chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had tested positive for COVID in March 2022. I woke up in the night with a dry, starchy, sore throat. By morning I was coughing up blood. I could not swallow because my throat was swollen. I went to an urgent care and they did a physical exam. They said I have a throat and ear infection, and I also have bronchial pneumonia. I was given a shot of prednisone. I was also prescribed prednisone, a Z-PAK of antibiotics, and something to gargle to numb my throat. I was advised to take some over the counter METAMUCIL. The swollen sore throat and earache lasted for about a week. I didn't cough much. I am still very weak. My legs are weak. Also the roof of my mouth, bottom of my feet, and palms of my hands felt like a bunch of needles sticking me.
(1) Perioral varicella/herpes labialis lesions. (2) Remarkable (L) arm swelling.
12:30 PM sudden onset of rapid heart rate, felt swelling in throat, flushed. Pulse 142-162. 1:00 PM felt better but heart rate increases when stands up. 1:25 PM given 1/4 tab of 150mg of Zantac. 1:30 PM stands without increase in heart rate, feels fine. 2:00 PM Fine until getting up then heart speeds up and get a little dizzy, maybe a little short of breath. Heart rate as high as 162, blood pressure 188/98, Respiratory rate 18, O2 saturation 100% per ER physicians notes. Discharged home with instructions to take Benadryl (not given in ED due to making her very sleepy). Co-worker drove her home.  By time of discharge reported to Employee Health Nurse that she was having some discomfort in her neck and a headache.
Received influenza immunization on 11/09/06.  Patient reported that at 6pm noted "whelp the size of a lemon".  Right arm warm, sore, raised area.  Took Ibuprofen for relief without improvement.  Whelp remained approximately one week.  Muscle soreness continues without improvement.  Worsens with use.  Ibuprofen provides very little relief.
Herpes zoster, otitie - information has been received from a physican concerning a 19 month old female who on 30 aug 1999 was vaccinated with one dose of varicella virus vaccine live in the right arm (lot 630678/0426J) On 14 apr 2000 the patient was diagnosed with herpes zoster, there were a few hundred lesions along the T6 dermatome on the right side.  The maximum temperature was 100 degrees f. there was no recent exposure to chickenpox or shingles.  A specimen has been obtained for PCR analysis.  The patient recovered.  Follow up information reported that PCR analysis indicated that the specimen is positive for wild type VZV.  Additonally, it was noted that the patient did not have a post vaccination rash within 42 days on the vaccine.  The patient was seen in the physician's office on 15 May 2000 for an ear infection at which time the patient was fully recovered from the herpes zoster.
Head pain the back left side of the brain, one day after injection, treatment-Tylenol did not help with symptoms
I experienced arm soreness at the injection site immediately after.  Fatigued two days afterwards. Also experienced Hixton Braxton contractions after the injection.
Patient described red circle at injection site and arm was warm. She also stated she had chest tightness.
Information has been received from a health professional from a physician's office a 25 year old female with type 2 diabetes mellitus and a history of migraines who on 18-OCT-2007 and 11-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first and second dose of GARDASIL (Lot #'s 658563/1063U and 659441/1446U), respectively. Concomitant therapy included NUVARING and LEVAQUIN. The caller reported that the patient was in the office today (16-MAY-2008) to receive the third dose of GARDASIL. At that time the patient stated that "the day after receiving the second dose, on 12-DEC-2007, she experienced pain in her arm at injection site and numbness in her face lasting 4 days". The patient was seen by her family doctor for symptoms. The third dose of GARDASIL was not administered. No laboratory diagnostic studies were performed. Subsequently, on approximately 16-DEC-2007 the patient recovered. No product complaint was involved. Additional information has been requested.
onset papulo-macular blanching rash w/scattered vesicles several hours p/vax;
Pt received PNEUMOVAX left arm SQ triceps area & AFLURIA 2012-13 flu shot IM left deltoid. 9/25 at 2:40 pm. Pt reported severe pain in triceps, fever 102 degrees & 140 BPM heart rate. 89/46 BP. Was taken to ER by ambulance 9/26 pm. Suffered chest pain. Nitroglycerin helped. She didn't have sepsis & cardiologist will be consulted Monday 10/1/12. Feeling better, still tender at triceps area but swelling down.
mild case of Shingles; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 65 years as dose number unknown (booster), single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), since 01Feb2021 (Batch/Lot number: unknown) at 11 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown, ), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown, ), for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "recovered", described as "mild case of Shingles". The action taken for tofacitinib citrate was temporarily withdrawn. Therapeutic measures were taken as a result of herpes zoster.  Additional information: No contactable reporter. Reporter was not a Healthcare Professional. Reporters contact information available to you or a sub-contracted party was reported as unknown.The reporter the prescribing HCP was reported as no. Patient noted he was instructed by MD to hold Xeljanz for 7 days after getting COVID-19 booster on 09Dec. Subsequently, patient  was restarted Xeljanz for 2 days and then developed mild case of Shingles, and was instructed by MD to once again hold Xeljanz for 7 days. Shingles were subsequently cleared with Valtrex therapy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 30 minutes after child received MMR, DTaP, and Influenza vaccines he developed generalized pruritic, urticarial rash and eye swelling. Mom brought him back into the office and PO BENADRYL given with improvement of symptoms. Rx'd PO BENADRYL Q 4 hrs and PRELONE BID x 5 days.
HCP calling in to report adverse event involving vaccines MMR II (stored in freezer) and VARIVAX, temperature excursion case number 01892408; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S039319 with expiration date 04-DEC-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T025945 has been verified to be valid, expiration date reported as 30-JUL-2022) for prophylaxis (dose number, exact dose and route of administration were not provided) (product storage error).  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion from -50 to 8 degrees Celsius (-1.6 degrees Celsius) for 1 hour 36 minutes 0 second. Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion from -10 to 8 degrees Celsius (-1.6 degrees Celsius) for 1 hour 36 minutes 0 second. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse event or product quality complaint was reported at this time.
[pregnant with mono-di twins during vaccination; had 1-2 subchorionic hemorrhages from around 6-16 weeks gestation ] 1 sac/water broke on 14-JUN-2021 and was hospitalized; delivered twins vaginally (twins were around 3 lbs each) at 28.5 weeks gestation on 02-JUL-2021 due to labor starting; post-partum bleed on 03-JUL-2021 while still in hospital requiring D/C after placenta was confirmed; post-partum bleed about 2 weeks after birth requiring a hospitalization and a uterine artery embolization; post-partum bleed about 4-6 weeks after birth requiring a hospitalization and another uterine artery embolization; twins are healthy - the one whose sac broke has periventricular leukomalacia but clinically doing well and both were released from the NICU at 42-43 weeks gestation
Patient presented to clinic after receiving pneumococcal vaccine from primary care physician at other location.  Patient c/o arthralgias in left lower leg and had exacerbation of lupus and herpes zoster 2 days after receiving the pneumococcal vaccine.  MD ordered Penciclovir and Famciclovir for symptoms.
Patient had soreness/redness and heat at the injection site.  3 days later, patient developed "shingle-like" rash on the left abdomen extending towards her back.  Rash is still present as of 9/13/23 but has gotten better
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 2nd dose01/27/21 Diagnosed covid positive:08/24/21 Symptom onset:08/23/21 Exposure:home Symptoms:fever, cough,fatigue,muscle aches,loss of smell/taste, sore throat, chills,runny nose,HA
Headache, Myalgia, NauseaVomiting & HYPERglycemia, Narrative:  Had vaccine 1/8/21 was feeling fatigue, HA, nausea, soreness of sight, the following week blood sugar spiked to 383 was high on and off all week long. EE reports feeling better and blood sugar is back to normal. EE followed up with PCP. Next vaccine date is 1/ 29/ 21.
Systemic: Fainting / Unresponsive-Mild, Systemic: patient was alert, felt dizzy and was sitting on floor when ambulance arrived-Mild, Additional Details: Patient reported no nervousness when taking the flu vaccine and said she has taken flu vaccines before. She reported no allergies. Patient felt dizzy, was alert and sitting on the floor in the cosmetic isle when ambulance arrived. When they arrived, they report normal vital signs and helped her walk out to her car.
facial rash has still not gone away.  Of significant note, was inflammation in joints, especially hips which caused great difficulty going u p and down stairs. Absolutely NO strength to get up when sitting, required 2-person assist for 3 months
sick; fever; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever and general body pain. On an unknown date, the outcome of the sickness, fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the sickness, fever and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The case was reported by patient. The patient just received 2nd dose of Shingles vaccine and felt sick with fever and body aches for a week. The patient asked what could he/she do to help with the symptoms. Additional supportive information: The patient self-reported this case via interactive digital media. The follow-up would not possible, as no contact details were available.
chronic spasms in her jaw; achy; pain in the back; unstable; almost lost her balance; skin on both her arms hurt/ached for hours; feverish; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable) and BALANCE DISORDER (almost lost her balance) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (have some lasting things from the surgery). Previously administered products included for Product used for unknown indication: J and J (Dose no : 1st dose) in March 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Drug allergy (compazine), Drug allergy (codeine), Drug allergy (morphine), Milk allergy (milk and some dairy), Hypertension, High cholesterol, Cystitis interstitial, Depression (depression with anxiety), Anxiety (depression with anxiety) and Plantar fasciitis. Concomitant products included METOPROLOL, ATORVASTATIN, MIRABEGRON (MYRBETRIQ) and GABAPENTIN for an unknown indication.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish). The patient was treated with BACLOFEN at an unspecified dose and frequency; CLONAZEPAM at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. In July 2022, MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish) had resolved.            Relevant medical history includes patient had received shingles vaccine 2 weeks ago from the time of the call. Patient had taken 1st booster dose at around 12noon. Patient felt better at 2:00am and was able to sleep and woke up at around 8:30. Other treatment were includes heat pads.
An expired dose that had been left in the fridge from the previous evening was erroneously administered to the patient the following morning
UTI symptoms (frequent urge to urinate, burning sensation when passing urine), lightheadedness,  heaviness in sternum region, chills, fever (38 C)
Muscle stiffness in left arm (could not raise arm without support from right arm) within first 3 days after vaccination, moved to carpel tunnel type symptoms in both wrists and hand joints, shoulder stiffness in both shoulders, knee stiffness in both knees. Progressed for 1.5 weeks until symptoms subsided after 2 weeks.
Sm presented to his pcp with enlarged left axillary lymph node, malaise 24FEB11.  Sm presented to me on 07MAR11 with same complaints.  He stated he receive the MMR in the left arm on or around 21 FEB 11.
On 3/2/21, one month after second vaccination, sick with fever, nausea and fatigue.  Tests positive for Covid-19 by PCR.
Narrative: This patient received two doses of COVID 19 Pfizer vaccine in Feb/Mar 2021. This patient tested positive for COVID 19 on 22 Dec 21 and was admitted for altered mental status, low oxygen saturation, and during the admission had elevated troponin. Reported per the EUA.
Abdomen pain, sore neck, L arm pain (17 Apr 08/1045; 5 hrs). Visual Auras w/migraine, nausea, hot flashes, light/noise/smell sensitivity (18 Apr/1150; 6 hrs). Facial sinus pain under eyes, fatigue/weakness, sore throat, L arm pain, abdomen pain, R ear ringing, light/noise sensitivity (19-24 Apr/all days).
This is a spontaneous report from a noncontactable consumer or other non-HCP. The consumer (patient's mother) reported for a 17-year-old female patient (daughter) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced a fast heart rate and breathing problems on an unspecified date. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
1st 2/23/2021  reports severe head ache within 12 hrs subsequently subsided to mild but constant. 2nd dose  03/16/2021 Pfizer lot # E?6955  had both vaccine at the health Dept  per patient self reported.  Patient verbalizes never had head aches in past, reports to office 3/25/2021 with transient severe head aches has been to other urgent care centers with same complaints, patient feels the vaccine caused the head aches.
Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-JUN-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster immediately after being vaccinated. The patient was later treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Patient received the vaccine on 11/8/2017 and came back to pharmacy and report side effects of redness and swelling on left upper arm and a red spot on the left forearm. Patient said she is being seen by Dr. She came back and told us Dr. said it was an allergic reaction.  She was also given Benadryl. Called pt later the afternoon to inquire other health condition to complete this report.  Pt said the redness and swelling has gone down.
Exactly A week later i developed fever, chills, fever blisters and my urticaria kicked in where i needed to spray myself on a regular basis to cool down my body
patient called pharmacy today 3/28/21 stating her arm was swollen at the injection site a day later after receiving Moderna COVID vaccine on 3/26/21, had a fever of 101-102 but went away with some aspirin. Denied difficulty breathing, rash/hives.
Report small lump to the left ankle 3 weeks post vaccination, not sure if it is related to the vaccine. States it was not there prior to the vaccine. Treatment: none .  Outcome: Does interfere with ADLs.  Recommend to follow-up PCP for any concerns.
About 10:30 PM developed Rigor shaking in bed, Temp  96. Cold hands , headache and muscle aches. Lasted about 45 minutes. Took1 650 Tylenol arthritis at 6pm.  Took same dose at 1045PM. Now 11:30 pm. Improved.
Sore left injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site). At the time of the report, VACCINATION SITE PAIN (Sore left injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-117044 (Patient Link).
Unable to sleep well / can't get a full nights sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "Unable to sleep well / can't get a full nights sleep". Additional Information: The reporter mentioned that the patient had been experiencing the same symptom she had.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355281 Same reporter, drug and event; different patient.;US-PFIZER INC-2021338094 Same reporter, drug and event; different patient.
Not feeling good at all; Very very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling good at all) and FATIGUE (Very very tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling good at all) and FATIGUE (Very very tired). At the time of the report, VACCINATION COMPLICATION (Not feeling good at all) and FATIGUE (Very very tired) outcome was unknown.            No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
pt recv vax 11APR97 lt deltoid;12APR97 in the evening devel some numbness over the lt shoulder by Monday it was involving the entire lt arm & hand;in the clinic 15APR97 was eval by MD & was referred to neurologist for eval;
Severe stomach pain; Gastroenteritis; swollen and inflamed intestines; swollen and inflamed intestines; Mesenteric Adenitis; Multiple kidney cyst confirmed by CT scan; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (lot number: EN6198) as single dose for COVID-19 immunisation. The patient's medical history included hypertension, and allergies to penicillin. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced severe stomach pain, gastroenteritis, swollen and inflamed intestines, mesenteric adenitis, and multiple kidney cyst confirmed by CT scan, all on 09Mar2021 19:00. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 1 day. Prior to vaccination, the patient had no COVID. Patient was tested for COVID post vaccination. The patient underwent lab tests and procedures which included qualitative PCR: negative on 10Mar2021. Therapeutic measures were taken as a result of the events. The patient had no other vaccine for four weeks and had other medications in two weeks. Vaccine facility type was school or student health clinic. The outcome of the events were not recovered.