chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US003628 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 13-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on 28 DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the data received on 21 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Severe nausea, muscle aches, headache, soreness at shot site, fever, fatigue.
Nurse: Patient received flu and Prevnar 20 vaccine on the 2/16/23 in left deltoid region.  Patient reports she notice a little redness the day after vaccine. Since then the injection site has been getting redder, and hotter, with increase pain within the last 3 days. Site assessed.  Warm to touch. Red patch ~9cm(w)/6cm(h), with pain around injection site.   MD:  O: 3-4cm red, warm, indurated, tender patch on left upper arm    A/P:  - duricef bid x 1 week  - has hydrocortisone cream at home, can also use for burning / itch  - Discussed red flag symptoms, ER/UCC precautions, and return precautions if not improving in 2 days
ACHY JOINTS ALL OVER, HEADACHE IN THE BACK OF THE HEAD, LOW-GRADE FEVER.
vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). On 27-Jan-2021, VOMITING (vomiting) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
varicella - Information has been received from a consumer concerning her 7 year old daughter with an amoxicillin allergy who on 29 Feb 1996 was vaccine vaccinated with one dose of varicella virus vaccine live (site unkown).  On 28 apr 2000 the patient developed a mild case of chickenpox with approximately 30 plus pox on the back, chest, arms, legs, foot and forehead.  She presented to a pediatrician's office that same day and was treated with diphenhydramine HCL (Benadryl). She was uncomfortable on that day, but was playing normally on 29 apr 2000 and 30 apr 2000 she did not attend school on 01 may 2000.  follow up information received from a physician indicated that on 20 apr 2000 the patient developed mild chicken pox with less than 50 vesicular, pruritic lesions.  On an unspecified date, the patient recovered. no further information is expected.
THREE SMALL VESSICULAR LESIONS AT THE VACCINATION SITE, CHARACTERISTIC OF VARICELLA. IN ADDITION A GENERALIZED MACULOPAPULAR RASH LEGS AND FACE, POST AURICULAR LYMPHADENOPATHY AND SMALL OCCIPITAL NODES.  FIRST NOTED AT THE VACCINATION SITE 10 DAYS AFTER VACCINATION, THEN GENERALIZING OVER THE NEXT THREE DAYS. NO FEVER NOTED.  TREATED SUPPORTIVELY AND WITH ISOLATION/CONTAGION PRECAUTIONS. PARENTS TO MONITOR PROGRESS AND CALL IF ANY COMPLICATIONS.
I contracted COVID-19, Bronchitis, and a cold after getting the vaccine. I noticed symptoms initially on November 28, 2022. The symptoms were sneezing and coughing. I did not have any loss of taste. It seemed like cold like symptoms. I was treating the symptoms with TYLENOL. I spoke with my doctor, and he prescribed PAXLOVID on November 30, 2022. Within 24 hours I was feeling better. I felt pretty good. I continued to test positive after 10 days, but I had no symptoms. I have been struggling with bronchitis and the beginning of a cold all in the month of March. I was seen by a doctor on March 08, 2023, and March 09, 2023. I had a chest x-ray and they determined it was viral and not bacterial. I was given 2 medications for cough. One was benzonatate and glycinamide codeine. I did not finish all the medication because I felt it was ineffective. I would use my inhaler when I was coughing and it felt like my throat was closing, I was prescribed prednisone. I continued to cough, and I was wheezing so I utilized the albuterol Inhaler. It's been a long-drawn-out thing. I was told that I could have a dry cough reflex for maybe a month more. In the last 2 weeks I feel I have come down with a secondary illness. In addition to coughing, I had prior, I have developed sneezing and soreness in the glands in my throat. The soreness has gone away.
Bot fatigue and nasal/sinus congestion 2 days post-inoculation; Bot fatigue and nasal/sinus congestion 2 days post-inoculation; Soreness at injection site; This is a spontaneous report from a non-contactable consumer. A 61-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 08Jan2021 at single dose for COVID-19 immunization.  Medical history included allergies: shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included spironolactone (ALDACTONE), dextrin (BENEFIBER), folic acid, atorvastatin (LIPITOR), famotidine (PEPCID), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC), estradiol (VIVELLE). The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration on the left arm on 19Dec2020 for COVID-19 immunization. The patient experienced soreness at injection site on 08Jan2021, bot fatigue and nasal/sinus congestion 2 days post-inoculation on 10Jan2021. The patient was recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I attended a wedding on 06/11/22 out of state. On 06/12/22 I noticed some chest pain while I was walking. The next day I was notified that multiple people at the wedding had tested positive for COVID-19. I had done some at home testing for COVID-19 and those were negative but I was feeling sick with coughing and a runny nose. So I went to a local hospital for a PCR test on 06/15/2022 and I received my positive results the next day. I had a telehealth appointment on 06/17/22 and was prescribed PAXLOVID. After I began the medication, my cough and congestion became much better but I developed headaches and diarrhea that persisted for a week after completing the medication. All of my symptoms improved with the exception of fatigue that lasted until this week. The week of 07/11/22.
Patient had presumed fainting episode post. Blood pressure checked (117/78) pulse 77. once determine glucose was run and ended up 77 after some lemonade. Patient Denied EMS later and signed AMA. Patient stable, with friend at end and was told s/s to re call ems if needed.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Since the excursion on 21-OCT-2015, doses of PNEUMOVAX 23 (lot # K007826, expiration date 03-FEB-2016, dose and route unknown) which were exposed to temperatures outside of the recommended range, had been administered to the patients on unspecified dates in 2015. No adverse experience was reported. This is one of several reports received from the same source. Additional information has been requested.
16AUg94 mom states since last vax pt exp weakness in lt leg; did not have fever or local reactions, but approx 1 wk p/vax devel weakness & difficulty walking on lt leg; took pt to MD who did not feel this was vax related-poss viral inf;
Pt recvd series of 3 hep B vax on 0,1, 6 mo schedule.6 mo dose given 17APR90.Pt did not seroconvert.
not sure if she got the second shot, first over 3years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix in left arm  on 31st January 2019 over 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-May-2022 Reporter's comment: The patient self reported this case. The patient was not sure if she got the second shot of Shingrix. The patient stated she could not found documentation of 2 vaccines. Did not consent to follow-up. Additional Supportive Information: Till the reporting the patient did not receive second of Shingrix, which led to incomplete course of vaccination. Note: Vaers details were added to second dose but it was related to first dose. No permission to follow up was granted, and no confirmation of a second dose was provided, incomplete course of vaccination was conservatively coded.
Extremely enlarged/swollen left lymph node near collarbone. Did not want injection in right arm because I had a nerve conduction test of my right arm/hand scheduled for 09/16/21.
pt had a temp (recorded in ER to be 104.4 p/antipyretic) w/in 36hr p/vax;
Vaccine expired on 9/30/22 and was given to pt. on 10/4/22.  Attempted to reach out to mother to explain that shot would need to be repeated. Unable to reach mother so contact program who alerted us to the vaccine error. They will talk to mother about getting vaccine repeated.
Migraines; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraines) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced MIGRAINE (Migraines). At the time of the report, MIGRAINE (Migraines) had not resolved.            No concomitant product use was reported.  The patient stated that due to the weather patient was having migraines and wanted to know if a migraine medication with codeine would interfere with the vaccine as patient received the bivalent booster on 24-Oct-2022 in the morning.   Reporter did not allow further contact
chills, shaking, headache, neck ache, joint pain, nausea, vomiting
weakness on the right side of the body; she cannot lift her arm; This case was reported by a pharmacist via call center representative and described the occurrence of weakness generalized in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   On 10th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, an unknown time after receiving Shingrix, the patient experienced weakness generalized and mobility decreased. On an unknown date, the outcome of the weakness generalized and mobility decreased were unknown.   It was unknown if the reporter considered the weakness generalized and mobility decreased to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and presented weakness on the right side of the body and could not lift her arm. The reporter stated, it had been 14 days and it still had not resolved.  The reporter consented to follow up.
pt devel a rash over face, arms & chest-rash was getting worse in 2min;epi given rash resolved p/10min;
10 minutes after the patient received the vaccine he experienced severe sharp shooting pain in both of his kidneys as well as his heart and both sides of his body. He also became very dizzy, he could not stand, he was hot, he was experiencing black out spots in his vision and he stated his whole body was tingling.  911 was called and he was taken to the Hospital
Lt bicep erythematous, warm and swollen to touch, painful. Myalgias and arthralgias  Sleepy
This spontaneous report as received from a registered medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the multiple unspecified patients received doses of improperly stored oral, ROTATEQ (dose, route and site of administration were not reported) lot# K013868, expiry date 27-MAY-2016. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Wasn't feeling good due to other reasons; Its past 42days of 1st shot; A spontaneous report was received from  a consumer concerning a 79 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wasn't feeling good due to other reasons and it's past 42 days of 1st shot.  The patient's medical history included chronic obstructive pulmonary disease. Relevant concomitant medications included salbutamol, budesonide, formoterol fumarate and tiotropium bromide.   On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23-Feb-2021, the patient was not feeling good due to other reasons as he has chronic obstructive pulmonary disease (COPD) and was hospitalized. The patient tested negative for COVID-19 on an unknown date.   On 25-Feb-2021, the patient was discharged. No treatment information was provided.  The outcome of the event, it's past 42 days of 1st shot, was resolved.  The outcome of the event, wasn't feeling good due to other reasons, was unknown.; Reporter's Comments: This case concerns a 79-year-old, male patient with a medical history of chronic obstructive pulmonary disease  who experienced unexpected event of past 42 days of 1st shot (inappropriate schedule of vaccine administration) and not feeling good. The event of not feeling good was attributed to the underlying COPD.as such, assessed s unlikely due to vaccine administration. Inappropriate schedule of vaccine administration is assessed as not applicable.
body aches; headache; fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 51, Unit: Unknown) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter's wife received first dose of vaccine yesterday, 27Feb2021 and last night she started having body aches, she still have now body aches and a strong headache and she has a bit of a fever 99.4 (unit unknown).  Patient was experiencing the following symptoms today (28Feb2021): headache, having body aches, fever of 99.4. Reporter would like to know if it is okay for his wife to take Tylenol. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started bleeding and I was very scared because I couldn't get the blood to stop. I had to stand in the bathtub because the blood was so heavy. I passed a bunch of blood clots that were black and I was extremely tired. I had minor cramps and that not normal for me my usual cycle last 3 days and its very light. I had to wear something like a diaper because the blood was so heavy. I had zero energy. I felt hot all the time .It was like a mixture of so many different things at once. I didn't take my temperature but I felt very hot. After two days of nonstop bleeding I went to the ER. Stayed in the ER for a couple of hours all test came back fine. My cycle is now longer and heavier that it was before I took the shot. I also now have bad cramps whenever I have a cycle.
"achy the rest of the day". More severe pain started 10/30/2004. Pain extends from neck to elbow. "it feels like when I had bursitis", continues to be very painful, taking antiinflammatory. Reaction site occurred from influenza vaccine left deltoid.
Patient received a different dosing schedule outside of the prescribing information; This spontaneous report was received from a pharmacist, referring to a 23 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date in October 2014, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On an unknown date in April 2015 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on an unknown date November 2017, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  The pharmacist stated that the patient received a different dosing schedule outside of the prescribing information.
I got this second shot a month ago.  My arm still hurts.  It's not as bad as it was the night I got the shot but I have a constant pain in my left arm.  A constant nagging dull pain.
Reported severe nausea, fatigue, weakness with chills and fever, and joint pain Severe enough she couldn't work, Poor response to NSAIDs. 3 days of hard, edematous, hot to touch, painful injection site. Redness > 110cm to site Grade 3
I was getting my flu vaccine and the vaccine placement seemed high up on my shoulder causing pain at the time of injection and continued soreness, pain at touch. Have had some nerve twinges along back.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 28-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 15-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804112 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: The info number (SEQ18-02667) was added in additional information tab. No new information was received. Hence, no changes were done in the narrative.
Large hives on right upper back, neck and right scalp. Itching in these areas only.
Tingling/numbness and weakness of left arm from biceps to wrist... on and off throughout the day... when the tingling feeling happens my arm gets weak and I cant lift things safely and my hand grip is weaker. the tingling sensation is like "falling asleep" limb.
I waited the extra time to make sure I was fine. 40 min after I was driving, I felt like something was moving under my skin; it went to the neck and up my face. Left head of my head was numb. From right side of my face, both arms, were numbed. I went home. On February 5 went to see the doctor but he did not see anything, so he only gave me B supplements and told me to relax and to get back to him if I did not feel better.
After 2 hours of injection, major soreness in left arm. Little fatigue day of injection. Following day, feeling great.
It was reported that a male patient received a fourth dose of DTaP-Tripedia, first dose of OPV and MMR and the fourth dose of ActHIB vaccines on 12/30/97. Reportedly, on 9/11/99, a nasopharyngeal swab culture was done which was positive for Bordetella Pertussis. Nasopharyngeal swab culture was negative. Nasopharyngeal swab stain was posiitive. Follow up #1 (6/26/02): During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (pharyngeal swab culture positive for Bordetella pertussis).
Patient received 3rd dose of COVID vaccine 4 weeks earlier then recommended. No adverse symptoms  at time of administration.
Tired for six days, fast heart beat one day, arm weakness in same arm of injection few days.
This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced high fever, body aches, dizziness, fatigue and polyuria, all on unspecified date. The outcome of the events was unknown. Information regarding batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2017546610 same reporter, product and event; different patient.
Mother stated the Patient developed Right arm swelling, redness, and itching (started small and progressed) at the injection site on Friday (05/03/2019). Patient also developed warmth "spiked a fever", temp unknown and the Patient did not feel well (went to bed early). Mother applied OTC topical solutions to the Right arm to help with symptoms. Symptoms elevated by Monday (05/06/2019).
Today, I got a phone call from pt's husband about his wife's reaction after getting shingrix vaccine. On day 1(07/28/2020), pt got heart palpitation which is disappeared now. But Pt started to feel headache and red inflamed site reaction from day 2 to upto now. According to pt's husband, pt felt better day by day. He got consulted that pt can take tyrenol for headache and use ice pack for the injection site.
Patient developed diffuse itching following vaccination, presented to the ER 3 hours post vaccine. No airway compromise.
Swollen lymph nodes and pain in the right arm, fever, diarrhea, headache, body aches
Patient was admitted to the hospital Oct. 23, 2021 for COVID-19 related symptoms. This is considered a breakthrough case.
Right after shot left hand went numb still numb following day with cold chills and feeling nauseous