chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 35-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. On 19th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 16th October 2014, less than a day after receiving FLULAVAL, the patient experienced swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache, nasal congestion and chills. On an unknown date, the patient experienced pharmaceutical product complaint. On 21st October 2014, the outcome of the swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache, nasal congestion and chills were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache and nasal congestion to be probably related to FLULAVAL. It was unknown if the reporter considered the chills and pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: The events required a doctor visit (or an emergency room visit). The is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
pink eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE COLOUR CHANGE (pink eye) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE COLOUR CHANGE (pink eye). At the time of the report, EYE COLOUR CHANGE (pink eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medications include high blood pressure medication.  No treatment medications were provided.   This case was linked to MOD-2021-396106 (Patient Link).
Regular moderna vaccine given instead of moderna bivalent. Wrong vial chosen from refrigerator. Patient called and no ADR on 10/27/22
Received 1.0 ml Flu vaccine IM. Usual soreness at injection site for 2-3 days. No complain of unusual adverse symptoms.
high fever 104.6, blacked completely out, transferred from ER to another hosp;18APR97 adm;discharged 21APR97;readmit 22APR97 for flu sx;will have f/u EEG 15MAY97;
swelling, warmth, severe pain @ site of inj;also exp diffuse arthralgias/myalgias;
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 10 years (age at vaccination was five years) old female patient who was vaccinated with ADACEL. This is actual medication error case due to Inappropriate age at vaccine administration. It was an actual medication error due to drug administered to patient of inappropriate age. (patient received ADACEL at age 5). On 03-Jul-2012, the patient received a dose of ADACEL (batch number, expiration date, dose, route and site of administration was not reported). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Left 15 minutes after vaccine. Heart rate increased to 130 and I needed to sit down outside. Heart rate sustained 120 for about an hour and then dropped to 100 before decreasing back down to a normal baseline. Did not report experience to Kaiser because I didn?t know why my heart rate was so rapid.
The patient was given undiluted Pediatric Pfizer. Normally the pediatric Pfizer has to be diluted with 1.3 ml saline. But the pharmacist did not dilute and gave to patient.
04/08/2021 I waited half house, got fatigue, so tired, could barely lift arms, could barely walk, went on for months, still going on. Thyroid issue may be result of this. Mental Fogginess, shaking all over. Called Doctor two weeks later, because I was still going through it. I taking sam-E 400mg and colostrum for immune system transfer factor plasmyc
swollen arm, red blotchy itchy.  Felt ill for 24 hours approx.
PATIENT WAS ADVISED TO WAIT FOR 15 MINUTES. THE PATIENT AFTER LEAVING THE PHARMACY FELL ON THE GROUND REPORTED BY ANOTHER PERSON WHO CAME TO THE PHARMACY. HE SAID HE GOT DIZZY AND FELL AND SUFFERED A WOUND ON HIS HEAD. PARAMEDICS CAME AND THE BLOOD PRESSURE WAS FOUND TO BE LOW. PATIENT WAS BROUGHT TO THE HOSPITAL
Pt had a possible seizure the following morning post vax.  Duration of 5 - 10 seconds.
second vaccine on 03-14-2021 I had a headache and diarrhea with body aches for about a week . I almost didnt get my booster but when I found out it was half dose figured I would do better .. After I got my booster on 12-27-2021  I started with a headache and dizziness about one hour later. That nite I started with chills and sweating and a fever of 101 . Worse headache of my life . legs felts like heavy weights and could hardly walk. hurt all over . threw up on the third day . Diarrhea also started on the third day.  This continued for about 5 days after which I started feeling better and no fever but a headache and Diarrhea continued on for a couple more days. Headache was horrible . Couldnt move my head a inch or 2 without pain shooting thru.. Hurt all ever but around the eyes really bad.. Affected vision also .  I saw my family dr on Jan 3 2022 and told her about it and she said I should not get any more covid vaccines .
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (used a vial first punctured yesterday on Aug 26, 2021 at 8:28 am) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 27, 2021, patient administered expired product (used a vial first punctured yesterday on Aug 26, 2021 at 8:28 am). On Aug 27, 2021, administered expired product (used a vial first punctured yesterday on Aug 26, 2021 at 8:28 am): resolved. The reporter did not provide any causality assessments, concomitant product use or treatment information.
Employee reports sensation of significant warmth/heat that comes in waves.  Vital signs checked:  10:35- 144/95 1045- 137/89 1049- 123/90  Episodes of warmth would come in waves. Symptoms would resolve and then return. Improved after 35 minutes of observation
Her left arm is still hurting; She could not even raise her left arm up without it hurting her; her shoulder swell up like a big knot in it/ got a big knot at the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) (at the age of 62 years old), dose 2 via an unspecified route of administration, administered in arm left on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0162), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid-19 Vaccine on 05May2021 in her left arm. Her left arm was still hurting. It felt like she was getting a shot into it all over again. She needed to take Tylenol and Ibuprofen to stop the pain, but she did not want to do that forever. It was her second vaccine, and it made her shoulder swell up like a big knot in it. That took six weeks to go away. She could not even raise her left arm up without it hurting her. Her doctor did a Magnetic Resonance Imaging (MRI) on her arm, but she could not finish the test because she felt like she was in a casket. The outcome of the events Her left arm is still hurting was not recovered, her shoulder swell up like a big knot in it/ got a big knot at the injection site was recovered on an unknown date and She could not even raise her left arm up without it hurting her was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
high blood pressure , dizziness , blurred vision , nausea  saw doctor , was in hospital  4/15-contacted the patient , patient  has been feeing much better for some time , no issues now
Significant swelling to right thigh.  Swelling was from the groin to below the knee.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 18-AUG-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Covid vaccination series completed on 3/1/2021; resident tested positive for COVID 19 on 5/5/2021.
Copied from Clinic Progress Note dated 2/5/2021:  "Last seen in our clinic 1/28/21 with progressive joint stiffness, arthralgia and "burning of hands" starting a few hours after she received the COVID vaccine on 1/14/21. Unclear etiology. Labs including CCP, rheumatoid factor, SLE panel, SSE Ro and ENA all returned unremarkable. Rx protonix for increased ibuprofen use, Celebrex and prednisone (short burst) and advised to follow up in 5 days.   Pt was seen 2/2/21 in the ED for myalgias, fatigue, progressive paresthesias in hands intermittently x 2 weeks. EDP discussed with neuro who recommended CT/CTA, MRI, LP which all returned unremarkable. CBC, CMP, ESR, CRP, TSH, CK, and multiple sclerosis labs all returned unremarkable. No focal deficits on exam but did have positive Phalen's and Tinel's. Discharged home with R wrist splint and Rx Neurontin BID for neuropathy.    Has scheduled follow up with PCP on 2/10/21, but today is requesting a excuse from work note. She works as a CNA. Has not worked in 3 weeks. Right hand goes numb and she drops things. Requesting light duty work note for at least next week.    Gabapentin 300 bid started from ER. She reports much improvement in all over body pain, but does make her feel she has a flat affect when she takes it during the day."
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 100 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from same source. Additional information is not expected.
Within two weeks of receiving the vaccination site experienced running nose, cough, fever and later refusal of meals and not playing time course span over 2 months and received treatment for bronchitis, pneumonia and cough variant asthma.
4/11 Hives on both arms and both thighs 4/13 Hives on left arm and buttocks
103 fever, severe body aches, headache, nausea, weakness in hands, could not open a pill bottle or hold a glass of water.   ?Sinking spells? continue several times per day (sudden body aches, weakness)  to  day four (day of reporting)
Information has been received from a certified MA concerning a 4 year old white male with no known allergies or medical history and in "good health" who on 12/18/00 was vaccinated with a first dose of varicella virus vaccine live. Concomitant vaccinations on the same day included a first dose of MMRII, a third dose of HIB conj vaccine (manufacturer unknown), a first dose of Streptococcus pneumoniae vaccine (Prevnar), a third dose of DTP and a third dose of IPV.  There was no illness at the time of vaccination. The reporter indicated that the child had chickenpox two years after vaccination. On 05/16/03 the pt was seen at the practice with an unspecified number of lesions at varying stages and no fever. Varicella disease was confirmed. Supportive care was recommended. It was also noted that treatment was required. Subsequently, the pt recovered. The reporter also indicated that the vaccine was administered at another practice. It was noted that the pt was a foster child and was with different parents at the time of vaccination. A product quality complaint was not involved. No further information is expected.
No adverse effects.; A patient was administered improperly stored PROQUAD.; This spontaneous report was received from a Medical Assistant referring to a 4 year old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 30-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) with lot # S009759 and expiration date 27-SEP-2020 (strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The sterile diluent(MERCK STERILE DILUENT) that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD)  was properly stored.   The administered dose of the vaccines experienced the temperature excursion of 15°F to 46°F (17.6 °F) degrees Fahrenheit  for 56 hours and 40 minutes and a previous excursion of 6 °F to 14°F (6.2 °F) degrees Fahrenheit  for 10 minutes  There was no digital data logger invloved,and no adverse effects reported.
This spontaneous report as received from nurse practitioner (as informed by the mother of an unspecified patient) refers to a male patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (lot#, route of administration, dosage were not reported). No concomitant medication was reported. On an unknown date, the patient experienced a severe headache, a migraine after receiving the second dose of GARDASIL. The patient sought medical attention. The patient was seen in the emergency room. The headache lasted for one week and the patient was unable to attend school. It was also reported by the physician that the headache was severe. On an unspecified date, headache was resolved and the outcome of migraine was unknown. The event severe headache was considered serious as it had caused disability (patient was unable to attend school). Additional information has been requested.
I got home and immediately felt awful. I felt so bad that even though the roof was being done over my head and the workers were banging above me, I went right to sleep.  I was back to sleeping for long periods of time. This lasted 2 1/2 weeks. I took Tylenol which helped some.  I also had a sore arm.  After the 2 1/2 weeks, my symptoms went away.
CLIENT RECEIVED MMR ON 7/17/2006.  REPORTED SHE GOT SICK ON FIRST DAY AND REMAINS SICK 7/20/2006.C/O HAVING FEVER OF 100 FOR A FEW DAYS. WNE TO SEE MD 7/20/2006 AND MD SENT HER TO HD. AWOKE THIS A.M WITH RED RASH ALL OVER HER BODY. CLINIC NURSE OBSERVED RED RASH ON ARMS, LEGS, UPPER TORSO, BACK, FACE WITH REDNESS AND ITCHING.  TEMP 98.2.; CALL BY CENTRAL OFFICE NURSE ON 7/24 @ 3:23 P.M.CLIENT  STATES RASH STILL PRESENT.  PLANS TO RETURN 07/25/2006.
Patient experienced a vasovagal episode with syncope, paramedics called and fluids administered via IV, transported to ER via ambulance and later released to home.
Headache, feverish, fatigued, sore muscles,no desire to eat or drink
Immune response, COVID-19 pneumonia. Patient told the pharmacist giving vaccine he was not feeling well. They did not test him for COVID and gave vaccine anyway. It is unknown if he officially had COVID-19, but he became sick almost immediately after getting the vaccine. Taken to hospital by ambulance on 08/06/2021, put on a ventilator on 08/13/2021 and died on 08/31/2021.
Pfizer 4/21/21 and 5/12/21. Positive on 1/27/22
severe shaking and chills for abut 2.5 hours extreme pain at injection site for 36 hours swollen glands both in upper arm and underarm on injected arm. extreme fatigue for 36 hours
Following the yellow fever vaccine, the pt experienced pain in the vaccinated arm from underarm to the wrist. No redness, fever, or swelling. Did not see MD for this. On 1/5/01 reports the arm feels about the same, maybe slightly better. Still has not followed up with MD.
SWOLLEN TOP LIPS; SORENESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (SWOLLEN TOP LIPS) and INJECTION SITE PAIN (SORENESS AT INJECTION SITE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LIP SWELLING (SWOLLEN TOP LIPS) and INJECTION SITE PAIN (SORENESS AT INJECTION SITE). At the time of the report, LIP SWELLING (SWOLLEN TOP LIPS) and INJECTION SITE PAIN (SORENESS AT INJECTION SITE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  Treatment information was not provided.
This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck) PROQUAD lot # N022973 with expiration date of 19-FEB-2019, by subcutaneous route (strength, dose, and anatomical location) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature range between -14°C to -10°C (-13.7°C) during a time frame of 30 minutes which was called by a data logger. No previous temperature excursions were reported. Sender's Comments: US-009507513-1805USA006861.
I have pain at the injection site, tiredness,  muscle pain, chills, joint pain, and fever.
pt recv vax OCT95 & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;
No adverse event; A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022 at 11:00 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Aug-2022 at 11:00 AM, the patient experienced WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose).    No concomitant medications were reported.  The vial/syringe was stored at room temperature for up to 3 hours. No reactions or follow-up documented from receiving the wrong dose.  Treatment information was not provided.
After my 4th vaccine I had noticed my leg would quiver when I was doing physical therapy. I spoke with my neurologist and they stated it may be due to an old injury. I noticed my hand would tremor as well when trying to drink water or coffee, and my neurologist notated that my head was also showing signs of tremors. After dinner in July, my smart watch had alerted me that my heart rate was over 120. I started to then feel a stiff arm and chest pain. I went to the emergency room and they had diagnosed me with a sinus ventral tachycardia. Now I feel fine except the episode has given me anxiety.
Information has been received from a physician concerning a 21 year old female with Raynaud's syndrome and hypertension who on 26-FEB-2009, at 9:40 AM, was vaccinated with the second 0.5ml dose of GARDASIL. Concomitant therapy included DIFLUCAN, ALLEGRA, albuterol, hypertension medications and an unspecified beta-blocker. On 26-FEB-2009, at 16:00 at work, the patient felt tingling of her lips. The patient went to bed and had "terrible sleep" that night. On 27-FEB-2009 the patient woke up with periorbital redness, swollen lips, swollen nose ("like Bozo the clown"), shortness of breath and chest pain. The patient also had a periorbital itching. The physician instructed the patient to take BENADRYL. At the time of this report, the patient's adverse events improved, the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
PATIENT FAINTED AND HAD SLIGHT LEFT ARM/LEG TWITCHING 5 MINUTES AFTER ADMINISTERING VACCINE