chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 39 year old female who on 05-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # 665396/1170Y). Concomitant therapy included tetanus toxoid. Later that day the patient developed redness and pain at the VARIVAX (Merck) injection site. On 06-MAY-2010 the patient returned to the physician with a fever of 100.2 F and extreme tenderness at the injection site. The area was described by the physician as "very red and almost looked like an abscess". At the time of the report, the patient had not recovered. Follow up information was received from the physician concerning a 31 year old (also reported as 39 year old) female with no known drug allergies who on 04-MAY-2010 (previously reported as 05-MAY-2010) was subcutaneously vaccinated with the first dose of VARIVAX (Merck) (lot # 665396/1170Y) in her right arm. In the afternoon of 05-MAY-2010, the patient experienced local reaction: tenderness, erythema and fever. At the time of the report, the patient had recovered on unspecified dates. No further information is available.
Pain/swelling at injection site, low-grade fever, chills, body aches and pains, mild nausea, severe headache, loss of energy, insomnia
The original monovalent Moderna  was sent to the pharmacy labeled Booster Doses Only.  It was not the Bivalent Booster that the pharmacy was expecting.  The monavalent booster was administered before it was discovered that it was not the Bivalent Booster
Redness, sore, mild fever; redness in left arm (upper) deltoid, due to Tdap.
received only the diluent portion of the vaccine; received only the diluent portion of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter inquired if the diluent portion of Menveo has vaccine in it or it was only a diluent. The reporter stated that, they were doing inventory and found a lyophilized portion of the vaccine but could an not track down the diluent, noting that a patient might had received only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered . No patient identified at the time of reporting. The reporter consented to follow up via email.
Vaccine on 1/5- within the hour, developed severe headache and altered cognition/"brain fog." Within a few hours, developed chills, body aches, nausea  1/6- 102 fever, severe headache, brain fog, chills, body aches, nausea, pain at injection site  1/7- 102 fever, severe headache, brain fog, chills, body aches, nausea, pain at injection site  1/8- 99 fever, severe headache, brain fog, body aches, nausea, pain at injection site and now very red/itchy/swollen  1/9- severe headache, body aches, nausea, injection site painful/red/itchy/swollen  1/10- severe headache, body aches, nausea, injection site painful/red/itchy/swollen and now bruised
Mother bought pt to office for a rash that was present over entire body including face and neck. No fever or other symptoms reported. PCP confirmed that rash was consist ant with post-vaccination reaction to one of the live-virus vaccines (MMR/Varicella).
Got shot and got shingles / suspected vaccination failure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included autologous hematopoietic stem cell transplant (in August 2020). Concurrent medical conditions included blood cholesterol increased. Concomitant products included acetylsalicylic acid (Aspirin), atorvastatin and acyclovir.   In JUL-2022, the patient received Shingles vaccine. On 17-APR-2023, between 8 and 10 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot and got shingles / suspected vaccination failure) (serious criteria hospitalization and GSK medically significant) and shingles (Verbatim: Shingles) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-MAY-2023 The patient self-reporter this case. The patient got shingles vaccine as part of protocol. Took Acyclovir after treatment until January 2023. The patient was in hospital for Shingles after receiving Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter was consented to follow up.
He had 3 vaccines on 4/17/23 (tdap, Hep A, Shingrix). He felt achy for a few days and his tongue felt "burnt" for several days after. However 6 days later had sudden onset of R eye inability to blink and R side felt weak, speech was starting to get affected. He thought he was having a stroke. Mouth/lips felt numb. Went into ER, dx Bell's palsy. Felt secondary to the Shingles vaccine, sx felt isolated to facial nerve. Started on 4/24/23 on prednisone (20mg daily x 8 days) and Valtrex 1 gram TID x 7days. That first week while on the meds he only had a "headache" but the day he finished meds everything got worse. Now for the last 5 days he has had shooting pains and the entire R side of face/head especially around the eye has a sensitivity to touch. He's taking both motrin and tylenol for pain. Even laughing, moving jaw causes electric jolts of pain He's using eye lubricant, taping eye shut at night. R eye is slightly red, sensitive to light. He sees his eye doctor on Monday (4 days) He's been working but with pain, wonders how he will be able to work if he takes a pain med/gabapentin.
I recieved my scond dose on the date listed above at Pharmacy. When I got in my car after the injection, I noticed the shot was very high on my shoulder and realized I had never recieved a shot so high up on my arm. I immediatlely looked up if this could affect me negatively and sure enough I found results explaining arm issues that could last a lifetime. I hoped for the best. Had soreness in arm for about 4 days and then it went away. Then around last week when I woke up, i realized my arm was difficult to move from under my head. Ever since then, I have soreness around the spot of my injection on my left arm, I sometimes have difficulty having a tight grasp around
MMR - Wednesday 2/7/07 febrile seizure. Friday 2/9/07 seen in office 2/12/07 - no sequelae.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional in  on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
pt recv vax & 6 days post vax pt devel 20 spots or so that were chickenpox;
I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower part of my body. I took Tylenol every 6hrs. and zyrtec. It took 3 days, feeling better.
Patient vomited post vaccine. BP 1052: 122/100, at 10:56am 150/90. Patient felt better. EMS offered, patient declined.
Fully vaccinated on 2/8/22. Not boosted. COVID-19 infection breakthrough.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female patient who was vaccinated with a dose of GARDASIL (no lot number provided).  At "some point in the past" after receiving GARDASIL, the patient became pregnant and subsequently experienced miscarriage.  At the time of reporting, the outcome was unknown.  The patient sought unspecified medical attention.  Upon internal review, miscarriage was considered to be an other important medical event.  Additional information has been requested.
10NOV04 woke up w/soreness in calf seen by MD on 11NOV94; leukemia dx 14NOV94 chem-last Friday
Chills, was freezing cold, then a fever & chest pain, felt my heart beating irregular. Made conscious effort to breath slowly & keep heart beat normal. Fatigued for 3 days. Joints in knees, wrists & elbows, plus lower spine & hips hurt so much I couldn't walk around normally.
Anaphylaxis; Persistent cough; This is a literature report were authors reported 21 cases listed in table 1. This is the 20th of the 21 patients.  This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States.   As of 23Dec2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Reporting System. Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours. Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2-150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home.  A 29-year-old female patient who received the 1st dose of the bnt162b2 (BNT162B2 vaccine, unknown lot number) at single dose in Dec2020 for covid-19 immunisation.  Medical history included allergy to sulfa drugs. The patient had no prior history of anaphylaxis. The patient's concomitant medications were not reported.   The patient experienced anaphylaxis (signs and symptoms: generalized urticaria) and persistent cough, 54 min after vaccination, in Dec2020. It was determined to be Brighton level 2 of diagnosis. The patient received treatment at emergency department and received treatment with epinephrine. At the time of the report, the outcome of the events was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis based on the known safety profile and temporal association ,Linked Report(s) : US-PFIZER INC-2021043915 same article/drug, different patient;US-PFIZER INC-2021043908 same article/drug, different patient;US-PFIZER INC-2021043909 same article/drug, different patient;US-PFIZER INC-2021043916 same article/drug, different patient;US-PFIZER INC-2021043911 same article/drug, different patient;US-PFIZER INC-2021043910 same article/drug, different patient;US-PFIZER INC-2021043912 same article/drug, different patient;US-PFIZER INC-2021043913 same article/drug, different patient;US-PFIZER INC-2021043914 same article/drug, different patient;US-PFIZER INC-2021043597 same article/drug, different patient
The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003202: US-009507513-2108USA003205: US-009507513-2108USA003206:
After receiving the vaccine the patient started having trouble with his vision. He stated that his vision blurred and went black. He never lost consciousness but was very pale and sweaty. He stated that this has happened before after giving blood.  He felt back to normal after about 15 minutes.
pt complained of being flushed. face red. vss. 97.4; 107/58; 17 80. will continue watching pt x 15 min; 99% 115/72 86 98 pt denies wanting to go to er; feels fine; wants to go home
Experiencing tiredness; 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 FATIGUE (Experiencing tiredness) 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 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced FATIGUE (Experiencing tiredness). At the time of the report, FATIGUE (Experiencing tiredness) had not resolved.            No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Fever 102.7 degrees F, full body aches, shaky, fatigue, hoarseness, "heavy chest", sore/swollen (L) arm.
Chills; A spontaneous report was received from a consumer, concerning  a 78 years adult male patient, who received Moderna COVID-19 Vaccine and experienced 1 dose.  The patient's medical history was not provided.  The concomitant products was cholesterol and blood pressure.  On  22-Jan-2021,prior to the onset of events,the patient received the first dose of  mRNA-1273(lot number: 030L20A) and on 19-Feb-2021 the patient received the second dose  and route of administration is  intramuscular (lot number : 006M20A) route for COVID-19 infection prophylaxis.  Treatment history was she has been taking Tylenol,Nyquil and Dayquil.  Action taken with mRNA-1273 in response to the events were not reported.  The Outcome of the event(s)  chills was considered to be not resolved at the time of this report.
Weakness in right arm. Left arm was vaccination site. Weakness in right arm still noticable after 6 months
Treatment of COVID-19; Treatment of COVID-19; Dose 1=Pfizer/BioNTech, Dose 2=Pfizer/BioNTech, Dose 3= Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 12:00 as dose 1, single (Lot number: EN6204), in right arm and on 01Apr2021 at 12:00 as dose 2, single (Lot number: EP7533) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Dec2021 as dose 3 (booster), single (Lot number: 070h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 15Jul2021, stop date: 16Sep2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: 15Jul2021. Past drug history included: Amoxicillin for drug use for unknown indication, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2021 at 12:00, outcome "unknown", described as "Dose 1=Pfizer/BioNTech, Dose 2=Pfizer/BioNTech, Dose 3= Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Patient was treated for Covid-19 with anti-viral from Pfizer from 17Sep2022 to 21Sep2022. Patient reported Stroke in July2021 which was a rebound COVID after Paxlovid. Adverse event start date: 27Sep2022, with outcome Recovering. No treatment received.
I had started getting a cough late in the evening. The next day I had a fever, and I took a COIVD-19 home test and it was positive. The day beforehand my wife had been in the hospital and when she was admitted to the hospital, she tested positive for COVID-19. She was not showing any symptoms and I had only tested because she was positive and then I had started with the cough. I have been very fatigued and am just tired. I am still coughing but the fever is now gone. I did want to report that I have had a breakthrough case of after being vaccinated.
13 yo patient was given Dtap instead of Tdap as a catch up immunization.  No known adverse events
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had my vaccination on 09/13/2022. I started to experience congestion sore throat sneezing on 11/04/2022. I tested COVID-19 positive on 11/04/2022. I was prescribed PAXLOVID but did not take. I am feeling almost back to normal on 11/22/2022 with some residual congestion and fatigue.
Pt actually was fine, but the event was that we gave a Fluzone to a 2 month old and it should not be given until 6mo of age.
one week from the first vaccination my upper arm started itching.  The area around the injection site was red and firm, about the size of my palm.  It has been one week and is just now beginning to fade.
skin bumps on arm after first shot. Sore throat, white blisters on gums and lips. Numb tongue and very white
Case number PHEH2014US016495, is an initial spontaneous report received from a nurse on 14 Aug 2014 and with a follow up information received from the nurse on 16 Sep 2014. This report refers to a 13 years old male patient. His medical history was not reported. His vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on unspecified date and was well tolerated. His concomitant vaccinations included administration of GARDASIL (other manufacturer, batch number: J015378) intramuscularly at a dose of 0.5 ml in the left arm on 13 Aug 2014. He was administered only MenCYW-135 liquid component of MENVEO (batch number: X13054) without being reconstituted with MenA lyophilized powder, intramuscularly in the right arm on 13 Aug 2014. No adverse reaction was reported following the administration error (inappropriate preparation of medication). His vaccination status was reported as up to date. Follow up information received from the nurse on 16 Sep 2014: Updated patient demographics (height), vaccination history, concomitant vaccination, site of vaccination and vaccination status in the narrative.
1 day, post vax, pt had mild redness at site of right thigh; 3 days after vaccine pt had 9cm X 18cm redness and swelling, induration and warmth. No fever. Treated with Augmentin and resolved.
On Day 2 after the injection (5/2), developed injection site pain and swelling, shoulder pain. On 5/7 developed rash on upper back and increase in pain. Seen at Clinic 5/8. Rash was more widespread over Lt scapula, arm hurt and felt burning. On 5/9 Pt reported pain seemed to be going down Lt side body in hip and it was hard to walk very much. She was treated wiht Valtrex 1 Gram tid for 7 days and Lidoderm patches to the area.
This spontaneous report as received from a female patient of unknown age and refers to herself. The patient's pertinent medical history included migraine. The patient's concomitant therapies included sumatriptan (IMITREX). The patient had no drug reactions/allergies. On 17-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# and dosing details were not reported) for prophylaxis. Within 24 hours of being administered PNEUMOVAX 23, the patient experienced warmth and red spots on her left arm and shoulder. The patient also reported red spots that look like cellulitis. Her arm pit has another red spot. The patient reported she has never had a reaction to a vaccine before and her physician said he had no other report of adverse reactions from the stock he has. On 18-AUG-2017, the patient saw the physician. Diphenhydramine (BENADRYL) was prescribed and the patient was given a prescription for an unspecified antibiotic in the event the reaction does not subside. The outcome of cellulitis, skin warm and rash papular was reported as not recovered/not resolved. No product quality complaint (PQC) was involved. The reporter did not provide the causality of cellulitis, skin warm and rash popular with PNEUMOVAX 23. Upon internal review, cellulitis was determined to be medically significant.
Patient stated that she had severe body aches that was relieved by the next day with no residual symptoms.
Tinnitus increased dramatically approximately 4 days after first Pfizer vaccine. It slowly subsided and then again spiked a few days after my second Pfizer vaccine shot. It has ever so slowly subsided since the spike after the second shot, but is still much louder than prior to shot one.
Patient called to report a severe reaction to her influenza vaccine.  She states this is the first time she has ever received the vaccine.  Patient states that within five minutes of receiving the vaccine she began to "see spots." Her symptoms progressed to a heaviness in her chest and swelling of her throat. She states her husband had to wake her several times during the night because she had "stopped breathing." Patient states she has developed a "growth" under her tongue. Patient states she did not go the the ED. She is going to see her PCP this morning.