chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a male patient who received SHINGRIX. On 15th February 2018, the patient received SHINGRIX. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness. On 21st February 2018, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site tenderness, injection site swelling, injection site erythema, injection site warmth and injection site induration were unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX shot on the left arm at pharmacy on Thursday evening, and had very little issues and almost no pain in the shot area unless pressed. On the date of reporting, the patient noticed the area of the shot was swollen to a little degree and there was large area about 3 inches high by 5 inches on the surface of the left arm that had some redness and warm to the touch. On 21st February 2018, 6 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site induration. The muscle tissue under this red area was hard compared to the surrounding tissues. The patient had no concern at the reporting point but was just wondering if this swelling and firmness of the muscle tissue was a known side effect of the shot. The patient would keep an eye on the area and advise pharmacist of this effect.
THIS PATIENT WAS INADVERTENTLY GIVEN ROTARIX VIA PARENTERAL ROUTE ( IM ) INSTEAD OF ORAL ROUTE
elevated heart rate; broke out into a raised rash on shoulders, back and buttocks; the patient received the first dose of vaccine on 12Jun2021 and the second dose on 28Aug2021; This is a spontaneous report from a contactable consumer (patient).  A 15-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FD8498), via an unspecified route of administration, administered in Arm Right on 28Aug2021 at the age of 15-years-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Right on 12Jun2021 09:00 at the age of 15-years-old and she had experienced hearth rate elevated. Medical history included Covid-19. Concomitant medications included ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP) taken for an unspecified indication, start and stop date were not reported; tazarotene (FABIOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced elevated heart rate/highest was 214 and broke out into a raised rash on shoulders, back and buttocks on Sep2021 with outcome of recovering. The patient underwent lab tests post vaccination which included sars-cov-2 antibody test: negative and sars-cov-2 nasal swab test: negative on unknown date. Therapeutic measures were taken because of the events: received prescription for steroid.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101197093 Same reporter/, same patient, different dose of vaccine.
Systemic: Fainting / Unresponsive-Medium, Additional Details: about 5 minutes after vaccine, patient was waiting in the waiting room, fell to the floor, and seized up for about 5 seconds before coming to. Patient alert and stable. EMS not activated. Patient accompanied home by family member
Really bad chills; sore arm at the injection site; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Really bad chills), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (Exhaustion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (horrible asthma) and Kidney disorder (kidney issues).   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Really bad chills), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (Exhaustion). At the time of the report, CHILLS (Really bad chills), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (Exhaustion) outcome was unknown.            Patient stated that she can't take Ibuprofen because of the kidney issue. No concomitant medications were provided. Treatment for the events were not provided.   This case was linked to MOD-2021-382447 (Patient Link).
Pt recvd vax & exp severe pain @ the inject site & the entire arm; CNS involvement, consisting of tingling, numbness & heaviness in the injected arm, lightheadedness, dizziness; No further details were provided;
Child had facial twitching and redness of the face, neck and chest. Given 3/4 teaspoon of Benadryl.
Patient comes to the pharmacy to report that the injection on 10/28 was too high (went into the bursa). Patient ended up needing physical therapy for a couple months.
t104.4 w/APAP q 4hr alternating w/Ibuprofen;pt pvt MD has been notified-order for no more pertussis;pt still w/temp on 28AUG96;very whinny & not self at all;still recovering;
PT CALLED REPORTING INTENSE HEAT IN LEFT ARM /INJECTION SITE. NO SWELLING, BRUISING, INFLAMMATION, ERYTHEMA.
armpit on the left arm is really swollen; I cannot take the temperature of it but it is warm, it is really warm compared to the rest of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) 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: SWELLING (non-serious), outcome "unknown", described as "armpit on the left arm is really swollen"; FEELING HOT (non-serious), outcome "unknown", described as "I cannot take the temperature of it, but it is warm, it is really warm compared to the rest of the body". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report was not related to a study or programme. Reason for no lot number of Covid-19 Vaccine: Other: Consumer stated he don't know what that is. Consumer was concerned about the vaccine side effects. When probed for the concern: Consumer stated, the vaccine was taken under left arm and that was on Friday afternoon, now the armpit on the left arm is really swollen, obviously I cannot take the temperature of it, but it is warm, it is warm compared to the rest of the body, is that normal? Consumer was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday. 10:11 AM, 2nd attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Phone answered by consumer who did not want to provide mailing address, but agree to provide e-mail address instead QR Comment: Reporter type was not available over the call as the consumer denied answering further questions, hence reporter type captured as consumer or non-healthcare professional by default.  Follow-up attempts completed. No further information is expected.
Symptoms - ? at approximately 8:00 PM EE reports mild HA, ?queasy,? tired and chills.  Denies fever.  EE reports he called off of work today due to feeling ill.  EE reports mild congestion but consistent with his regular allergies.  EE reports he usually takes Flonase.  EE denies fever.  Home remedies? -   supportive care, rest. Any improvement? ? EE reports improvement in symptoms at time of call. Recommendation? EE notified he is able to return to work and to follow to manager per Illness in the Work place Policy.  EE encouraged to continue to monitor her symptoms and to call back with further concerns.  EE verbalized back understanding and denied further questions at this time.
nauseated; chills; Runny nose; aches; spasms; symptoms just like the flu; lost a little bit of weight; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 07Mar2021 (Lot number: EL3248) at the age of 75 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "nauseated"; CHILLS (non-serious) with onset 14Mar2021, outcome "unknown", described as "chills"; RHINORRHOEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "Runny nose"; PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "aches"; MUSCLE SPASMS (non-serious) with onset 14Mar2021, outcome "unknown", described as "spasms"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Mar2021, outcome "unknown", described as "symptoms just like the flu"; WEIGHT DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "lost a little bit of weight". The events "nauseated", "chills", "runny nose", "aches", "spasms", "symptoms just like the flu" and "lost a little bit of weight" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
After her 2nd Moderna dose on 5/25/21, she experienced enlarged lymph nodes on her neck beginning 12 hours later for 2-4 days. She also experienced mild itching on the outside of her neck for about 4 hours 1-2 days later. Resolved on it's own
Over due by a week for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Over due by a week for the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Over due by a week for the second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Over due by a week for the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was not provided by the reporter.  The patient missed her second dose due to being out of town.  Treatment information was not applicable.
pt recvd vax 20APR93 & 29APR93 devel a fever of 38.7; the following day fever inc to 39.3; pt's mom treated w/APAP & pt recovered on 1MAY93; pt also exp sore throat which persisted for 1 wk;
Patient had Pfizer vaccine and came in with Mild urticaria and hives after receiving COVID vaccine Mild urticaria and hives after receiving COVID vaccine, with no signs of anaphylaxis or shock and no indication for medication administration (e.g. epinephrine, diphenhydramine). Symptoms spontaneously resolved.  Tryptase level was 6.7 ug/l (within normal limit). Patient discharged in stable condition. Further follow up showed that patient is feeling fine after allergic reaction. Plan is underway to schedule for the second vaccine, although they have tentatively told her that she will get her second dose in the allergy clinic. Possible this was due to the vaccine given the proximity of timing and adverse event but since the second dose will be given in allergy clinic, the pt will be monitored closely.
Pt seen in ER on 3/16/03 due to increased fever over the entire weekend. On 3/16/03, had blood and urine cultures done. Temperature of 104.8F (rectally) at ER.
Severe Tinnitus (driving me nuts!!!!) Vertigo feeling, dizziness and lightheaded
LUMP ABOUT THE SIZE OF AN ALMOND FORMED TWO INCHES BELOW THE INJECTION SITE; LUMP PAINFUL TO TOUCH; RASH AT INJECTION SITE; LIGHT BRUISE AT LUMP; This spontaneous report received from a patient concerned a 46 year old female. 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced light bruise at lump. On 10-MAR-2021, the subject experienced lump about the size of an almond formed two inches below the injection site. On 10-MAR-2021, the subject experienced lump painful to touch. On 10-MAR-2021, the subject experienced rash at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash at injection site, and had not recovered from lump painful to touch, lump about the size of an almond formed two inches below the injection site, and light bruise at lump. This report was non-serious.
Patient presented with generalized weakness and feeling "unwell". Patient ended up testing positive for COVID and are fully vaccinated
On 7/27/23, immunization reconciliation, the counts for specific lots of Pediatric MMR vaccine and Pediatric MMRV vaccine in system were noted to be discrepant from the physical Count of inventory in the clinic. MMRV (Lot: X007087 Exp: 9/4/24) was showing in system as having 10 doses in inventory with no doses having been administered, however, the physical count revealed only 9 doses in clinic. MMR (Lot: W007041 Exp: 02/29/2024) was showing in system as having 6 doses remaining, however, physical count of the vaccine in the unit was 7 doses. All other inventory counts were correct. 4 patients had documentation in system showing vaccination with this lot of MMR, since last reconciliation. All 4 patients were also vaccinated with Varicella vaccine during each of their visits. Documentation for each of the 4 patients also noted the MMR (and Varicella) vaccinations. Due to the discrepancies in count, however, it can be presumed that one of these children (although we cannot determine which child) were vaccinated with MMRV in the place of MMR and therefore received MMRV and Varicella on the same day inadvertently. PHN reported findings to supervisor. Immunization Program Nurse and Regional Director were notified by RN. Dr. was also noted of above information. PHN contacted parents of all 4 minor patients and notified them of the possibility of vaccination error. No adverse reactions reported for this child.
Patient experienced itchy hives on hands (five total hives) about 1 hour following vaccination. Then, on 10/10/22 when most of the hives on the hands had gone away, another hive appeared on the left forearm. Shot was administered in the right arm, ID, deltoid region. Patient reports that hives are getting better and are less itchy.
You got your vaccine, she had a sore arm, but otherwise nothing.   She then developed blisters on her feet that started out small, and progressed to be huge blisters.  She now has very blotchy skin on both arms. The left foot blister were worse than the right foot that eventually burst, and  3" long and 2" wide.  Mainly on the big toes and third toe of both feet.  They were itchy and came very red and blotchy.  Now is very dry skin and very scaly.  She has not worn shoes for a couple of weeks due to the blisters, and is still not able to wear them still.   She saw her doctor on the 30th and he did not give her anything to take as he said that he didn't know what it was in order to treat her.  She made a FU appointment and told her if they burst and it doesn't look any worse than when he saw her then to keep on doing what she was doing.  She has been putting on triple antibiotic ointment, and keep her feet elevated.
Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning a 6 month old male who on approximately 27-JUL-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought. At the time of this report, no adverse reaction was noted. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for vitamin d deficiency, severe COPD, malignant tumor of lung, htn, disorder of kidney, former smoker, hypercholesterolemia. Patient did present at a outside entity hospital on 5/8/21 after falling from a wheelchair. No other information from this visit available. No information regarding death available.
mouth sores; fever; This spontaneous case was reported by an other and describes the occurrence of STOMATITIS (mouth sores) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of head, face, and neck, Hypothyroidism, Malignant neoplasm of intrahepatic bile ducts, Malignant neoplasm of liver, specified as secondary and Adenoid cystic carcinoma. Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DOCUSATE SODIUM (COLACE), PEMBROLIZUMAB (KEYTRUDA), LACTULOSE, MACROGOL 3350 (MIRALAX), LEVOTHYROXINE, PROBIOTICS NOS, SENNA ALEXANDRINA (SENNA PLUS [SENNA ALEXANDRINA]) and CHLORHEXIDINE GLUCONATE, METRONIDAZOLE (DENTAGEL [CHLORHEXIDINE GLUCONATE;METRONIDAZOLE]) for an unknown indication.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced STOMATITIS (mouth sores) and PYREXIA (fever). At the time of the report, STOMATITIS (mouth sores) and PYREXIA (fever) outcome was unknown.
Report couldn't breath, couldn't stand up or walk.  Stated started to black out, fever 102.0, chills and nausea. Treatment: nothing Outcome: Continue to be short of breath with walking, body aches improved. Advise to see her PCP or seek urgent or emergent care if become SOB.
pt recv vax 22DEC95 & w/in 1month following vax pt exp buccal lichen planus;pt is responding to tx;
Minor chills the night of shot #2. Headache and exhaustion the day after. By day 3, I was feeling back up to 90% and been feeling fine since.
Had sz activity 4MAR92 @ 730PM; 6MAR had sz activity t101;
12.22.22 - Pt. verbalized seasonal allergies, denied any other known allergies to food or medication at time of COVID Novavax immunization visit. VAERS report created after vaccination r/t client stating had ingest food prior to vaccination, later on stating that she hadn't eaten since 2 am.  Pt. educated r/t ensuring proper nutrition, food and fluids prior to any future vaccines. Client is a wheelchair-bound 26 y.o. female, patient, assisted by guardian, having received first COVID-19 Novavax dose #1 earlier in the evening.  Client found in hallway with guardian, verbalized ?feeling tired and dizzy after? being vaccinated, and ?feeling groggy and shaky, like the room is spinning.?  Client denied any swelling of face, neck, throat or any other symptoms.
rn rpt pt vax w/1 dose of varivax & pt exp a rash over abd
vasovagal/syncopal episodes morning after receiving the vaccine. Resting HR was 115 BPM for the whole morning.,no fever present. Normally HR is in the 50's. HR still mildly elevated in the 70's.
The patient received Pentacel vaccine at 4 months and 12 months with no AE; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (age unspecified) who received DIPHTHERIA/TETANUS/5 HYBRID ACPERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] at 4 months and 12 months (Inappropriate schedule of product administration).  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's past vaccination(s) included Vaxelis with at 2 months for prophylactic vaccination.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for prophylactic vaccination at 6 months.  On unknown dates, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number not reported, Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination at 4 months and 12 months.  It was a case of an actual medication error due to Inappropriate schedule of product administration   It was reported "This account is utilizing Vaxelis at 2 months and 6 months and using Pentacel at 4 months and 12 months"  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.
Devel t105 24 hrs p/1st DTP/OPV/HBOC; Pt was checked in ER & no other problems found;