chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Pt reported soreness and bruising x 3 days, then reported warmth and weal on arm; went to urgent care (6/25/17) and rcvd dx of cellulitis.
Information has been received from a consumer concerning his 24 month old grandson whose grandmother was vaccinated with a dose of Zostavax. The reporter noted that his wife received the vaccination and then "transmitted it to her grandson who then developed chickenpox." The child developed chickenpox four to five days after his grandmother received Zostavax. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. No further information is available.
Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five years old male patient who was vaccinated with a dose of vaccine PENTACEL lot number, Exp. date, route and administration site not reported on 16-Mar-2018. The patient's medical history and concomitant medications were not reported.It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient experienced any adverse event. 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 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. List of documents held by sender: none.
Pt reported rash at injection site (3x1/12x3", increased red in center) 10/14 that's swollen/tender. Per mfg injection site sxn's 41.3% incidence at his age, starting median 3-5 days post vac and median lasting 5 days (seems usual) wife reported 10/14 looking better already.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included COVID 19 Treatment with Paxlovid from 04Dec2022.  No follow-up attempts are possible. No further information is expected.
1hr p/vax arm started swelling became red & hard-upper 1/2 of arm-parent started applying ice packs-then 36hr p/vax;
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves a 2 months old patient who was administered expired dose of PENTACEL. The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications were not reported. On 29-Jun-2018, the patient received a 0.5 ml dose of suspect Diphtheria, Tetanus, AC Pertussis, IPV and HIB vaccine, lot C5400AA in the left thigh, expiry date 24 Jun 2018. This was a case of actual medication error due to expired product administered. The patient outcome is reported as Not Applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in 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.
soreness/tenderness in about 3 inch area below the injection site; This is a spontaneous report from a contactable consumer (Patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 15:30 (at the age of 67-years-old) as single dose for COVID-19 immunization. The patient medical history included known allergies to Sulfa drugs, gluten and tomatoes. Concomitant medications included levothyroxine and multi vitamins. The patient did not receive any other vaccines within 4 weeks prior vaccination and not had Covid prior vaccination. 05Mar2021 at 01:30 (next day after vaccination), patient experienced soreness/tenderness in about 3-inch area below the injection site. The patient did not receive any treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Swelling arm; This spontaneous report was received from a registered nurse which is also the patients mom and concerns to a male patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date (reported as a couple years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, anatomical site, lot# and expiration date were unknown) for prophylaxis.  On an unknown date (reported as a couple years ago), the patient had swelling of the entire upper arm (peripheral swelling). It was reported that no treatment was given to the patient.  At the reporting time, the outcome of peripheral swelling was unknown.  The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and peripheral swelling was not reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1905USA010094:
Information has been received from a physician concerning a 14 year old female patient who on 26-FEB-2000 was vaccinated with MMR II (HSA route, site, dose and lot number was not reported). On 30-NOV-2009 the patient experienced mumps (the date of diagnosis was reported as 04-DEC-2009). The first blood work done on 04-DEC-2009 included serum IgM <1:10, serum IgG 5.13 and serum amylase 129. The patient's symptoms included right parotitis and headache for 2 days. The outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
Experienced fatigue, headache and chills throughout day on 1/11/21.  These symptoms ended by 1/12/21.  On 1/14/21, I woke with very strong headache but no other symptoms.
Fatigue, muscle aches, joint paint, slight headache beginning early morning on 1/9/2021.  Chest pain from 9pm 1/9/2021 to 2am on 1/10/2021.  Symptoms resolved without any interventions.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Weakness; Fever; Body aches; Cold Chills; This is a spontaneous report received from a contactable health care professional. A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6206) intramuscularly in right arm on 07Mar2021 at 12:45 PM (at the age of 43-years) as a single dose for COVID-19 immunization. Patient received her first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EJ1686) intramuscularly in right arm on 06Jan2021 at 02:30 PM for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not have any medical and known allergic history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. Patient did not take any other medications within 2 weeks of vaccination. No concomitant drugs were reported. The patient experienced cold chills, body aches, fever and weakness on 14Mar2021 at 09:00 PM. The patient received fever reducers as a treatment for fever. It was not reported if the patient received any treatment for other events. At the time of this report, the patient was recovering from the event cold chills, body aches, fever and weakness.  No follow-up attempts are needed. No further information is expected.
Extreme exhaustion. I slept from 10pm on the 18th until noon on the 19th and again from 2pm until 7pm on the 19th and slept from 11pm on the 19th until 10am on the 20th. Also suffered a headache that has not completely subsided yet.  Muscle aches. Low Back ache.  I rested, drank plenty of water when awake. I also took Ibuprofen. The morning of the 20th I'm feeling somewhat better though I still have a bit of headache and low back ache. NOTE: headaches are very rare for me.
Red and swelling in arm; stomach pain within 30 minutes; weakness; fast heartbeat; nausea; continual stomach issues for days; diarrhea; fever from day one and continual
M-M-R II administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-JAN-2021,  the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, recombinant human albumin (rHA) (M-M-R II) Lot number S032036, expiration date 10-OCT-2021, at a dose of 0.5 milliliters intramuscularly as prophylaxis.  The vaccine experienced a temperature excursion of 9.6 degree Celsius (°C) for 7 hours on an unknown date; no previous temperature excursions were reported. The call was made due to a digital data logger.
On day of vaccination, (hours later) redness and swelling developed around injection site.  At ER, patient was given ibuprophen and benadryl.  2 days later, e was seen the office with tenderness and swelling down right arm and into right side of chest.  Arthralgias were also present in the right elbow and shoulder.
chronic diarrhea for approx 100 days after vaccine.; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 2nd single dose for COVID-19 immunisation. Patient medical history included underlying condition of postherpetic neuralgia. Patient had no concomitant medications. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st single dose for COVID-19 immunisation. On an unspecified date, the patient experienced chronic diarrhea for approximately 100 days after vaccine. The outcome of event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Broke out into itchy hives the day day after. Hives were on inside left elbow, left shoulder, and left side of neck. Treated with oral Benadryl tablet on top of OTC Tylenol for fatigue/aches.
Severe bone and muscle pain, fever, severe headache. Symptoms appeared 7-9 hours after vaccination and only lasted about 12 hours.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick), DYSPHONIA (Throat was a little hoarse), INJECTION SITE PAIN (Injection site pain) and VOMITING (Throwing up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0s7b21a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSPHONIA (Throat was a little hoarse). On 17-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 18-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick) and VOMITING (Throwing up). On 18-Apr-2021, VOMITING (Throwing up) had resolved. At the time of the report, PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick), DYSPHONIA (Throat was a little hoarse) and INJECTION SITE PAIN (Injection site pain) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced a swollen throat after having 3 drinks in a 6 hour period. Her throat was a little hoarse on 16-Apr-2021, and patient almost went to emergency room (felt like throat was going to swell shut). The patient also experienced injection site pain which lasted 3 days. On 19-Apr-2021, the patient felt a lot better. The patient took ibuprofen and allegra treat the symptoms caused by covid vaccine. The concomitant medications were not provided.
patient presented to pharmacy requesting covid vaccine and answered no to having received a vaccine previously. pharmacy checked state registry and there was no record of patient. upon billing after administration insurance rejected stating  it had previously been billed. we confirmed with insurance that he had received 2 doses previously. contacted patient following day and he confirmed that he was a physician and intentionally lied on the consent form  in attempts to obtain a 3rd booster dose which he was aware he was not approved to receive. when informed that he was not approved he reported that side effects to 3rd dose 24 hours our were similar to those following 2nd dose. patient did not call to state an adverse reaction, pharmacy is reporting because he lied to obtain 3rd unapproved dose
Blurring vision loss in both eyes began 24 hours after injectin.  Also c/o pressure in both eyes after several days.  Vision returned and pressure resolved.  Has an occasional "pressure in eyes".
Pt. developed low back pain and body aches. Late evening 11/15 he developed chest pain and diaphoresis.
Localized swelling, redness, tenderness, mild fever, swelling and hives on face.
terrible joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (terrible joint aches) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (terrible joint aches). At the time of the report, ARTHRALGIA (terrible joint aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-554862, MOD-2022-554863, MOD-2022-554864 (Patient Link).
Swelling with large red hives that itched and burned, but if touched burned like acid and sent searing pain through my arm and shoulder. Over the course of two weeks the swelling spread to my elbow and could be seen above the collar of my shirt. It was recommended that the 2nd shot be received in the opposite arm. The opposite arm, the adverse reaction occurred within 45 minutes after injection, I could feel the tingling and burning. It too had similar effects as described above that lasted about two weeks. However, my right arm continues to hurt and throb periodically to this day (12/10/2021.). I am unable to lay on my right arm in bed at night as the pain becomes rather intense. Upon receiving my booster dose in my right arm, the pain has diminished considerably, but still present periodically.
I started to feel heart palpitations about 1 day after the shot.  It was minor at first but by the second day I was waking up thru the night from the heart palpitations I was feel while sleeping.
Mild fever, increased heart rate for 20 minutes after injection.  Dizziness, blurred vision for 5 minutes only. Site tenderness the next day.  Client will see MD next week.
Severe pains down both legs from hips to feet, left leg being worse. As the day progressed I was unable to arise by myself. Doctor on vacation so took 2 weeks to see him. He then gave me pain medication and put me on physical therapy. Pt has been to a rheumatologist and a neurologist neither of which has been able to help pt. At this point the pt is partially paralyzed in both legs and feet. He also has pain in both shoulders and arm.
Upon administration, the vaccine leaked out of the area where the needle tip is screwed into. Upon removal, of the syringe, the needle separated from the syringe.  It was determined that patient probably did not receive any of the vaccine, so a second dose was administered without and issues.
This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 20-year-old female patient (reporters daughter). A 20-years-old female patient received first dose of BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8733; Expiration date: Jul2021) via an unspecified route of administration, administered in Arm upper Right on 29Apr2021 13:30 (at the age of 20-year-old) as 1st dose single for COVID-19 immunization. The patient medical history (including any illness at time of vaccination) were not reported. The concomitant medication included Sometimes, the patient will mix up Calm, which is like magnesium. She mixes a teaspoon with water. It is not something her patient drinks every day, it is like a supplement mineral. She didn't give it to her for days before, maybe even a week. The patient received her last vaccine was the flu vaccine on unspecified date on September. Patient had not had any allergies and no family history relevant to adverse events. The reporter stated that her daughter just finished college and has to work at a day care this summer. They just had an outbreak in April and thought after that, it might be a good idea to make sure her daughter is protected, especially when she goes back to college in the fall, they are not doing remote anymore and caller wanted her to be protected. The patient experienced sore arm on an unspecified date. After the first dose of vaccination on 29Apr2021 and had no reaction at all. She had a little sore arm but it was no big deal (stated by reporter). She had a little sore arm. She had not any blood work done recently. She had her yearly check up last September. The outcome of event was recovered. Information on lot number was available. Additional information has been requested.
Patient is a 76-year-old male with a history of moderately severe COPD on home oxygen, CVA, CAD and peripheral vascular disease presented to the emergency room with worsening shortness of breath, fevers, chills and nonproductive cough.  Home positive test for COVID.  Patient required increased level of oxygen when he entered the ER at 4 L.  He was evaluated by infectious disease.  Started on remdesivir.  He was also started on IV steroids.  Oxygen supplementation.  By day 3, patient was beginning to feel better.  Steroids started to wean, and then eventually switched to oral prednisone.  Recommendation was 40 mg a day for 5 days at discharge.  Patient was feeling much better on the day of discharge, was on 3 L oxygen.  Oxygen saturations remained above 90% even with ambulation inside the room.  He was asked to follow-up with his primary care and his pulmonologist.
Received shot on 04/23/21 and symptoms began on 04/27/21 in the morning: sensitive to touch on left side of the body and the pain did not go away throughout the day. The pain sensitivity continued for the next few days. Took 2 Naproxen (220 mg each) on 04/30/21. On 05/03/21 I started getting blisters on the left side of my torso. Went to the doctor on 05/05/21 and he diagnosed me with Shingles. He prescribed Valacyclovir 1GM (generic for Valtrex 1GM) tablets, 1 tablet 3 times daily for 7 days. Pain continued, worsening at night; went to see a dermatologist on 05/06/21 and he prescribed SSD 1% Silver Sulfadiazine Cream 50 Grams to apply topically twice a day on the blisters. Condition has since started to improve. Some blisters are scabbing over. Nerve sensitivity is terrible still. I am still continuing to take 3 Aleve PM (220mg) before going to sleep.
Red Bump on Injection Site; Soreness on Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red Bump on Injection Site) and PAIN IN EXTREMITY (Soreness on Arm) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Red Bump on Injection Site) and PAIN IN EXTREMITY (Soreness on Arm). At the time of the report, VACCINATION SITE MASS (Red Bump on Injection Site) and PAIN IN EXTREMITY (Soreness on Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Pharmacist reported on behalf of patient moderna booster on dec 7 and on dec 18 experienced hived on body went to urgent care and got prednisone. Pt still has hives but mild.
Information has been received from a registered nurse concerning a 17 year old female patient with a family history of migraines and no known allergies, who on 13-AUG-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot# 658490/0802U).  On 18-SEP-2008, the patient received the second 0.5 ml IM dose of GARDASIL (lot# 659964/1978U).  There was no concomitant medication.  On 18-SEP-2008 the patient experienced intermittent severe headaches after administration of her second dose.  No lab diagnostics studies was performed.  At the time of this report, the adverse event was ongoing.  The patient sought medical attention via telephone.  Additional information has been requested.