chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain in the lower legs area; discomfort in  joints; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 04Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 14:00 the patient experienced muscle pain in the lower legs area and discomfort in joints. After 24 hours of the first dose,  the patient presented muscle pain in the lower legs area and discomfort in the joints - ankle area. The symptoms were noticeable by the end of the Sunday ( >30 hours) after the administration. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle pain in the lower legs area and discomfort in joints was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") (seriousness criterion medically significant). At the time of the report, DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported. Company comment:Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; severe diarrhea; vomiting; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient, non-pregnant, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in hospital, via an unspecified route of administration on 23Dec2020 at 10:30, at 37-years of age, at single dose in right arm for COVID-19 immunization.  Medical history included anxiety, depression and migraines, all from an unknown dates. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), ibuprofen and levocabastine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache/migraine 6-24 hours after vaccine (onset reported also as 25Dec2020 at 12:00 - to be clarified) and, on 25Dec2020 at 12:00, also reported as 24-72 hours after vaccine, she experienced intermittent severe stomach cramping, nausea, severe diarrhea and vomiting. The patient didn't receive any treatment for the events. The outcome of the events was unknown at the time of the report.  Information on the lot/batch number has been requested.
Mom states that she had varicella vaccine on 5/13. Mom states that she is having redness and swelling on arm. Redness was the size of quarter yesterday and then spread to half dollar and now is slightly bigger but not by much. Denies pain or warm to the touch. Not bothersome to patient.
Rash started approximately 1 week after vaccination and continues to this day now almost 6 months later. Biopsy shows lichen planus.
tingling in arms; tingling in lips; pain that went down her whole arm; arm feels painful and she can't move it; has been hurting all day; red ring around injection site; A spontaneous report from was received from a Reporter  concerning a unknown year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events    like Paraesthesia, Oral Paraesthesia, Limb discomfort, injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.        On unknown date, after receiving the dose of Moderna COVID vaccine (mRNA-1273) (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.      On date or an unknown date, The patient experienced tingling in the arms, tingling in lips, pain that went down her whole arm, arm hurting, red ring around her injection site, and painful arm which can't be moved. Treatment included diphenhydramine hydrochloride and two steroids for her symptoms, which subsided.         Action taken with mRNA-1273 in response to the events was reported.       On date 5 January 2021 the outcome of the events like pain in extremity, limb discomfort, injection site erythema are unkown.; Reporter's Comments: This case concerns a female of unknown age who had serious unexpected events of tingling of extremity, oral paraesthesia, and pain in extremity, NS unexpected arm discomfort, and NS expected injection site erythema. Event onset 15 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Events subsided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
TIREDNESS; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 13:30 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious. This case, from the same reporter is linked to 20210400347.
got a fever / had a 101 fever /  This morning her fever is 100.4; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2020 12:30, the patient received the 1st dose of Shingrix. On 29th November 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose around 12:30 PM in her upper left arm. By dinner time, the patient got a fever. She took her temperature in the middle of the night and she had a 101 degree F fever. On 30th November 2020, her fever was 100.4 degree F. The reporter consented to follow up.
No reaction reported.  Pt requested FLUZONE PF, received FLUZONE NDC49281-0386-15 Lot #UH181AC 30 June 11.
Erysipelas - left upper arm below injection site. Began as a few spots 12/21/18, worsened 12/22/18.
he never got his 2nd dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 10-Oct-2019).   On an unknown date, the patient received the 2nd dose of Shingrix (injection). On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: he never got his 2nd dose of Shingrix). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 15-May-2023  Reporter was the wife calling on behalf of her husband who was a male patient that reports that he received his 1st dose of Shingrix 10-OCT-2019 at his doctor's office, and then due to the covid pandemic, he never got his 2nd dose of Shingrix. The reporter did not have any further information about the patient's 1st dose, no Lot number or the location of the administered dose. The reporter had reported all the information. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023069447:Patient's wife report
Patient reported feeling light headed, dizzy, and clammy after immunization. Remained in the pharmacy for 20-30 min after. Given some water, granola bar, cool compress. Reported feeling better and left the pharmacy without further issues.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 10-MAY-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 plague forming units (PFU) (lot # L036823 with expiration date 24-DEC-2016; dose and route were not reported). The vaccine was improperly stored at 12 degree Fahrenheit for 4 months (incorrect product storage). There was no previous temperature excursion and no data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe muscle ache (calves), loss of appetite, headache - took acetaminophen as needed - lasted for 24 hours soreness and redness at injection site - took acetaminophen as needed - 3 days
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 07-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Very sore and painful to touch the night after receiving the injection (more than usual after a flu shot); second day a red rash developed around and below the injection site; 4 inches by 7 inches oval; hot to the touch and itchy throughout; lasted for 3 days; for up to a week after the rash disappeared the site turned red again when exposed to heat (e.g., hot bath).
Hurt; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unknown number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist reported that some patients said they didn't want to get the second dose because the first one hurt. The reporter consented to follow up.  The reporter had no specific patient information or lot/expiry to provide.
Student received a second dose of Fluarix mistakenly. She had last received Flu vaccine on  10/12/2021
Allergic reaction, shortly after shot, including difficulty breathing, swollen lips and tongue.  Patient received epinephrine and oral corticosteroids and has to her description, fully recovered.
Intense shoulder soreness that day.  The next morning woke up with extreme muscle cramps all over my entire body.  Developed sore throat later in the day.   Symptoms worsened over the course of the week, sore throat, headache, malaise, extreme sinus congestion, coughing, sneezing, excess saliva production.  It was as if I contracted a sever cold.  Today is June 3'rd and it is the first day I am feeling close back to 100%.  I should note that I have a strong immune system and have not been sick in years.
Vomiting and elevated temperature resolved over night. 12/09/16 very low energy and "spacing out". 12/10/16 sudden and unusual pain in mouth after eating a banana (favorite fruit), developed hives around mouth and one in throat, still continuing 12/11/16, woke up at 1:00 am screaming about pain and itchiness around his mouth. Developed hives on hands and arms.
fatigue; This is spontaneous report from a contactable consume via Pfizer Sales Representative. This consumer reported similar events for 2 patients. This is a second of two reports. A 9-decade-patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue after use of vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for the COVID-19 Virus; tested positive for the COVID-19 Virus; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported similar events for her and her husband. This case refers to the husband.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for the COVID-19 virus on an unspecified date. The outcome of the event was recovered on an unspecified date. The wife asked on how the patient should proceed for the second dose (if they will wait for 90 days).  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021034841 Same reporter/drug/event, different patient
Felt dizzy the evening of receiving flu shot. Took a day and a half for dizziness to go away. Doing fine. Case closed. 11/13/2002
Headache, NauseaVomiting, fatigue Narrative:  missed work following second dose due to above symptoms
Homebound patient vaccinated with 2nd dose Pfizer at around 10:30 am after the first 15 minutes of observation, around 10:45 patient looked dizzy as she was getting ready to get up from the sitting position to escort us out. At this time, the patient indicated that this happened with the last dose. I noticed her dizziness and pale advised the patient to lie down legs propped up and gave her some water to drink. Attempted to take blood pressure with her own blood pressure cuff but the batteries died out. Continued to monitor for another 15 minutes, while patient continued to lie down and sipping water. After an additional 15 minutes passed I remembered we had a blood pressure cuff in the emergency kit , blood pressure reading was 138/56 and pulse was 76. Pt stated she felt better and wanted to escort us to the door. I advised against getting up and discussed the event with her son in law. Advised to monitor mother in law, call 911 if symptoms worsen. I also asked the son in law to escort us to the door so that the patient did not feel the need to get up out of the bed. Placed a call to person of contact on homebound list, Daughter currently out of town. Advise daughter of the event and to follow-up with her mother to see if she is okay, call 911 if symptoms worsen, and to follow up with PCP regarding event and any other concerns.
Patient indicated debilitating fever, aches, and fatigue that lasted approximately 10 days. Patient reported having hallucinations and having trouble getting out of bed.
unease and irritation, similar to what steroids can cause; irritation/rash started on my right forearm (shot was in left arm); minor burning; itching; very bad muscle pain; stiffness at shot location; very uncomfortable; radiating to between shoulder blades, and up into neck. On a 1-10 scale of pain, about 8.5.; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient). A 66-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no /lot number: not reported) via an unspecified route of administration in arm left on 10Mar2021 10:00 AM (at the age vaccination of 66-year-old) as dose 2, single for cvis019 immunization. Patient's medical history included seasonal allergies and Concomitant medications included other medications in two weeks as finasteride (FINASTERIDE), meso zeaxanthin, xantofyl, zeaxanthin (MACUHEALTH WITH LMZ3) and Mediherb thyroid complex all were taken for an unspecified indication from an unknown start and stop date. Historical vaccine included patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no /lot number: not reported) via an unspecified route of administration in right arm on 17Feb2021 10:00 AM (at the age vaccination of 66-year-old) as dose 1, single for COVID-19 immunization, no issues with first shot. Patient did not receive other vaccine within four weeks of vaccination. Patient did not have COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. It was reported that patient had no issues with first shot and with the second shot, nothing was life threatening. On 11Mar2021 08:00 AM patient experienced with very uncomfortable, very bad muscle pain and stiffness at shot location, radiating to between shoulder blades, and up into neck. On a 1-10 scale of pain, about 8.5, which were started less than 24 hours after 2nd shot. At about 48 hours an irritation/rash started on his right forearm (shot was in left arm). The site was about 1" wide by 6" long and persisted with minor burning and itching for about 24 hours. On the 3rd day after the 2nd shot, he also felt a lot of unease and irritation, similar to what steroids can cause, which lasted a couple of days. Patient did not receive any treatment for the events reported. Outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information expected.
Onset/recurrence of cardia arrhythmia -- PVCs, PACs, etc.  palpitations
One hour, post vax, pt had hives all over back to trunk. Given epinephrine and Benadryl and it decreased. Called 911 and was seen in ER at 18:00. Call in the morning. Hives all resolved.
urine was becoming discolored and becoming a little darker than usual; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (urine was becoming discolored and becoming a little darker than usual) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced CHROMATURIA (urine was becoming discolored and becoming a little darker than usual). At the time of the report, CHROMATURIA (urine was becoming discolored and becoming a little darker than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Information has been received from a physician concerning a 17 year old female who on 07-FEB-1994 and 28-MAY-1996 was vaccinated with the first and second dose of MMR II (LOT # not reported).  On 26-DEC-2009 the patient experienced mumps.  On 14-DEC-2009, the patient was diagnosed with mumps.  The patient had fever (101 F) and had a parotitis on the right side. The blood work was done on 14-DEC-2009 and the result was not reported.  The patient's outcome was unknown, this case was non-serious. This is one of several reports from the same source.  Follow-up information was received from the physician indicating that on 18-JAN-2010 (previously reported as 26-DEC-2009) the patient experienced mumps and mumps was diagnosed on 19-JAN-2010.  The patient had right facial swelling.  It was unknown if the patient got orchitis.  On 19-JAN-2010, the first blood work was performed, the results were as follows:  IgM <1:10, IgG 5.44 (normal range >1.10), serum amylase 49.  Additional information has been requested.
rashes; hives; itching; headache; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. On 02Jun2021, patient experienced rashes, hives, itching, headache and swollen lymph nodes. The outcome of events was unknown.   Information about batch/Lot number has been requested.
1 year after receiving Covid vaccine I began having bloody, loose stool 6-10 times a day, until I was ultimately diagnosed with ulcerative colitis one month later. IBD does not run in my family and besides food intolerances, I was perfectly healthy.
Respiratory difficulty, facial swelling, wheezing. Pulse oximetry 92 prior to treatment. Treated with Xopenex 0.63mg; Benadryl 0.5 ml (IM); Epinephrine 0.2 ml (SC) and Oraprid 15/5 X 3 days.