chrisvoncsefalvay/vaers-outcomes huggingface dataset:
missed 2 - 3 doses; new swollen joints; worsening joint pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2 - 3 doses), JOINT SWELLING (new swollen joints) and ARTHRALGIA (worsening joint pain) in a 34-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2 - 3 doses), JOINT SWELLING (new swollen joints) and ARTHRALGIA (worsening joint pain). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2 - 3 doses), JOINT SWELLING (new swollen joints) and ARTHRALGIA (worsening joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non- Significant Follow Up- (Contact Info Updated- Name, address, phone of pharmacist)
Sore muscles, unwell, chills, headache, body ache ,nausea , tired. Tylenol every four hours, fluids and rest.
Patient had no adverse effects; vaccine administered after temperature excursion and before temperature excursion evaluation occurred; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. No information regarding the patient's concurrent conditions, medical history and drug reactions or allergies was provided. His concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX).  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) dose 1, subcutaneously, lot # S006830, expiration date 02-SEP-2020 in the right thigh (exact dose was not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 5 degrees Celsius for 12 hours. There was a previous temperature excursion of 8.4 degrees Fahrenheit for 60 hours. Digital Data Logger was involved. No additional adverse effects were reported.
Pharmacist call because they gave a expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication included Prostate medication No Treatment medications reported.   This case was linked to MOD-2022-482662 (Patient Link).
this time her arm is really painful/her arm was aching/right arm so painful that she cannot put any pressure on it; received her Booster dose of the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient).   A 78-years-old female patient received third booster dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number : FE3590), via an unspecified route of administration, administered in arm right on 30Sep2021 (age at vaccination 78 years) as dose 3 (booster), single for covid-19 immunisation. The patient medical history included none. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number : EL0140) via an unspecified route of administration on 27Jan2021 (age at vaccination 77 years) as dose 1, single and second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number : EL0140) via an unspecified route of administration on 17Feb2021 (age at vaccination 77 years) as dose 2, single for covid-19 immunisation and she hardly had any problem, she just had a sore arm. On 02Oct2021, after third shot patient stated her arm was aching and really painful. Patient started out sore and now aching and was now painful cannot put any pressure on it. she had wanted to report that this as a side effect of the shot. Wanted to know why she was having a problem with the third one. Is for Pfizer Covid 19. Patient received treatment of two tylenol about an hour or so ago. Stated that the Tylenol had helped a little bit. The outcome of right arm sore was not recovered.  Follow-up attempts are completed. No further information is expected.
I have a 3 inch in diameter mass of swollen lymph nodes under my left arm (had both shots in left arm).  I read online that this is a sign of my body fighting the vaccine and it is a good sign.  I went to my doctor just to have it checked out and because both of my eyes look like I have pink eye.  My doctor isn't sure if my eyes have anything to do with the vaccine but said probably not.  She said that I needed to report my mass as it is not one of the most common side effects.  I also went to the health department, where I had both shots, and had them look at the mass.  They said the same thing about my body fighting the vaccine.  My doctor and the health department said that while they have seen the swollen lymph nodes from the shot, they haven't seen such a large mass like mine.  Both of them said I needed to report this.
Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent); Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent); Having a lot of pain in his right hip, in right calf and right ankle; Having a lot of pain in his right hip, in right calf and right ankle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 4), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 5), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Patient received 6 dose of COVID-19 Pfizer (3 dose of bivalent)"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "Having a lot of pain in his right hip, in right calf and right ankle". The events "having a lot of pain in his right hip, in right calf and right ankle" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient received the bivalent adult formulation of the Pfizer BioNTech Covid 19 vaccine 7 weeks ago. This has been his 6th dose of the Pfizer Covid vaccines. He was having a lot of pain in his right hip, in right calf and right ankle that has not gone away. He has gone to his primary care physician, he's gone to his rheumatologist, he's gone to the chief medical officer for (Withheld). They're all at a loss at how to help him and he is still having this pain. His rheumatologist has thrown the kitchen sink at him and 7 weeks later he still has all this pain. The pain started two days after receiving the most recent vaccine. He is hoping we can help him. He took the Pfizer booster, and now he has a severe side effect.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Cellulitis infection (diagnosed on 10/31 at urgent care facility) below shot area appeared a "couple of days" after shots given.  Provider told patient it was due to vaccination.
received first dose on May 2021 and second on Sep 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HAB (Twinrix) (batch number 75c72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date in May 2021).   On 23rd September 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd September 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 details were provided as follows: The pharmacist reported that the patient received Twinrix 2nd dose on day of reporting, later than recommended schedule which led to lengthening of vaccination schedule. The reporter consented to follow up.
Swollen arm pit lymph node under right arm. (About  the size of a small egg.); Swollen arm pit lymph node under right arm. (About the size of a small egg.) It also hurts.; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 18Apr2021 at 12:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient  was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products and did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) from an unknown date for unknown indication and unknown if ongoing. On 19Apr2021, the patient experienced swollen arm pit lymph node under right arm (about the size of a small egg) and it hurted. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen arm pit lymph node under right arm (about the size of a small egg) that also hurted was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient felt light headed after receiving the vaccine. Onsite EMS was called vitals BP 137/87  Blood Sugar HR 76. asked she about any allergies or meds she said none. She said she was feeling bettter.  Patient  left aginst medical advice .
No, adverse events. However, wrong vaccine given since it was discovered later that patient had Pfizer for their 1st dose. Database sites were checked and it appears that vaccinating facility that gave first dose did not report it to registry.
REDNESS WITH GOLD BALL SIZE HARD LUMP ON LEFT DELTOID AREA WHERE INJECTION GIVEN. SHE WAS OUT OF THE COUNTRY AND HAD TAKEN SOME BACTRUM WITH HER AND TOOK 500 MG, THREE TIMES A DAY FOR 7 DAYS. DID NOT SEE MD AND THE RX WAS NOT PRESCRIBED FOR THIS EVENT. DID NOT STOP HER FROM DOING ANYTHING. QUESTIONABLE ADVERSE EVENT.
Within a minute of administering MENACTRA to him he lost consciousness. He was laid flat on the couch and he regained consciousness in another minutes or two with residual nausea and frontal headache.
site of injection was itchy and bright red raise welt ~1/2". Red area was 3" long by 2" wide.
Headache, Myalgia, Chills, Pain@ injection site Narrative:  Other Relevant History:
Vaccine was administered outside of storage recommendations. patient returned on 6/4/21 to re-vaccinate.
1.  Headache (27 hours total course - began 5 hours after shot) 2.  Chills (started 12 hours after shot and last for about 4 hours) 3.  Nausea (intermittent - started 16 hours after shot and lasted about 12 hours) 4.  Soreness at injection site and arm - immediate and still current (44 hours so far) 5. Stomach CRAMPS - severe and unusual  (intermittent) began 24 hours after shot and still occurring  6. Menstrual cycle disrupted! - I am not scheduled to start my period for another week. I always have my cycle every 28 days like clock work, and I started spotting yesterday , which is a week early (roughly 30 hours after the shot.) I am not stressed.
12:15 C/O headache and stomach hurting. BP 108/70 P 50 R 18 T 98.8. 13.10 spoke to child's mother, picking student up. Student already had appt with MD for 12/16. Temp 100 orally.
Nerve Pain in lower left leg. Two weeks later, hyper-thyroid onset. Neck pain, and continued nerve pain. Fever.
This spontaneous report as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot# L004651, expiration data: 11-FEB-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15.9 degrees Fahrenheit for 565 minutes. This is one of two reports from the same reporter. Additional information has been requested.
This spontaneous report as received from Register Nurse refers to unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (dose, strength, frequency and lot number were not reported), which since 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter.
I experienced flu like symptoms including fever (103.0), headache, extreme body aches and chills. This lasted about 24 hours and then just went away as quickly as it came on. It resulted in me missing a day of work. I could not get out of bed.
Pt turned white & pale, arms were limp, eyes dilated & had weak cry; MD dx hypotonic episode;
Entire body rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Entire body rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced RASH (Entire body rash). At the time of the report, RASH (Entire body rash) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Tdap at about 2 pm 6/9/14. On 6/10/14 felt aches in neck, back, hips. Felt feverish in afternoon. Very fatigued. No rash/no local reaction. Felt better by 6/11/14.
Information was received on 02-JUN-2017 from a physician who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The physician reported that this patient received a dose of VARIVAX (lot M054882, expires 17-DEC-2017) on an unknown recent date following a temperature excursion of 34 degrees F for 5 hours. No adverse effects were reported. No other information is available. On 05-JUN-2017, the office manager called to report a correction to the temperature/time frame date. The VARIVAX was actually exposed to 15 degrees F to 46 degrees F for 3.5 hours. All of the data listed was reconfirmed with the reporter. On 05-JUN-2017, an e-mail was received from the physician that stated: "There is a 30 minute period that the vaccines were in a box with an ice pack in the car at a comfortable temperature for a person driving to the deep freezer. They started at 34 degrees F at the beginning of that 30 minutes. It is possible that they were still under 44 degrees F but it is possible they went over that during the 30 minute time period." The physician inquired "would they still be supported for use by Merck if they were in the next range for 30 minutes?" A call was made to the physician to clarify temperature for this 30 minute period. Physician stated she would like the vaccine evaluated at the room temperature range for 47 degrees F-77 degrees F for 30 minutes, in additional to the 3.5 hours in the 15 degrees F- to 46 degrees F temperature range "just to be safe". Re-evaluation was performed and outcome provided to physician. (Not specified). No adverse effects reported. No other information was provided. Lot number M054882 is not a valid lot number for VARIVAX. Additional information has been requested.
fatigue,mental fog,swollen glands,chills Narrative:  When pt received his 2nd dose of covid vaccine, she reported the following adverse effects from the first dose she received. Post Moderna Covid Vaccine dose #1 pt reports nausea X1 day, sore muscles X3 days, fatigue and "mental fog" on the 2nd, 3rd and 4th days, she also reports swollen glands, constipation, severe HA, chills and fever-low grade. Pt did not report any treatment medications but symptoms resolved.
No additional adverse effect reported; on 5/19/2020 patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S028771, which has been verified to be valid, expiration date reported and validated as 09-APR-2021), administered orally as prophylaxis (vaccination scheme was not reported) (product storage error). The administered dose of the vaccine underwent a temperature excursion below 36 degrees Fahrenheit (F) (34.9F) for 16 hours, as recorded by data logger. There was no previous temperature excursion. No additional adverse effect reported.; Sender's Comments:  US-009507513-2005USA008524:
pt had redness, swelling & itching, warmth to touch of lt deltoid region;5/8"needle was used for vaccination;pt sought family MD 7MAY97;
high pitched (by hx), inconsolable cry x 3 1/2hr;began 1hr p/vax;no tx;given APAP;
Left deltoid area with erythema, firm swelling, warm to the touch ATARAX 25 mg 1 four times a day as needed for itching, PREDNISONE (pak) 10 mg 6-D pak was given.
gave a dose of acthib on 10/28 that expired on 10/26, with no reported adverse event; Initial information received  on 28-Oct-2022 regarding an unsolicited valid  non-serious case from other health professional.  This case involves an unknown age female patient who was given a dose of HIB (PRP/T) VACCINE [ACT-HIB] on 10/28 that expired on 10/26, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Oct-2022, the patient received suspect HIB (PRP/T) VACCINE at an unknown dose (lot number not reported, expiry date: 26-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On 28-Oct-2022 the patient was given a dose of acthib on 10/28 that expired on 10/26, with no reported adverse event (expired product administered, same day latency).  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.
Today whelps are fading, but light red; Itching; Was sitting on the sofa and it felt like something bit her/Awful; Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; This is a spontaneous report from a contactable consumer or other non hcp.   This consumer (patient) reported that a 77-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL8982), dose 1 via an unspecified route of administration, administered in Deltoid Right on 27Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery from 17Mar2020 to an unknown date. There were no concomitant medications. Patient did not had family medical history and illness. Patient did not had any history of previous immunization. On 04Feb2021, the patient experienced Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; Itching and was sitting on the sofa and it felt like something bit her; On 05Feb2021, Today whelps are fading, but light red. Patient did not performed any relevant test. Patient took COVID vaccine because she wanted to be protected from the virus, it was awful. It was reported that caller reports she had the COVID shot on 27Jan and everything was fine. Yesterday she had some whelps on her back near the shoulder and on the side of her breast. It was so very red, like blood red yesterday and itching. Today they are fading, but are light red. Yesterday she was sitting on the sofa and it felt like something bit her. Then she noticed the whelps and they were raised. Still has a few on the breast and one almost on the dark area near the nipple and still itching right now. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. They called her to come get the vaccine due to her age group. Patient had no AE prior vaccination. Patient was not visited to emergency room and physician room. The clinical outcome of event Whelps very red, like blood red, raised was recovering; Was sitting on the sofa and it felt like something bit her was unknown; while all other event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient was given 4th dose of Hep B instead of 2nd dose of Hep A.
patient complained of lightheadedness following vaccination. he was given water & crackers & monitored for an additional 10 mins. his disposition improved.