chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm had some mild soreness the following day. One week later she noticed her right arm had become red, slightly raised, and warm to the touch. Patient stated no discomfort, wasn't sure how long it had been red since it didn't hurt. I recommended antihistamines, hydrocortisone cream, and NSAIDs for any discomfort that may present. I told her to follow up with her PCP if it got worse or no change in a few days.
Initial consumer (patient) report received on 06 Jan 2011: This patient was vaccinated with first dose of RABIPUR (batch number unknown) on 04 Nov 2010 (pre-exposure series). He was vaccinated with second dose and third dose on 11 Nov 2010 and 25 Nov 2010 respectively. Few days after receiving second dose (close temporal relationship to the second dose on 11 Nov 2010), the patient presented with persistent increased heart rate (160 beats/minute). Few days later, he was diagnosed with dilated cardiomyopathy. The seriousness, causality and outcome were not reported.
Case number PHEH2012US009549 is an initial spontaneous report received from a medical assistant on 04 May 2012 with a follow up information received on 16 May 2012: This report refers to a 44-year-old female patient who was a nurse. She accidentally squirted some MENVEO (batch number: M11066) in her eye while administering it to a patient on 04 May 2012. It was reported that any irritation that was present after eye exposure disappeared after irrigation of eye with saline. The outcome of the event was reported as complete recovery. Follow up information received on 16 May 2012: Eye irritation was captured as an event.
dizziness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizziness) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter.
104.4 temp; chills; severe body aches; 1st 48 hours very lethargic, 48 hours later 104.4 temp, severe body aches & chills for 3 days. Tylenol does not help fever.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications was reported as N/A. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced 1st 48 hours very lethargic. On 05Apr2021, 48 hours later,  the patient experienced 104.4 (unspecified units) temperature, severe body aches and chills for 3 days. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the reported events and included treatment with Tylenol which did not help with the fever. The clinical outcome of the events lethargy, body aches and chills was recovering and the outcome of the event fever was not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approximately six hours after injection, a hard swollen and painful knot appeared at the injection site.  The pain was sufficient to disrupt sleep and normal activities. Ibuprofen brought partial relief at 800mg every six to eight hours. Site was not hot or red. The pain resolved to a mere nuisance in approximately 36 hours from start of symptoms. Swelling persists.
Information has been received from a LPN concerning a 42 yr old disabled white female with a erythromycin allergy, who on 08Nov04 was vaccinated IM in the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot649988/0692). On 09Nov04 the pt developed localized swelling, warmth, and erythema, approx 3 inch diameter. The nurse reported that the pt had a viral upper respiratory infection at the time of vaccination. It was also reported that the pt was treated with diphenhydramine hydrochloride (Benadryl), 25-50mg PO every 8 hrs and cefditoren pivoxil (Spectracef), 200mg PO, twice a day for 5 days. The pt recovered on 12Nov04. No additional information is expected.
patient began complaining of signs of double vision, unsturdiness, shortness of breath and tightness of throat. Called 911 still awaiting outcome
Pt recvd 3 doses of Engerix-B & did not respond; 15JAN92 recvd a 4th dose of Engerix-B; 21FEB92 tested pos;
Redness and swelling at the site immediately after giving injection in Left deltoid slowly.  Benedryl 25 mg given, MD ordered Benedryl 50 mg but patient refused 50mg and took 25 mg
extreme sore arm one week following injection. Uncontrollable muscle spasms for a duration of 12 days 2 weeks post injection.
From day2 after injection until today (day15), I have had headache, low fever, muscle and joint pain, extremely uncomfortable/ dry eyes and fatigue, I understood these are common side effects but shouldn?t last for a couple weeks. What I really wanted to share in here is I had heart and nerve issues from the 2nd day to the 6th day (10/12-10/16) after the shot, which impacted me badly. I felt pounding heart, pressure in chest, short of breath, sometimes even I was at rest or in bed. I had to stay home rest for most of that week. I also had edema in my lower legs in addition to the muscle pain, my legs were very weak that I felt I could fall if I use stairs. Numbness, tingling and pain in both arms from elbow to fingers were worse than those in lower legs and feet. From day7 (10/17), the palpation and short of breath improved a lot, that made me feel much better physically and psychologically; I came back to work last Monday. Today is day 14, I have been getting better each day since last week, but I still have edema around ankle area, tightness in chest, numbness and tingling localized to fingers, palms and feet; plus the other whole body symptoms described earlier, I still feel very tired every day. I highly suspected what I have experienced are not only common vaccine side effects but also some adverse events, maybe cardiac and nerve inflammation, that's why I am reporting my case.
pt recvd vax; pt devel mild digestive problems, slight fatigue, slight nausea & arthralgia in left arm distal to inject site;
had a dull pain in my bilateral upper arms since receiving the vaccine; My right arm has significant less strength; had an episode approximately 2 weeks after receiving it where I had severe itching; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "had an episode approximately 2 weeks after receiving it where I had severe itching." (unspecified if ongoing), notes: No rash but had to take Benadryl to be able to sleep. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset Feb2022, outcome "not recovered", described as "My right arm has significant less strength"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "not recovered", described as "had a dull pain in my bilateral upper arms since receiving the vaccine"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "had an episode approximately 2 weeks after receiving it where I had severe itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, asthenia. Therapeutic measures were taken as a result of pruritus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client was vaccinated with Moderna vaccine for Covid on or about April 1 and May 1, 2021.  Developed Covid symptoms (mild) on 8/16.  Tested PCR + on 8/19.   Reported as a breakthrough Covid case in a fully vaccinated person.
Administered ROTATEQ orally before other vaccines - within 1 min of giving oral vaccine, infant mucous membranes of upper and lower lips began to swell - em. blister-like bumps appeared across membranes of upper and lower lips - no difficulty breathing.
I first started with small rash around my breast. A few weeks later on 2.14.21, I noticed a large amount of small rashes all over both my breast. Then a few days after that, I had more rashes around my trunk and inner thighs then went to my under arms, back, legs, top of my feet, thighs  and abdomen. A lot of the rashes are starting to dry out, however I am still getting new ones each day. I had it biopsied by the dermatologist .
Red mark; The spot were the vaccine was injected at is still sore; A spontaneous report was received from a consumer concerning a 49-year old, female patient who received Moderna's COVID-19 vaccine and experienced injection site soreness and a red mark at injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to experience soreness at the site of injection. The spot was sore to touch. One to two days later, the patient reports the appearance of a red mark at the injection site approximately 2.5 inches long and 1 inch wide. No treatment information was provided.   Action taken with mRNA-1273 in response to the events is not applicale.   The outcome of the events, injection site soreness and injection site redness were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After the first dose, my hands and neck broke out with eczema. I did not have eczema until I was vaccinated. The eczema appeared about 1 week after the first dose and got worse after the second.
ON MAY 20, 2021 HE RECEIVED THE FIRST DOSE BY MODERNA LOT NUMBER 036C21A FROM A LOCAL DRUG STORE. ON 8/26/21 HE WAS AT A LOCAL NURSING HOME THAT WE WENT TO AND HE WAS GIVING PFIZER BRAND VACCINE.  THE NURSING SUPERVISOR IS AWARE OF THIS, AND UNDERSTANDS THAT THE SERIES IS COMPLETE.
At 2:37pm upon check out a team member asked the patient if she felt any reaction before she leaves the office, the patient mentioned she felt "off".  She was escorted back to an exam room and Dr. was called in to see the patient.  She complained of feeling lightheaded, cold sweats, lower pulse than usual and itching of the roof of her mouth. Dr. examined the patient and the patient was found to have lip edema.  At 2:44pm Dr. administered one 0.3 mg Epi Pen dose and EMS were called.  The patient was transported by EMS to the emergency room at 2:55pm.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bump showed up 2 centimeters above injection site 3 minutes after injection was given. 4mL of BENADRYL was given and a cold pack was placed over bump and injection site. After 15 minutes of observation, bump has gone down.
Generalized rash From initial information received on 10/27/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 40 year old female patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1267AA, administered in the right deltoid (route not reported) on 10/14/2003 at 01:30 PM. Half a hour later, the patient developed a rash on the right side of her body, leg, arm and face. She was treated with allerga and hydroxyzine 20mg. intra-muscularly. Reportedly, the patient recovered from this event. The reporting facility for this case is the same as for case 2003-02792.
On 4/4/2022 I received my 4th Moderna vaccine, then I tested positive for COVID-19 on 06/06/2022. I have a breakthrough case.
Chills, painful joints (elbows, shoulders, knees, ankles, thumbs, wrists), headache.  Took aspirin at 9 PM and went to bed.  Continued headache, chills and painful joints.
I took patient to receive the 3rd shot of GARDASIL. The person who administered the shot squeezed patient's arm and stuck the needle in her arm and the needle almost went out her arm the other part of her skin. Like she was sewing a piece of fabric.
Nausea the evening of 7/15/2021. Took Nausea Medicine says she has a prescription due to "colon issues"  7/16-7/19 had nausea with intermittent vomiting.  On 7/16/21, patient notices hard knot near injection site on left arm. Approximately 2 inches in length, 1.5-1 inch wide. Patient describes as football shape. Patient developed generalized rash at injection area on 7/17/21 with bruising. Patient reports that later the site become itchy. Called Pharmacy who administered vaccinations, advised to take benadry and tylenol continue to monitor. Advised patient to speak with PCP if injection site reaction does not resolve within 7-10 days after vaccination. Patient already has phone call in to PCP.
Within 5-10 minutes after receiving the dose, I felt chest heaviness but it is mild and not sure if Im just anxious so I just observe myself, it was gone 2-3 hours after. I was also really sleepy that night. Woke up in the morning tired. Still went to work but went home early because was dizzy/lightheaded & felt feverish. I felt better the day after.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (Lot # N010106; expiration date 15-NOV-2018) for prophylaxis (dose and route not reported). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA011937: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627:  US-009507513-1708USA003630:
On 8/13/23, 5 days after vaccine, patient had blurry vision, ringing ears,c old sweat for 10 min.  Was exhausted the rest of the day.
fever 104.7-febrile sz x 2 went to ER;28OCT95 seen in office by primary care peds;MD states no evidence of acute illness today
There was some soreness at the injection site the next day, but that went away.  About 6 days later the injection site became itchy and a rash developed.  There is a little soreness at the site also.  I have been using an over the counter hydrocortisone ointment.
Started 11-9-10 pain, sensation "fleas" on Rt hip. E.M.G, MRI, lumbar puncture. 3/7/11 continues to have problems with coordination.
Ten minutes after Covid vaccine begin to feel "itchy" , lips tingling/itchy; dry heaving, chest pressure.E rythematous rash on face. Evidence of excoriation on neck and upper chest. No shortness of breath  Rapid response team called and transported to ED.  Received epinephrine, Benadryl, Pepcid, Zofran and Solu-Medrol.  Discharged at 8:20 PM home.   E Today she is experiencing: itching all over, lips tingling, legs and arms feel very heavy, weak. Will follow up with her healthcare provider MD @ Hospital.
Initial pregnancy report received from a healthcare professional on 04 September 2013. A 27-year-old female patient had received intramuscular first dose of ADACEL (lot number: U4618AA and expiry date: 23 October 2015) in the right deltoid on 30 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown and the expected date of delivery was reported as an unspecified date in October 2013. The patient had no significant medical history or risk factors (e.g. : alcohol, tobacco or recreational drugs) and her concomitant medications were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
Initial and follow up information has been received from a physician concerning a 72 yr old white, retired, female who on 17Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650370/0740P) into the left deltoid. On 17Aug05 the pt developed pain and swelling at the injection site. Follow up information reported that the pt also developed  and erythematous rash at the injection site. Unspecified medical attention was sought. At the time of the follow up report, the pt had recovered. Additional information is not available.
36 y/o male  shoulder pain. PT received T/D WED, and then on THURS pain started to get worse especially with movement. PT tried  ice w/ little to no relief. PT reports egg like swelling at injection site redness was minimal. PT goal is exam, consult, and treatment plan.
Patient was given the wrong MFG.  first Covid vaccine was Moderna, I gave Pfizer as his 2nd vaccine.  First vaccine (Moderna) 7/14/21, second vaccine (Pfizer) 8/16/21  Pt was informed of error and instructed that this would be counted as his second dose, would not need a second dose of Moderna.  Pt verbalized understanding.
pt came in for flu shot and blood draw in afternoon. several hours later, at dinner, felt lightheaded (had eaten some, drank 1 glass alcohol), got up to go to the bathroom and syncopal event. came to in a chair, witnessed and witnesses had helped her into chair
This case was reported by a consumer via call center representative and described the occurrence of balance disorder in a 75-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site lump and injection site erythema. On 19th January 2018, the patient experienced shivering. On 21st January 2018, the patient experienced balance disorder, dizziness and stumbling. On an unknown date, the outcome of balance disorder, dizziness and stumbling were not recovered/not resolved and the outcome of the injection site swelling, injection site itching, injection site lump and injection site erythema were recovering/resolving and the outcome of the shivering was recovered/resolved. The reporter considered the balance disorder, injection site swelling, injection site itching, dizziness, injection site lump, stumbling, shivering and injection site erythema to be related to SHINGRIX. Additional details were provide as follows: This case was reported by the patient herself. On 18th January 2018 at 10:00, the patient received a dose of SHINGRIX vaccine. The site reactions began almost right away. The reporter described the lump as 4 inches wide and 2 inches thick. It was itchy and very red but these reactions were subsiding. On 19th January 2018, 1 day after receiving SHINGRIX, the patient experienced shivering (began on Friday and lasted about 24 hours). On 21st January 2018, 3 days after receiving SHINGRIX, the patient experienced balance disorder, dizziness and stumbling. The patient did not experience any shivering since then. Then on Sunday morning she woke and felt dizzy and off balance. On the day of reporting, in morning, when the patient woke up, the feeling of being off balance was worse and she was stumbling. The patient had consulted with her doctor. The patient did ask for product information.
Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 14-FEB-2013, had been administered a dose of GARDASIL, lot # 668261/1397AA, expiration date 04-SEP-2013 (dose and route not reported) that was exposed to a temperature of 11 C. No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Arm still very sore; Red spot size of a dollar bill; Warm spot size of a dollar bill; Hard Spot size of a dollar bill; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, erythema, feeling of warmth and induration. On an unknown date, the outcome of the pain in arm, erythema, feeling of warmth and induration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema, feeling of warmth and induration to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received Shingrix shot since one week. The patient reported that arm was still very sore and red warm raised hard spot and the size of a dollar bill had formed. The reporter asked if he/she should concerned or not Follow-up would not possible, as no contact details were available.
received HAVRIX 720ELU/0.5ML Prefilled syringe; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 45-year-old patient who received HAV (Havrix pediatric) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis A with an associated reaction of no adverse event (My initial dose was given by my previous employer).   On an unknown date, the patient received the 2nd dose of Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Age at vaccination was not reported. The patient received first dose of Hepatitis A vaccine from employer. The patient received Pediatric dose of Havrix of 0.5 ml as second dose, which led to inappropriate age at vaccine administration. The patient confirmed the event from pharmacist. The patient was requested for consent to follow up.