chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; cold symptoms; weakness; diagnosed positive for covid; diagnosed positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172086).  A 83 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 83 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Cancer" (unspecified if ongoing), notes: he is a two time cancer survivor. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "diagnosed positive for covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Consumer was calling on behalf of her 83 year old father, withheld. He was diagnosed positive for covid today. He had a lot of pre existing health issues like diabetes and he was a two time cancer survivor. He was fully vaccinated and boosted. He was experiencing cold symptoms and weakness. Is it safe for him to take the Paxlovid pill?  The lot number for bnt162b2 was not provided and will be requested during follow up.
After second dose reports the following two weeks having back pain and continuous fatigue; After second dose reports the following two weeks having back pain and continuous fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19 infection" (unspecified if ongoing), notes: Person that previously had covid-19 infection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "fever"; Bnt162b2, for Covid-19 immunization, reaction(s): "weariness". The following information was reported: BACK PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "After second dose reports the following two weeks having back pain and continuous fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of PREVNAR 13, via an unspecified route of administration in Oct2018 at a single dose for immunization. The patient's medical history was and concomitant medications were not reported. The patient experienced swelling in arm, fever, vomiting, and diarrhea for 2 weeks. Outcome of the events was unknown. Information on batch number has been requested.
body aches/chills; rash over arms/trunk/back/neck.  Rash spread over next 2 days before subsiding.
vomiting; temperature of 99 almost 100; a sore arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (a sore arm), NAUSEA (Nausea), VOMITING (vomiting) and PYREXIA (temperature of 99 almost 100) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced AXILLARY PAIN (a sore arm), NAUSEA (Nausea) and PYREXIA (temperature of 99 almost 100). On an unknown date, the patient experienced VOMITING (vomiting).   At the time of the report, AXILLARY PAIN (a sore arm), NAUSEA (Nausea), VOMITING (vomiting) and PYREXIA (temperature of 99 almost 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 100 (High) Patient had body temperature of 99 F almost 100 F..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI
Patient had felt something in her eye and was not sure what it was. She tried cleaning it with Visine, but she complains that there is a black line in her vision from one eye. She is concerned that it might be due the Moderna Covid 19 vaccine that she received on 04/30/21, as she did not have this issue prior to vaccination.
About 15 minutes after receiving vaccine symptoms started.  Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle.   I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two.  I took Tylenol and Benadryl to control symptoms but still felt miserable.  The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell.  I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high.
first dose of shingrix on August 25th 2023 and got the 2nd dose too early; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of shingrix on August 25th 2023 and got the 2nd dose too early).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Sept-2023 The pharmacist asked that need to repeat dose. The reporter did not consent to follow-up. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Did not feel well going to bed woke up during the night and could only walk to bathroom with difficulty weakness loss of feeling in legs and she felt nauseated lasted 3 hrs had muscle pain the following day and by the 7th she was feeling better.
Pt has experienced pain in R arm continually since receiving vaccine-worsens with exertion of extremity. A "divit" at injection site 1st appeared about February 1st, 2009.
a dose of improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 15-JAN-2020, a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, with lot # S013712 and expiration date on 01-NOV-2020, for prophylaxis (dose number, route of administration and anatomical injection site were not reported) was administered to the patient. The sterile diluent used to reconstitute the vaccine was properly stored.  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion below 12.2 Celsius (C) degrees for 25 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.
One day post vax the pt "experienced erythema multiforme on arms, legs, and trunk with no other symptoms." This reaction was described as "target lesions." The pt was presented to a physician with symptoms. The physician suspects Hib B and Hep B "may be the cause." Subsequently, the pt recovered.
Approximately 5 minutes after receiving the vaccine the donor started to feel dizzy, lightheaded, nauseated, upset stomach, hot and diaphoretic, pale in color. donor was brought back into a medical office and observed.
anaphylaxis; This literature marketed report has been received from the authors of a published literature article and refers to a 5 year old patient with maculopapular cutaneous mastocytosis.  On an unknown date, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot #, strength, dose, route and site of administration were not reported) for prophylaxis.  On an unknown date, the patient experienced flushing, abdominal pain, vomiting, wheezing, dizziness and had an anaphylactic episode two hours after receiving the second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown). Tryptase level was 5.1 ng/mL. The patient was treated with epinephrine.  The outcome of anaphylactic reaction was unknown. The authors considered anaphylactic reaction to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).     Upon internal review, the event of anaphylactic reaction was considered to be medically significant.  This is one of 2 reports derived from the same literature article (cross referenced with MARRS# 2006USA006736).; Sender's Comments:  US-009507513-2006USA004886:
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 10-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Her face started to feel sore/her face, is very sore, tender, and swollen; Her face, is very sore, tender, and swollen; Face is tender; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Her face started to feel sore/her face, is very sore, tender, and swollen), SWELLING FACE (Her face, is very sore, tender, and swollen) and TENDERNESS (Face is tender) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), SPIRONOLACTONE, MINOXIDIL and ETHINYLESTRADIOL, LEVONORGESTREL (LEVORA [ETHINYLESTRADIOL;LEVONORGESTREL]) for an unknown indication.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced FACIAL PAIN (Her face started to feel sore/her face, is very sore, tender, and swollen), SWELLING FACE (Her face, is very sore, tender, and swollen) and TENDERNESS (Face is tender). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FACIAL PAIN (Her face started to feel sore/her face, is very sore, tender, and swollen), SWELLING FACE (Her face, is very sore, tender, and swollen) and TENDERNESS (Face is tender) outcome was unknown.            The patient symptom included the patient had symptom where a filler in the face, also had face tender.
Varicella Information has been received from a health professional concerning a 7 year old female with unknown drug allergies, who on 11-AUG-1999 was vaccinated with a 0.5ml subcutaneous dose in the "right" of varicella virus vaccine live (Oka/Merck) (Lot #6699J). The second week of February 2006 on approximately 08-FEB-2006, the patient got a mild case of chickenpox from her sister. Unspecified medical attention was sought. No product quality complaint was involved. The patient's sister also experienced chickenpox following vaccination with varicella virus vaccine live (Oka/Merck) (WAES#0603USA00490). Additional information has been requested.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions, pertinent drug allergies and medical history of the patient were not reported. On 01-AUG-2016, the patient was vaccinated with improperly stored PEDVAXHIB lot # L035878, expiry date 11-AUG-2018. Concomitant medication were not reported. No adverse effect reported. Additional information has been requested.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. It was unknown if patient received any other vaccines 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
following patients injection, during  the post vaccination wait time, patient fainted. Her guardians were with her, and said she frequently faints with immunizations. She came to quickly. Her caregiver went to get her some food and drink, as they said she had not eaten yet today. They stayed 30 minutes longer to make sure she was ok, then left.
Information has been received from a physician concerning an adult female nurse who on 10/11/2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 10/17/2005, the patient developed lesions on her face and at the injection site. It was reported that she came back to work but there was no present status reported. additionally, it was reported that a patient was exposed to another nurse who subsequently developed an adverse experience (WAES#0511USA03072). No product quality complaint was involved. Follow-up information has been obtained regarding the results of the VZV identification program. The specimen was obtained on 11/11/2005 from a vesicular lesion, the VZV DNA was amplified. The strain identified was wild-type. There was no further information at the time of this report. Additional information has been requested.
mom says pt devel listlessness for 1 wk commencing; 2 hrs p/receiving DTP/OPV/HIB on 10JUL92;
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with ZOSTAVAX administration site. The patient complained that it really bother her about 7 days administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
fever, nausea, very dizzy, light headed,  all lasted from when I woke up at 7:15 am to around 8:00pm
Called to Residents room. upon entering resident was laying in bed very pale states he is having hot and cold flashes. and chest pain. vitals obtained Temp- 97.8, Resp. 18, pulse 39 BP was unable to capture. 911 called as well as Daughter and Dr. to make aware of event. awaiting call back
At 1am mom heard patient breathing funny and found him having a seizure that lasted about 20 minutes. She gave him Diastat as prescribed per doctor and called 911. Fever was 101.9 at that time. Was last given Ibuprofen @ 8p. States doctor felt it was fever induced.
Approx. 2 weeks after receiving the vaccine, I woke up with diffuse joint pain. I saw my rheumatologist, who did a workup and stated that this was a flareup of my pre-existed RA which had previously been in remission for 12 years. Over the past year, I was treated with PLAQUENIL and Prednisone for help with the pain. After many doctors appts I was given shots of Cortisone to help with pain which lasted only a few days. Now it is a year later and I am still in some pain even with the meds.
Skin/subcutaneous-red papules with white heads scattered in right groin, crossing the midline in the fold under the belly, with some eschar/opened blisters noted near the midline.
No additional AE reported; temperature excursion; This spontaneous report has been received from a medical assistant, concerning a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 31-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection (valid lot number W019627 [expiration date 19-DEC-2023 obtained per internal validation]) (dose, vaccination scheme, anatomical location, and frequency were not provided) for prophylaxis, after a temperature excursion. Total time in the range of -9 degrees Celsius (C) to 8 degrees C: 72 hours, 8 minutes. Total time at 26 degrees C or warmer: 2 hours.  Total combined excursion time: 74 hours, 8 minutes, 0 seconds (product storage error).   No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:Original case
PT GOT BOTH MMR VACCINE AND MODERNA VACCINE AT THE SAME TIME. INITIALLY, PT WAS REQUESTING FOR MMR AND NOT MODERNA.PT ALREADY HAD GOT JOHNSON AND JOHNSON VACCINE IN APRIL 2021.COVID VACCINE GOT DUPLICATED.
Starting around 5:45, heart rate  in excess of 140 bpm and quite irregular.  lasted for more than 6hrs.  Upon awakening around 7:00 am,, Heart rate had returned to around 60bpm and and was regular.    However, so far, heart beat irregularity has returned each evening since.  Lasts from ~10::pm  for well more than an hour, until some time while I'm asleep
pt recv vax 7AUG96 & exp arthralgia;ER visit required;sx improve from AM to PM;ROM WNL;26NOV96 cont w/stiffness & soreness;
Gums were sore and bled a little.   Nervous about the 2nd shot as I've read that it can cause (Thrombocytopenia).  Went away after a few days.
Sweating; tired; thinks he had a fever; lost his appetite; pain in his groin; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Right on 15Jul2021 (Lot Number: EW0198) (at the age of 56 years old) as dose 1, single, and dose 2 via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) (at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history reported as None. There were no concomitant medications. The patient experienced pain in his groin on 09Aug2021, sweating, tired, thinks he had a fever, lost his appetite on an unspecified date. Reported as, patient was calling about the Pfizer Covid-19 Vaccine and said that he got the vaccine about 3.5 weeks ago. He said that he got the symptoms which was normal, like sweating. He told that he got a pain in his groin that went up about 6 inches above his groin towards his stomach. It was weird the way he feels. Patient clarified the normal symptoms he experienced were sweating profusely, tired, he may have had a low grade, although he did not check his temperature. He said that the sweating was nonstop and pretty bad. He said that the first shot was not bad, but the second shot was worse, the second day after the second dose, he had lost his appetite. He thinks he had a fever because he was sweating. He said that his groin felt like a nasty pull in his groin. It's starting to slowly go away. The tinge/the pull was going away. It felt like an elastic band pulling. It was something he never had before. He got it at the same time as his other symptoms. He experienced the groin pain 2 days after he got his second dose. He woke up and thought he would breeze through and wasn't hungry that night, then he had sweats and was tired, someone mentioned lymph nodes and he does not know what was causing his groin symptoms. The pull/ tinge or yank was improved. There was just weird symptoms from it. No further details provided. Outcome of all the events were unknown.  Information on lot/batch number has been requested.
I did not have an adverse reaction to the vaccine. I tested positive on 06/08/2022 for COVID-19.  I had a scratchy throat, fever and nasal congestion.  I took Ibuprofen for the headache and a couple of throat lozenges for the scratchy throat.  I had a telehealth visit with a provider at an urgent care center because my primary care physician was not available. They prescribed Paxlovid.