chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 51 years old female patient with multiple sclerosis, hypercholesterolemia, drug allergy to AUGMENTIN, CLEOCIN, ULTRAM, ibuprofen and sulfa. The patient was vaccinated with ZOSTAVAX (lot#reported asH013940, exp 25-OCT-2013) 0.65ml subcutaneously in left deltoid on 19-DEC-2012. No other co-suspects were reported. Concomitant medications included morphine, oxycodone, tizanidine hydrochloride, lovastatin and gabapentin. On 19-DEC-2012 evening, the patient experienced full-body rash. This experience was accompanied by itching, which seems to be alleviated by BENADRYL. The patient had sought medical attention by consulted pharmacist. The action taken was not reported. The outcome was reported as not recovered. Additional information has been requested.
Bexsero/ Boostrix/ Engerix B/ Havrix/ Kinrix/ Infanrix + Administration to patient after Below Temperature Excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Engerix B, Kinrix, Infanrix and Havrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Kinrix, Infanrix and Havrix, the patient experienced incorrect storage of drug (Verbatim: Bexsero/ Boostrix/ Engerix B/ Havrix/ Kinrix/ Infanrix + Administration to patient after Below Temperature Excursion.). The outcome of the incorrect storage of drug 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: GSK Receipt Date: 11-MAY-2023 The clinical manager reported that vaccines Bexsero, Boostrix, Engerix B, Havrix, Kinrix, Infanrix   were exposed to minimum temperature of -148.3°F. It was determined that the vaccines were not stable at that temperature.  The temperature excursion occurred in December, since then, the clinic has been administering the unstable vaccines to patient.  The reporter mentioned that will callback to provide information about patients and administration dates as well as lot number and expiration. Yet no call was returned.  Till the time they don't know how many patients were involved. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.  The patient received Bexsero, Boostrix, Engerix B, Havrix, Kinrix, Infanrix below temperature excursion which led to incorrect storage of drug.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administrated unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 05-MAR-2015, the patient was vaccinated with improperly stored doses of MMR II (lot# reported as J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Widespread flu like aches; Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:15 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies_PCN" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number 1, Product: COVID 19, lot number: unknown, Administration date: 01Mar2021, Administration time: 09:15 AM, vaccine location: Left leg), administration date: 01Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "No reaction". The following information was reported: PAIN (non-serious) with onset 25Mar2021, outcome "recovering", described as "Widespread flu like aches"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of pain, fatigue.  Additional information: The patient did not receive any other medications within 2 weeks. The patient did not receive any other vaccine in four weeks of covid-19 vaccine. Prior to vaccine, the patient did not have covid-19 and since vaccination the patient has not been tested for covid-19. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received the vaccine at Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The Pfizer Drug safety unit recently received the attached report submitted by you via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chronic fatigue, brain fog, insomnia, early awakening, aggravation of underlying sacroiliac and facet joint arthritis, and 1 month of mild anemia hct. 36, and depression, for 31/2 months unending, since 2nd dose Novavax vaccine.   Intravenous ozone, sugar free diet, many health supplements unsuccessful. Unable to work for 2 weeks recently with excess fatigue and brain fog.  Past history of Lyme disease, now proven cured by blood tests, never produced such fatigue and brain fog.  Primary care MD, hematologist, physical therapist unable to effectively treat this adverse effect of Covid vaccine.
Redness at the injection site; Pain at the injection site; Rash at the injection site; Difficulty raising arm; Platelet count dropped to 116; Systolic pressure over 200; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number DP2X9, expiry date unknown) for prophylaxis.   Concurrent medical conditions included immune thrombocytopenia and platelet count abnormal. Concomitant products included rituximab (Rituxan).   On 14th October 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a month after receiving Shingrix, the patient experienced platelet count decreased and blood pressure systolic increased. On an unknown date, the patient experienced injection site erythema, injection site pain, injection site rash and mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site rash were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the platelet count decreased and blood pressure systolic increased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site rash and mobility decreased to be related to Shingrix. The reporter considered the platelet count decreased and blood pressure systolic increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was was the patient.  The reporter reported receiving Shingrix, in the left arm.  The reporter reported that, having Immune Thrombocytopenia, which affected their platelet count.  The reporter reported having a platelet treatment with Rituxan on 13th September 2022 and being told the effects of the Rituxan lasts approximately 6 months and they should be ok to proceed with Shingrix dose by hematologist's assistant, despite hematologist advising patient not to receive vaccinations.  The reporter reported that, the platelet count was 241 after last treatment with Rituxan.  The reporter reported that, having platelet count checked last week and being advised their platelet count had dropped to 116, which was unusual for them so soon after Rituxan treatment.  The reporter reported that, systolic pressure was over 200, which was associated with the drop in platelet count.  The reporter reported that, belief drop in platelet count was due to receipt of Shingrix dose, as it had been over 2 and a half years since they experienced such a drop in their platelet count.  Th reporter also reported experiencing pain, redness, and a rash at the injection site.  The reporter reported experiencing difficulty raising their arm, due to the pain from the injection.  The reporter reported platelet count and blood pressure had yet to return to normal.  The reporter reported pain, redness, and rash at injection site had resolved. The reporter consented to follow up.
arthritis; very deep pain in left side of body; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (arthritis) and MYALGIA (very deep pain in left side of body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced ARTHRALGIA (arthritis) and MYALGIA (very deep pain in left side of body). At the time of the report, ARTHRALGIA (arthritis) and MYALGIA (very deep pain in left side of body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication.  Patient reported taking medication for arthritis no medication name was provided.
Mother noted welt and rash inches below the injection site on the left thigh several hours after she received the vaccine. Rash spread to the nearest injection site. Noticed Ph since advised to see her Doctor. To Dr the next day, he thought it was a reaction to the vaccine. Treated with Benadryl. Cleared up in 2 days.
Starting mid-May, I had left breast pain. It was intermittent. It did not seem to be associated with my menstrual cycle at all. I wanted to wait a couple of months to see if it would go away. I did not feel a mass or soreness where I pressed. I saw my physician on 08/23/2021. She thought she saw my lymph node in my left armpit. I had imaging done on 09/10/20/21, a diagnostic mammogram which was completely normal. She said I could do Ibuprofen or a warm compress, but I did not take anything. The pain has gone away. My period has been very irregular since May. It seems with my last period I had a normal cycle, normal days and normal flow.
patient was supposed to receive the Menactra vaccine, but instead was given Trumenba with reported no adverse event; Initial information received on 23-May-2023 regarding an unsolicited valid non-serious courtesy case received from  Pfizer via other health professional (nurse).  This case involves a 11 years old male patient who was supposed to receive the Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine, but instead was given Meningococcal Vaccine B RFHBPA/FHBPB [Trumenba] with reported no adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 19-May-2023, the patient was supposed to receive the menactra vaccine, but instead was given trumenba with unknown formulation, strength, batch number & expiry date for prophylactic vaccination with reported no adverse event (wrong product administered) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
Very high fever after vaccines, child was lethargic, fussy 105 fever on 7/17/03. Vaccines were given 7/16/03. Mother called today 7/22/03, child getting better but not herself yet. It has taken her more than 1 week to get over reaction to vaccines.
patient was given an extra dose of DTaP via PENTACEL administration with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient who was given an extra dose of dtap after receiving Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] And Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) And Pneumococcal Vaccine 13v (Pneumococcal 13 Valent Vaccine) For Prophylactic Vaccination.  On 28-Sep-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (strength: standard, frequency: once and lot UJ8068A) (expiry date: unknown) via intramuscular route in the left thigh, also received a unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, expiry date, and lot number not reported) via unknown route in unknown administration site as immunization and given an extra dose of dtap via pentacel administration with no reported adverse event (extra dose administered) (same day latency). Information on he batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
my shoulder blew up; it hurt when I touched it; had an allergic reaction to the shot; I can almost feel a little bit of hardness.; Past weekend, I woke up with something in my eye. My nose and my eyes tearing. I went through; 5 days after the shot, I felt symptoms of COVID.; it is sensitive to touch; arm was swelled, injection site swelled up for 2 weeks; red, not blood red but pink red. It was 2.5 inch below the injection site; Med Info Agent: Update to case number MOD21-16065  Per the contact on 22JUL2021,  She has received 2 phone calls but was unable to understand the caller. She recognized the call was from moderna and received a number "MOD021-0256." Today they called back again, it was staff, she said she wanted to send me some kind of a form by email, but did not have my address.  She received the both doses of the moderna covid-19 vaccine by injection to the left arm on 8JAN2021 (lot number 025J20A) and 5FEB2021 (lot number 028L20A).   She originally called after the first dose because she had questions after she took the first shot. Swelling in her arm for a while, and it looked like an egg. She took the second shot and everything was fine. Her shoulder blew up, got swollen. It hurt when she touched it. It was like half of a ping pong ball. She thought she possibly had an allergic reaction to the shot and was worried about getting the second dose. The swelling did not go down until 1 month later. A doctor friend of her told her not to worry. She has a history of immune problems.  Consented to follow up by safety. Caller does not want any additional personal information shared to anyone outside Moderna. Discussed sending information to the FDA and CDC through the VAERS program which she consented to as long as name and email are not included.
This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 07-JAN-2019, the patient was administered 1 dose of improperly stored PROQUAD (therapy type: recombinant Human albumin (rHA), two lot numbers and expiration dates (lot # R011214 with expiration date 15-OCT-2019; lot # R008203 with expiration date 16-SEP-2019) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) (product storage error) for prophylaxis. Two lots of PROQUAD were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1902USA004203; US-009507513-1902USA004204; US-009507513-1901USA007256.
Patient developed a 5x6 cm irregularly shaped erythematous welt 2 days after injection, to her left thigh.
Fever, chills, headache, body aches, muscle pain, taking ibuprofen over the counter.
Eleven days after vaccine, patient started abdominal pains that went on and off. Four days later on Oct 29, patient went to see  Dr. He diagnosed possible appendicitis, and recommended to go straight to the hospital. Patient went to Hospital, after tests they were ready for surgery to remove the appendix, but realized he takes Eliquis for his heart condition. So instead of surgery, he was given antibiotics and had four nights in hospital recovering. Before being released he was given a Flu shot on 11/2/21. On November 21 at 11pm, patient found breathing painful. Then went back to Hospital for the day and diagnosed Pleurisy and sent back home. Then he was gaining about a pound a day of fluid. He started  taking Furosimide 20-40mg and 12.5mg Spironolactone, but surprisingly was not losing weight, but continued to gain weight. Since patient had severe back pain, the doctor had back x-ray done, and nothing notable, so then he had an MRI done of his back. Fluid around the lungs was scene and and arachnoid web at T3 zone. Then December 8th patient complained of pain in his abdomen again, and also had been having severe back pain as well. So off we went to Hospital again. After tests, they found his appendix looked better than the month previous, but the echo cardiogram showed fluid around the heart(pericarditis) and fluid around the lungs. You would have to confirm with the hospital what all was given, but I believe he was given prednisone. He did come home on prednisone and colchicine and diuretics. It took about two weeks for patient to gain 20 pounds of fluid, and about 10 days to take off the 20 pounds when he was given the anti-inflammatory medications. Patient was released on December 11th. The first night home was bad! Back pain and confusion. He needed help into his PJ's and had to sleep in a recliner. Today patient has much improved, but still recovering. He is still on prednisone, but it is on a taper. Being decreased as the sed rate continues to decrease. In the hospital patient's sed rate was up over 130! It kept decreasing each week, and this week it tested at 28. A repeat echo cardiogram done December 20 showed that the fluid was off the heart now. patient's back pain is much improved, but still is an issue. The doctor's saw an injury at the T9 zone and he has osteoarthritis.
DIVERTICULITIS; HEADACHE; This spontaneous report received from a patient concerned a 53 year old African American and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient was non alcohol user, non-smoker, and the patient had no known allergies. The patient did not have any drug abuse/illicit drug use.   The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at unspecified time to left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of this report.  On 08-MAR-2021, the patient experienced headache. On 04-APR-2021 patient experienced unbearable abdominal cramps and went to emergency room on 08-APR-2021 where lab test of CAT scan was done and the patient diagnosed with diverticulitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and had not recovered from diverticulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210428413-covid-19 vaccine ad26.cov2.s-Diverticulitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).