chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stiff neck; pain in neck area and base of the skull; Patient received the second dose more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in neck area and base of the skull) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (She takes Asthma inhalers, takes a tranquilizer very seldom) and GERD. Concomitant products included CLONAZEPAM (KLONOPIN), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in neck area and base of the skull) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK, tid and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 16-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (pain in neck area and base of the skull) had not resolved.            Upon internal review on 11-Nov-2021, Age units and date of birth removed   This case was linked to MOD-2021-281261, MOD-2021-281261 (Patient Link).
Information has been received from a nurse concerning a 67 year old male patient who on 20-OCT-2010 was vaccinated in the right arm with a 0.5ml dose of PNEUMOVAX 23 (lot number 665924/0930Z). Concomitant therapy included ADACEL in the left arm. On 21-OCT-2010 the patient went to an urgent care facility at the physician's office address for redness and swelling in his right arm. While there he was advised to apply an ice pack on his right arm. On 08-NOV-2010 the patient called in to the physician's office complaining of redness and swelling in his right arm and was advised to come in the next day. On 09-NOV-2010 the patient arrived at the office complaining of redness and swelling in his right arm and he stated that he had had a fever for 3 days. The physician diagnosed it as a reaction to PNEUMOVAX 23. On 20-FEB-2011 the patient called the office back, complaining of pain in the right arm and was told to take TYLENOL and apply ice packs to the affected arm. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness and tingling in entire left side. I found it difficult to ambulate and lift my arm at all. This was followed by malaise, weakness, and fatigue. The decreased strength and sensation on the left side of my body lasted for several hours, gradually fading around 4am. The weakness of the left side of the body improved over time and I was just left with fatigue and malaise.
Fever, malaise, muscle aches x36 hours. Ibuprofen helped with symptoms.
Weight loss/ LOST TWENTY POUND; Fever/ HIGH FEVER; Swollen glands; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss/ LOST TWENTY POUND), PYREXIA (Fever/ HIGH FEVER), LYMPHADENOPATHY (Swollen glands) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced WEIGHT DECREASED (Weight loss/ LOST TWENTY POUND), PYREXIA (Fever/ HIGH FEVER), LYMPHADENOPATHY (Swollen glands) and VOMITING (Vomiting). At the time of the report, WEIGHT DECREASED (Weight loss/ LOST TWENTY POUND), PYREXIA (Fever/ HIGH FEVER), LYMPHADENOPATHY (Swollen glands) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: LOST TWENTY POUNDS.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.  Humira was discontinued on an unknown date.
2nd day slight pain at vaccination spot moved around to back of shoulder, gradually moving to top of shoulder, gradually moving up side of neck, stopping  under right ear. slight ear ache intermittent.  eventually an ache in upper right muscles in back developed, eventually moving to upper left muscles in back. slight weakening in these muscles as well as the musculature in the upper right arm.
Muscle pain at the site of injection, can't lift arm above head, lower back pain, joint pain, fatigue and head fog.
Tremors within 8 hors of shots. Tremors have continued daily since shots.
Rash with multiple crusted spots on (R) thigh near where vaccine given concerning for primary varicella.
The next morning after the vaccine I had a headache, nausea and a fever developed. The injection site was swollen and red. My body ached which all lasted about 2 days. On 7/5 I developed a runny nose and a headache. A couch developed and my body and joint ached. I was super nauseated and lost my sense of smell. On 7/7 I visited my PCP who diagnosed me with a Sinus Infection and gave an antibiotic and I lost my taste by this time and on 7/9 I went to Urgent Care and took a COVID test which was positive.
Patient has a red  itchy rash on left arm.  Patient desribes it being warm to the touch itchy and also very knotted under the injection site. Patient states its has been 2 weeks that she has had the rash.
Chills, slight fever (100.2), achy, swollen neck glands, headache and sore arm at injection site.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient concomitant medications was not reported. The patient is scheduled for second vaccine dose on 08-Jun-2021.
This spontaneous report was received from a nurse referring to a 22-year-old female patient. The patient did not have any pertinent medical history, concurrent conditions or drug reactions/allergies. Concomitant medication included unspecified birth control. On 21-MAR-2017, the patient was vaccinated with GARDASIL 9 (lot # M018810), intramuscularly for human papillomavirus (HPV) vaccination (dose and expiration date were not reported). The nurse reported that a few hours after the vaccination (approximately on 21-MAR-2017) the patient experienced nausea which lasted for three days (until 23-MAR-2017). It was also reported that the patient developed a swollen lymph node on her neck (lymphadenopathy) that appeared on 24-MAR-2017. The patient did not receive treatment for the adverse events and no laboratory tests were performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered from lymphadenopathy and the causality regarding both adverse events was not reported. No further information was provided. Additional information has been requested.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient received PENTACEL diluent instead of mixing it with the vaccine, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2018, the patient received a 0.5 ml once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5324AG, expiry date- 05-Sep-2019 via intramuscular route in the left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. Final diagnosis was a patient the pentacel diluent instead of mixing it with the vaccine. The patient outcome is reported as Not Applicable for a patient the pentacel diluent instead of mixing it with the vaccine. 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 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.
High dose of pediatric Pfizer Covid-19 vaccine  (20 mcg) was administered due to a failure to dilute the vial with 1.3 ml of Sodium Chloride prior to drawing up the dose. Mother was contacted and no adverse reactions are reported at this time. Per CDC guidelines, patient should be monitored for adverse events over next few days. From a quality control standpoint, only the pharmacist may dilute pediatric Pfizer vaccine (and not an intern or certified tech immunizer).
Patient stated she woke up feeling bad the next day and came to work but condition got worse with N/V/D and no fever. She had pseudo-seizures  for 3 days.
Felt soreness at the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 09:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included dormant prostate cancer, borderline high blood pressure, borderline obesity, prediabetic and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Mar2021 at 21:00, about 12 hours after injection the patient felt soreness at the site of injection, and no other symptoms were noted. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event felt soreness at the site of injection was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
She is tired/tired was reported as worsened; daily headache; ache to be all over her head, neck, and "everything."; still wants to take a nap when she wakes up; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249, Expiration date not reported), via an unspecified route of administration on 19Jan2021 (at the age 45-year-old), as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced injection site soreness for 1-2 days on an unknown date in Jan2021 and has also had a daily headache on 19Jan2021 since received the vaccine. The patient reports that the headache isn't a huge headache, but it is a nuisance. Caller stated that she had a headache within an hour of receiving the vaccine and reports the ache to be all over her head, neck, and everything on an unknown date in Jan2021. Ever since then, she has had this daily mild headache every day. She is wondering if this is normal. On 20Jan2021, she is tired (was reported as worsened) and has a headache. She is a busy mom so it is hard to say if the tiredness is partly from that. It is like if she had a moment to take a nap she will take a nap. She feels like she is getting a good night sleep, but still wants to take a nap when she wakes up on an unknown date in Jan2021. It may not be out of norm. The headache portion is out of the norm. Treatment received with Advil or Excedrin daily once or twice a day for headache. The outcome of the tired, daily mild headache was reported as not resolved and all other events were unknown.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable consumer. No new information was found.  Follow-up attempts are completed. No further information is expected.
No additional AE information; Licensed practical nurse reporting expired dose of VAQTA administered to patient; This spontaneous report was received from a Licensed practical nurse refers to a patient of unknown age and gender.There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On 08-APR-2022, the patient was vaccinated with 1 milliliter expired dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, dose:1 milliliter,  frequency reported as once, lot # t040581, expiration date: 28-MAR-2022,  for prophylaxis (route and dose number were not reported) (expired product administered). No temperature excursion.  Read supported statement.  No additional adverse event information.  No PQC.
I gave patient the Pfizer 5-11 year old bivalent booster, instead of the 12+ Pfizer bivalent booster. Dr. spoke with patient's mom and explained that she does not recommend any additional doses. Mom was okay with that plan. No adverse reaction risk due to lower dose.
Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported No concomitant medications were provided by the reporter. The caller stated that she will have her sister call moderna if she did receive moderna vaccine.
Patient reports she developed redness around the area of the injection site. The  injection was given in the Left Deltoid, the site was warm to the touch, and the patient also reported some itching to the site.  Patient was advised to follow up with MD and follow his recommendations.
RUNNY NOSE; DIARRHEA; SORE THROAT; LOSS OF TASTE; VOMITING; UP ALL NIGHT; CHILLS; FEVER 101; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lactose intolerant, seasonal allergies, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug use. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced runny nose. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced loss of taste. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced up all night. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever 101. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, vomiting, chills, and fever 101 on APR-2021, had not recovered from headache, sore throat, runny nose, and loss of taste, and the outcome of up all night was not reported. This report was non-serious.
administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The nurse reported that they administered Fluarix 2020-2021 expired doses to the patient, which was expired on 30th June 2021, which led to expired vaccine used. The reporter consented to follow up via email. This was 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207378:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter
Started with a runny nose. A sore throat, tired, head achy. After about two days I had a fever of 100.4 degrees, fatigue, no appetite, and diarrhea. I spoke to my doctor on the 3rd day when I tested positive and had a digital meeting with him. I then took Paxlovid. Instantly the next day the fever was gone.
sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration, administered in arm left on Mar2021 (Lot number: ER8727, age at vaccination 60-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no known allergies. Facility type vaccine was other. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. On an unknown date in Mar2021 at 03:00 PM, the patient experienced sore shoulder for 24 hours. There was no treatment received for adverse event. It was reported that no other vaccine in four weeks, no COVID prior vaccination, no COVID tested post vaccination and no known allergies. The outcome of event was reported as recovered.  No follow-up attempts are possible. No further information is expected.
I had flu symptoms - nauseated; muscle aches; headache; sore throat. That lasted two days. Everything went away but I noticed my joints were still sore. Not sure the arm injection, but joints in legs and hips and that continued and it ended up getting worse and worse. I ended up getting a hip replacement in April. Now, surprisingly, I am waiting to be scheduled for the 2nd hip replacement. And that wasn't even discussed prior to the vaccine.  I had had the second vaccine on February 5th - same lot number as the first injection. Experiencing that it's hard for me walk. I need a walker or a cane. I have a lot of pain and I'm on a lot of pain reliever now.
seizure; Grand mal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LUPI21-04196 (Reference).  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Her sister's seizures were dormant for a while" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "seizure"; GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "unknown", described as "Grand mal". Event description: The reporter said that her sister's seizures were dormant for a While, but she experienced a lot of seizures when she took Pfizer's vaccine in Sep2021. After taking the 1st shot the patient experienced 13 episodes of back to back seizures, like Grand mal, She said that the patient got 1st shot of Pfizer's vaccine but now she cannot get the 2nd shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hive localized at shot point, started small 2 inches, 24 hours later was 6 inches, another 24 hours later was 9 inches, lasted for 7 days.
Potencially not received the second dose on the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potencially not received the second dose on the recommended time frame) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ISSUE (Potencially not received the second dose on the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potencially not received the second dose on the recommended time frame) had resolved.            No concomitant medications are provided . No treatment medications are provided.
Patient had swelling of tongue 45-60 minutes after vaccination.   Received PO benadryl.  Had eyelid and facial swelling requiring IV Solu-medrol.   Monitored for short period of time in emergency department and released.  No further symptoms.