chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headaches  lethargic for24 hrs. Very fatigued for next 24 hrs. The headache was pounding unrelenting unresponsive to extra strength Tylenol I?ve never experienced such a severe headache!Mild nausea more of a food aversion. Low grade temperature 99.9
has a bulge in her (L) clavicle, it's gotten a little bit bigger and feels warm. No PCP/no insurance to be seen by a doctor. I suggested to keep monitoring and to apply a warm compress on it. Will follow her one more day before closing case.  Follow up call by  Spanish interpreter on the line as well as patient, patient still has lump on collar bone but tenderness has decreased, was recommended by cvs clinical staff to apply Icy hot and warm compress CVS clinical staff will see her on Friday.
Gave 40 mcg Dose of Heplisav-B; Initial Report Received on 10-Jun-2021  A registered nurse reported that a patient (age, gender, race, and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 04-Jun-2021, the patient received a 40 mcg dose of HEPLISAV-B (Lot #, expiration date, NDC #, serial number, route, and site were not reported) from the registered nurse. No additional information was provided.   Company Comment: The company assessed the event as non serious.; Sender's Comments: The company assessed the event as non serious.
Johnson and Johnson Vaccine   tingling in extremities Severe stiffness in lower back  weakness in legs extreme Sore legs Cant lift right leg Right hip pain limited movement hard to walk
Information has been received from a registered nurse concerning a one year old male who on 17-NOV-2006 was vaccinated with Pneumovax 23 (0.5 ml) (lot # 651400/0618F), intramuscularly.  The patient was supposed to received PREVNAR.  The reporter stated that this was not a case of product confusion.  It was a mistake made due to the fact that they had just received a shipment of Pneumovax 23, which was on the shelf, and during the course of the busy day the patients were mistakenly given Prevnar.  Subsequently, the patient had not experienced any known symptoms.  Unspecified medical attention was sought.  Additional information has been requested.
pt had a positive COVID test on 8/23/21 from a facility; pt passed away in the facility; DC and med records sent to vaers website
16:30-Started coughing, eyes red, throat itchy. 19:30 - eyes blurry, coughing, bloodshot eyes, spouse took to ER.  was treated with CORTISONE IM, ROCEPHIN IM, BENADRYL IM, 1 ltr fluids IV. 10-01-09 reports achy, eyes swollen, congested.
Pfizer on 4/13 and 7/26. Positive on 11/29
chest pain that presented a few days after her first vaccine.  Did have EKG and labs drawn which were all normal.
I started to feel poorly about 10pm the evening of the shot. I had a fever and body aches along with a headache that started in the night. As time went on, my fever got worse and it felt like ibuprofen and acetaminophen did. It help the aches and headache much.
Employee received 1rt dose of COVID-19 vaccine on dec,16, 2020, two days later she developed rash at the chest, arms, swelling at Rt eye, and skin lessions on posterior aspect of thigh, legs.
CRAMPS IN LEGS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On MAR-2021, the subject experienced cramps in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps in legs on MAR-2021. This report was non-serious.
chills/shivering, body aches, fatigue Narrative:  chills, shivering, body aches, fatigue. 1/8/21 around noon developed swollen and painful lymph nodes in armpit of injection arm.
Fever of 102.6- tylenol wouldn't help but ibuprofen did finally.  Fatigue,  muscle soreness,  headache,  chills, sweating, loss of appetite
developed bad cough, no fever 5 days/p vax. Coughed up green sputum
Chills, fever, nausea, headache Chills started approx 7pm. Fever with nausea and headache started approx 2am followed by chills then fever then chills and fever again. I took tylenol 2am Symptoms were subsiding by approx 8am.  I took more tylenol at 8am and finally got out of bed around noon.
I had a mild fever; I did not visit a doctor. I felt achy and sick, the day after the vaccine. I began to feel better after each successive day. I felt fatigue, headache, fever, body aches. I began to notice around 06/10/2021 I was having tinnitus, mostly in my right ear. I went to the doctor on July 7. The doctor advised me to eat turmeric, do squats and take Flonase. I did not take the Flonase.
pt recv vax & exp a large local rxn @ the inj site: redness & a large bump;sx resolved;
Prior to this, I had never been informed of any gallbladder-related issues. My slightly elevated cholesterol and BP are genetic, and were managed by diet.  On 2/11/2021 I experienced severe chest pain while driving with my child. I had to pull over because the pain would get worse with every breath. I believe it was 5 full minutes before the pain subsided and I could continue driving.  I experienced this same episodic pain on 2/15, 2/16, and 2/19. I recall the pain coming on in the afternoons but I didn't think to record them at the time. The dates I recall based on events and appointments. On 2/21/2021 the onset of the pain was about 4pm, and this time it did not stop. Eventually, I thought I was having a heart attack.  I had to arrange care for my son as I'm a single mom, and I took myself to the ER at 7pm.  They determined cholecystitis and performed an emergency gallbladder removal on 2/22/2021.  Since then I have had multiple symptoms including extreme fatigue (having to sleep at work, falling asleep while driving), irritability, severe constipation, brain fog.
Patient developed chest pain this week and was seen in the emergency department.  Patient has had intermittent chest pain since arrival.  Diagnosed with myocarditis with troponin 4500
Patient had extreme soreness in the arm where the Pneumovax was given. Patient treated it with OTC pain meds.
hives all over body seen on 7APR95 still has hives; itching-given DPH
Cellulitis of left lower leg - Improving much, wound care to continue + local care + elevation +   iv abx's Rocephin 2 gram  Daily via PICC. Severe sepsis, was heading to septic shock, resolved during stay. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
I had a growth related to HPV.  This was probably dormant, but possibly activated by vaccine.  I read about reactivation of chickenpox/shingles and thought this may be similar as it started about 6 weeks after 2nd shot.
Starting immediately after the vaccine, I had flushing red and hot across my chest, numbness in my left hand and horrible nerve pain shot down to my fingers.  I also had pain in my back and shoulder.  After the 30 minute waiting period, I tried to get up to stand and my foot was asleep and had "firey" nerve pain.  When I got home, my nerve pain worsen and I had whole body pain.  I have horrible headaches, eye pain and extreme left arm pain at injection and all the way down to my elbow.  It a very deep pain.  The pain is above a 10 of 10 and not control with my regular pain meds (baseline pain before covid vaccine 6/10).  It seems like the COVID vaccine has made my body pain unbearable and more intense. I also have been having to urinate every 30 minutes.
Information has been received concerning a 16 month old white female who on 07/22/03 in the PM was vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 643123/0550M).  Concomitant medications that day included a dose of MMRII, Prevnar.  On 07/29/03 the pt developed "bumps" on her trunk and a "varicella reaction". On 07/30/03 the pt had a positive "strep test". She was treated with Omnicef. On 08/01/03, she had a fever of 102.9 degrees and "bumps" with about 3-5 vesicles. Unspecified medical attention was sought. There were no adverse events following prior vaccinations. Additional information has been requested.
GUILLAIN BARRE; This spontaneous report received from a consumer (offspring of the patient) via a company representative concerned a 77 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNWON) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, 2 weeks after vaccination, the patient was hospitalized for a week without a diagnosis. The patient was then transferred to another hospital in a plane ambulance, where the patient was diagnosed with Guillain Barre and was hospitalized (dates unspecified). It was reported that the patient made it even with critical breathing conditions, and that the patient did not have a lung collapse. The patient was hospitalized for 3 weeks and currently in rehabilitation since 4 weeks for therapies. It was reported that patient is expected to be get back home probably on the first week of November. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211028698-covid-19 vaccine ad26.cov2.s- Guillain-Barre. This event(s) is labeled per regulatory authority and is therefore considered potentially related.
pt recv vax 17DEC96 mom states pt had sz AM 18DEC96 & pm 18DEC96 w/fever;
pt started running a fever that evening p/shots of 102, it was still 102 the next morning-took pt to MD-no reason for fever found-given rx for advil-fever cont & became worse on 19JUL94 in the evening (105) came down w/bathing & Advil;
Child broke out in hives all over body afternoon of day vaccine was given. Taken to ER by parents, oral benadryl prescribed. Child completely recovered by next day. No other  symptoms.
Pain, redness, warmth, and swelling at injection site. Started day after injection was given and lasted several days (duration unknown, but was less than 4 days).
Dose 2 of serie.   0.5ml dose administered to left deltoid.  Patient experienced dizziness, sweating, tingling of face and hands, and chest tightness.   Patient observed, given water, cold towels to neck, did not improve, taken from vaccine clinic to Emergency Room for evaluation.   Patient states she tolerated dose #1 well with the exception of some nauses
Shaking, vomiting, fever, chills, sensitivity across body, lethargy, nausea
Before receiving vaccine, patient was visibly anxious and fearful of the shot.  Within 5 minutes of receiving vaccine, patient complained of lightheadedness.  Vital signs showed slight hypotension which improved with hydration.
Tolerable dizziness for @ 15 mins immediately following injection. Within 30 minutes of injection:   Excrutiating headache for 30 hours following the injection. Within minutes of injection:   swelling at injection  site 5"x5", 2'3" high (looked like a tennis ball sliced in half mounted on my arm) & redness and feverish heat at the injection site. 4 DAYS LATER:  injection site still red, hot, swollen and now extremely painful with any use of upper arm
After administration of vaccine, vaccinator reported to supervisor that she felt there was not much left in vial after drawing up first dose. Upon assessment, determined that vaccinator reconstituted Pfizer with only 0.18mL of sodium chloride instead of 1.8mL.
Malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date. Please refer the US2019AMR143602).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter reported that the patient received experienced malaise for approximately 1 day. The reporter consented to follow up.
PT HAD LOCALIZED HIVE REACTION AT THE PPD SITE IN 24HOURS. BY 36HRS DEVELOPED ITCHY RED BUMPS WITH HALO & SOME HIVES ON TRUNK, ARMS, & LEGS. HAD BEEN TREATING W/ BENADRYL BUT ONCE WHOLE BODY REACTION WE GAVE BENADRYL, SINGULAIR, PEPCID & STEROID TAPER. NO ITCHING & ONLY MILD ERYTHEMA @ SITE OF OTHER VACCINES SO DO NOT THINK  IT WAS THE VACCINES. PPD SITE RAISED/PRUITIC ON THE SAME ARM WHERE HIVE REACTION STARTED.
On 1/5/2020, I, the patient woke up at 3:30 with sharp boring epigastric pain. Progressed to include nausea. On evaluation in the ED was diagnosed with acute pancreatitis.  Prior hx includes 2 episodes with hospitalization for gallstone pancreatitis in 2016.  Subsequently had laparoscopic cholecystectomy in 2016.  Last alcoholic beverage prior to 2020 ED presentation was 3 weeks prior. No tobacco or drug use.
Patient felt achy and tired 10/17/2012 the following day she had a few red bumps on her chest that was itchy by 10-23-2012 her entire body was covered in a red rash with bumps and it was warm to the touch. SOLU-MEDROL injection given.
This case involves a patient of unknown demographics who experienced flu while 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, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported" I stopped getting the flu after I stopped getting the flu vaccine. 15-year period where I got the shot every year after getting into nursing. Then every year I would get the flu sometime that season. Prior to that I was not catching the flu. Makes you wonder." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (flu). At time of reporting, the outcome was Unknown for the event flu.
Approximately more than 1 month after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms; voice hoarseness, low grade temperature. I contacted my doctor and was prescribed with PAXLOVID for 5 days. It did help with my mild symptoms and after taking it for 5 days I tested negative for COVID-19.
While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face began to feel numb and tingly.  I immediately took Benadryl when I arrived home and had no further facial symptoms.  However, approximately 23 hours post vaccination I developed a fever of 102 and chills that lasted approximately 6 hours.  After the fever broke, I have had no further symptoms other than a sore arm and have not missed any work.
Swollen and tender arm; tender arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen and tender arm) and TENDERNESS (tender arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to Egg).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen and tender arm) and TENDERNESS (tender arm). On 04-Mar-2021, PERIPHERAL SWELLING (Swollen and tender arm) and TENDERNESS (tender arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-064728 (Patient Link).
1st dose of Shingrix on 24May2019 and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24 May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix on 24May2019 and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-MAY-2023 HCP stated patient received her 1st dose at a different pharmacy location (not address listed for HCP). HCP did not have the patient's date of birth. HCP agreed to follow-up via postal mail. Till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination.
COVID 19 Treatment; COVID 19 Treatment; 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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: GR8730), in left arm, on 19Apr2021 as dose 2, single (Lot number: GW0161), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 28Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FENOFIBRATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was taking Paxlovid from 19Oct2022 to 23Oct2022 for COVID 19 treatment.  On 31Oct2022, the group reported the following investigational results. Conclusion: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lots GH9703 and FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed.
Soreness in arm; Headache; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that: A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration on 21Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included liver disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ursodiol (URSODIOL) taken for an unspecified indication, start and stop date were not reported. Patient stated, I have a couple of questions about the vaccination. The first one I had on the 21Jan2021, I had very little reaction like the soreness in the arm and maybe a little headache on an unspecified date, but then this past Thursday I had the second one and I had quite a reaction and I was wondering are they different Is one dose different than the other when confirmed the vaccine as Pfizer's COVID-19 Vaccine, consumer stated, correct. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration on Feb2021 as single dose for covid-19 immunisation and experienced Fever, I was weak, Tired, and Hurt all over; every muscle in my body, every joint hurt. Therapeutic measures were taken as a result of the events with Advil. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
fatty necrosis, pt recvd vax no problem w/lump or redness @ inject site; had sl discoloration; 2 wks p/vax was abn fussy; no temp 6 wks p/vax sm indentation lt thigh;
This case was reported by a healthcare professional who is a nurse and described the occurrence of Guillain Barre syndrome in an unspecified number of subjects of unspecified age and gender who were vaccinated with influenza vaccine (manufacturer unspecified). On unspecified dates the subjects received unspecified doses of influenza vaccine (unknown). At unspecified times after vaccinations with influenza vaccine, the subjects experienced Guillain Barre syndrome. The nurse was inquiring about FLULAVAL and "she mentioned that about 10 people she knows, know someone either young or elderly that have had Guillain Barre syndrome (GBS) in the past. She thinks these people were vaccinated at one time with the flu vaccine (but she didn't specifically state that). The reporter did not mention any GSK flu vaccines and GBS. The nurse just stated that people she knows; know someone who have had GBS in the past." She also stated that her "mother in law developed GBS in the 1970s after she received the swine flu vaccine." No further information was provided; reporter declined to be contacted for follow-up. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
A report was received from a consumer concerning a 13 years-old male patient. Medical history and concomitant medication were not reported. In Sep-2011, patient received nasal FLUMIST single dose. On 11-Feb-2012, patient was tested positive for influenza A. Action taken with suspect drug was not reported. At the time of reporting, the outcome of the event was unknown. The reporter assessed the event to be non-serious. Corrected Report 04-Jun-2012: ethnic origin, action taken, narrative updated.
After immi's pt became dizzy, light headed and flushed/hot. Pt pale. Pt laid down, ammonia inhalant used along with cool compress. Mother present. Water given. Mother states pt had adverse event after last immi's in 2010. Pt observed x 25 min. No further issues.