chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 hours fever, fatigue malaise. 6 weeks very large tender lymphadenopathy. 3+ months dysmenorrhea
Felt nauseated, then vomited and then felt fine. Paramedics Arrived, vitals stable.
Pt had episodes on significant crying and apnea. Pt also experienced difficulty feeding so he was admitted for observation overnight. 9/25/09 Medical records received for DOS 9/1/09 to 9/2/09. Presenting symptoms: difficulty breathing, increase crying/fussiness hard to console. Admit and D/C DX: Stridor   Suspect: underlying mild laryngo/trechea malacies. Admit and D/C DX: Stridor. 786.1.
This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 84, via an unspecified route of administration, on Mar 13, 2021, at 11:00, single dose for COVID-19 immunisation. The medical history included diabetes, hypertension and penicillin allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications not reported. On Mar 14, 2021, the area where the vaccine given on the patient was hard, red and hurt. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of the area where the area where the vaccine given on the patient was hard, red and hurt: not resolved (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Pt developed swelling in right thigh 1 day post vax. Two days post vax lesion became red and redness, warmth, swelling and pain increased over 2 days until presentation in office.
This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date (reported as "a couple of weeks ago"), the patient as vaccinated with a dose of ZOSTAVAX 1 shot once, subcutaneously (lot # and expiration date were not reported). On an unknown date, the patient developed redness and swelling at the injection site. On approximately 24-FEB-2016 (reported as "about a week ago"), the patients redness and swelling went away. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 69 year old male "immunocompromised" patient with chronic myeloid leukemia (CML) for 10 years. It was not specified how long the patient has been immunocompromised. On 05-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were unspecified). Concomitant therapies included atenolol and nifedipine (reported as "nisedipine"). On approximately 07-FEB-2015 (reported as "4 days ago"), the patient experienced "flu-like symptoms" such as chills, loose stools, hypoxemia, and pericardial friction rub. On 08-FEB-2015, the patient was admitted to hospital due to those symptoms. Since being in the hospital, he had had unspecified labs and diagnostic studies performed and received intravenous acyclovir as well as intravenous doxycycline and acetaminophen for fever/chills (on an unknown date in February 2015). The pharmacist also reported that the patient was going to be undergoing induction therapy on an unspecified date for acute lymphatic leukemia (ALL) which was diagnosed on an unknown date. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. The reporting pharmacist considered the symptoms that the patient developed with being "immunocompromised" including: "flu-like symptoms"/fever/chills, loose stools, hypoxemia and pericardial friction rub to be life-threatening. Upon internal review acute lymphocytic leukemia (ALL) was considered to be medically significant. Additional information has been requested.
Patient stated that developed a rash over her entire bicep that started the day after receiving her 2nd COVID vaccine. Patient also described some slight difficulty breathing
Tired; Achy; Little bit of reaction; Tingling in my mouth and lips; Facial numbness; Tongue swelling; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness), SWOLLEN TONGUE (Tongue swelling) and FATIGUE (Tired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 16-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 ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness) and SWOLLEN TONGUE (Tongue swelling). On an unknown date, the patient experienced FATIGUE (Tired) and MYALGIA (Achy). On 16-Apr-2021, ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness) and SWOLLEN TONGUE (Tongue swelling) had resolved. At the time of the report, FATIGUE (Tired) and MYALGIA (Achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were provided.  Treatment information was not reported.
Elevated temp of 100.0,  increased from 99.0, Upper Back Pain, Soreness of left arm (vaccine inj site).  Started around 7 am today.  OTC med for elevated temp, recheck temp in 4 hours, if no relief by 6 pm, notify PCP.   If symptoms continue to worsen, notify PCP.
Blood in urine; Pain in the bladder; Pain in the bladder, groin; Pain in the bladder, groin, lower abdomen; Pain in the bladder, groin, lower abdomen, or pelvis; The patient received the third/booster dose of BNT162b2; Patient was administered booster dose with BNT162B2 and  received  initial complete immunisation with non-Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis C. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included dietary supplements (unspecified) for unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of COVID-19 vaccine (NOVAVAX; Lot Number: 28004) via an unspecified route of administration in the right arm on 20Apr2021 and the second dose of COVID-19 vaccine (NOVAVAX; Lot Number: 28004) via an unspecified route of administration in the left arm on 11May2021; both as single doses for COVID-19 immunisation. On 13Nov2021, the patient experienced blood in urine, also pain in the bladder, groin, lower abdomen, or pelvis. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blood in urine, pain in the bladder, groin, lower abdomen, or pelvis was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent, which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008347:
Patient received Influenza vaccine last Thursday 11/2/23 at 6 AM in her left arm at microbiology. Throughout the day on Thursday, patient who is an employee, had slight swelling and soreness which was normal to her understanding. Later on, in the evening/night of 11/3, while at work she realized that the swelling did not look normal and was bigger than usual and it was itchy, she thought it was an allergic reaction and took 2 Benadryl Friday morning however, by Friday night the swelling had gotten bigger and was spreading across her arm. At this point she was thinking it was still an allergic reaction and took more Benadryl, since she was told that the swelling can last up to 3 days. By Saturday morning the swelling had almost wrapped around her arm completely and she was in excruciating pain, by the evening her fingers were numb and tingling. Sher states she could barely move my arm. She visited clinic where she was diagnosed with Cellulitis due to the injection site not being cleaned at all or not cleaned properly. She doesn't recall the nurse who administered the vaccine ever wiping  her skin that morning and she states something about the way the nurse administered the shot didn't feel right.  She is on antibiotic treatment with Cephalexin which she started Saturday 11/04 and is on 2nd day of treatment. She was prescribed Cephalexin for 5 days. She states the swelling is getting better. She has no discoloration to arm and fingers indicating cyanosis and is able to move her left arm as well as fingers. She states pain in left arm is currently rated a 4/10 whereas before it was a 6/10.
Faint, possible seizure (jerking on groud for a few seconds). BPs 89/47 (pulse 56), 130/77 (pulse 75). Hit head - recommended getting CT scan.
didn't "tolerate it well; This case was reported by a consumer via call center representative and described the occurrence of drug intolerance in a 35-year-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced drug intolerance. On an unknown date, the outcome of the drug intolerance was unknown.   It was unknown if the reporter considered the drug intolerance to be related to DTPa vaccine.     Linked case(s) involving the same patient:  US2022AMR091738, US2022AMR091740   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comments:  The patient reported case for herself. The patient mentioned that her mother said that when she was a baby, she only got one TDAP shot because she did not tolerate it well whatever that meant, so she only received 1 of the 2 that was recommended by pediatricians at that time. The patient did not have any of those records now, of course. She wondered if there was an excipient, preservative or something else that she was not tolerant of, and if so the patient really like to know what it was and avoid it in the future. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091740:Same reporter US-GLAXOSMITHKLINE-US2022AMR091738:Same reporter
This spontaneous report was received from a 68 years old female consumer reporting on herself who on 03-JAN-2013 was vaccinated with a dose of live ZOSTAVAX (route, lot # and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-JAN-2013, the patient had a pain in her hip at the joint that will not go away, and did not wish to share additional information. The outcome of the event was unknown. No labs were performed. The relatedness for the event was unknown for live ZOSTAVAX. Additional information is not expected.
felt like a fib episode where her heart rate was high; dizziness/felt light headed; This is a spontaneous report from a contactable consumer (patient) A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 3 via an unspecified route of administration on 18Oct2021 10:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation  .  Age ta vaccination :75 years.Medical history included , atrial fibrillation (diagnosed  with a fib, 2 years ago (a couple years ago).     The patient's concomitant medications were not reported.  The clinical course was reported as follows: "The patient  received the Pfizer BionTech covid 19  booster this morning she was fine until 2 hours ago, dizziness, felt like a fib episode where her heart rate was high, she was diagnosed  with a fib, 2 years ago (a couple years ago) , her apple watch notified her of her heart rate was 110 to 120 beats per minute. Caller states, her AFib it's not constant it comes and goes, intermittent, sometimes it doesn't happen all the time maybe once a month or once every other month, not on a daily basis. It was unusual for it to happen during the day. She said that it usually happen overnight or in the morning.  "I am calling my cardiologist when we hang up".  Then the patient added again : I received the booster dose at 10AM almost 6 hours ago, did a yoga class and zoom, had lunch, then felt light headed, I usually don't feel that it is fast.  I checked my smart watch my heart rate was in the 110's to 120's bpm.  Started feeling this way 4 hours after the booster dose". The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After the first shot I had extreme muscle twitches (which is a known side effect so I didn't worry too much) these never have subsided and I still got my second shot. These have just gradually gotten Worse and worse. I get twitches all over my body and they seem worse at nighttime. Monday July 19th 2020 I has having extremely long lasting twitches in my left ankle and now I'm starting to get burning sensations in my feet and calves. Sometimes I feel pain in my feet and calves. And still getting pretty consistent twitches.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 21-MAY-2010, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2 (dose unknown), from lot # 665413-1128Y, with expiry date of 07-AUG-2011.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.
flu; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious Social Media case received from a consumer/non-hcp (patient).  This case involves patient of an unknown age and gender who experienced flu after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 1988, the patient received a unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
A day after injection my son had a red welt at injection site that lasted 3 days once the redness and swelling went down, he had lump that lasted a month.
carried the herpes virus for over 30 years/The outbreaks came back prior to a booster shot of your vaccine and subsided after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes virus" (unspecified if ongoing), notes: I've carried the herpes virus for over 30 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "carried the herpes virus for over 30 years/The outbreaks came back prior to a booster shot of your vaccine and subsided after the booster".  Additional information: Patient carried the herpes virus for over 30 years. Patient was now 76. After their COVID vaccine the outbreaks were virtually eliminated. The outbreaks came back prior to a booster shot of their vaccine and subsided after the booster. Patient was grateful for the protection the vaccine provided against COVID. Patient was grateful for the vaccine's extended suppression of the herpes outbreaks. Patient hope was that they would find this side effect of their vaccine worthy of further research.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right after shot, before I left the Dr's office - headache; by the time I reached my car - headache, sweating, runny nose & eyes. The next  day -rash on my right arm, chest. In days to follow still had rash, headsche.  extremely weak, muscle aches, no strength or energy, lack of  appetite..  To date - still extremely weak, muscle aches - w/xtreme muscle cramping w/muscles locking up, rash comes & goes, overall exhausted.
This spontaneous report was received from an Office Manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection with lot number: N000236 and expiry date: 24-OCT-2019 (exact dose, route of administration, were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot number and expiration date not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 16 hours. A digital data logger was not involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005224: US-009507513-1708USA004174.
This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Nine days later she had knot on her arm), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy in arm), ERYTHEMA (Red in her arm) and RASH (Circular rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced LIMB DISCOMFORT (Nine days later she had knot on her arm), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy in arm), ERYTHEMA (Red in her arm) and RASH (Circular rash). At the time of the report, LIMB DISCOMFORT (Nine days later she had knot on her arm), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy in arm), ERYTHEMA (Red in her arm) and RASH (Circular rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Expired vaccine used; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment information were not reported.
Varicella was the last vaccine given subcutaneous injection to left arm. She bended head to knees. Pale, reposition to straight position gave alcohol, then ammonia to smell conscious. Complaining of nausea and feeling shaking. Stated last time she ate a little was in the morning.  Granola bar and water given. 3:23 B/p 89/60 p 70 pale color, skin warm to touch, alert and oriented  3:34 B/p 92/60 pulse 77 alert, oriented C/o nausea 3:40 RN informed of clients status. 3:45 B/p 96/70 pulse 77 good skin color, skin warm o touch, alert and oriented. 3:50 B/p 113/71 pulse 79. Alert, oriented granola bar and water taken no vomiting states feels better. Dismissed with mother. Mother advice Mother advice if not feeling better seek medical attention and let us know. 8:15pm Telephone call to client states feels better. Mother stated continued with nausea, feeling tired, and shaky. Unable to eat much of chines food and Carnitas. Mother had bought. RN informed of follow up call. Mother stated 10/21 patient slept well 10/22 she felt much better.  10/23/2020 Telephone called spoke to mother stated doing well.