortly after injection, worsened over next several hours and unable to abduct arm without pain. Limited ROM arm, shooting pains in area.  No edema erythema induration.  No discrete paralysis. Has had multiple flu shots as well as other vaccines in military and never had reaction.
I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; I'm currently experiencing headache, chills, fever, body aches and weakness.; This is a spontaneous report received from a contactable consumer. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unknown route of administration on the left arm on 18Mar2021 08:15 (age at vaccination was 40-year-old) as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unknown route of administration on the left arm on 26Feb2021 as single dose for COVID-19 immunisation. Medical history of the patient included myasthenia gravies. Patient was allergic to hydromorphone and promethazine. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), CELLCEPT, gamunex (MANUFACTURER UNKNOWN), MESTINON and SOLIRIS. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 18Mar2021 at 17:30 after receiving the second dose of vaccine in her left arm, the patient experienced headache, chills, fever, body aches and weakness. The patient did not receive any treatment for the events. The clinical outcome of events headache, chills, fever, body aches and weakness were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 68 years, in left arm 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: "Asthma" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN, start date: 04Apr2022, stop date: 27Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid. Clinical information: Other medication in 2 weeks product was Atorvastatin. Other medication in 2weeks brand was Generic for Lipitor. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a covid-19 vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
COVID-19 infection the patient is not hypoxic and does not have any respiratory symptoms however she does have history of COPD and ESRD.  In light of those comorbidities I think to be reasonable to treat her with a course of remdesivir.  Her COVID infection is in the setting of her recent hospitalization for surgery however she most likely got her infection from her apartment where 6 people tested positive for COVID
COLLAPSED; HEADACHE; This spontaneous report received from a consumer concerned a 70 year old male. 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 not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced headache, was clammy to the touch. On same day at 14:00, checked blood pressure (BP) and it was 145/75 and his oxygen level read in the 90's. At 18:00, he collapsed while getting up out of his chair and emergency medical services (EMS) was called performed cardiopulmonary resuscitation (CPR) but never got him back. On 10-MAR-2021, the patient died from cause unknown. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of collapsed on 10-MAR-2021, and the outcome of headache was not reported. This report was serious (Death, and Other Medically Important Condition). The suspected product quality complaint has been confirmed to be no product quality complaint identified within the reported. Complaint is approved for void, based on the PQC evaluation/investigation performed. This report was associated with product quality complaint :90000173895.; Sender's Comments: V0: 20210341940-COVID-19 VACCINE AD26.COV2.S- COLLAPSED. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: Cause unknown
Mother reports that the evening of 4/27/10 infant was a little fussy, however, nothing more than what she expected after immu.  This is her 3rd child.  At 2pm 4/28/10 Babysitter brought infant to mother's work.  Infant had rash over entire body including face. Mother immediately rushed infant to pediatricians office.  Dx with hives and referred to an allergist.  Hives resolved within 36hr. No fever.  No other problems.  Infant is breastfed.  Mother reports that even with rash "infant did not act anything other than happy".  Rash resolved before the allergist's appointment. Allergist wishes to administer immu in her office in controlled setting, however, pediatrician's office reports that allergist is concerned that it might be Prevnar that caused the hives.
Pt recvd vax & the same day @ 7PM exp a tonic-clonic sz w/apnea which lasted 1 min; pt is currently on apnea monitor; pneumogram was WNL x//for a few episodes of disorganized breathing;
This case was reported by a other health professional via sales rep and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. Concomitant products included adalimumab (Humira). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, vomiting and pain in arm. On an unknown date, the outcome of the nausea, vomiting and pain in arm were unknown. It was unknown if the reporter considered the nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced intense arm pain. For the tolerance after 2nd dose refer case US2018GSK151204, for same patient.
24 hrs after injection pt c/o itching all over. Rash observed on right arm. State had temp 100.5. Referred to DR for evaluation. 11-11-05 Ordered Medrol DOS pack
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an approximately 56-year-old female patient (pt) who was 56 years old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 28-JUL-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at physician's offices for the long-term prevention of shingles and zoster-related conditions. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about December 2016, including any and all of its sequelae (also reported as subsequently (date not provided), the pt was treated by a healthcare provider for shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX)). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) defective design, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences (also reported as had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). The pt had endured substantial pain and suffering. She had incurred significant expenses for medical care and treatment, and would continue to incur such expenses in the future. The pt had lost earnings and had suffered a loss of earning capacity. The pt had suffered and would continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
4/30/04:  Pt called 4/30/04 at approximately 11:15am. States she's developed enlarged lymph nodes in the right clavicular area as of 4/29. Has a slight sore throat, No fever. Has tender, sore spots on neck and pain in one arm. States she used the rototiller yesterday lymph enlargement not mentioned in the adverse event section of the vaccine insert. Asked patient to keep us informed. 05/03/04: Called patient states lymph node on right clavicle greatly reduced. Had decided to get a temp. check: Was 99.6 last week. States arm doesn't ache like it did. No fever today. 05/03/04: Pt called back and stated "I checked the clavicle again and it hasn't reduced. Like I thought. I do have a slight temp of 99.2 I did some shoveling this weekend. And my arm doesn't ache like it did last week." Will call pt again to check for progress.
MUSCLE WEAKNESS RIGHT LEG; MUSCLE WEAKNESS ARMS; TINGLING ON RIGHT LEG; TINGLING ON BACK; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included guillian barre syndrome, transverse myelitis, non-alcoholic, non-smoker, beesting allergy, and left leg paralysis, and other pre-existing medical conditions included no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1821288 expiry: 15-SEP-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUL-2021, the subject experienced tingling on right leg. On 04-JUL-2021, the subject experienced tingling on back. On 11-JUL-2021, the subject experienced muscle weakness right leg. On 11-JUL-2021, the subject experienced muscle weakness arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling on right leg, tingling on back, muscle weakness right leg, and muscle weakness arms. This report was non-serious.
very bad stomach cramp; Diarrhea; Frequent urination (5 times last night); sore shoulder; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (very bad stomach cramp), DIARRHOEA (Diarrhea), POLLAKIURIA (Frequent urination (5 times last night)), ARTHRALGIA (sore shoulder) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (very bad stomach cramp), DIARRHOEA (Diarrhea), POLLAKIURIA (Frequent urination (5 times last night)), ARTHRALGIA (sore shoulder) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (very bad stomach cramp), DIARRHOEA (Diarrhea), POLLAKIURIA (Frequent urination (5 times last night)), ARTHRALGIA (sore shoulder) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treeatment include antacids,anti diarroheal and hydration.   This case was linked to MOD21-041492 (E2B Linked Report). This case was linked to MOD-2021-031438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Details of AEs and consumer agreed to fill out ADR form; Sender's Comments:  MOD21-041492:
pt recvd vax & w/in 5mins post vax devel a hive 2 inches below inj site,exp itching;sx subsided w/in 24hrs;
fever to 104 evening of vax; APAP given-fever to 101; fever inc to 104 again 30NOV93;
PER PATIENT'S MOM - PATIENT WOKE UP THE NEXT DAY FEELING LIKE SOMETHING WAS GRABBING HIS CHEST. EXPERIENCED THIS ON AND OFF UP UNTIL TODAY (7/6/21) WHERE HIS CHEST LOOKS SWOLLEN AND HAD DIFFICULTY BREATHING AT WORK. ADVISED PATIENT'S MOM TO GET TESTING/IMAGING DONE