chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 70 year old female patient who on 27-SEP-2006 was vaccinated with a dose of Pneumovax 23 (route not reported; Lot# 654981/0674F). The nurse reported that on 27-SEP-2006, the patient developed a cellulitis-like reaction at the injection site. The patient was seen in the emergency room and released. At the time of the report the outcome of the patient's cellulitis-like reaction at the injection site was not reported. Follow-up information has been received from the consumer. The consumer was concerned and requests that a lot check be performed immediately and response be sent to the physician and consumer. Follow-up information has been received from a licensed practical nurse concerning this female patient (weight 156 #) who was a housewife with a history of hypertension, hyperlipidemia, osteopenia, colonic polyps, chronic obstructive pulmonary disease, peripheral neuropathy, monoclonal gammopathy and hyperglycemia. Concomitant therapy included cyanocobalamin. The nurse reported that the patient had severe pain and was unable to move left arm for 2 days following Pneumovax 23 injection into the left deltoid. The patient had a local reaction with redness and swelling which was treated with ice and elevation. The patient recovered from the events on 29-SEP-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory authority. Additional information is not expected.
10/1/19 849 AM  flu vaccine given into the sub-acromial space.  10/1/19 346 PM patient called office complaining of pain. Ibuprofen and ice prescribed to patient  10/2/19 patient came into office due to continued pain and swelling. Could not move arm. Provider prescribed steroids, heat and gentle motion of arm.  10/7/19- patient called back stating that she had continued pain, but swelling went down. Provider recommended she go to the Ortho Urgent Care. Patient did and provider wanted patient to continue on the steroids, prescribed Naproxen and  recommended 3 weeks of physical therapy. if does not in 3 weeks, patient to have MRI.
fever; chills; body aches; developed a sore throat; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female 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 a year after receiving Shingrix, the patient experienced fever, chills, general body pain and sore throat. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, general body pain and sore throat to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient recently received Shingrix vaccine in her left arm. After getting the injection she developed the fever, chills and body aches. Those symptoms have resolved and afterwards she developed the sore throat and had not resolved till the time of reporting. The reporter declined to gave the health care professional information. The reporter did not consent to follow up.
Veteran contacted call center, Reporting LT Arm swelling from hand to above elbow, No redness reported around injection site. Veteran reports swelling has incresed over last 24 hours, painful to rest arm on object. No other symptoms reported, including No elevation in body temperature.  Directed veteran to mission act urgent care for evaluation.
This is a spontaneous report from a contactable other health care professional. A 20-year-old female patient received TRUMENBA (Lot# M95612, Exp date Jul2017), via an unspecified route of administration in arm left, on 07Jul2016, at single dose, for immunisation and the 3rd dose of GARDASIL (Lot# N000326, Exp date Oct2019), via an unspecified route of administration in arm left, on 07Jul2016, at unspecified dose, for immunisation. The patient's medical history was not reported. Concomitant medications were not reported. The patient previously took 1st and 2nd dose of GARDASIL on unspecified date, for immunisation. The patient experienced injection site swollen, painful and red on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017252924 Same drug/event, different patient.
First 48 hours headache, chills hot and cold fatigue. Felt better but never felt right , felt off for months tested for lime , couldn?t pinpoint what was wrong. In the beginning of November starter to have pain in my hip area went on for 3 weeks on the night of the 26 couldn?t sleep all night from pain in the hip area .when I woke up on the 27 of November I looked down at my legs ,my left leg was 3 times bigger than my right . I went to the ER in my local hospital and ther admitted me , I had a DVT . I had surgery on the 28 to remove the blood cloths ,  was sent home on the 29 ,leg was still huge could not walk . Next day called doctors office and was seen , was sent back to hospital,the blood cloths had returned ,had surgery on the 1 Of December had surgery also the 2 of December had surgery.
pt devel zoster 2mo p/being exposed to vaccinated niece & nephew;pt has not been vaccinated;
Patient is 80y.o. male who was admitted to the hospital with acute hypoxic respiratory failure. CTA PE protocol was performed without acute PE but did show evidence of volume overload. He was diuresed and his O2 was weaned. His echocardiogram showed a normal EF with moderate AR. Cardiology was consulted in his care during admission.  Facility was consulted for inpatient rehabilitation, but insurance declined coverage. After discussion with family, they elected to take patient home with home care rather than pursue appeal.
A few hours after receiving the vaccine I started to feel fatigue and started getting shooting pains through my back,  injection site was slightly sore.  Second day my whole body felt stiff.  Third day I started getting shortness of breath.  Fourth day I woke up with swollen itchy eyes and ears as well as a sore throat.  It started to become even harder to breath.  I took allergy medicine, Allegra and zertex and felt some immediate relief.
Information has been received from a health professional concerning a 20 year old female patient who on 06-NOV-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 661044/0548X), intramuscularly in her right deltoid at 13:10.  The health professional reported that after the vaccine was given, at 13:13, the patient became dizzy, nauseous and her blood pressure decreased to 76/40.  At 13:15, the patient was given cold compress.  Upon discharge, the patient's blood pressure raised to 92/58.  The health professional reported that the patient experienced a vasovagal reaction.  On 06-NOV-2008, the patient recovered.  The patient sought medical attention.  No further information is available.
pt recv vax 4MAY96 & pt was taken to an out of state ER & dx w/full blown chicken pox;
No adverse events occurred. The patient was administered a Pfizer Pediatric Covid vaccine that was stored in the refrigerator for 10 days beyond what is approved by the manufacturer.
Headache, Arthralgia, Fever, CoughWheeze, chills, fagitue, malaise Narrative:  employee was seen at her PCP's office where she was given  steroids and antibiotics. She was also tested for Flu and Covid due to her  cough which both came back negative
Fever, adenopathy, listless and fatigue with decreased appetite for 3+ days. Presenting at clinic with: Right tender anterior cervical node.  Size: 2cm and Left non-tender anterior cervical node.  Size: 2cm.  R/o strep: Throat culture negative for rapid strep, culture came back negative as well.  Treatment: Symptom support, return to care if worsens.  Patient has not called or returned to care for continued c/o as of today of report.
Fever started approximately 24hrs after vaccines increased to 103.5 lasting approximately 48 hours, blanching macular rash on trunk started 5 days after vaccines.
Short of breath Body/muscle pain Dizzy Lightheaded Loss of appetite  Nausea Diarrhea   All of which lasted for 4 days, flowed by 10 hours of feeling fine then unable to move without assistance.
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
12/8mm keloid developed in smallpox vaccination site scar.  Is erythematous and bulging. Experiences occasional itching in lesion.  Symptoms: Nodule, epidermal, Pruritus.
At time of vaccine-slight dizzy, tired for 2 days. 2 weeks later:  rash, raised bumps, redness, swelling, itching at injection site.  Shaky at times in first 12 hours.
10 days p/vax pt became irritable w/inconsolable crying, fever & entire lt leg was swollen red & hot since has suffered developmental delay & spastic diplegia w/nl development up until that time
pt recv vax 22MAY96 & JUL96 pt devel a chicken pox like rash;
just got a positive PCR result for COVID-19; just got a positive PCR result for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received bnt162b2 (at the age of 47-year-old), dose 2 on 23Mar2021 13:00 (Lot number was not reported) as single dose, dose 1 on 02Mar2021 13:00 (Lot number was not reported) as single dose; both via an unspecified route of administration, administered in Arm Left for covid-19 immunisation. There were no medical history and concomitant medications. It's that patient just got a positive PCR result for COVID-19, test taken on 28Sep2021, result 29Sep2021. No treatment received. The patient underwent lab tests and procedures which included covid test: positive (Nasal Swab, PCR) on 28Sep2021. The outcome of the events was recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up.
2 days after patient received FLUVIRIN she had extreme itching, redness (red bumps) on most of her body parts.
Patient administered ZOSTAVAX vaccine on 5/24/2011 in patients left upper posterolateral arm - presented herself to us on 5/28/11 with reddened erythema, swollen, hot, 2 inch red blister on left arm - suggested oral BENADRYL & to call Dr .
sore arm at injection site (lasted a day and a half) muscle/joint aches/pains - ongoing - first day my body felt "heavy and slow" then by the nighttime my joints started to ache and by the next day they felt like someone had crawled inside me and punched my bones. By the fourth day, most joints and muscles feel close to normal except left hip and thigh which are still intensely painful especially when getting up and down from lying/sitting.
I had both the Covid 19 (bivalent) booster and flu shot at 9 am.  I did not have any symptoms throughout the day except for a slight dull pain in the injection area on my arm.  I have had the same for each of my previous Covid boosters.  (2 original and 1 booster)  The latest was administered in December 2021.  While at home that evening and right about 9 pm, I stood up and was quickly hit with severe chills.  I quickly crawled back into bed to try and get warm and within approximately 30-45 seconds, I began having trouble breathing.  I told my wife I was waving issues breathing and to call 911.  She came over to me and began calling.  At that point I lost consciousness and according to my wife, stopped breathing.  She said I was out for roughly 10-20 seconds.  I began to gain consciousness to her on the phone with the 911 dispatcher and pressing on the left side of my chest.  She said she was not instructed to do so but rather just started doing it.  I recall it felt positive and asked her to continue doing so.  The first responders arrived and took my vitals and started giving me oxygen.  EMS took me to an ER and was there roughly 8 hours.  While being admitted, they ran an EKG and everything looked good.  The doctors also ran a cat-scan on my head and X-Ray of my chest.  Again, they said everything looked good there.  There is not a defined reason for the experience however leans heavily towards a reaction to one or both of the shots.
Dizziness, Headache, Myalgia, Arthralgia, Fever & Nausea Vomiting  Narrative:  DOSE 1-DAY 1-PAIN AT INJ SITE; DAY 1-3- FEVER; CHILLS; HA DOSE 2-DAY 1-PAIN AT INJ SITE; OTHER SYMPTOMS: CHILLS;FEVER;FATIGUE;JOINTPAIN;MUSCLE PAIN; HA;NAUSEA;DIZZY;
Missed period and menstrual cycle changes. I have had missed and unpredictable periods for 4 months post second shot.
night of vaccine admin developed rash (not raised just very red skin) itchy on trunk, arms & neck, cough when breath deep, severe chills, afebrile, rash/cough still present, she say gets rash when she get flu like symptoms
Injection site redness and swelling that occurred days after the vaccine. Bell palsy that developed approximately 5 days after receiving the vaccine.
facial swelling on the left side of the face; facial swelling on the left side of the face; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on an unknown date in Jul2021 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication and birth control (MANUFACTURER UNKNOWN) both from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 05:00 the patient experienced facial and lip swelling on the left side of the face. It was reported that the patient had filler on both the left and right side of the face but only the left side was swollen. Therapeutic measures were not taken as a result of the events. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event facial and lip swelling on the left side of the face was not resolved.  No follow-up attempts are possible. No further information is expected.
Approx 24 hours after shot 1 I started developed a rash and hives.  It was mild at first but was getting worse when I got my second shot.  The hives are very uncomfortable but benedryl alleviates them for 12 to 24 hours.1.5 weeks after shot 2 it is remaining the same or getting worse.
Fainted, dizziness, blurryness on left eye. Mom reported seizure. No shortness of breath. Monitor and send to Emergency room via ambulance.
Flu-like symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) in a 46-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Pfizer-BioNTech COVID 19 Vaccine EUA Pain in injection area, stiffness, hard time moving arm
Patient Covid + on 10/29/2021. Received Pfizer vaccine with 1st dose #EW0164 on 04/13/2021 and 2nd dose #EW0182 on 05/04/2021. Patient was on inpatient Behavioral Health unit when tested positive. Patient admitted to unit on 10/12/2021. Per IN Progress Note from 10/29/2021: Assessment/Plan  Acute Covid infection, rule out pneumonia, check stat chest x-ray D-dimer and other inflammatory markers with patient drops his oxygen is not 90% we will transfer to medical floor consult ID,  Hypokalemia replace and recheck  Discussed with nursing staff in details  All labs and imaging were reviewed by me in details  Active Diagnoses      Mood disorder due to known physiological condition with mixed features      Subjective     I was called to evaluate the patient as patient tested positive for Covid from a recent outbreak patient stated he does not feel well when I asked him about shortness of breath he said he has this chronic shortness of breath his lowest oxygen saturation was 90% on room air and he is having some cough
extreme diarrhea; nausea; slept 11 hours last night; tired and left early from work/ fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022 16:00, the patient received Shingrix. On 9th November 2022, 1 days after receiving Shingrix, the patient experienced fatigue and sleepiness. On 10th November 2022, the patient experienced diarrhea and nausea. On an unknown date, the outcome of the fatigue, diarrhea and nausea were not recovered/not resolved and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the fatigue, diarrhea, nausea and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-NOV-2022  Reporter's comment: The case was self reported by the patient. The patient received a dose of Shingrix vaccine this past Tuesday around 4pm (post meridiem) and reported that she was tired yesterday and slept 11 hours last night and left early from work. The patient reported that on the day of reporting she now had nausea, extreme diarrhea and fatigue. No other information reported to the agent by the patient.  No other information could be collected as patient immediately disconnected the call after having her questions about Shingrix addressed.  The reporter did not consent to follow up.
Patient presents to the emergency department. Per his wife he had been sleeping all day, has not been eating, had vomiting and hematuria for the past 2 days. He has also ben more confused and had a fall out of bed.  He was subsequently admitted for subarachnoid hemorrhage. He was discharged 10 days later in worsening condition to a hospice.
Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID, and allergies (unspecified). The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included unspecified medication. The patient experienced headache, body aches, fever, dizziness, sore arm, drowsiness, loss of balance, agitation, and "skin ach" on 15Jan2021 21:00. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovered with sequel on an unspecified date in Jan2021.
Body aches, fatigue, headache, pain in left armpit, random twinges throughout body,  sensitivity to cold, etc.
My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Information has been received from a medical assistant concerning a female patient greater than 65 years of age who was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine.  It was reported that no other vaccinations were given with the pneumococcal 23v polysaccharide vaccine.  It was reported as generally healthy with "no major health problems".  Subsequently, the patient experienced injection site cellulitis which lasted at the most for 3 days.  The patient recovered from the injection site cellulitis.  No further information is available.